HANDHELD PULSE OXIMETER MODEL M800

K101694 · Guangdong Biolight Meditech Co., Ltd. · DQA · Sep 8, 2010 · Cardiovascular

Device Facts

• Record ID: K101694
• Device Name: HANDHELD PULSE OXIMETER MODEL M800
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.

Device Story

Handheld pulse oximeter; inputs SpO2 and pulse rate via LED/detector sensor; processes signals via internal CPU/driving circuit; outputs data to OLED display (waveform, %SpO2, pulse rate, pulse amplitude) and speaker (audible alarms/indicators). Used by clinicians or patients in hospitals, clinics, or home environments. Provides real-time monitoring and alarm functionality for physical parameters (user-settable limits) and technical status. Assists healthcare providers in assessing patient oxygenation status for clinical decision-making.

Clinical Evidence

Bench testing only. Verification tests performed per risk management protocols demonstrated that risks associated with design changes (OLED display, alarm functionality, speaker) were reduced to acceptable levels.

Technological Characteristics

Handheld device; OLED display; speaker for audio alerts; LED emitter/detector sensor; CPU-based processing; battery-powered. Features include physical parameter and technical alarming. No specific material standards or software architecture details provided.

Indications for Use

Indicated for spot checking functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients in hospital, hospital-type, and home care settings.

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

• M700 Handheld Pulse Oximeter (K081712)

Submission Summary (Full Text)

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Premarket Notification Special Section 510(k) Submission Report SN: JN00520100609FDA Submission Date: 11 JUN 2010

Exhibit #3 510(k) Summary

Image /page/0/Picture/3 description: The image shows the number K101694 at the top. Below the number is a logo with the letters BLT and the word BIOLIGHT. The logo also contains a graphic of a plant with three leaves.

Exhibit #3 510(k) Summary

SEP 0 8 2010

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

## The assigned 510(k) Number is: K101694

| Date of Preparation | 11 JUN 2010 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Guangdong Biolight Meditech Co., Ltd [Reg #:3007305624]<br>Innovation First Road, Technology Innovation Coast<br>Zhuhai, Guangdong, 519085, China<br>Contact Person: Mr. Tianbao Li, Chief Engineer<br>Tel: [phone] Fax: [phone] E-mail: [e-mail] |
| Submission<br>Correspondent | Ms. Diana Hong / Mr. Lee Fu<br>Shanghai Mid-Link Business Consulting Co., Ltd<br>Suite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China<br>T: [phone] F: 240-238-7587 E: [e-mail] |
| Proposed Device | M800 Handheld Pulse Oximeter<br>Modification to: M700 Handheld Pulse Oximeter (K081712) as predicate device<br>21 CFR 870.2700 DQA Class II |
| Intended Use | M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial<br>oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in<br>hospital, hospital type facilities as well as in the home care environment. |
| Device Description | The proposed device is a handheld device, which can display %SpO2, waveform,<br>pulse rate value, pulse amplitude bar indication. It consists of detector and emitter<br>LED, OLED display module, CPU, driving circuit, power supply circuit and battery.<br>In addition, it has alarming function including physical parameter alarming and<br>technical alarming. The physical alarming limit can be set by user. The modifications<br>to M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List on<br>the next page. |
| Test Summary | Per the risk management during the design change control, the verification tests<br>performed demonstrated that risks of each hazard are reduced to acceptable region. |
| Conclusion | The information in this 510(k) Summary demonstrate that the proposed device,<br>M800 Handheld Pulse Oximeter, is Substantially Equiavlent (SE) to the predicate<br>device, M700 Handheld Pulse Oximeter (K081712), with respect of effectiveness<br>and safety. |

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Premarket Notification Special Section 510(k) Submission

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Report SN: JN00520100609FDA Submission Date: 11 JUN 2010

Exhibit #3
510(k) Summary

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Image /page/1/Picture/3 description: The image shows a logo with the letters "BLT" in bold, black font on the left side. Above the letters, there is a stylized graphic of a person with their arms raised. To the right of "BLT", there are Chinese characters, followed by the word "BIOLIGHT" in bold, black font. The logo appears to be for a company or organization called "Biolight".

| Table 5-4 Modifications List | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | M700 Handheld Pulse Oximeter<br>(Predicate/Existed) | M800 Handheld Pulse Oximeter<br>(Proposed / Modified) |
| Display | LED Display, which can display the following information:<br>Pulse Rate<br>SpO2<br>Pulse Strength<br>System Information<br>Status Information. | OLED Display, which can display the following information:<br>Pulse Rate<br>SpO2<br>Pulse Strength<br>System Information<br>Status Information.<br><br>In addition, it can display:<br>SpO2 waveform, Alarming Limit and<br>Alarming Information. |
| Audio | Beeper, which can audio indicate the followings:<br>Sensor Detachment Indicating;<br>Pulse Indicating;<br>Key Pressing Indicating;<br>Low Voltage Indicating; | Speaker, which can audio indicate the followings:<br>Sensor Detachment Indicating;<br>Pulse Indicating;<br>Key Pressing Indicating;<br>Low Voltage Indicating;<br><br>In addition, it can indicate: Starting<br>and Alarming. |
| Alarming | Without Alarming Function | With Alarming Function |

Table 3-1 Modifications List

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circular border.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 Shanghai Midlink Business Consulting Company, Limited Suite 5D, No. 19, Lane 999 Zhongshan Road (S-2) Shanghai China 200030

SEP 0 8 2010

Re: K101694

Trade/Device Name: M800 Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 11, 2010 Received: August 11, 2010

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

Enclosure

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,

Jawed for

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

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Premarket Notification Special Section 510(k) Submission Report SN: JN00520100609FDA Submission Date: 11 JUN 2010

Section III Indication for Use Form

K101694

**BLT. BIOLIGHT** 廣萊特

SEP 0 8 2010

Section III Indication for Use Form

510(k) NUMBER (if known):

DEVICE NAME: M800 Handheld Pulse Oximeter

## INDICATION FOR USE:

M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-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)

Z. Schulten

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

510(k) Number: K101694

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