Comen Multi-Parameter Patient Monitor models C50, C60, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor.

The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.

The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

Device Description

COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 obtain and display physiological data of the patient including waveforms and numerical data in real time. COMEN C series can be custom confiqured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), respiration (RESP) or temperature (TEMP). These physiological signals are converted into digital data and displayed.

For each parameter, COMEN C series examine the data for alarm conditions and present them on the display. COMEN C series have audio alarming function that may raise the user's attention of system error or as dictated by the physiological parameter settings.

COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the COMEN Multi-Parameter Patient Monitor (K112877) and its acceptance criteria and study information:

Based on the provided document, the device is a multi-parameter patient monitor. The summary emphasizes that the device is deemed "substantially equivalent" to predicate devices, which implies that its performance is expected to be similar or within acceptable ranges of previously cleared devices. However, the document does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages or error margins) for each physiological parameter, nor does it provide a table of reported device performance against such criteria. Instead, it refers to compliance with various international standards as the basis for proving safety and effectiveness.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

As mentioned above, the document does not explicitly list specific numerical acceptance criteria or a table of device performance. Instead, it relies on compliance with various international standards, which inherently contain their own performance and safety requirements. The document states:

"COMEN C series meet the following standards: IEC 60601-1-2, IEC 60601-2-30, IEC 60601-2-27, EN1060-1, EN1060-3, EN1060-4, EN60601-2-49, EN 60601-1, AAMI EC13, ISO10993-1, ASTM E1112-00, ISO 9919, ISO 80601-2-56."

Meeting these standards would mean the device implicitly meets the performance and safety criteria outlined within each respective standard for various parameters (ECG, NIBP, SpO2, Respiration, Temperature). For example:
* IEC 60601-2-27: Specific requirements for the safety and essential performance of electrocardiographic monitoring equipment.
* EN1060-1, EN1060-3, EN1060-4: Non-invasive sphygmomanometers (blood pressure monitors).
* ISO 9919 / ISO 80601-2-61 (relevant for SpO2, although ISO 9919 is older): Requirements for pulse oximeter equipment.
* AAMI EC13: Cardiac monitors.
* ASTM E1112-00: Electronic thermometers.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide information on sample sizes for test sets or data provenance. It states: "A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." This implies internal testing but no specific details are given about the subjects or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts or ground truth establishment in the context of a specific test set. The validation is primarily based on compliance with international standards through non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for a test set, as no dedicated clinical test set is elaborated upon.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned. This device is a diagnostic/monitoring tool, not an AI-assisted interpretation system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone monitor. The "testing was conducted to validate the systems overall operation" refers to its standalone performance in accordance with the listed standards. However, the document does not explicitly detail specific "algorithm only" performance data separate from the overall system validation based on standards compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests performed, the "ground truth" would be the reference values or established methodologies defined within each of the international standards (e.g., standard blood pressure cuffs for NIBP accuracy checks, calibrated temperature probes for TEMP accuracy, defined ECG signals for ECG performance). No clinical ground truth (like pathology or outcomes data) is mentioned as the basis for testing.

8. The sample size for the training set

The document does not mention any training set or associated sample size. This type of device (a multi-parameter patient monitor) typically relies on engineering design, calibration, and validation against established physiological signal processing principles and standard test procedures outlined in the relevant IEC/ISO standards, rather than machine learning training sets.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable and not provided.

Summary of Key Takeaways from the document K112877:

Acceptance Criteria: Based on adherence to a comprehensive list of international safety and performance standards (e.g., IEC 60601 series, EN1060 series, AAMI EC13, ASTM E1112-00, ISO 9919, ISO 80601-2-56). Specific numerical performance data against these criteria is not detailed in the summary.
Study Type: Non-clinical bench testing and risk analysis to demonstrate compliance with the listed standards and overall system operation validation.
No Clinical Studies: The summary explicitly states "Discussion on Clinical Tests Performed: Not Applicable." This means no human subject trials or clinical performance evaluations were conducted or provided in this 510(k) submission to assess the device's accuracy or effectiveness in a patient population.
Ground Truth: For non-clinical testing, ground truth would be established by the physical or simulated reference values and methods specified within the compliance standards.
No AI/Machine Learning Aspects: The device is a traditional multi-parameter patient monitor, and there is no indication of AI, machine learning, training sets, or comparative effectiveness studies involving human readers and AI assistance.

Summary

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510(k) Summary -- K112877

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. 510(k) Applicant Information:

Name:	Shenzhen Comen Medical Instruments Co., Ltd.
Address:	South of Floor 7, Block 5 & Floor 6, Block 4, 4th Industrial Area of Nanyou, Nanshan District, Shenzhen, Guangdong, 518052, P.R. China
Phone:	86-755-26431236
Fax:	86-755-26431232
Contact:	Henry Duan
Title:	Regulations Manager
Date Submitted:	10/18/2012

Device Name:

Trade Name:	COMEN Multi-Parameter Patient Monitor C50, C60 and C80
Common Name:	Monitor, Physiological, Patient
Device Classification:	Class II
Classification Reference:	21 CFR 870.2300, Cardiac monitor (including cardiotachometer and rate alarm)
Product Code:	MWI

3. Predicate Device:

The legally marketed devices to which the submitter claims equivalence:

Goldway UT4000F Patient Monitor (K021154) Goldway UT4000A Vital Signs Monitor (K033988) VS-800 Vital Signs Monitor (K060281) PM-9000 Express Patient Monitor (K070791) OxiMax N-560 Pulse Oximeter (K021090)

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K112877

4. Device Description:

COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.

5. Intended Use:

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

Predicate Devices: 6.

The Substantial Equivalence of the subject device of this 510(k) notification COMEN C series (the "subject devices"), is claimed to Goldway UT4000F Patient Monitor, Goldway UT4000A Vital Signs Monitor, PM-9000 Express Patient Monitor, VS-800 Vital Signs Monitor, and OxiMax N-560 Pulse Oximeter (the "predicate devices").

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The subject devices are Substantially Equivalent (SE) to the predicate devices with respect of effectiveness and safety.

7. Discussion on Non-Clinical Tests Performed:

COMEN C series meet the following standards:

IEC 60601-1-2 IEC 60601-2-30 IEC 60601-2-27 EN1060-1 EN1060-3 EN1060-4 EN60601-2-49 EN 60601-1 AAMI EC13 ISO10993-1 ASTM E1112-00 ISO 9919 150 80601-2-56

A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.

Discussion on Clinical Tests Performed:

Not Applicable

9. Conclusion:

COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 are substantially equivalent to, and as safe, as effective as, the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV. 7 2012

Shenzhen Comen Medical Instruments Co., Ltd. c/o Mr. Jimmy Wu Lee & Xiao 2600 Mission St., Suite 100 San Marino, CA 91108

Re: K112877

Trade/Device Name: Comen Multi-Parameter Patient Monitor, Model C50, C60, and C80 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: MWI, DPS, DXN, DQA, FLL Dated: October 18, 2012 Received: October 23, 2012

Dear Mr. Wu :

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.

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

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Page 2 - Mr. Jimmy Wu, Attorney

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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): K112877

Device Name: Comen Multi-Parameter Patient Monitor Models C50, C60, C80

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Eyaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K112877

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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).