FINGERTIP PULSE OXIMETER

K123871 · Beijing Choice Electronic Technololgy Co., Ltd. · DQA · May 10, 2013 · Cardiovascular

Device Facts

• Record ID: K123871
• Device Name: FINGERTIP PULSE OXIMETER
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: May 10, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip Pulse Oximeter MD300CF315 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). It is not for continuous monitoring.

Device Story

Battery-powered fingertip pulse oximeter; detects, displays, and provides voice output of SpO2 and pulse rate. Uses dual-wavelength LED (660nm red, 940nm infrared) and photo detector to measure light absorption in pulsating arteriolar vascular bed. Ratio of systolic/diastolic light absorption calculates SpO2. Operated by clinicians or patients for spot checks. Provides immediate visual feedback on OLED display. Assists healthcare providers in assessing patient oxygenation status. Benefits include non-invasive, portable, rapid assessment of arterial hemoglobin saturation.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, ISO 9919, ISO 10993-5, and ISO 10993-10 verified design specifications. Clinical testing exempted due to shared blood oxygen module with predicate device.

Technological Characteristics

Materials: ABS plastic, medical silicone gel. Sensing: Dual-wavelength LED (660nm/940nm) and photo detector. Power: 2 AAA alkaline batteries. Form factor: Fingertip device (60x36x39mm). Display: OLED. Connectivity: None. Sterilization: Non-sterile, reusable. Software: Embedded, non-life-supporting.

Indications for Use

Indicated for spot checking SpO2 and pulse rate in adult and pediatric patients 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 MD300C (K070371)

Submission Summary (Full Text)

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## 1123871

MAY 1 0 2013

#### Section 3 510(k) Summary

(As required by 21 CFR 807.92)

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

3.1 Date of Submission: Dec. 14, 2012

3.2 Sponsor Information

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

Phone: [phone] Ext 6020

Fax: [phone]

Email: [e-mail]

3.3 Proposed Device Information Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CF315 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology

3.4 Predicate Device 510(k) Number: K070371 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300C Classification Name: Oximeter Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

3-1

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### 3.5 Device Description

The applicant device of Fingertip Pulse Oximeter MD300CF315 is a battery powered fingertip device, which can detect, display and speak out the measured %SpO2 and pulse rate value. The device is normally applied to adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc).

The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit.

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 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector 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 applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The devices are software -driven and the software validation is provided in Section 11 Software.

#### 3.6 Intended Use

The Fingertip Pulse Oximeter MD300CF315 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO22) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is not for continuous monitoring.

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emarket Notification 510(k) Submission – Sec 3 510(k) Summar

3.7 Comparison with the Predicate Device

| ITEM | | Proposed Device | Predicate Device |
|-----------------------------|--------------------------------|---------------------------------------|---------------------------------------|
| Product Name | | MD300CF315 Fingertip Pulse Oximeter | MD300C Fingertip Pulse Oximeter |
| Power | | 2 AAA-size alkaline batteries | 2 AAA-size alkaline batteries |
| Low Power Beep Tip Function | | Yes | No |
| Display Part | | OLED | OLED |
| User Interface | | 4 directions for display | 6 directions for display |
| SpO2 | Display Range | 0~99% | 0~99% |
| | Measurement 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 | 0~254BPM | 0~254BPM |
| | Measurement Range | 30~235BPM | 30~235BPM |
| | Accuracy | 30~99bpm, ±2bpm; 100~235bpm,<br>±2% | 30~99bpm, ±2bpm; 100~235bpm,<br>±2% |
| | Resolution | 1bpm | 1bpm |
| Sensor<br>Wavelength | LED RED | 660±2nm | 660±2nm |
| | IR | 940±10nm | 940±10nm |
| Environment<br>Requirements | Operation Temperature | 5~40℃ | 5~40℃ |
| | Storage Temperature | -20~55℃ | -20~55℃ |
| | Operation Relative<br>Humidity | ≤80%, no condensation | ≤80%, no condensation |
| | Storage Relative Humidity | ≤93%, no condensation | ≤93%, no condensation |

Table 3-1 Performance Specification Comparisor

3-3

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emarket Notification 510(k) Submission – Sec 3 510(k) Summar

| Construction Materials | |
|-------------------------|------------------------------------------------------|
| 1. ABS plastic | 1. ABS plastic |
| 2. Medical silicone gel | 2. Medical silicone gel |
| Outline product | |
| Dimension | $60mm \times 36mm \times 39mm (L \times W \times H)$ |
| | $58mm \times 32mm \times 34mm (L \times W \times H)$ |
| Weight | 46g |
| | 32g |

able 3-2 Differences between the Proposed Device and Predicate Device

| ITEM | | Proposed Device | Predicate Device |
|--------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | Fingertip Pulse Oximeter MD300CF315 | Fingertip Pulse Oximeter MD300C (K070371) |
| Components | | Power supply module, detector and emitter LED,<br>signal collection and process module, display<br>module, user interface, voice module and button<br>control circuit | Power supply module, detector and emitter<br>LED, signal collection and process module,<br>display module, user interface and button<br>control circuit |
| Low Power Beep Tip | | | |
| Function | | Yes | No |
| User Interface | | 4 directions for display | 6 directions for display |
| Outline product | Dimension<br>Weight | 60mm×36mm×39mm (L×W×H) | 58mm×32mm×34mm (L×W×H) |
| | | 46g | 32g |

3-4

:

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#### Premarket Notification 510(k) Submission - Sec 3 510(k) Summary

#### 3.8 Test Conclusion

Bench 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 60601-1:1988 + Al(1991) + A2(1995), Medical Electrical Equipment Part1: . General requirements for safety.
- . IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
- ISO 9919:2005, Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment for medical use.
- ISO10993-5: 2009, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity.
- ISO10993-10: 2010, Biological evaluation of medical device - Part 10: Tests for irritation and delayed-type hypersensitivity.

The Fingertip Pulse Oximeter MD300CF315 share the same Blood Oxygen Module with the predicate device MD300C, so we believe the clinical test of MD300CF315 can be exempted.

#### 3.9 Substantially Equivalent Conclusion

The proposed device, Fingertip Pulse Oximeter MD300CF315, is determined to be Substantially Equivalent (SE) to the predicate device, Fingertip Pulse Oximeter MD300C, K070371, in respect of safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

#### May 10, 2013

Mr. Lei Chen Beijing Choice Electronic Technology Company, Limited North Building 3F, No.9 Shuangyuan Road Badachu Hitech, Shijingshan District Beijing, China 100041

Re: K123871

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: April 10, 2013 Received: April 12, 2013

#### 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.

Public Health Service

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer for
-s FDA

Anthony D. Watson, B.S., M.S., M.B.A. 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 2 Indications for Use

# Indications for Use Form

510(k) Number (if known): k12387/

Device Name: Fingertip Pulse Oximeter

Indications for Use:

The Fingertip Pulse Oximeter MD300CF315 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). It is not for continuous monitoring.

Prescription Use _ V

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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ivision Sign-Off) sion Sign-Off)
sion of Anesthesiology, General Hospital Division of Ancouroental Devices

510(k) Number: K123871

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