Baxter Healthcare Corporation August 30, 2022

Dhiraj Bizzul
Sr. Manager, Regulatory Affairs
One Baxter Parkway
Deerfield, Illinois 60015

Re: K211125
Trade/Device Name: Novum IQ Syringe Pump
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion pump
Regulatory Class: Class II
Product Code: FRN, LZH
Dated: May 18, 2022
Received: June 1, 2022

Dear Dhiraj Bizzul:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.05.00
Silver Spring, MD 20993
www.fda.gov
K211125 - Dhiraj Bizzul Page 2

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias -S
Courtney H. Lias, Ph.D.
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

TBD

Device Name
Novum IQ Syringe Pump

Indications for Use (Describe)

The Novum IQ Syringe Pump is intended to be used for the controlled administration of fluids. These include
pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition.

The Novum IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of
administration: intravenous, arterial, enteral and subcutaneous.

The Novum IQ Syringe Pump is intended to be used in conjunction with legally marketed and compatible administration
sets, syringes, and medications provided by the user.

The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ Syringe Pump is intended for use on adults, pediatrics and neonates.

The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction through guided programming,
including a way to automate the programming of infusion parameters and documentation of infusion therapies when
integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of
programming errors.

The Novum IQ Syringe Pump is intended to be used by trained healthcare professionals.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(k) Summary

Date: August 25, 2022

Owner:

Baxter Healthcare Corporation

One Baxter Parkway
Deerfield, IL 60015

Contact Person:

Dhiraj Bizzul
Sr. Manager, Global Regulatory Affairs
35212 W. Illinois Route 120
Round Lake, IL 60073
Telephone: (847) 909-6828
Fax: (224) 270-4119

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Novum IQ Syringe Pump

Classification Panel: 80 General Hospital
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: II
Product Code: FRN, LZH

Table 1. Catalogue Code for Novum IQ Syringe Pump

Code Number Name
40800BAXUS Novum IQ Syringe Pump

PREDICATE DEVICE:

The Novum IQ Syringe Pump is substantially equivalent to the following predicate

device:
 Table 2. Predicate Device
Device Company Predicate 510(k) Clearance Date
Medfusion Model 4000 Smith’s Medical, MD K111386 August 29, 2011
Syringe Pump INC.

DESCRIPTION OF THE DEVICE:

The Novum IQ Syringe Pump is a general purpose, syringe-based, smart pump within the
Novum IQ infusion platform. The Novum IQ syringe pump offers various programmable
delivery modes to address specific patient care needs. The delivery modes available to
support the patient are determined by how the Novum IQ Syringe Pump and its
associated drug library are configured. The Novum IQ syringe pump is capable of
delivering fluids in syringes ranging in size from 1 mL – 60 mL.

The Novum IQ Syringe Pump is a system that provides delivery of fluids into a patient in
a controlled manner, as identified in 21 CFR 880.5725. The system includes a software
controlled, electromechanical syringe pump used for the controlled administration of
fluids including pharmaceutical drugs, parenteral nutrition, blood and blood products, and
enteral nutrition through compatible syringes and administration sets at user selectable
rates and volumes.

The Novum IQ Syringe Pump is intended to be used for the controlled administration of
fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood
products, and enteral nutrition. The Novum IQ Syringe Pump is intended to deliver an
infusion through the following clinically accepted routes of administration: intravenous,
arterial, enteral, and subcutaneous. The Novum IQ Syringe Pump is intended to be used
in conjunction with legally marketed and compatible administration sets, syringes, and
medications provided by the user.

The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient
health care facilities. The Novum IQ Syringe Pump is intended for use on adults,
pediatrics, and neonates.

The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction
through guided programming, including a way to automate the programming of infusion
parameters and documentation of infusion therapies when integrated with an Electronic
Medical Record (EMR) system. This automation is intended to aid in the reduction of
programming errors. The Novum IQ Syringe Pump is intended to be used by trained
healthcare professionals.

The feedback-controlled, motorized pumping mechanism of the Novum IQ Syringe

Pump is a stepper motor acting with a lead screw to depress the plunger of a syringe. The
syringe pump accepts a horizontally loaded syringe, held in place by a barrel clamp. The
outer diameter of the loaded syringe is sensed, and compared against a stored look-up
table to enable user assisted identification of the loaded syringe.

The Novum IQ Syringe Pump is designed to detect and react to situations that could
impact patient safety. When a situation that could impact patient safety is detected, the
syringe infusion pump will notify the clinician with a visual alert and an audible alarm
tone.

The Novum IQ Syringe Pump is designed to operate on AC power with an internally

mounted rechargeable battery pack to facilitate the continuation of therapy during patient
transport or AC power loss.

INDICATIONS FOR USE:

The Novum IQ Syringe Pump is intended to be used for the controlled administration of
fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood
products, and enteral nutrition. The Novum IQ Syringe Pump is intended to deliver an
infusion through the following clinically accepted routes of administration: intravenous,
arterial, enteral, and subcutaneous. The Novum IQ Syringe Pump is intended to be used
in conjunction with legally marketed and compatible administration sets, syringes, and
medications provided by the user.

The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient
health care facilities. The Novum IQ Syringe Pump is intended for use on adults,
pediatrics and neonates.

The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction
through guided programming, including a way to automate the programming of infusion
parameters and documentation of infusion therapies when integrated with an Electronic
Medical Record (EMR) system. This automation is intended to aid in the reduction of
programming errors. The Novum IQ Syringe Pump is intended to be used by trained
healthcare professionals.
DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE:

Table 3. Comparison of Indications for Use

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences
Indications for Use
Indications for Use The Novum IQ Syringe Pump is The Medfusion Model 4000 Syringe Lipids are types of nutritional fluids and
(see below for full list of intended to be used for the Infusion Pump is indicated for the antibiotics are types of pharmaceutical
indications for use) controlled administration of fluids. follow uses: In the administration of drugs. These differences do not raise
These include pharmaceutical drugs, fluids requiring precisely controlled different questions of safety and
parenteral nutrition, blood and blood infusion rates including blood or blood effectiveness.
products, and enteral nutrition. products, lipids, drugs, antibiotics,
enteral solutions, and other therapeutic
fluids.
Routes of The Novum IQ Syringe Pump is By following delivery routes: arterial, The intended use of the device is the
Administration intended to deliver an infusion epidural, intravenous, intrathecal, same as the predicate. The absence of one
through the following clinically subcutaneous and enteral. route of administration in the subject
accepted routes of administration: device does not raise new questions of
intravenous, arterial, enteral and safety and effectiveness.
subcutaneous.
Syringe Usage The Novum IQ Syringe Pump is Not specified as part of indication for Although not specified, Medfusion Model
intended to be used in conjunction use 4000 syringe infusion pump is to be used
with legally marketed and with legally marketed and compatible
compatible administration sets, administration sets, syringes and
syringes, and medications provided medications as defined in the predicate
by the user. operator’s manual.
 Table 3. Comparison of Indications for Use
Characteristic Subject Device Predicate Device (K111386) Discussion of Differences
Use The Novum IQ Syringe Pump is In critical care, anesthesia, neonatal and The clinical care areas for the predicate
Environment/Treatment suitable for patient care in hospitals pediatric applications or other healthcare device are all found within hospitals and
Population and outpatient health care facilities. settings where the use of the syringe outpatient health care facilities. These
infusion pump can be monitored or differences do not raise different
supervised by a clinician. questions of safety and effectiveness.
The Novum IQ Syringe Pump is
intended for use on adults, pediatrics
and neonates.
Other indications for The Novum IQ Syringe Pump is By following delivery modes: Both devices provide guided
Use intended to aid in the reduction of continuous, volume/time, mass, body programming workflows and transfer
operator interaction through guided weight, custom dilution, intermittent and infusion information and configured drug
programming, including a way to bolus. libraries using established bidirectional
automate the programming of communication protocols. The subject
infusion parameters and device also utilizes auto-programming
documentation of infusion therapies and auto-documentation features to
when integrated with an Electronic transfer information to/from an EMR
Medical Record (EMR) system. This using wireless technology. Although the
automation is intended to aid in the subject device’s indications do not list
reduction of programming errors. specific delivery modes, the subject
device supports the same delivery modes
as the predicate. The differences do not
The Novum IQ Syringe Pump is
raise different issues of safety and
intended to be used by trained
effectiveness.
healthcare professionals.
 Table 4. Comparison of Design Attributes
Characteristic Subject Device Predicate Device (K111386) Discussion of Differences
Design Attributes
Pumping Mechanism Stepper Motor Driving Leadscrew Same as subject device N/A
Modes of Delivery Continuous, Intermittent Same as subject device N/A
Microprocessors Multiple processors Dual Processor The difference in allocated functions for the
subject device is based on a Hardware safety
feature to initiate corrective action and/or safe
states.
Fluid Ingress Protection IPX2 IPX3 Difference in IPX2 and IPX3 does not have a
significant impact based on the use environment
indicated for the devices and do not raise different
questions of safety and effectiveness.
User Interface Display LCD display with adjustable backlit Same Displays provide pump operating and status
capability. information. Differences do not raise different
questions of safety and effectiveness.
External Interfaces USB 2.0, Type-A receptacle Ethernet Both provide a means of transferring data,
differences do not raise different questions of
safety and effectiveness.
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Features/Functions and Performance Specifications
AC Power Input: 100-240 V~, 50-60 Hz, 0.5A (0.5A- Input: 100-240 VAC 50/60Hz The differences in power ratings do
0.35 A) Output: Not Known not raise different questions of safety
Output: 16 VDC/1.25 A, short circuit and effectiveness.
protected
Battery Smart Battery Pack Rechargeable Lithium ion The pump is able to operate
independent from AC power during
- Lithium Ion (internal battery unit), 10.8 transport situations or interruptions of
10 hrs at 5 mL/hr with 60 mL syringe
VDC nominal the voltage supply. Differences do not
Charge time: 10 hrs raise different questions of safety and
-Maximum 16 hour recharge time at 23 ±2o C
(73.4 ±3.6o F)* effectiveness.
-Battery capacity for a new fully charged
Smart Battery Pack, at the medium backlight
setting and wireless enabled use is as follows:

Flow Rate (mL/hr) Capacity (hrs)

10 ≥8
1200 ≥6

Alarms Per IEC 60601-1-8 Not known The subject device is designed
according to current FDA recognized
standards. Both the subject and
predicate devices have similar alarms
and alarm priorities, as such, any
difference in alarm setting to the
predicate do not raise different
questions of the safety and
effectiveness.
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Logging Yes Same as subject device N/A
Capability
Bolus Yes Same as subject device N/A
Capability
Bolus Volume ±10% under most conditions Information not publicly available Differences do not raise different
Accuracy questions of safety and effectiveness.

Detailed bolus accuracy disclosed in

the labeling.
Syringe size 1 – 60 mL Same as subject device N/A
Flow Rate 0.01- 1200 mL/hr 0.01 – 1130 mL/hr Equivalent resolution over the flow
range rate range. Both the subject and
(mL/hr) predicate devices have implemented
Minimum programable and minimum
recommended flowrates.
The subject device has implemented
equivalent minimum programmable
flow rate as the predicate and
established higher minimum
recommended flow rate as compared
to the predicate.
These differences do not raise
different questions of safety and
effectiveness.
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Flow Rate For most of the Compatible Syringes: Information not publicly available Differences do not raise different
accuracy ±5% under most conditions questions of safety and effectiveness.
Detailed flow rate accuracy disclosed
in the labeling.
Certain syringes:
-10% to +5% under most conditions

Drug Library Number of Care Areas: 32 Number of Care Areas: 16 While the devices have different
Capacity capacity, both allow for user defined
Number of Drugs: 5000 Number of Drugs: 4608 differentiation. This difference does
Number of Clinical Advisories: 800 Number of Clinical Advisories (Drug Alerts): not raise different questions of safety
Information Not Known and effectiveness.
Number of Modifiers: 1000
Number of Modifiers: N/A
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Keep Vein Range 0.01 – 5 mL/hr based on the drug in the Range 0 – 9.9 mL/hr KVO can be enabled in the drug
Open (KVO) drug library library or configured at the pump and
Rate will deliver at the KVO rate at the end
of an infusion for both the predicate
. and subject device. The rate range for
KVO is intended to differentiate the
KVO rate from the infusion rate to
maintain site patency. The different
range does not raise different
questions of safety and effectiveness.
Restrictions regarding maximum
KVO flow rate per syringe size is
provided as an additional safety
mitigation.

Occlusion User selectable downstream occlusion Same as subject device N/A

Pressure
pressure settings.
Setting
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Dose Modes Continuous Delivery Modes: Continuous The subject device also provides
mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr, mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr, continuous and intermittent infusions.
mg/kg/hr, mg/min, mg/kg/min, mg/kg/day, mg/kg/hr, mg/min, mg/kg/min, mg/kg/day Differences do not raise different
mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min, questions of safety and effectiveness.
mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min,
mcg/kg/day, ng/min, ng/kg/min, Units/hr, mcg/kg/day, ng/min, ng/kg/min, Units/hr,
Units/kg/hr, Units/min, Units/kg/min, Units/kg/hr, Units/min, Units/kg/min,
mUnits/min, mUnits/kg/hr, mUnits/kg/min, MillionUnits/day, mUnits/min, mUnits/kg/hr,
mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr,
MillionUnits/day mmol/kg/hr
Amount / Time
Intermittent Delivery Modes: Non-weight-based:
mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2, mg, Units, g, mcg, mEq, mmol, MillionUnits
mcg, mcg/kg, mcg/m2, Units, Units/kg,
Weight based:
Units/m2, mEq, mEq/kg, mmol, mmol/kg,
MillionUnits, MillionUnits/kg, mL/kg, mg/kg, Units/kg, g/kg, mcg/kg,
MillionUnits/m2 mEq/kg, mmol/kg, MillionUnits/kg
BSA based:
mg/m2, Units/m2 , g/m2, mcg/m2,
MillionUnits/m2
Volume / Time
Total Volume / Total Time
Rate or Dose 0.01 – 1200 mL/hr (depending on syringe size 0.01 mL/hr to 1130 mL/hr in increments of Equivalent resolution over the flow
Limits and rate). 0.01 or 0.1 mL/hr (depending on syringe size range. Differences do not raise
and rate). different issues of safety and
effectiveness.
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Operational Operating temperature: Temperature: 5° to 40° C (40° to 104° F) Functional and performance tests
Conditions 50 to 104°F (10 to 40° C), 10 to 95% relative Relative Humidity: 20 to 95% non-condensing support the operational conditions for
humidity non-condensing. Ambient Pressure: 70 kPa to 106 kPa (10.2 psia the subject device. These differences
to 15.4 psia) do not raise different questions of
Atmospheric Pressure: 70 kPa to 102 kPa
safety and effectiveness.

Storage Storage temperature: Store at controlled room temperature 15° to Functional and performance tests
Temperature 14 to 120°F (-10 to 49°C), 10 to 95% relative 30°C (59° to 86°F). support the storage conditions for the
humidity non-condensing subject device. These differences do
not raise different questions of safety
and effectiveness.
Approximate 102mm H x 240mm W x 161mm D 160x270x145 mm Human Factors studies support the
Size physical dimensions and Form Factor
for the subject device. These
differences do not raise different
questions of safety and effectiveness.
Approximate 2.8 kg (6.2lb) 4.5 lb Human Factors studies support the
Weight weight of the subject device. This
difference does not raise different
questions of safety and effectiveness.
Auto- Yes No The subject device allows automated
programming population of infusion delivery
information from an EMR in addition
to manually programming infusions
through the pump interface.
Automated data transfer using
establish protocols does not raise
different questions of safety and
effectiveness as infusion programming
is confirmed by the clinician prior to
starting an infusion.
 Table 5. Comparison of Features/Functions and Performance Specifications

Characteristic Subject Device Predicate Device (K111386) Discussion of Differences

Wireless Yes Same as subject device N/A
DISCUSSION OF NON-CLINICAL TESTS
Non-Clinical testing of the Novum IQ Syringe Pump has been performed against
requirements for performance, physical attributes, environmental conditions and safety,
and to provide objective evidence that the device’s intended use is met.

As recommended by FDA guidance, “Infusion Pumps Total Product Life Cycle” issued
December 2, 2014, Baxter has developed a Safety Assurance Case (SAC) to demonstrate
that hazardous situations resulting from the design, intended use, and reasonably
foreseeable misuse of the device have been appropriately mitigated.

The stated goal of the safety assurance case is to document that the design of the Novum
IQ Syringe Pump is adequately safe for its intended use. The assurance case defined the
device system, including the indications for use, patient populations, use environments,
and system specifications. The supporting assurance arguments confirmed that:

• potential risks have been mitigated and the residual risk is acceptable,
• design verification and validation of the device is acceptable,
• device reliability is acceptable,
• the device meets clinically valid essential performance.

Performance testing of the Novum IQ Syringe Pump was verified against requirements
for performance, physical attributes, environmental conditions, safety, and to provide
objective evidence that the device intended use is met.

• Validation demonstrated that design inputs and user needs were met. Verification
involves testing of both subsystem and system level requirements against pre-
defined and approved protocols containing validated test methods and established
acceptance criteria. System verification including software verification
demonstrated that design outputs meet design input requirements, connectivity
requirements, interface requirements and cyber security requirements. System
verification also includes testing of interfaces with other devices or accessories
that are intended to be used with the system.
• Cleaning and Disinfection validation was performed according to FDA Guidance
Reprocessing Medical Devices in Health Care Settings: Validation Methods and
Labeling issued March 17, 2015.
 • Wireless functionality was implemented according to FDA Guidance Radio
Frequency Wireless Technology in Medical Devices, issued August 14, 2013.
• Software verification and validation was performed according to Guidance for the
Content of Premarket Submission for Software Contained in Medical Devices,
issued May 11, 2005 and Infusion Pumps Total Life Cycle, issued December 2,
2014. The software is considered a major level of concern. Software testing
included code review, static analysis, unit testing, integration testing, and
regression testing.
• Cybersecurity verification and information was performed and provided
according to FDA’s Guidance for Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices, issued October 18, 2018, and
FDA’s draft Guidance Postmarket Management of Cybersecurity in Medical
Devices, issued December 28th 2016.
• Interoperability was assessed and testing in accordance with FDA’s Guidance on
Design Considerations and Pre-Market Submission Recommendations for
Interoperable Medical Device, issued September 6, 2017.

Electrical safety, EMC and essential performance testing was successfully completed
according to the following standards and associated methods:

• IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirement for

Basic Safety and Essential Performance
• IEC 60601-2-24 Medical equipment – Part 2-24: Particular requirements for the
basic safety and essential performance of infusion pumps and controllers
• IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard: Electromagnetic
Compatibility Requirements and Tests
• IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for
alarm systems in medical electrical equipment and medical electrical systems.
• AIM 7351731 rev 2: 2017, Medical Electrical Equipment and System
Electromagnetic Immunity Test for Exposure to Radio Frequency Identification
Readers.
 • IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline
or other non-acid electrolytes - Safety requirements for portable sealed secondary
cells, and for batteries made from them, for use in portable applications - Part 2:
Lithium systems
• UL 2054 2nd Edition Household and Commercial Batteries
• UL 1642 5th Edition Lithium Batteries
In addition to the above, and in consideration of IEC 62366-1ed. 1.0 b:2015, Medical
devices – Part 1: Application of usability engineering to medical devices as well as FDA
guidance, “Applying Human Factors and Usability Engineering to Medical Devices”
issued February 3, 2016, Baxter conducted Human Factors evaluations in a simulated
environment. The human factors study was conducted with the intended user population,
use environment and use scenarios to simulate clinical conditions. Results of human
factors studies show the device is suitable for its intended use.

DISCUSSION OF CLINICAL TESTS:

No clinical testing was performed in support of this premarket notification.

CONCLUSION:

The Novum IQ Syringe Pump has been verified and validated against design input
requirements, user needs, and intended uses. The subject device is substantially
equivalent to the predicate device.
'