PULSE OXIMETER CMS50EW by CONTEC MEDICAL SYSTEMS CO., LTD.

The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.

Device Description

The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology.

The proposed device is composed of power module, signal acquisition module, control and signal processing module. The power source of it is a built-in rechargeable lithium battery. And it has alarm function, to raise the user's attention for exceeding of physiological limit and device error via visual and audio alarming indicator. And the pulse oximeter can communicate with computer by USB data wire and Bluetooth.

The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry technology including the sensor was unchanged.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Contec Medical Systems Co., Ltd.'s Pulse Oximeter CMS50EW, which is seeking substantial equivalence to its predicate device, the Pulse Oximeter CMS50E (K090671). The key modification is the addition of Bluetooth functionality, while the oximetry technology and sensor remain unchanged.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily in the context of performance specifications for SpO2 and Pulse Rate (PR) measurement, which are identical to the predicate device. The "reported device performance" is implicitly that the device meets these existing specifications due to the unchanged oximetry technology.

Metric	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed)
SpO2 Accuracy	70%~~100%: ±2%, 0~~69%: unspecified (Same for predicate)	70%~~100%: ±2%, 0~~69%: unspecified (Identical to predicate)
SpO2 Range	0%-100% (Same for predicate)	0%-100% (Identical to predicate)
PR Measurement Range	30bpm~250bpm (Same for predicate)	30bpm~250bpm (Identical to predicate)
PR Accuracy	±2bpm or ±2% (select the larger) (Same for predicate)	±2bpm or ±2% (select the larger) (Identical to predicate)
Electrical Safety	Comply with IEC 60601-1 (Same for predicate)	Complies with IEC 60601-1
EMC	Comply with IEC 60601-1-2 (Same for predicate)	Complies with IEC 60601-1-2
Wireless Function	Complies with FDA guidance for Radio Frequency Wireless Technology	Wireless transmission performance, data integrity, wireless coexistence, and security of wireless data complied with acceptance criteria.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical testing was not necessary in this submission to support the device modification because the oximetry technology including the sensor is unchanged from the predicate device."

Therefore, there is no information provided regarding a specific clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) for this device modification. The equivalence is based on the predicate device's established performance and non-clinical testing for the new Bluetooth functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical testing was deemed necessary for the oximetry performance, there is no mention of experts establishing ground truth for a test set related to SpO2 or PR accuracy for the CMS50EW. Any such data would pertain to the original clearance of the predicate device (K090671) and is not detailed here.

4. Adjudication method for the test set

Not applicable, as no clinical test set for oximetry performance was performed for this submission.

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

Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

This refers to the performance of the device's core functionality (SpO2 and PR measurement). The device's performance is standalone in the sense that it provides direct measurements. The non-clinical tests conducted (IEC standards, wireless transmission tests) assess this standalone performance. No detailed "algorithm only" performance separate from the device's integrated operation is described in a way that suggests a disaggregated study.

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

For the SpO2 and PR measurements, the ground truth would typically be established by established measurement techniques (e.g., co-oximetry for SpO2, ECG for heart rate) during the original clinical validation of the predicate device. However, this specific submission does not detail the ground truth methodology for this device because it relies on the predicate's established oximetry technology. For the new wireless functionality, the "ground truth" would be the expected technical specifications and performance indicators for wireless transmission.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense. The device's oximetry technology is formula-based, using the Lambert-Beer Law.

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

Not applicable for the same reason as point 8. The device's operation is based on established biophysical principles and calibrated with known values, not trained on a dataset.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

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

April 23, 2015

Contec Medical Systems Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China

Re: K141362

Trade/Device Name: Pulse Oximeter CMS50EW Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 18, 2015 Received: March 23, 2015

Dear Ms. Hong:

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.

{1}------------------------------------------------

Page 2 - Ms. Hong

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 devicerelated 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 contact the Division of Industry and Consumer Education 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 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 yours,

Tejashri Purohit-Sheth, M.D. Tejash

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141362

Device Name Pulse Oximeter CMS50EW

Indications for Use (Describe)

The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of noninvasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.

	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

PRAStaff@fda.hhs.gov

"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."

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

ing the

{3}------------------------------------------------

Tab #1 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K141362

1. Date of Submission: 04/20/2015
1. Sponsor Identification

Contec Medical Systems Co., Ltd No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.

Establishment Registration Number: 3006979678

Contact Person: Xueyong Li Position: Quality Manager Tel: 86 355 8015489 Fax: 86 355 8015490 Email: lxy1011@163.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

{4}------------------------------------------------

1. Proposed Device Identification
  Proposed Device Name: Pulse Oximeter CMS50EW Proposed Device Model: CMS50EW Proposed Device Common Name: Pulse Oximeter

Regulatory Information: Classification Name: Oximeter; Classification: 2; Product Code: DQA; Regulation Number: 870.2700; Review Panel: Anesthesiology;

Intended Use Statement:

న్. Predicate Device Identification

510(k) Number: K090671 Product Name: Pulse Oximeter CMS50E Manufacturer: Contec Medical Systems Co., Ltd

1. Device Description
  The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology.

The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry

{5}------------------------------------------------

technology including the sensor was unchanged.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) + AM1 (2012), Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance.
A IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
A ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

In addition, wireless transmission function test, including wireless transmission performance, data integrity, wireless coexistence, and security of wireless data, was conducted per the FDA guidance, Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued on January 3, 2007. The test results complied with the acceptance criteria.

1. Clinical Test
  Clinical testing was not necessary in this submission to support the device modification because the oximetry technology including the sensor is unchanged from the predicate device.
Substantially Equivalent (SE) Conclusion 9.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device	Predicate Device
Product Code	DQA	Same
Regulation No.	21 CFR 870.2700	Same
Class	2	Same
Intended Use	The Pulse Oximeter CMS50EW is a non-invasive deviceintended for spot-check or continuous monitoring ofnon-invasive oxygen saturation of arterial hemoglobin	Same
	(SpO2) and the pulse rate through the finger of adultpatients in home and hospital environments (includingclinical use internist/surgery, anesthesia, and intensivecare settings). The device is reusable and not intended forout-of-hospital transport use.
Features	%SpO2 and PR measurement,Pulse bar, Alarm function,Bluetooth	%SpO2 and PRmeasurement,Pulse bar, Alarmfunction, no Bluetoothfunction.
Principles of operation	An experience formula of data process is establishedtaking use of Lambert Beer Law according to SpectrumAbsorption Characteristics of Reductive Hemoglobin(Hb) and Oxyhemoglobin (HbO2) in glow &near-infrared zones. Operation principle of the device is:Photoelectric Oxyhemoglobin Inspection Technology isadopted in accordance with Capacity Pulse Scanning &Recording Technology, so that two beams of differentwavelength of lights can be focused onto human nail tipthrough perspective clamp finger-type sensor. Thenmeasured signal can be obtained by a photosensitiveelement, information acquired through which will beshown on screen through treatment in electronic circuitsand microprocessor.	Same
Measurement wavelength	Red: 660nmInfrared: 880nm	Same
SpO2 range	0%-100%	Same
SpO2 accuracy	70%~~100%:±2%, 0~~69%,unspecified	Same
PR measurement range	30bpm~250bpm	Same
PR accuracy	$±2bpm$ or $±2%$ (select the larger)	Same
Patient Contact	Silicone	Same
Material
Electrical Safety	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2	Same
Label and Labeling	Meet FDA's Requirements	Same

Table 1 Comparison of Technology Characteristics

{6}------------------------------------------------

{7}------------------------------------------------

Based on the comparison above, the proposed device, Pulse Oximeter CMS50EW, is determined to be Substantially Equivalent (SE) to the predicate device, Pulse Oximeter CMS50E (K090671).

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).