Fingertip Pulse Oximeter
Device Facts
| Record ID | K213430 |
|---|---|
| Device Name | Fingertip Pulse Oximeter |
| Applicant | Shenzhen Witleaf Medical Electronics Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Dec 30, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
Intended Use
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
Device Story
Fingertip pulse oximeter; measures SpO2 and pulse rate via transmittance optical sensor. Device clamps to finger; dual light source (660 nm red, 905 nm infrared) transmits through tissue; photodetector captures light intensity; microprocessor calculates SpO2 based on light absorption ratios during systole/diastole (Lambert-Beer Law). Powered by 2 AAA batteries; features OLED/LED display. Used in home and hospital settings by patients or clinicians for spot-checks. Output displayed on screen; assists clinicians in assessing patient oxygenation status. Benefits include non-invasive, portable, rapid assessment of arterial hemoglobin saturation.
Clinical Evidence
Clinical hypoxia study conducted on human adult volunteers per ISO 80601-2-61:2017. Accuracy validated against arterial oxygen saturation (SaO2) measured via co-oximetry. Results support accuracy claims for the specified SpO2 range.
Technological Characteristics
Materials: ABS enclosure, silicone clip (ISO 10993-1 compliant). Sensing: Transmittance optical sensor (660 nm red, 905 nm infrared). Power: 2x AAA 1.5V alkaline batteries. Form factor: Fingertip clamp. Protection: Type BF applied part, internally powered. Connectivity: None (standalone).
Indications for Use
Indicated for adult patients in home and hospital environments for non-invasive spot-checking of functional oxygen saturation (SpO2) and pulse rate (PR). Not for continuous monitoring, use during motion, or use with low perfusion.
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
- Pulse Oximeter, A2, A3, A4, A5 (K203854)
Related Devices
- K093757 — MD300C1 FINGERTIP PULSE OXIMETER · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 3, 2010
- K212385 — YUWELL Finger Pulse Oximeter · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Aug 16, 2022
- K203854 — Pulse Oximeter · Shenzhen Hexin Zondan Medical Equipment Co., Ltd. · Apr 23, 2021
- K210274 — Fingertip Pulse Oximeter · Zhuhai Linte Medical Instrument Co., Ltd. · Jul 30, 2021
- K213984 — Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) · Shenzhen Zhengkang Technology Co., Ltd. · Dec 16, 2022
Submission Summary (Full Text)
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December 30, 2022
Shenzhen Witleaf Medical Electronics Co.,Ltd % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K213430
Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 18, 2022 Received: November 18, 2022
Dear Kevin Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K213430
Device Name Fingertip Pulse Oximeter
### Indications for Use (Describe)
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
| Type of Use (Select one or both, as applicable) | <table><tr><td><span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr><tr><td><span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | |
| <span> <div style="display:inline-block;"> <div style="display:inline-block; vertical-align:middle;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY/jPgBABAAEqAk0gqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIakAEogWSGpABKIFkhqQASiBZIAAD+gD9l643YAAAAAElFTkSuQmCC" width="16"/> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | | |
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# 510(K) Summary
### Prepared in accordance with the requirements of 21 CFR Part 807.92
# Prepared Date: 2021/11/17
#### 1. Submission sponsor
Name: Shenzhen Witleaf Medical Electronics Co., Ltd. Address: 13/F-B2, Block 1, Senyang Science Park, No.7 Road, West District of High-Tech Park, Guangming, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Wu Tao Title: Management Representative E-mail: wutao@szwitleaf.com Tel: +86-755 21384132
#### 2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang
E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Fingertip Pulse Oximeter |
|-------------------|---------------------------------|
| Model | WIT-S200, WIT-S400 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
#### 3 Subiect Device Information
#### 4. Predicate Device
Manufacturer: Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd Device name: Pulse Oximeter, A2, A3, A4, A5 510(K) Number: K203854
#### 5. Device Description
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Fingertip 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
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light; the other is 905 nm, which is Infrared 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
#### 6. Intended use & Indication for use
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
| Features | Subject Device | Predicate Device K203854 | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Fingertip Pulse Oximeter<br>WIT-S200, WIT-S400 | Pulse Oximeter, Model: A2, A3, A4, A5 | |
| Applicant | Shenzhen Witleaf Medical<br>Electronics Co., Ltd. | Shenzhen Hexin ZONDAN<br>Medical Equipment Co., Ltd. | / |
| Classification<br>Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same |
| Classification<br>and Code | Class II, DQA | Class II, DQA | Same |
| Prescription or<br>OTC | Prescription | Prescription | Same |
| Intended use | This Fingertip Pulse Oximeter<br>is non-invasive device<br>intended for spot-checking of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2)<br>and pulse rate (PR). It is<br>indicated for adult patients in<br>home and hospital<br>environment. The device is not | The Pulse Oximeter is intended<br>for measuring the functional<br>oxygen<br>saturation and pulse rate (PR)<br>through a<br>patient's finger. It is applicable for<br>spot-checking SpO2 and pulse<br>rate (PR) of adult and pediatric<br>patients in homes and clinics. | Same |
| Indication for<br>use | intended for continuous<br>monitoring, use during motion<br>or use with low perfusion. | The Pulse Oximeter is non-<br>invasive device intended for spot-<br>checking of functional oxygen | Same |
| Features | Subject Device | Predicate Device K203854 | Comparison |
| | Fingertip Pulse Oximeter<br>WIT-S200, WIT-S400 | Pulse Oximeter, Model: A2, A3, A4, A5<br><br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate (PR). The<br>portable fingertip device is<br>indicated for adult and pediatric<br>patients in home and hospital<br>environment(including clinical<br>use in internist/surgery,<br>anesthesia, intensive care, etc.) | |
| Design<br>principle | A mathematical formula is established making use of Lambert Beer<br>Law according to Spectrum Absorption Characteristics of Reductive<br>hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-<br>infrared zones. Operation<br>principle of the instrument: Photoelectric Oxyhemoglobin<br>Inspection Technology is adopted in accordance with Capacity<br>Pulse Scanning and Recording Technology, so that two beams of<br>different wavelength of lights can be focused onto a human nail tip<br>through a clamping finger-type sensor. A measured signal obtained<br>by a photosensitive element, will be shown on the Oximeter's<br>display through process in electronic circuits and microprocessor. | | Same |
| Environment<br>of<br>use | Home and Hospital | Home and Hospital | Same |
| Patient<br>populations | adult | adult or pediatric | different |
| Motion<br>condition | Not applicable | Not applicable | Same |
| Perfusion<br>condition | Not applicable for low<br>perfusion | Not applicable for low perfusion | Same |
| Type of SpO2<br>Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | Same |
| Application<br>Site | Fingertip | Fingertip | Same |
| Light Emitting | Red: 660 nm<br>Infrared: 905nm | Red: 660 nm<br>Infrared: 905nm | Same |
| SpO2<br>Measuring<br>Range | 0%-100% | 0%-100% | Same |
| SpO2 | 1% | 1% | Same |
| Features | Subject Device | Predicate Device K203854 | Comparison |
| | Fingertip Pulse Oximeter<br>WIT-S200, WIT-S400 | Pulse Oximeter, Model: A2, A3,<br>A4, A5 | |
| Resolution | | | |
| SpO2 | 70~100%, ±2%. | 70~100%, ±2%. | Same |
| Accuracy | <70%, unspecified. | <70%, unspecified. | |
| PR Range | 25 bmp – 250 bmp | 30 bmp – 240 bmp | different |
| PR Accuracy | ±3bpm | ±1bpm | |
| PR Resolution | 1 bpm | 1 bpm | Same |
| Power source | 2*AAA 1.5V alkaline<br>battery | 2*AAA 1.5V alkaline<br>battery | Same |
| Type of<br>Protection | Internal Powered | Internal Powered | Same |
| Degree of<br>Protection –<br>sensor | Type BF – applied part | Type BF – applied part | Same |
| Contacting<br>material | ABS for enclosure, silicone for<br>clip | ABS for enclosure, silicone for<br>clip | Same |
| Contact type | Skin surface-contacting | Skin surface-contacting | Same |
| Patient Contact<br>Materials | Complies with ISO10993-1 | Complies with ISO10993-1 | Same |
| Operating | Temperature: :10°C~40°C<br>Relative Humidity :30%~<br>75%<br>Atmospheric pressure:<br>700hPa~1060hPa | Temperature: 5°C ~ 40°C<br>Humidity: 30% ~ 80% (non-<br>condensing)<br>Atmospheric pressure: 70kPa ~<br>106kPa | different |
| Storage | Temperature :-40°C~+60°C<br>Relative humidity :5%~95%<br>Atmospheric pressure:<br>500hPa~1060hPa | Temperature: -20°C ~ +55°C<br>Humidity:<br>10% ~ 93% (non-condensing)<br>Atmospheric pressure:<br>70kPa ~ 106kPa | different |
7. Comparison to the Predicate Device
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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.
#### 8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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### Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- . Cytotoxicity
- Sensitization .
- Irritation .
# Non-clinical data
The Pulse Oximeter has been tested according to the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-. Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
The test was selected to show substantial equivalence between the subject device and the predicate.
# Clinical data
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- . ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- . Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
#### 9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
