November 1, 2017

GE Medical Systems (China) Co., Ltd.

℅ Mr. Robert Casarsa
Regulatory Affairs Leader
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, Wisconsin 53223

Re: K171580
Trade/Device Name: Monitor B125/B105
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm)
Regulatory Class: Class II
Product Code: MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSB, DSK, GWQ, FLL,
NHO, NHP, NHQ
Dated: May 30, 2017
Received: May 31, 2017

Dear Mr. Robert Casarsa:

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. 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
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.01.96
Silver Spring, MD 20993
www.fda.gov
Page 2 – Robert Casarsa K171580

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the
Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-
7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of
Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its
Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,
y,

or
for
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
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: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K171580

Device Name
Monitor B125/B105

Indications for Use (Describe)

The Monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, recording, and to generate alarms
for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during
intra-hospital transport.
The Monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.
The Monitor B125/B105 is not intended for use during MRI.
The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.
The Monitor B125/B105 monitors and displays : ECG (including ST segment, arrhythmia detection, ECG Diagnostic
Analysis and Measurement,), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure
(systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous
monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a
reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/
Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, CO2.

The Monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia,
VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, “R on
T”, Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Multifocal PVCs, Missing Beat, Premature Ventricular
Contraction (PVC) and Ventricular fibrillation.

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:
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Office of Chief Information Officer
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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 K171580
Page 1 of 7
510k Summary
K171580

I. SUBMITTER
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
No. 19 Changjiang road National Hi-Tech Dev. Zone
Wuxi, Jiangsu, China 214028
Sun YanLi
Regulatory Affairs Leader

Primary Contact Person:

Robert Casarsa
Regulatory Affairs Leader
GE Medical Systems Information Technologies, Inc.
Telephone: 414-362-3063
Fax at 414-362-2585
E-mail: [email protected]

Secondary Contact Person:

Douglas Kentz
Regulatory Affairs Director
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, Wisconsin 53223
Phone: 414 362-2038
Fax: 414-262-2585
E-mail: [email protected]

II. DEVICE
Name of Device: Monitor B125/B105
Common or Usual Name: Multi-parameter Patient Monitor
Classification Name:
21 CFR 870.1025 monitor, physiological, patient (with arrhythmia detection or alarms)
21 CFR 868.2375 monitor, breathing frequency
21 CFR 868.1700 analyzers, gas, nitrous-oxide, gaseous phase (anesthetic conc.)
21 CFR 868.1620 analyzers, gas, halothane, gaseous-phase (anesthetic conc.)
21 CFR 868.1500 analyzers, gas, enflurane, gaseous-phase (anesthetic concentration)
21 CFR 868.1400 analyzers, gas, carbon-dioxide, gaseous-phase
21 CFR 868.1720 analyzers, gas, oxygen, gaseous-phase
21 CFR 870.1130 system, measurement, blood-pressure, non-invasive
21 CFR 870.2700 oximeters
21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm)
 K171580
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21 CFR 870.2770 plethysmographs, impedance

21 CFR 870.1110 computers, blood-pressure
21 CFR 882.1400 full-montage standard electroencephalograph
21 CFR 880.2910 thermometers, electronic, clinical
21 CFR 868.1500 analyzers, gas, desflurane, gaseous-phase (anesthetic concentration)
21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)

Regulatory Class: II
Product Code:
MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSB, DSK, GWQ, FLL,
NHO, NHP, NHQ

III. PREDICATE DEVICE

K151063 Monitor B40 and K102239 CARESCAPE Monitor B650
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The Monitor B125/B105 is a multi-parameter patient monitor that is developed based on the
predicate Monitor B40 (K151063) platform. The Monitor B125/B105 provides additional
support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor
B650(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen.

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 is a multi-
parameter patient monitor, utilizes 12inches /10inches LCD display with an integrated
keypad and a pre-configuration (hemodynamic module (Hemo module) which provide basic
parameters: ECG, RESP, NIBP, IBP, TEMP, SPO2.

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has optional
CO2 parameter provided by the identical E-MiniC module (K052582).

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has a
mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of
ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting
accessories.
 K171580
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V. INDICATONS FOR USE

The Monitor B125/B105 is a portable multi-parameter unit to be used for monitoring,

recording, and to generate alarms for multiple physiological parameters of adult, pediatric,
and neonatal patients in a hospital environment and during intra-hospital transport.
The Monitor B125/B105 is intended for use under the direct supervision of a licensed health
care practitioner.
The Monitor B125/B105 is not intended for use during MRI.
The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via
network.
The Monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia
detection, ECG Diagnostic Analysis and Measurement,), invasive blood pressure, heart/pulse
rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial
pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring
(including monitoring during conditions of clinical patient motion or low perfusion),
temperature with a reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/
Myocardial/Core/Surface temperature, impedance respiration, respiration rate, CO2.

The Monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias:
Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated
Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, “R on T”, Tachycardia,
Bradycardia, Pause, Atrial Fibrillation, Multifocal PVCs, Missing Beat, Premature
Ventricular Contraction (PVC) and Ventricular fibrillation.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE

PREDICATE DEVICE

The proposed Monitor B125/B105 is a multi-parameter patient monitor that is developed based
on the predicate Monitor B40 (K151063) platform. The proposed Monitor B125/B105 provides
additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650
(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen

The proposed Monitor B125/B105 uses the identical hemodynamic module (Hemo module) as
the predicate Monitor B40 (K151063) in the monitoring of ECG, Resp, NIBP, IBP, SpO2 and
Temp parameters data.

The proposed Monitor B125/B105 uses identical E-MiniC module (K052582) as the predicate
Monitor B40 (K151063).

The fundamental technology of the proposed Monitor B125/B105 is the same as the predicate
devices.
The proposed Monitors B125/B105 is as safe and effective as the predicate devices.

The following table includes comparisons of the main features of

the device, and includes the features that are different from the
predicate.

WLAN Support wireless communication.

WLAN module is FCC qualified, FCC ID: OU5B1X501)

Touch screen Support touch screen per customer needs

ECG arrhythmia Enabled ECG full arrhythmia analysis

analysis
The proposed device uses the same ECG algorithm (EK-Pro
V12) as predicate device B40 (K151063)
The proposed device enabled full arrhythmia analysis which
disabled in the predicate device B40 (K151063).
Full arrhythmia analyses implemented with EK -ProV12 ECG
algorithm was cleared in B650 (K102239)

CARESCAPE Added the compatibility with CARESCAPE Central Station

Central Station V2 (K162012)
V2 (K162012)
compatibility CARESCAPE Central Station V2 (K162012) has the same
communication protocol as CARESCAPE central station V1
(K133882) which has been cleared in predicate device B40
(K151063)

Improved • Add standby and night mode

operating • Up to 168 hours trending storage and 200 snapshot
workflow checks
• Add event view software feature to combine alarm history
and snapshot

Peripheral I/O • Add DVI-D connector to support slave display.

interface • Add USB connector to support USB disk for service
purpose
Masimo SpO2 Add Masimo RD sensors and related cables, the sensors are
accessories compatible with MS-2011SB board (K053269)
change Two reusable sensors (K051212)
MASIMO-RD-4050
MASIMO-RD-4051
 Four adhesive sensors (K042346):
MASIMO-RD-4000
MASIMO-RD-4001
MASIMO-RD-4003
MASIMO-RD-4004
Two RD cables (K042536)
MASIMO-RD-4085
MASIMO-RD-4084

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence
determination.
Biocompatibility testing
No biocompatibility testing was performed as the Monitor B125/B105 is not in contact with
the patient. All supplies and accessories for use with the proposed Monitor B125/B105 that
contact the patient have been previously cleared by FDA.

Electrical safety and electromagnetic compatibility (EMC)

The Monitor B125/B105 is designed and tested for compliance with the following
performance standards:
 IEC 60601-1:2005 + A1:2012 Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
 IEC60601-1-2: 2007 Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
 IEC 60601-1-8:2006 + A1:2012 Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
 IEC 60601-2-27: 2011 + C1:2012 Medical electrical equipment - Part 2-27: Particular
requirements for the basic safety and essential performance of electrocardiographic
monitoring equipment
 IEC 80601-2-30:2009 + A1:2013 Medical electrical equipment – Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-
invasive sphygmomanometers
 IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular
requirements for the basic safety, including essential performance, of invasive blood
pressure monitoring equipment
 IEC 60601-2-49:2011 Medical electrical equipment – Part 2-49: Particular
requirements for the basic safety and essential performance of multifunction patient
monitoring equipment
 K171580
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 ISO 80601-2-55:2011 Medical electrical equipment — Part 2-55: Particular

requirements for the basic safety and essential performance of respiratory gas
monitors
 ISO 80601-2-56:2009 Medical electrical equipment - Part 2-56: Particular
requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement
 ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter equipment
 IEC 62366-1:2015 Medical devices—Part 1: Application of usability engineering to
medical devices
 IEC 60601-1-6:2010+A1:2013 Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance – Collateral standard:
Usability

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided
as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content
of Premarket Submissions for Software Contained in Medical Devices.” The software for this
device was considered as a “Major” level of concern, where a failure could result in death or
serious injury, either to a patient or to a user of the device.
The following bench tests were performed:

Software Verification include below Testing:

 Unit Testing: Code reviews and/or static code analysis are the methods are adopted
for the software unit verification to ensure the unit acceptance criteria, as defined in
the SDLC procedure, are met.
 Software Integration Test: Performed to confirm that integrated (changed) SW units
conform to the architecture and requirements, and other portions of the system have
not been adversely affected.
 Software Regression Test: The purpose of this test is to verify the side effect of code
changes. Software leader and engineering team shall review the side effect of all
SPRs and it shall be mentioned in the SPR test description or individual test
procedure.
 System Testing: Performance testing included the system level testing and subsystem
level testing. System level procedures were executed to confirmed that all product
system requirements specified in the product specifications were met. Design
Specifications specify design requirements for each subsystem of Patient Monitor
B125/B105. Each Design Specification has one or more corresponding Verification
Procedures that were used to verify that the design requirements have been met.
Software Validation is integrated with System Validation: System Validation will
confirm that the product fulfills the user needs and intended uses under actual or simulated
use conditions.
 K171580
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Environmental Testing:
Perform Rapid Change of Temperature, Change of Temperature, Dry heat for non-heat-
dissipating specimen with gradual change of temperature, Damp heat, Cold for non-heat
dissipating specimen with gradual change of temperature, Cold for heat-dissipating specimen
with gradual change of temperature and steady state testing to ensure the unit preference
meet the environmental requirements.
Mechanical stress Testing:
Perform sinusoidal vibration, shock, free fall, altitude test and broadband random vibration
testing to ensure the unit meet the Mechanical stress requirements.
Package Testing
Perform package transport testing to ensure the packaged product withstand the distribution
environment and to show the serviceability of the transport packages.
Animal Study
No animal studies have been performed on the Monitor B125/B105.
Clinical Studies
No clinical studies have been performed on the Monitor B125/B105.

VIII. CONCLUSIONS

GE Healthcare considers the proposed Monitor B125/B105 to be as safe, as effective, and

performance is substantially equivalent to the predicate devices.
i