FINGERTIP PULSE OXIMETER

K112804 · Guangdong Biolight Meditech Co., Ltd. · DQA · Jan 27, 2012 · Cardiovascular

Device Facts

• Record ID: K112804
• Device Name: FINGERTIP PULSE OXIMETER
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Fingertip Pulse Oximeters M70A, M70C and M70D, are intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospital type facilities as well as in the home care environment. The oximeters are not suitable to monitor patient continuously for long term.

Device Story

Fingertip pulse oximeter (models M70A, M70C, M70D) measures functional arterial oxygen saturation (SpO2) and pulse rate. Device clips onto patient's finger; uses optical sensors to detect pulse and oxygen levels; displays %SpO2, pulse rate, and waveform pulse amplitude bar. Used in hospital or home care environments by patients or clinicians. Provides spot-check measurements; not intended for continuous long-term monitoring. Output assists healthcare providers in assessing patient oxygenation status.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance similarities to the predicate device.

Technological Characteristics

Fingertip form factor; optical sensing principle for SpO2 and pulse rate; battery-operated; digital display of SpO2, pulse rate, and pulse amplitude bar. Models M70A, M70C, and M70D share identical internal configuration and performance specifications.

Indications for Use

Indicated for adult patients in hospital or home care settings to measure functional arterial oxygen saturation (SpO2) and pulse rate. Not for continuous long-term monitoring.

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

• M70 Fingertip Pulse Oximeter (K081712)

Submission Summary (Full Text)

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Premarket Notification 510(k) Submission Section III 510(k) Summary Project #: M0302011Aa

#### Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K | | 2 80

- 1. Date of Submission: September 26, 2011
- 2. Sponsor

..............................................................................................................................................................................

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast, Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Mr. Tianbao Li Position: Chief Engineer Tel: [phone] Fax: [phone] Email: li [e-mail]

- 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
Proposed Device Identification 4.

> Proposed Device Name: Fingertip Pulse Oximeter Proposed Device Model: M70A, M70B, M70C, M70D

Classification: Class II

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Premarket Notification 510(k) Submission Section III 510(k) Summary Project #: M0302011Aa

Product Code: DQA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

### Intended Use Statement:

Con

The Fingertip Pulse Oximeters M70A, M70C and M70D, are intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospital type facilities as well as in the home care environment.

The oximeters are not suitable to monitor patient continuously for long term.

- ડ. Predicate Device Identification
## 510(k) Number: K081712 Product Name: M70 Fingertip Pulse Oximeter Manufacturer: Guangdong Biolight Meditech Co., Ltd

#### Device Description 6.

The proposed devices of Fingertip Pulse Oximeters M70A, M70C and M70D are fingertip devices, which can display %SpO2, pulse rate value, waveform pulse amplitude bar indication.

The four models share the same configuration, function, intended use, safety and performance, the only difference is external appearance.

#### 7. Substantially Equivalent Conclusion

The proposed devices, Fingertip Pulse Oximeters M70A, M70C and M70D, are determined to be Substantially Equivalent (SE) to the predicate device, M70 Fingertip Pulse Oximeter (K081712), in respect of safety and effectiveness.

[II-2

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### Public Health Service

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

Guangdong Biolight Meditech Company Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

JAN 2 7 2012

Re: K112804

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: December 28, 2011 Received: December 29, 2011

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 Eederal 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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ler Ankeny J. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Section II Indications for Use

510(k) Number:

Device Name: Fingertip Pulse Oximeter

Indications for Use:

The Fingertip Pulse Oximeters M70A, M70C and M70D, are intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospital type facilities as well as in the home care environment.

The oximeters are not suitable to monitor patient continuously for long term.

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510(k) Number: k112804

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

## DOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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