Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities, algorithms, or related concepts.

Therapeutic

No
The device is described as a "Multi-parameter Patient Monitor" intended for "monitoring, reviewing and storing of multiple physiological parameters". It explicitly states it is "not intended to be used on the patients with pacemaker," and there is no mention of treating, rehabilitating, or diagnosing conditions in the provided text.

Diagnostic

No
The device is described as a "Multi-parameter Patient Monitor" used for "monitoring, reviewing and storing of multiple physiological parameters." It provides real-time data on parameters like ECG, heart rate, respiration, SpO2, and NIBP. While this data can be used by healthcare professionals to inform diagnosis, the device itself is explicitly for monitoring and does not state that it provides a diagnosis.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate this is a hardware device (Patient Monitor) that measures multiple physiological parameters using sensors and likely includes software for processing and displaying this data. The testing includes electrical safety, bench testing for specific physiological parameters, and clinical testing, all of which are indicative of a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "monitoring the physiological parameters of patients." It lists parameters like ECG, heart rate, respiration, temperature, SpO2, pulse rate, and non-invasive blood pressure. These are all measurements taken directly from the patient's body.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Lack of Mention of Samples: The description and intended use do not mention the analysis of any biological samples.

Therefore, the C30 Multi-parameter Patient Monitor is a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker. The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

Product codes (comma separated list FDA assigned to the subject device)

DRT, DPS, DSJ, DSK, DXN, DOA, DSB, FLL

Device Description

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is intended to be used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. Other parameters can be applied to adult, pediatric or neonate.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, Pediatric, Neonate

Intended User / Care Setting

Health care professionals, doctors and nurses who are qualified through training. Used for monitoring the clinical patients.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The C30 Multi-parameter Patient Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. The risk analysis has been developed to identify potential hazards and documents the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements. Clinical and/or bench performance testing are also provided. The C30 Multi-parameter Patient Monitor has been evaluated by end-users and found to meets performed within its intended use and met their specific needs. The C30 Multi-parameter Patient Monitor has been tested and found to be in compliance with the following safety, performance and electromagnetic compatibility standards:
Electrical Safety and Electromagnetic Compatibility:
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1-2:2007
Bench testing:
IEC 60601-1-8 Edition 2.0 2006-10
IEC60601-2-27 Edition 3.0 2011-03
IEC 80601-2-30 Edition 1.1 2013-07
IEC 80601-2-56 First Edition 2009-10-01
IEC 80601-2-61 First Edition 2011-04-01
IEC 62366-1 Edition 1.0 2015-01
ISO 80601-2-55 First Edition 2011-12-15
Clinical testing:
According to ISO 81060-2:2013, NIBP clinical accuracy was verified.
To verify respiration rate (RR) accuracy, Clinical study was conducted comparing the RR from the subject device with that from capnography.
Software Verification and Validation Testing:
The software was developed according to IEC 62304 First Edition 2006-05. Testing was conducted to verify and validate the software performs according to the requirements. Documentation in accordance with FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" was provided.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123074, K112877

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 16, 2018

Shenzhen Comen Medical Instruments Co., Ltd. Hongbo Yan Registration Engineer South of Floor 7, Block 5 4th Industrial Area of Nanyou Nanshan District Shenzhen, 518052 CN

Re: K173454

Trade/Device Name: Multi-parameter Patient Monitor, Model C30 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: DRT, DPS, DSJ, DSK, DXN, DOA, DSB, FLL Dated: Julv 23, 2018 Received: July 23, 2018

Dear Hongbo Yan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica E. Paulsen -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173454

Device Name

Multi-parameter Patient Monitor, Model C30

Indications for Use (Describe)

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.

The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary C30 Multi-parameter Patient Monitor

This 510(k) Summary is provided in accordance with the requirements of 21 CER 807.92.

Date:	Aug 14, 2018
Submitter:	SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD
	South of Floor 7, Block 5 4th Industrial Area of Nanyou, Nanshan District,
	Shenzhen, Guangdong, 518052, P.R.China
	No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming Sub-district,
	Guangming New District, Shenzhen, Guangdong, 518106, P.R.China.
Contact:	Hongbo Yan
	Registration Engineer
Telephone:	+86-13424152596
Facsimile:	+86-755-26431232
Device Trade Name:	Multi-parameter Patient Monitor, Model C30
Common Name:	Multi-parameter Patient Monitor

Device Classification:

Device Panel	Classification	ProCode	Description
Cardiovascular	§870.2300, II	DRT	Cardiac Monitor (incl. Rate Alarm)
	§870.1110, II	DSK	Computer, Blood Pressure
Devices:	§870.1130, II	DXN	System, Measurement, Blood-Pressure,
Non-Invasive
	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.2300, II	DRT	Monitor, Cardiac (incl.
Cardiotachometer& Rate Alarm)
	§870.2340, II	DPS	Electrocardiograph
	§870.2700, II	DQA	Oximeter
	§870.2770, IT	DSB	Plethysmograph, Impedance
General Hospital	§880 .2910, II	FLL	Thermometer, Electronic, Clinical
Predicate Devices:	K123074, BeneView T1 Patient monitor, Shenzhen Mindray Bio-medical
Electronics (The primary predicate device)
	K112877, C80 COMEN Multi-parameter Patient Monitor, Shenzhen Comen
Medical Instruments Co., Ltd
Device description:	C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is
intended to be used for monitoring, reviewing and storing of multiple physiological
parameters as following: ECG, heart rate (HR), respiration (Resp), temperature
(Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single
patient. Other parameters can be applied to adult, pediatric or neonate.
Indications for Use:	C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is
indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients. It's used for monitoring,
reviewing and storing of multiple physiological parameters as following: ECG,
heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR),
non-invasive blood pressure (NIBP) of single patient. All parameters can be
applied to adult, pediatric or neonate. The Patient Monitor is not intended to be
used on the patients with pacemaker. The monitor is used for monitoring the
clinical patients, so only the doctors and nurses who are qualified through training
can use these monitors.
	The table below lists the patient population for each parameter as appropriate:
Patient
Population
Parameter	Adult	Pediatric	Neonate
ECG	√	√	√
RESP	√	√	√
	SpO2	√	√	√
	TEMP	√	√	√
	NIBP	√	√	√
	Et CO2	√	√	√
	Remark:	1. The patient population for each parameter as
appropriate is marked with '√';

The neonatal patient type is not included in the
patient type of pediatrics for COMEN
multi-parameter patient monitors. | | |
| Indications for Use
Comparison to
Predicate Devices | The C30 and the predicate devices' indications for use are similar. The subject
and predicate devices are all patient monitors that are intended to be used in
healthcare facilities by physicians or clinical staff. The devices measure similar
patient parameters.
The device provides single patient monitoring for parameters such as ECG,
impedance respiration (Resp), temperature (TEMP),SpO2, pulse rate(PR),
noninvasive blood pressure (NIBP), respiration rate (RR) and EtCO2. All
parameters can be applied to adult, pediatric or neonate..

These minor differences between the predicate device and subject devices'
indications for use do not constitute a new intended use and are not significant
changes in indications for use. | | | |
| Technological
Comparison to
Predicate Devices: | Both the subject devices and the predicate devices provide a means for
interfacing with a patient, collecting parameter and specific physiological data,
and processing the data for alarm generation and display of numeric values and
waveforms. | | | |

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Feature	Subject Devices	Predicate Device(primary) K123074	Predicate Device K112877
Dimension	C30	T1	C80
	190×82×105mm	143×77×102mm	344.5x291×165 mm
Integrated
display and
touchscreen	4.3"
480*272 pixels	5"
same	12.1"
800*600 pixels
	Power
supply	One standard
rechargeable
lithium-ion battery
or AC power	Same	Same
Battery		11.1V, 2600mAh	14.8V, 4400Ah	12V, 2500mAh
ECG		3-lead, 5-lead or
12-lead selectable,	3-lead, 5-lead or
12-lead selectable,
arrhythmia
detection, ST
segment	3-lead, 5-lead or
12-lead
selectable
		ECG
measurement range and
accuracy	HR:
Neonate /
Pediatric: 15 to
350bpm
Adult: 15 to
300bpm
Accuracy: ±1% or
±1bpm, whichever
is the larger.	Same	Same
	Respiration
rate (Resp)		Measurement
range: Adult: 7 to
120rpm, Neonate:
7 to 150rpm.
Accuracy: 7 to 150
rpm: ±2rpm or
±2%, whichever is
greater; 0 to 6rpm:
Not specified.	Measurement
range: Adult: 0 to
120rpm, Neonate:
0 to 150rpm.
Accuracy: same	Measurement
range: same
Accuracy:
7 to 150rpm:
±1rpm
			Temperature
(Temp)	Measurement
range: 0 to 50°C (32
to 122°F )
Accuracy: ±0.1 ℃ or	Same	Same
					±0.2°F (without probe)
Pulse oxygen saturation (SpO2)				Masimo SpO2 Module:
Measurement range: 1 to 100%
Accuracy: 70 to 100%: ±2% (measured without motion in adult/pediatric mode)
Accuracy: 70 to 100%: ±3% (measured without motion in neonate mode)
Accuracy: 70 to 100%: ±3% (measured with motion)
1 to 69%: Not specified
NellcorSpO2 module:
Measurement range: 0 to 100%
Accuracy: 70 to 100%: ±2% (adult/pediatric mode)
Accuracy: 70 to 100%: ±3% (neonate mode)
0 to 69%: Not specified	MindraySpO2 Module:
Measurement range: 0 to 100%
Accuracy: 70 to 100%: ±2% (adult/pediatric mode)
70 to 100%: ±3% (neonate mode)
0 to 69%: Not specified
Masimo SpO2 Module: Same
NellcorSpO2 module: Same	Masimo SpO2 Module: Same
NellcorSpO2 module: Same
Pulse rate				PR from MasimoSpO2 module:
Measurement	PR from MindraySpO2 module:
Measurement	/

		range: 25 to 240
bpm
Accuracy: ±3bpm
(measured without
motion)
±5 bpm (measured
with motion)

PR from
NellcorSpO2
module:
Measurement
range: 20 to 300
bpm
Accuracy: 20 to
250bpm: ±3bpm,
251 to 300bpm:not
specified. | range: 20 to 254
bpm
Accuracy: ±3bpm

PR from
MasimoSpO2
module: Same

PR from
NellcorSpO2
module: Same | | | |
| Non-invasive blood
pressure
(NIBP) | | Measurement
range:
Adult:
Systolic:
40-270mmHg
Mean: /
Diastolic:
10-215mmHg
Pediatric:
Systolic:
40-200mmHg
Mean: /
Diastolic:
10-150mmHg
Neonate:
Systolic:
40-135mmHg
Mean: /
Diastolic:
10-100mmHg

Accuracy:
Max mean error: | Measurement
range:
Adult:
Systolic: same
Mean: 20-230
Diastolic:
10-210mmHg
Pediatric:
Systolic: same
Mean:
20-165mmHg
Diastolic: same
Neonate:
Systolic: same
Mean:
20-110mmHg
Diastolic:
10-110mmHg

Accuracy: Same | Measurement
range:
Adult:
Systolic: same
Mean: 20-235
Diastolic: same
Pediatric:
Systolic: same
Mean:
20-165mmHg
Diastolic:
10-100mmHg
Neonate:
Systolic:
40-150mmHg
Mean:
20-110mmHg
Diastolic: same

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	The differences do not raise questions of safety and effectiveness
Summary of
Performance Testing:	The C30 Multi-parameter Patient Monitor has been tested and found to be in
compliance with recognized safety, performance and electromagnetic
compatibility standards.
The risk analysis has been developed to identify potential hazards and
documents the mitigation of the hazards. The device's software has been verified
and validated in accordance with the appropriate test requirements. Clinical
and/or bench performance testing are also provided.
The C30 Multi-parameter Patient Monitor has been evaluated by end-users and
found to meets performed within its intended use and met their specific needs.
The C30 Multi-parameter Patient Monitor has been tested and found to be in
compliance with the following safety, performance and electromagnetic
compatibility standards:
Electrical Safety and Electromagnetic Compatibility:
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012
IEC 60601-1-2:2007
Bench testing:
IEC 60601-1-8 Edition 2.0 2006-10
IEC60601-2-27 Edition 3.0 2011-03
IEC 80601-2-30 Edition 1.1 2013-07
IEC 80601-2-56 First Edition 2009-10-01
IEC 80601-2-61 First Edition 2011-04-01
IEC 62366-1 Edition 1.0 2015-01
ISO 80601-2-55 First Edition 2011-12-15
Clinical testing:
	According to ISO 81060-2:2013, NIBP clinical accuracy was verified.
	To verify respiration rate (RR) accuracy, Clinical study was conducted comparing
	the RR from the subject device with that from capnography.
	Software Verification and Validation Testing:
	The software was developed according to IEC 62304 First Edition 2006-05.
	Testing was conducted to verify and validate the software performs according to
	the requirements. Documentation in accordance with FDA's guidance document
	"Guidance for the Content of Premarket Submissions for Software Contained in
	Medical Devices" was provided.
Conclusion:	Based on similarities in intended use and technological characteristics, results of
	performance and validation/verification testing, and conformance with applicable
	standards, the C30 Multi-parameter Patient Monitor is considered substantially
	equivalent to the predicate devices.

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