FINGERTIP PULSE OXIMETER

K141128 · Beijing Choice Electronic Technololgy Co., Ltd. · DQA · Aug 13, 2014 · Cardiovascular

Device Facts

• Record ID: K141128
• Device Name: FINGERTIP PULSE OXIMETER
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip Pulse Oximeter MD300CL37 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities, and home environments.

Device Story

Battery-powered fingertip pulse oximeter; detects and displays SpO2 and pulse rate. Uses dual-wavelength LED (660nm red, 940nm infrared) and photodetector to measure light absorption in pulsating arteriolar vascular bed. Device automatically powers on when finger is inserted; powers off after 8 seconds of no signal. Used by clinicians or patients for spot-checking in hospitals, clinics, or home. Output displayed on OLED screen. Provides non-invasive physiological monitoring to assist in assessing oxygenation status.

Clinical Evidence

Prospective clinical study with 12 healthy adult volunteers (ages 21-33). Subjects underwent induced hypoxia (70-100% SaO2) under steady-state conditions. Accuracy compared against reference CO-Oximetry. Results demonstrated SpO2 accuracy within ±3% over the 70-100% range. No adverse events reported.

Technological Characteristics

Battery-powered (2 AAA) fingertip device. Materials: ABS plastic enclosure, laser-etched medical silicone gel cushion. Sensing: Dual-wavelength (660nm/940nm) LED and photodetector. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult, adolescent, child, and infant patients in hospitals, hospital-type facilities, and home environments.

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 MD300CF315 (K123871)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

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

August 13, 2014

Beijing Choice Electronic Technology Co., Ltd. Mr. Lei Chen North Building 3F, No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District, Beijing, P.R. China, 100041

Re: K141128

Trade/Device Name: Fingertip Pulse Oximeter MD300CL37 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 13, 2014 Received: May 15, 2014

Dear Mr. Chen:

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 - Mr. Chen

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

### Mary S. Runner -S

Erin I. Keith, M.S. 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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# Section II Indications for Use Statement

### Indications for Use

510(k) Number (if known): Device Name: Fingertip Pulse Oximeter MD300CL37

Indications for Use:

The Fingertip Pulse Oximeter MD300CL37 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities, and home environments.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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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# Section III 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92

There is no prior submission for the device.

#### 3.1Submitter Information

#### ● Manufacturer Name:

Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 320,West Building 4, No.83 FuXing Road Beijing 100039, P.R.China

#### ● Contact Person:

Mr.Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: [phone] Ext 6020 Fax:[phone] Email: [e-mail]

#### ● Date prepared: Mar.25, 2014

#### 3.2Proposed Device Information

Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CL37 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology

#### 3.3Predicate Device

510(k) Number: K123871 Common Name: Pulse Oximeter

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Premarket Notification 510(k) Submission—Section III 510(k) Summary Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CF315 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Device Class: II Panel: Anesthesiology Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

### 3.4Device Description

The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface.

The Pulse Oximeter 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 660nm, which is red light; the other is 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically.

The proposed 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.

The device is software-driven and the software validation is provided in Section of Software.

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## 3.5 Comparison list of the technological characteristics

| Comparison Elements | Proposed Device | Predicate Device | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter(K123871) | |
| Model | MD300CL37 | MD300CF315 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | II | II | |
| Classification Name | Oximeter | Oximeter | |
| Product Code | DQA | DQA | |
| Indications for Use | The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of arterial hemoglobin oxygen saturation(SpO2) and pulse rate of adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments. | The Fingertip Pulse Oximeter is a portable, non-invasive device intended for spot checking of 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 etc). | |
| Comparison Statement | The proposed device has the same indications for use and classification as the predicate device. | | |
| | device. | | |
| Components | The proposed device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit. | |
| Design Principle | The pulse oximeter works by applying a | The pulse oximeter works by applying a | |
| | | sensor to a pulsating arteriolar vascular bed.<br>The sensor contains a dual light source and<br>photo detector. The one wavelength of light<br>source is 660 nm, which is red light; the other<br>is 940 nm, which is ultra red light. Skin, bone,<br>tissue, and venous vessels normally absorb a<br>constant amount of light over time. The photo<br>detector in finger sensor collects and converts<br>the light into electronic signal which is<br>proportional to the light intensity. The<br>arteriolar bed normally pulsates and absorbs<br>variable amounts of light during systole and<br>diastole, as blood volume increases and<br>decreases. The ratio of light absorbed at<br>systole and diastole is translated into an<br>oxygen saturation measurement. This<br>measurement is referred to as SpO2. | sensor to a pulsating arteriolar vascular bed.<br>The sensor contains a dual light source and<br>photo detector. The one wavelength of light<br>source is 660 nm, which is red light; the<br>other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels<br>normally absorb a constant amount of light<br>over time. The photo detector in finger<br>sensor collects and converts the light into<br>electronic signal which is proportional to the<br>light intensity. The arteriolar bed normally<br>pulsates and absorbs variable amounts of<br>light during systole and diastole, as blood<br>volume increases and decreases. The ratio of<br>light absorbed at systole and diastole is<br>translated into an oxygen saturation<br>measurement. This measurement is referred<br>to as SpO2. |
| Measurement<br>Wavelength | Red | 660nm | 660nm |
| | Infrared | 940nm | 940nm |
| Comparison Statement | | The proposed device has the same design and similar components as the predicate<br>device. | |
| Device<br>specification | Display Type | OLED | |
| | Power Supply | 2 AAA-size alkaline batteries | |
| | Display Data | SpO2 , PR | |
| | SpO2<br>display | 0~99% | |
| | | | |
| | range | | |
| | Measurement<br>range | 70-99% | 70~99% |
| | Accuracy | 70%~99%: ±3%;<br>0%~69% no definition | 70%~99%: ±3%;<br>0%~69% no definition |
| | Resolution | 1% | 1% |
| | PR display range | 0~235BPM | 0~254BPM |
| | PR measurement<br>range | 30-235 BPM | 30-235 BPM |
| | PR Accuracy | 30~99bpm, ±2bpm; 100~235bpm, ±2% | 30~99bpm, ±2bpm; 100~235bpm,<br>±2% |
| | Resolution | 1bpm | 1bpm |
| | Operating<br>Temperature | 5~40°C | 5~40°C |
| | Storage<br>Temperature | -25~+70°C | -20~55°C |
| | Relative<br>Humidity | 15%~93% in operation<br>≤93% in storage | ≤80% in operation<br>≤93% in storage |
| | Atmosphere<br>pressure | 86kPa~106kPa | 86kPa~106kPa |
| | Low Power<br>Beep Tip<br>Function | No | Yes |
| | Automatically<br>powered on | Yes | No |
| Comparison Statement | | The applicant device has similar device specifications as the predicate device | |
| Construction | Battery Cover | ABS | ABS…