(493 days)
Not Found
No
The device description outlines a standard pulse oximetry technology based on light absorption and ratio calculations, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies focus on standard clinical validation against co-oximetry, not on the performance of any AI/ML model.
No
The device is intended for measuring and displaying functional oxygen saturation and pulse rate, which are diagnostic measurements, not treatments or therapies. The description explicitly states it is not intended for "life-supporting or life-sustaining" purposes.
Yes
Explanation: The device is intended for measuring functional oxygen saturation (SpO2) and pulse rate (PR), which are used to assess a patient's physiological state and can indicate potential medical conditions.
No
The device description explicitly lists hardware components such as a PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, plastic shell, and a compatible sensor. It is powered by batteries, indicating a physical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside the body.
- Device Function: This Handheld Pulse Oximeter measures functional oxygen saturation (SpO2) and pulse rate (PR) by applying a sensor to a pulsating arteriolar vascular bed (specifically, the finger). This is a non-invasive measurement taken on the body, not a test performed on a sample from the body.
- Intended Use: The intended use clearly states it's for measuring SpO2 and PR of adult patients. This aligns with a physiological measurement device, not an IVD.
- Device Description: The description details how the device uses light absorption through the skin and tissue to determine SpO2. This is a physical measurement process, not a chemical or biological analysis of a sample.
Therefore, this device falls under the category of a medical device that performs physiological measurements, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This Handheld Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Handheld Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Handheld 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 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 and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Handheld Pulse Oximeter is powered by 3 AA batteries.
The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The Handheld Pulse Oximeter is compatible with S0010B-S sensor. The device is a spot-check Handheld Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
adult
Intended User / Care Setting
hospitals, clinics, or home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical hypoxia test results were obtained in 12 human adult volunteers to validate the accuracy of Handheld Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry.
The pulse oximeter accuracy was tested in twelve healthy subjects, aged 21-50, with skin tones varying from Fitzpatrick I- VI. 3 subjects had dark skin with Fitzpatrick V- VI. 9 subjects had dark skin with Fitzpatrick I- IV. there were 6 males and 6 females taking part in this testing. The 12 subjects are health adult, and come from Africa(3), Caucasian(5)&Asian(4) which include Medium, light &dark race.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 o Requirements for Basic Safety and Essential Performance of Handheld Pulse Oximeter Equipment.
- Handheld Pulse Oximeters-Premarket Notification Submissions: Guidance for o Industry and Food and Drug Administration Staff
Clinical hypoxia test results were obtained in 12 human adult volunteers to validate the accuracy of Handheld Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
The pulse oximeter accuracy was tested in twelve healthy subjects, aged 21-50,with skin tones varying from Fitzpatrick I- VI.3 subjects had dark skin with Fitzpatrick V- VI.9 subjects had dark skin with Fitzpatrick I- IV. there were 6 males and 6 females taking part in this testing. The 12 subjects are health adult, and come from Africa(3), Caucasian(5)&Asian(4) which include Medium, light &dark race.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70~100%, ±2%.
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines.
April 5, 2023
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: K213431
Trade/Device Name: Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA
Dear Kevin Wang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 26th 2023. Specifically, FDA is updating this SE Letter due to an incorrect change made by the agency to the trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Vacant, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-7677, Ting.Song@fda.hhs.gov.
Sincerely,
Ting Song -S
For
Assistant 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 Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2023
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: K213431
Trade/Device Name: Handheld Pulse Oximeter S0010B Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 26, 2023 Received: January 26, 2023
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
2
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K213431
Device Name
Handheld Pulse Oximeter (model: WIT-100, WIT-300)
Indications for Use (Describe)
This Handheld Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2023/01/26
Submission sponsor 1.
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 | Handheld Pulse Oximeter |
|---|---|
| Model | WIT-S100, WIT-S300 |
| Common Name | Handheld Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
Manufacturer: Shenzhen Creative Industry Co., Ltd. Device name: Pulse Oximeter, AP-10 510(K) Number: K201468
5. Device Description
The Handheld Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Handheld 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
5
source is 660 nm, which is red 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 and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Handheld Pulse Oximeter is powered by 3 AA batteries.
The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The Handheld Pulse Oximeter is compatible with S0010B-S sensor. The device is a spot-check Handheld Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
Intended use & Indication for use 6.
This Handheld Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.
| 7. Comparison to the Predicate Device | ||||
|---|---|---|---|---|
| Features | Subject Device | Predicate Device | Comparison | |
| Classification | ||||
| Regulation | Handheld Pulse Oximeter, | |||
| WIT-S100, WIT-S300 | K201468 | |||
| Pulse Oximeter, AP-10 | Same | |||
| Classification | ||||
| and Code | 21CRF 870.2700 | 21CRF 870.2700 | Same | |
| Common name | Class II, DQA | Class II, DQA | Same | |
| Intended use | Handheld Pulse Oximeter | Pulse Oximeter | Same | |
| This Handheld Pulse | ||||
| Oximeter is intended for | ||||
| measuring and recording | ||||
| the functional oxygen | ||||
| saturation (SpO2) and | ||||
| pulse rate (PR). It is | ||||
| intended for spot check of | ||||
| SpO2, PR of adult patients | ||||
| in hospitals, clinics, or | ||||
| home. This device is not | ||||
| intended for continuous | This Pulse Oximeter is | |||
| intended for measuring | ||||
| and recording the | ||||
| functional oxygen | ||||
| saturation (SpO2) and | ||||
| pulse rate (PR). It is | ||||
| intended for spot check | ||||
| and continuous recording | ||||
| of SpO2, PR of adult or | ||||
| pediatric patients in | ||||
| hospitals, clinics, or | Same | |||
| Features | Subject Device | Predicate Device | ||
| K201468 | Comparison | |||
| Handheld Pulse Oximeter, | ||||
| WIT-S100, WIT-S300 | ||||
| monitoring, use during | ||||
| motion or use with low | ||||
| perfusion. | Pulse Oximeter, AP-10 | |||
| home. | ||||
| This device is not | ||||
| intended for continuous | ||||
| monitoring. | ||||
| Patient | ||||
| populations | adult | adult or pediatric | Same | |
| Type of SpO2 | ||||
| Sensor | Transmittance Optical | |||
| Sensor | Transmittance Optical | |||
| Sensor | Same | |||
| SpO2 Module | SpO2 Module with | |||
| S0010B-S Probe | KM-SPO-04 SpO2 | |||
| Module with KS-AR01 | ||||
| Probe | The | |||
| difference of | ||||
| SpO2 Sensor | ||||
| does not | ||||
| raise any | ||||
| new | ||||
| questions of | ||||
| safety and | ||||
| effectiveness | ||||
| and still | ||||
| complies | ||||
| with the | ||||
| ISO80601- | ||||
| 2-61 | ||||
| Application Site | Finger | Finger | Same | |
| Light Emitting | Red: 660 nm | |||
| Infrared: 905nm | Red: 660 nm | |||
| Infrared: 905nm | Same | |||
| Display | 2.8-inch OLED and LED | 1.44" color TFT LCD | The display | |
| size | ||||
| difference | ||||
| does not | ||||
| raise any | ||||
| new | ||||
| questions of | ||||
| safety and | ||||
| effectiveness. | ||||
| Measuring | ||||
| Mode | Spot-check and | |||
| Continuous recording | Spot-check and | |||
| Continuous recording | Same | |||
| SpO2 | ||||
| Measuring | 0%-100% | 0%-100% | Same | |
| Features | Subject Device | Predicate Device | Comparison | |
| Handheld Pulse Oximeter, | ||||
| WIT-S100, WIT-S300 | K201468 | |||
| Pulse Oximeter, AP-10 | ||||
| Range | ||||
| SpO2 | ||||
| Resolution | 1% | 1% | Same | |
| SpO2 Accuracy | 70~100%, ±2%. |