December 29, 2022

Shenzhen Comen Medical Instruments CO., LTD.

Charlotte Lin Jingfang
International Registration Engineer
FIYTA Timepiece Building, Nanhuan Avenue, Matian
Sub-District, Guangming District
Shenzhen, Guangdong 51806
China

Re: K211619
Trade/Device Name: Multi-Parameter Patient Monitor
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, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ,
CBS, CBR, CCL, NHQ, NHO, NHP, OLW, GXY
Dated: December 2, 2022
Received: December 2, 2022

Dear Charlotte Lin Jingfang:

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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.05.02
Silver Spring, MD 20993
www.fda.gov
K211619 - Charlotte Lin Jingfang Page 2

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) 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,

Shruti N. Mistry -S
for
Jennifer Shih Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics and Monitoring Devices
Office of Cardiovascular 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: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K211619

Device Name
Multi-parameter Patient Monitor, model: NC10, NC12

Indications for Use (Describe)

The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing
of multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia
detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and
Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
• BIS monitoring is intended for adult and pediatric patients only;
• C.O. monitoring is restricted to adult patients only;
• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and
neonatal population.
• When using COMEM SpO2, the monitor is intended to be used on adult patients only.
• NIBP measurement continual mode is not applicable to neonates.

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the
direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT,
Accelerated Idioventricular rhythm and Torsades de Pointes.

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 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
510(k) Premarket Notification Shenzhen Comen NC Multi-Parameter Patient Monitors

Section 5 - 510 (k) Summary

NC10 and NC12 Multi-parameter Patient Monitor

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
Date: 2nd December, 2022
Submitter SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD
Address Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building
2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District,
Shenzhen, 518106, Guangdong, China.
Contact Chuanqing Zhu
Telephone +86-18252006698
Facsimile +86-755-3431232
Ee-mail [email protected]
Device trade NC10 and NC12 Multi-parameter Patient Monitor
name
Common name Multi-parameter Patient Monitor
Classification Regulation, Classification name and Product Codes
Device Panel Regulation number & Product Description
Classification code
Cardiovascular §870.1025, II MHX Arrhythmia detector and alarm (including
ST-segment measurement and alarm)
Cardiovascular §870.1025, II DSI Arrhythmia detector and alarm (including
ST-segment measurement and alarm).
Cardiovascular §870.1025, II MLD Arrhythmia detector and alarm (including
ST-segment measurement and alarm).
Cardiovascular §870.2300, II DRT Monitor, Cardiac (Including
Cardiotachometer & Rate Alarm)
Cardiovascular §870.1100, II DSJ Alarm, Blood-Pressure
Cardiovascular §870.1130, II DXN System, Measurement, Blood-Pressure,
Non-Invasive
Cardiovascular §870.1110, II DSK Computer, Blood-Pressure
Cardiovascular §870.2340, II DPS Electrocardiograph
Cardiovascular §870.1435, II DXG Computer, Diagnostic, Pre-Programmed,
Single-Function
Cardiovascular §870.2770, II DSB Plethysmograph, Impedance
General §880.2910, II FLL Thermometer, Electronic, Clinical
Hospital
Anesthesiology §870.2700, II DQA Oximeter
Anesthesiology §868.1400, II CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-
Phase

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Anesthesiology §868.1500, II CBQ Analyzer, Gas, Enflurane, Gaseous-Phase

(Anesthetic Concentration)
Anesthesiology §868.1620, II CBS Analyzer, Gas, Halothane, Gaseous-Phase
(Anesthetic Conc.)
Anesthesiology §868.1700, II CBR Analyzer, Gas, Nitrous-Oxide, Gaseous
Phase (Anesthetic Conc.)
Anesthesiology §868.1720, II CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Anesthesiology §868.1500, II NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase
(Anesthetic Concentration)
Anesthesiology §868.1500, II NHO Analyzer, Gas, Desflurane, Gaseous-Phase
(Anesthetic Concentration)
Anesthesiology §868.1500, II NHP Analyzer, Gas, Sevoflurane, Gaseous-
Phase (Anesthetic Concentration)
Neurology §882.1400, II OLW Index-Generating Electroencephalograph
Software
Neurology §882.1320, II GXY Electrode, Cutaneous

Predicate
K191106, C50 and C80 Multi-parameter Patient Monitors, SHENZHEN COMEN
Device:
MEDICAL INSTRUMENTS CO., LTD

Device The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,
description: reviewing, alarming and storing multiple physiological parameters. These parameters
include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)),
Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide
(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
 BIS monitoring is intended for adult patients only;
 C.O. monitoring is restricted to adult patients only;
 Arrhythmia analysis is intended for use with adult patients only and is not intended
and shall not be used on pediatric and neonatal population.
 When using COMEM SpO2, the monitor is intended to be used on adult patients only.
 NIBP measurement continual mode is not applicable to neonates.

Both models are designed with:

Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.
Indications for The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,
Use: reviewing, alarming and storing of multiple physiological parameters. These parameters
include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)),

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Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide
(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
• BIS monitoring is intended for adult and pediatric patients only;
• C.O. monitoring is restricted to adult patients only;
• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall
not be used on pediatric and neonatal population.
• When using COMEM SpO2, the monitor is intended to be used on adult patients only.
• NIBP measurement continual mode is not applicable to neonates.

The monitors are to be used in general healthcare facilities by clinical physicians or

appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring
known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

Technological Both the subject devices and the predicate device provide a means for monitoring one
Comparison to patient, collecting specific physiological data, processing the data for alarm conditions and
Predicate display of numeric values and waveforms.
Devices: In terms of indications for use, basic operation and performance specifications, the NC10
and NC12 Multi-parameter Patient Monitor is equivalent to C50 and C80 multi-parameter
Patient Monitors (K191106). All devices can provide monitoring such as ECG(3-lead , 5-
lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate(RR),
Temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive
blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG) and
Bispectral index (BIS)for a single patient.
NC10 and NC12 restricted the arrhythmia analysis, BIS monitoring and COMEN SpO2 on
adults only, which is a subset of C50 and C80 multi-parameter patient monitor. These do
not affect the substantial equivalence of subject device and predicate device.
Table below compares the key technological feature of the subject devices (NC10 and NC12
patient monitors) to the predicate device (K191106, C50 and C80 multi-parameter patient
monitor). The features in gray are features that are different between the predicate devices
and the subject devices.
Device Comparison Table

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Feature Predicate device C50 Subject devices Comparison

and C80 (K191106) NC10 and NC12
Monitor C80: 344mm×291 mm× NC12: 308mm× 257 Similar. Both
Size 165mm mm ×142mm devices met IEC
C50: 291.7mm×250 NC10: 265mm 60601-1.
mm×146.5mm ×227mm×141mm

Integrated color TFT LCD color TFT LCD Same

display C80: 12.1 Inch NC12: 12.1 Inch Same
screen C50: 10.4 Inch NC10: 10.4 Inch
C80: 800×600 pixels NC12: Pixel: 800×600 Same
C50: 800×600 pixels NC10: Pixel: 800×600
Power C50 and C80: NC10 and NC12: Same
supply Two rechargeable Two rechargeable
Lithium-ion battery or Lithium-ion battery or
AC power supply AC power supply
Battery 11.1V, 2200mAh or 11.1V, 2200mAh or Same
4400mAh 4400mAh
ECG 3-lead, 5-lead and 12- 3-lead, 5-lead and 12- Same
lead selectable, heart lead selectable, heart
rate (HR) rate (HR)
ECG Asystole, ventricular Asystole, ventricular Same
(Arrhyth fibrillation, R ON T, fibrillation, R ON T,
mia VT>2, Couplet, PVC, VT>2, Couplet, PVC,
Analysis) Bigeminy, Trigeminy, Bigeminy, Trigeminy,
Brady (Bradycardia), Brady (Bradycardia),
PNC (Pacer Not PNC (Pacer Not
Capture), PNP (Pacer Capture), PNP (Pacer
Not Pace), Missed Not Pace), Missed
Beats, Heart Pause, Beats, Heart Pause,
Irregular Heart Beat, Irregular Heart Beat,
VTAC (Ventricular VTAC (Ventricular
Tachycardia), Tachy Tachycardia), Tachy
(Tachycardia), PVCs (Tachycardia), PVCs
Too High, Extreme Too High, Extreme
Tachycardia, Extreme Tachycardia, Extreme
Bradycardia, Bradycardia,
Ventricular Rhythm, Ventricular Rhythm,
Respiratio Method: Trans-thoracic Method: Trans-thoracic Same
n impedance impedance
Range: Range:

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adult:0-120 rpm; adult:0-120 rpm;

pediatrics:0-150rpm; pediatrics:0-150rpm;
neonate:0-150rpm neonate:0-150rpm
Accuracy: Accuracy:
7 to 150rpm: ±2rpm or 7 to 150rpm: ±2rpm or
±2%, whichever is ±2%, whichever is
greater. greater.
0 to 6rpm: not specified 0 to 6rpm: not specified
Pulse Method: red and Method: red and Same
oxygen infrared light method infrared light method
saturation Masimo SpO2: Masimo SpO2:
(SpO2) Range:1~100% Range:1~100%
Accuracy: Accuracy:
No motion Conditions: No motion Conditions:
70 to 100%: ±2%(in 70 to 100%: ±2%(in
adult/pediatric mode) adult/pediatric mode)
70 to 100%: ±3% (in 70 to 100%: ±3% (in
neonate mode) neonate mode)
Motion conditions: Motion conditions:
70%~100%: ±3% 70%~100%: ±3%
1%~ 69%: Not 1%~ 69%: Not
specified. specified.
Nellcor SpO2: Nellcor SpO2: Same
Range: 0~100% Range: 0~100%
Accuracy:70 to 100%: Accuracy:70 to 100%:
±2% (adult/pediatric) ±2% (adult/pediatric)
70 to 100%: ±3% 70 to 100%: ±3%
(neonate) (neonate)
0% to 69%: Not 0% to 69%: Not
specified. specified.
Comen SpO2: Comen SpO2: Different.
Range: 0 ~100%; Range: 0 ~100%; The subject
Accuracy: 70 to 100%: Accuracy: 70 to 100%: devices add
±2% (adult/pediatric ±3% (adult) exceptions on
mode) 0% to 69%: Not neonate and
70 to 100%: ±3% specified pediatric use of
(neonate mode) Comen SpO2.
0% to 69%: Not The SpO2
specified accuracy met ISO
80601-2-61 and
was validated by
the clinical study.

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Pulse PR FROM Masimo PR FROM Masimo Same

rate(PR) SpO2: SpO2:
Range: 25~240bpm Range: 25~240bpm
Accuracy: Accuracy:
±3bpm (without ±3bpm (without
motion) motion)
±5bpm (with motion) ±5bpm (with motion)
PR FROM Nellcor PR FROM Nellcor
SpO2: SpO2:
Range:20~300bpm Range:20~300bpm
Accuracy: Accuracy:
20~250bpm: ±3bpm 20~250bpm: ±3bpm
251~300bpm: not 251~300bpm: not
specified. specified.
PR FROM COMEN PR FROM COMEN
SpO2: SpO2:
Range: 20bpm Range: 20bpm
~254bpm; ~254bpm;
Accuracy: ±2bpm; Accuracy: ±2bpm;
PR FROM IBP: PR FROM IBP:
Range:25-350bpm Range:25-350bpm
Accuracy:±1bpm or Accuracy:±1bpm or
±1%, whichever is ±1%, whichever is
greater greater
PR FROM NIBP : PR FROM NIBP:
Range: 40 ~ 240 bpm; Range: 40 ~ 240 bpm;
Accuracy: ±3bpm or Accuracy: ±3bpm or
±3%, whichever is ±3%, whichever is
greater greater
Non- Method: Oscillometry Method: Oscillometry Same
invasive Range: Range:
blood Adult: Adult:
pressure systolic:40-270 mmHg systolic: 40-270mmHg
(NIBP) diastolic:10-215 mmHg diastolic: 10-215mmHg
pediatrics: pediatrics:
systolic:40-200 mmHg systolic:40-200mmHg
diastolic:10-150 mmHg diastolic:10-150mmHg
Neonate: Neonate:
systolic:40-140 mmHg systolic:40-135mmHg
diastolic:10-100 mmHg diastolic:10-100mmHg
Error: Error:
Max mean error: ±5 Max mean error: ±5
mmHg mmHg

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Max standard Max standard

deviation: 8 mmHg deviation: 8 mmHg
Temperat Method: Thermal Method: Thermal Same
ure resistance resistance
(Temp.) Range: 0-50℃ Range: 0-50℃
Accuracy: ±0.1℃ Accuracy: ±0.1℃
Carbon Method: Infrared Method: Infrared Same
dioxide absorption absorption
(CO2) Masimo Sidestream/ Masimo Sidestream/
Mainstream CO2 Mainstream CO2
Module: Module:
Range: 0-190mmHg, Range: 0-190mmHg,
0~25% (at 760mmHg) 0~25% (at 760mmHg)
AwRR:0~150rpm; AwRR:0~150rpm;
Accuracy: All Accuracy: All
environment: environment:
0mmHg~114mmHg: 0mmHg~114mmHg:
±(2.25mmHg+reading× ±(2.25mmHg+reading×
4%) 4%)
114 mmHg -190 114 mmHg -190
mmHg: not defined. mmHg: not defined.
Respironics Respironics
Sidestream/Mainstrea Sidestream/Mainstrea
m CO2 module: m CO2 module:
Range: 0 mmHg Range: 0 mmHg
~150mmHg ~150mmHg/
/0%~19.7% /0 kPa 0%~19.7% /0 kPa
~20.0kPa(at760mmHg) ~20.0kPa(at760mmHg)
Accuracy: 0~40mmHg: Accuracy: 0~40mmHg:
±2mmHg ±2mmHg
41~70mmHg: 41~70mmHg:
±5%×reading ±5%×reading
71~100mmHg: 71~100mmHg:
±8%×reading ±8%×reading
101~150mmHg: 101~150mmHg:
±10%×reading; ±10%×reading;
awRR awRR
range: 0, 2~150bpm; range: 0, 2~150bpm;
Accuracy: ±1bpm Accuracy: ±1bpm
invasive Method: Direct Method: Direct Same
blood invasive measurement invasive measurement
pressure(I Range: -50 to 300 Range: -50 to 300
BP) mmHg mmHg

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Accuracy: ±2% or ±1 Accuracy: ±2% or ±1

mmHg, whichever is mmHg, whichever is
greater (excluding the greater (excluding the
sensor error) sensor error)
cardiac Method: Method: Same
output Thermodilution method Thermodilution method
(C.O.) Range: 0.1 to 20 L/min Range: 0.1 to 20 L/min
Accuracy: ±5% or ±0.1 Accuracy: ±5% or ±0.1
L /min, whichever is L /min, whichever is
greater greater
anesthetic Method: Infrared Method: Infrared Same
gas (AG) absorption absorption
Range: Range:
CO2: 0%~25% CO2: 0%~25%
N2O: 0%~100% N2O: 0%~100%
Hal: 0%~25% Hal: 0%~25%
Enf: 0%~25% Enf: 0%~25%
Iso: 0%~25% Iso: 0%~25%
Sev: 0%~25% Sev: 0%~25%
Des: 0%~25% Des: 0%~25%
O2: 0%~100% O2: 0%~100%
awRR: 0~150rpm awRR: 0~150rpm
Accuracy: Accuracy:
CO2: 0%~15%: CO2: 0%~15%:
±(0.2%+reading×2%) ±(0.2kPa+reading×2%)
15%~25%: Not Not defined.
defined. N2O: ±(2 kPa+
N2O: reading×2%)
±(2%+reading×2%) Hal, Enf, Iso:
Hal, Enf, Iso: 0%~8%:
0%~8%:±(0.15 %+read ±(0.15%+reading×5%)
ing×5%) Not defined.
8%-25%: Not defined. Sev: 0%-10%:
Sev: 0%-10%: ±(0.15%+reading×5%)
±(0.15 %+reading×5%) Not defined.
10%~25%: Not Des: 0%-22%:
defined. ±(0.15%+reading×5%)
Des: 0%~22%: 22%~25%: Not
±(0.15 %+reading×5%) defined.
22%~25%: Not O2: ±(1%+reading×2%)
defined. awRR: ±1rpm
O2:±(1%+reading×2%)
awRR: ±1rpm

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BIS Range and accuracy: Range and Accuracy: Same

SQI: 0-100%; accuracy: BIS: 0-100; accuracy:
1%. 1%.
EMG: 0~100dB; SQI: 0-100%; accuracy:
accuracy: 1%. 1%.
BIS: 0-100; accuracy: EMG: 0~100dB;
1%. accuracy: 1%.
SR: 0~100%; accuracy: ESR: 0~100%;
1%. accuracy: 1%.

Substantial Equivalence Conclusion:

The above-detailed technical specification comparison for each parameter between the
subject device and the predicate devices (C50 and C80 multi-parameter patient monitor)
shows the difference lies in monitor size and Comen SpO2. Therefore, we declared that
the NC10 and NC12 Multi-parameter Patient Monitors can be found substantially
equivalent to the predicate device.

Performance The following performance data are provided to support the substantial equivalence
Data determination.
Software Verification and Validation Testing
Software verification and validation testing were 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.”
Biocompatibility Testing
The accessories with patient contact have been evaluated by biocompatibility testing in
accordance with ISO 10993-1.
Bench test
The NC10 and NC12 Multi-parameter Patient Monitor have been tested and found to be in
compliance with the following safety, performance and electromagnetic compatibility
standards:
⚫ ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical Equipment -
Part 1: General Requirements For Basic Safety And Essential Performance (IEC
60601-1:2005, MOD)
⚫ IEC 60601-1-2 Edition 4.0: 2014-02 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 Edition 2.1 2012-11Medical 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 Edition 3.0 2011-03 Medical Electrical Equipment - Part 2-27:
Particular Requirements For The Basic Safety And Essential Performance Of
Electrocardiographic Monitoring Equipment [Including: Corrigendum 1 (2012)]

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⚫ IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers
⚫ IEC 60601-2-34 Edition 3.0 2011-05 Medical Electrical Equipment - Part 2-34:
Particular Requirements For The Basic Safety, Including Essential Performance, Of
Invasive Blood Pressure Monitoring Equipment
⚫ ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56:
Particular requirements for basic safety and essential performance of clinical
thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
⚫ ISO 80601-2-61 Second Edition 2017-12 Medical Electrical Equipment - Part 2-61:
Particular Requirements For Basic Safety And Essential Performance Of Pulse
Oximeter Equipment
⚫ ISO 80601-2-55 Second Edition 2018-02 Medical Electrical Equipment - Part 2-55:
Particular Requirements For The Basic Safety And Essential Performance Of
Respiratory Gas Monitors
⚫ ANSI AAMI EC57:2012 Testing And Reporting Performance Results Of Cardiac
Rhythm And ST-Segment Measurement Algorithms
⚫ IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particular
requirements for the basic safety and essential performance of multifunction patient
monitoring equipment.
⚫ IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particular
requirements for the basic safety and essential performance of electroencephalographs.
⚫ EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: Requirements
and test methods for non-automated measurement type
⚫ EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems
⚫ IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General
Requirements For Basic Safety And Essential Performance - Collateral Standard:
Usability
⚫ IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of Usability
Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)]
⚫ ISO 14971 Third Edition 2019-12 Medical devices - Application of risk
management to medical devices

Clinical studies
The clinical accuracy of non-invasive blood pressure (NIBP) determination, SpO2
measurement, and respiratory rate were validated for the intended patient population.
Clinical data is provided to support the determination of substantial equivalence with
predicated devices that are currently marketed for the same intended use.
 The accuracy of the SpO2 accuracy during non-motion conditions as compared to CO-
oximetry in a controlled desaturation study was validated using the method outlined in

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510(k) Premarket Notification Shenzhen Comen NC Multi-Parameter Patient Monitors

ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification
Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration
Staff, March 2013.
 The clinical accuracy of non-invasive blood pressure determination was validated
according to ISO 81060-2 which contains the requirements for clinical accuracy and
the protocols for investigating the NIBP determination clinical accuracy.
 The clinical accuracy of respiratory rate was validated by clinical testing to compare
the measurement of the subject device and that of a clinician-scored capnography
device, manually scored end-tidal CO2 (EtCO2) capnography.
All clinical accuracy validation studies were conducted in accordance with standard ISO
14155:2020.

Summary
Based on the non-clinical and clinical performance above, we demonstrate that the NC10
and NC12 multi-parameter patient monitors were substantially equivalent and perform as
well as the predicate device.
Conclusion: The NC10 and NC12 Multi-Parameter Patient Monitor are substantially equivalent to the
predicate devices (C50 and C80 multi-parameter patient monitor, K191106) in terms of
indication for use and technological characteristics. Performance testing and compliance
with FDA-recognized consensus standards demonstrate that NC10/NC12 are
substantially equivalent to the predicate device.

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