PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D

K090671 · Contec Medical System Co., Ltd. · DQA · Jun 11, 2009 · Cardiovascular

Device Facts

• Record ID: K090671
• Device Name: PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
• Applicant: Contec Medical System Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

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 Story

Fingertip pulse oximeter; non-invasive; measures SpO2 and pulse rate via finger sensor. Device provides immediate screen readout. Used in home and hospital environments (internist, surgery, anesthesia, intensive care) by clinicians or patients. Output informs clinical decision-making regarding patient oxygenation status. Benefits include convenient, portable, low-power monitoring.

Clinical Evidence

Bench testing only. Laboratory testing conducted to validate and verify that the device met all design specifications, including electrical safety and EMC.

Technological Characteristics

Fingertip form factor; non-invasive optical sensing; low power consumption. Device is battery-operated. No specific materials or software architecture details provided.

Indications for Use

Indicated for adult patients requiring spot-check or continuous monitoring of SpO2 and pulse rate in home and hospital settings. Not for single use or out-of-hospital transport.

Regulatory Classification

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.

Predicate Devices

• Pm-60 Pulse Oximeter (K072581)

Submission Summary (Full Text)

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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:[phone] Fax: [phone] Email: [e-mail]

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: [phone] Fax: [phone] Email: [e-mail]

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 Oximeter<br>K072581 |
| Device Description | The Fingertip Pulse Oximeter is tiny, and with low power<br>consumption, convenient to use and carry. You just need to<br>put the fingertip into the sensor of the device, the SpO2 value<br>will appear on the screen immediately. |
| Test Conclusion | Laboratory testing was conducted to validate and verify that<br>the 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

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.

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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 [phone] or [phone] 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:

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.

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