PULSE OXIMETER CMS50EW

K141362 · Contec Medical Systems Co.,Ltd · DQA · Apr 23, 2015 · Cardiovascular

Device Facts

• Record ID: K141362
• Device Name: PULSE OXIMETER CMS50EW
• Applicant: Contec Medical Systems Co.,Ltd
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

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 Story

Battery-powered fingertip pulse oximeter; measures SpO2 and pulse rate via photoelectric oxyhemoglobin inspection technology. Uses two light wavelengths (660nm red, 880nm infrared) focused on finger nail tip; photosensitive element captures signal; microprocessor processes data based on Lambert-Beer Law. Displays SpO2, pulse rate, and pulse strength; includes visual/audio alarms for physiological limits and errors. Used in home and hospital environments by clinicians or patients. Communicates via USB or Bluetooth to external computers. Modification of predicate CMS50E adds Bluetooth functionality; core oximetry technology remains unchanged.

Clinical Evidence

No clinical data. Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-61 verified. Wireless transmission performance, data integrity, coexistence, and security tested per FDA guidance.

Technological Characteristics

Battery-powered fingertip device; silicone patient contact material. Sensing: Photoelectric oxyhemoglobin inspection (660nm/880nm). Connectivity: USB and Bluetooth. Safety: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61. SpO2 range 0-100%; PR range 30-250bpm.

Indications for Use

Indicated for adult patients requiring spot-check or continuous monitoring of SpO2 and pulse rate in home and hospital settings, including surgery, anesthesia, and intensive care.

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

• Pulse Oximeter CMS50E (K090671)

Submission Summary (Full Text)

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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.

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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 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 [phone] or [phone] 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 [phone] or [phone] 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

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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.

| <div><span style="text-decoration: underline;"> </span></div> | <div><span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
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| <div><span style="text-decoration: underline;"> </span></div> | <div><span style="text-decoration: underline;"></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
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Type of Use (Select one or both, as applicable)

ing the

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## 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. 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:

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.

## న్. Predicate Device Identification

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

- 6. 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

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technology including the sensor was unchanged.

- 7. 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.

- 8. 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 device<br>intended for spot-check or continuous monitoring of<br>non-invasive oxygen saturation of arterial hemoglobin | Same |
| | (SpO2) and the pulse rate through the finger of adult<br>patients in home and hospital environments (including<br>clinical use internist/surgery, anesthesia, and intensive<br>care settings). The device is reusable and not intended for<br>out-of-hospital transport use. | |
| Features | %SpO2 and PR measurement,<br>Pulse bar, Alarm function,<br>Bluetooth | %SpO2 and PR<br>measurement,<br>Pulse bar, Alarm<br>function, no Bluetooth<br>function. |
| Principles of operation | An experience formula of data process is established<br>taking use of Lambert Beer Law according to Spectrum<br>Absorption Characteristics of Reductive Hemoglobin<br>(Hb) and Oxyhemoglobin (HbO2) in glow &<br>near-infrared zones. Operation principle of the device is:<br>Photoelectric Oxyhemoglobin Inspection Technology is<br>adopted in accordance with Capacity Pulse Scanning &<br>Recording Technology, so that two beams of different<br>wavelength of lights can be focused onto human nail tip<br>through perspective clamp finger-type sensor. Then<br>measured signal can be obtained by a photosensitive<br>element, information acquired through which will be<br>shown on screen through treatment in electronic circuits<br>and microprocessor. | Same |
| Measurement wavelength | Red: 660nm<br>Infrared: 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

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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.

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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).