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

Device Description

The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, beyond general statements about testing. The document is primarily a 510(k) summary for a Pulse Oximeter (CMS-50E), focusing on its substantial equivalence to a predicate device and its intended use.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided excerpt.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in detail beyond general compliance.	Not specified in detail beyond general compliance.
Electrical safety	Met design specifications (stated in "Test Conclusion")
EMC	Met design specifications (stated in "Test Conclusion")
Other specifications	Met all design specifications (stated in "Test Conclusion")

Missing Information: Specific numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, resolution, measurement range, alarm limits, etc., as well as the exact performance metrics achieved by the device against these criteria.

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

Sample Size: Not specified.
Data Provenance: Not specified. It's implied that "Laboratory testing was conducted" to validate performance, but details about the origin of data (e.g., country, retrospective/prospective) are absent.

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

Not applicable/Not specified. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using a reference device (e.g., co-oximeter for SpO2) and not by expert human interpretation of images or signals. The text does not mention any expert involvement in establishing ground truth.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology studies). For a pulse oximeter, the comparison would be against a reference standard.

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, which directly measures physiological parameters. It is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

Yes, implicitly. The "Test Conclusion" states "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications," which implies direct testing of the device's performance (standalone) against its specifications. The device itself operates autonomously to measure SpO2 and pulse rate.

7. The type of ground truth used:

Not explicitly stated, but for a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using reference medical devices. For SpO2, this often involves a co-oximeter (a device that measures the actual ratio of oxygenated hemoglobin to total hemoglobin in a blood sample). For pulse rate, an ECG or an accurate reference pulse oximeter would commonly be used.

8. The sample size for the training set:

Not applicable. This is a measurement device, not an AI/ML algorithm that requires a training set.

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

Not applicable. (As above, no training set for this type of device.)

Summary of what is present in the document:

The device is a non-invasive pulse oximeter for spot-check or continuous monitoring of SpO2 and pulse rate.
It's intended for adult patients, used through the finger, in home and hospital environments.
Laboratory testing was conducted to validate and verify that the device met all design specifications, including electrical safety and EMC.
The FDA determined the device to be substantially equivalent to the predicate device (Pm-60 Pulse Oximeter, K072581).

Summary

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510(k) Summary KOQ67) Section 3

As required by 807.97

The assigned 510(k) Number is

Sponsor

Contec Medical Systems Co., Ltd No. 24, West Huanghe Road Qinhuangdao, Hebei, 066000, China

Mr. Li Xueyong, Quality Manager Tel:+86-335-8015490 Fax: +86-335-8015505 Email: lxyong1011@163.com

Submission Correspondent Ms. Diana Hong / Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd Sute 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: 760-466-5084 Email: diana.hong@mid-link.net

JUN 11 2009

Proposed Product
Trade Name	Pulse Oximeter
Model	CMS-50E
Product Code:	DQA
Regulation Number:	21 CFR 870.2700
Device Class:	Class II
Submission Purpose:	New Device
Predicate Device:	Pm-60 Pulse OximeterK072581
Device Description	The Fingertip Pulse Oximeter is tiny, and with low powerconsumption, convenient to use and carry. You just need toput the fingertip into the sensor of the device, the SpO2 valuewill appear on the screen immediately.
Test Conclusion	Laboratory testing was conducted to validate and verify thatthe proposed devices met all design specifications, including

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SE Determination

Use/Indication for Use

Intended

proposed device, Fingertip Pulse Oximeter, The is substantially equivalent (SE) to the predicate device Pm-60 Pulse Oximeter (K072581).

electrical safety, EMC, specifications.

CMS50E

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

JUN 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contec Medical System Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion, No 19, Lane 999, Zhong Shan, Shanghai CHINA 200030

Re: K090671

Trade/Device Name: CMS50E Fingertip Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 13. 2009 Received: March 13, 2009

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.

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.

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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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Gunner

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication For Use

510(k) Number (if known):

Device Name: _CMS50E Fingertip Pulse Oximeter

Indications for Use:

Prescription Use __ (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultr

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: k O

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).