Fingertip Pulse Oximeter
Device Facts
| Record ID | K151206 |
|---|---|
| Device Name | Fingertip Pulse Oximeter |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Aug 28, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.
Device Story
Fingertip pulse oximeter for non-invasive spot-checking of SpO2 and pulse rate; utilizes photoelectric sensor with dual light source (660nm red, 905nm infrared) applied to fingertip; measures light absorption ratio during systole and diastole to calculate oxygen saturation; device includes power supply, LED emitter/detector, signal processor, display, and Bluetooth module; operated by clinicians in hospital facilities; provides real-time SpO2, pulse rate, and pulse amplitude (MD300C208) on integrated display; aids clinical assessment of patient oxygenation status; benefits include portable, convenient monitoring without invasive procedures.
Clinical Evidence
Supported by laboratory accuracy testing (SpO2 and PR) and performance testing per FDA guidance and ISO 80601-2-61. Testing included weak perfusion, temperature/humidity, and cleaning performance. No clinical human subject data reported.
Technological Characteristics
Materials: ABS (enclosure/battery cover), laser-etched medical silicone gel (cushion/button), inks (coating). Sensing: Dual-wavelength (660nm/905nm) LED and photodetector. Power: 2x AAA alkaline batteries. Connectivity: Bluetooth. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 14971.
Indications for Use
Indicated for spot-checking SpO2 and pulse rate in adult, adolescent, and child patients in hospital 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
- Fingertip Pulse Oximeter Model MD300C29-H (K140682)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director No. 9 Shuangyuan Road, Badachu Hi-tech Zone Shijingshan District Beijing, 100041 CHINA
Re: K151206
Trade/Device Name: Fingertip Pulse Oximeter MD300C208/MD300C198 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 17, 2015 Received: July 24, 2015
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.
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
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
*Tejashri Purohit-Sheth, M.D.*
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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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#### Indications for Use
510(k) Number (if known) K151206
Device Name
Fingertip Pulse Oximeter MD300C208/MD300C198
Indications for Use (Describe)
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.
| Type of Use (Select one or both, as applicable) |
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| <span style="text-decoration: underline;"></span> |
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| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is K151206 .
#### 3.1 Submitter Information
#### ● Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, 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: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com
#### Date prepared: August 28, 2015 .
#### 3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C208, MD300C198 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Class: II
Panel: Anesthesiology
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### 3.3 Predicate Device
510(k) Number: K140682 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C29-H Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.
### 3.4 Device Description
The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
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 905nm, which is infrared-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 proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
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The device is software-driven and the software validation is provided in 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 | | |
| Model | MD300C208 | MD300C29-H | | |
| 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 MD300C208 is a<br>non-invasive device intended for spot-checking<br>of oxygen saturation of arterial hemoglobin<br>(SpO2) and pulse rate of adult, adolescent and<br>child patients in hospitals and hospital<br>facilities. | The Fingertip Pulse Oximeter MD300C29-H is a<br>portable, non-invasive device intended for spot<br>checking of oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate of adult,<br>adolescent and child patient in hospital. | | |
| Comparison Statement | The proposed device and the predicated device have the same intended use and classification | | | |
| Components | Power supply module, detector and emitter LED,<br>signal collection and processor module, display<br>module, Bluetooth module, user interface and<br>button control. | detector and emitter LED, signal amplify unit,<br>CPU, data display unit and power unit | | |
| Design Principle | 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 905nm, which is infrared-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 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 905nm, which is infrared-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. | |
| Measurement<br>Wavelength | Red | $660\pm3nm$ | $660\pm3nm$ | |
| | Infrared | $905\pm8nm$ | $905\pm8nm$ | |
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar measurement wavelength. The only difference is that the proposed device adds the Bluetooth module in the product components, and we can verify which will not affect the basic safety and essential performance of the proposed device. | | | |
| | Display Type | OLED | OLED | |
| | | | | |
| Performance Specification | Working Time | Approximately 28 hours of continuous monitoring | Approximately 25 hours of continuous monitoring | |
| | User Interface | 2 display directions and 2 displayed parameters | 6 directions for display | |
| | Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | |
| | Display Data | SpO2, PR, Pulse Amplitude | SpO2 ,PR | |
| | SpO2 Display Range | 35%~100% | 35%~100% | |
| | SpO2 Measurement Range | 70%~100% | 70%~100% | |
| | SpO2 Accuracy | 70%~100%, ±2%;<br>0~69% no definition | 70%~100%, ±2%;<br>0~69% no definition | |
| | SpO2 Resolution | 1% | 1% | |
| | PR Display Range | 30bpm~250bpm | 30bpm~250bpm | |
| | PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm | |
| | PR Accuracy | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | |
| | PR Resolution | 1% | 1% | |
| | Operating Temperature | 5°C~40°C | 5°C~40°C | |
| | | | | |
| | | Relative Humidity | ≤80% no condensation in operation;<br>≤93% no condensation in storage | ≤80% no condensation in operation;<br>≤93% no condensation in storage |
| | | Atmosphere Pressure | 86kPa~106kpa | 86kPa~106kpa |
| Comparison Statement | | | The proposed device has similar product specification as predicate device. | |
| Contacting | | Battery Cover | ABS | ABS |
| Material | | Enclosure | | |
| | | Fingertip Cushion<br>Power Button | Laser Etching Medical Silicone Gel…
