MD300C1 FINGERTIP PULSE OXIMETER

K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · DQA · Mar 3, 2010 · Cardiovascular

Device Facts

• Record ID: K093757
• Device Name: MD300C1 FINGERTIP PULSE OXIMETER
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MD300C1 Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

Device Story

Fingertip pulse oximeter; measures SpO2 and pulse rate via non-invasive optical sensor. Device uses dual-wavelength LEDs (660 nm red, 940 nm ultra-red) and photodetector to measure light absorption in pulsating arteriolar vascular bed. CPU calculates SpO2 based on ratio of light absorption during systole and diastole. Operated by clinicians or patients for spot-checks in home or hospital environments. Features low battery alarm and auto-power-off. Output displayed on integrated unit; assists healthcare providers in assessing patient oxygenation status. Benefits include portable, non-invasive monitoring without need for continuous observation.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 9919 (pulse oximeter performance), and ISO 10993 (biocompatibility). Software validation performed per FDA guidance.

Technological Characteristics

Fingertip form factor; dual-wavelength LED (660nm/940nm) sensor; CPU-based signal processing; powered by 2 AAA batteries. Reusable transducer; non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, ISO 9919, and ISO 10993.

Indications for Use

Indicated for adult and pediatric patients for non-invasive, spot-check measurement of arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Used in home and hospital settings (e.g., surgery, anesthesia, intensive care). Not for continuous 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

• Fingertip Pulse Oximeter model MD300C (K070371)

Submission Summary (Full Text)

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K093757

# 510(k) Summary

# MAR - 3 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: Pending

## 1. Submitter Information

- . Manufacturer Name and Address: Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B, Rm. 1127-1128, Fuxing Road, A36 Beijing, China 100039
Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road., Badachu Hi-tech Zone, Shijingshan District Beijing, China 100041

#### ● Contact Person:

Ms. Yajing Li North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: [phone] x 6046 Fax:[phone] Email: [e-mail] & [e-mail]

- . Date prepared: October 22, 2009
#### 2. Applicant Device Information

- Trade/Proprietary Name: MD300C1 Fingertip Pulse Oximeter ●
- . Common Name: Pulse Oximeter
- Classification: 21CFR 870.2700 Oximeter Class: II

# 3. Legally Marketed Predicate Device

Fingertip Pulse Oximeter model MD300C K-number: K070371 Beijing Choice Electronic Technology Co., Ltd

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# 4. Device Description

The applicant device of MD300C1 Fingertip Pulse Oximeter is a fingertip device, which can display % SpO2, pulse rate value.

The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit.

The Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and p venous vessels normally absorb a constant amount of light over time. The photodetector in fingersensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

#### 5. Intended use

MD300C1 Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

### 6. Effectiveness and Safety Considerations

The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -.

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Requirements and tests.

The applicant device is compliance with ISO 9919, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".

# 7. Substantially Equivalence Determination

The applicant device MD300C1 Fingertip Pulse Oximeter has same classification information, same intended use, same design principle, same product materials and performance effectiveness as the predicate device. These are no obvious differences to influence the effectiveness and safety of the device.

# 8. Conclusion

The applicant device MD300C1 Fingertip Pulse Oximeter is Substantially Equivalent (SE) to the predicate device which is US legally market device. Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices. Therefore, the applicant device is determined as safe and effectiveness.

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Image /page/3/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol consisting of three overlapping shapes that resemble a human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Yajing Li Beijing Choice Electronic Technology Company, Limited North Building 3F, No. 9 Shuangyuan Road Badachu Hi-tech Zone, Shijingshan District Beijing CHINA 100041

MAR - 3 2010

Re: K093757

Trade/Device Name: MD300C1 Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 4, 2010 Received: February 4, 2010

Dear Ms. Li:

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 vour 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. Li

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.html 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,

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

Enclosure

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# Indication for Use

510(k) Number (if known): __ Pending

Device Name: __MD300C1 Fingertip Pulse Oximeter

Indications for Use:

MD300C1 Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

L. Schulten

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

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510(k) Number: K093757