(493 days)
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.
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.
The provided text describes the 510(k) summary for a Handheld Pulse Oximeter (WIT-S100, WIT-S300) and its substantial equivalence determination. The document primarily focuses on non-clinical and clinical performance data to support the device's accuracy and safety.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for a pulse oximeter revolve around its accuracy in measuring functional oxygen saturation (SpO2) and pulse rate (PR). The standards cited provide these.
| Acceptance Criteria (from ISO 80601-2-61) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (70-100%) | ±2% (for 70-100%) |
| SpO2 Accuracy (<70%) | Unspecified (<70%). |
| PR Range | 25 bpm - 250 bpm |
| PR Accuracy | ±3 bpm |
| Biocompatibility | Complies with ISO 10993-1 |
| Electrical Safety | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Home Healthcare Environment Safety | Complies with IEC 60601-1-11 |
Note on SpO2 Accuracy Comparison: The subject device claims ±2% accuracy for SpO2 in the 70-100% range, which is better than the predicate device's ±3% for the same range. The document states this "does not raise any safety and effectiveness questions" and "conforms with ISO 80601-2-61 as the predicate."
Note on PR Accuracy Comparison: The subject device states ±3 bpm for PR accuracy, while the predicate device states ±2 bpm or ±2% (whichever is greater). The document acknowledges the "larger PR accuracy" of the subject device but states it "has been verified according to declared range and accuracy" and "does not raise any safety and effectiveness questions." This implies the declared ±3 bpm is acceptable and verified.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 12 human adult volunteers.
- Data Provenance: The text states, "Clinical hypoxia test results were obtained in 12 human adult volunteers..." and "The 12 subjects are health adult, and come from Africa(3), Caucasian(5)&Asian(4) which include Medium, light &dark race." This indicates the data is prospective and collected from a diverse group of subjects, likely within a clinical setting, though the specific country of origin is not explicitly stated beyond the racial/ethnic representation. It is a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not explicitly state the number of experts or their qualifications. However, for a pulse oximeter accuracy study, the "ground truth" for oxygen saturation (SaO2) is typically established by laboratory co-oximetry, which is considered the gold standard. The text mentions "arterial oxygen saturation (SaO2) as determined by co-oximetry," implying that the ground truth was established by this objective method, not by expert consensus readings of, for example, medical images.
4. Adjudication Method for the Test Set
Not applicable. This type of study for a pulse oximeter (clinical hypoxia study) does not involve human readers interpreting data that would require an adjudication method. The ground truth is established directly through objective measurements (co-oximetry).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret medical images. For a pulse oximeter, the study focuses on the device's accuracy against a known physiological standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While "algorithm only" isn't the precise term for a pulse oximeter's core function, the clinical study primarily assesses the device's accuracy in measuring SpO2 and PR independently against the co-oximetry standard. There isn't a human-in-the-loop component being evaluated in the same way as an AI diagnostic tool. The device itself performs the measurement. Therefore, in essence, the "standalone" performance of the hardware and its embedded algorithm is being assessed.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / objective physiological measurements, specifically arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the clinical gold standard for measuring oxygen saturation in blood.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set sample size. This is common for traditional medical devices like pulse oximeters, which are based on established physiological principles and signal processing, rather than deep learning AI models that require large structured training datasets. The "development" and "calibration" process for such a device is typically part of engineering and testing, not a separate "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, the question of its ground truth establishment is not directly applicable. The device's underlying principles and calibration would be based on physiological studies and engineering benchmarks, but not a distinct "training set" with established ground truth as seen in AI/ML validation.
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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
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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
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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 Quality Center for Devices and Radiological Health
Enclosure
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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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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
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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 | |
| ClassificationRegulation | Handheld Pulse Oximeter,WIT-S100, WIT-S300 | K201468Pulse Oximeter, AP-10 | Same | |
| Classificationand 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 PulseOximeter is intended formeasuring and recordingthe functional oxygensaturation (SpO2) andpulse rate (PR). It isintended for spot check ofSpO2, PR of adult patientsin hospitals, clinics, orhome. This device is notintended for continuous | This Pulse Oximeter isintended for measuringand recording thefunctional oxygensaturation (SpO2) andpulse rate (PR). It isintended for spot checkand continuous recordingof SpO2, PR of adult orpediatric patients inhospitals, clinics, or | Same | ||
| Features | Subject Device | Predicate DeviceK201468 | Comparison | |
| Handheld Pulse Oximeter,WIT-S100, WIT-S300monitoring, use duringmotion or use with lowperfusion. | Pulse Oximeter, AP-10home.This device is notintended for continuousmonitoring. | |||
| Patientpopulations | adult | adult or pediatric | Same | |
| Type of SpO2Sensor | Transmittance OpticalSensor | Transmittance OpticalSensor | Same | |
| SpO2 Module | SpO2 Module withS0010B-S Probe | KM-SPO-04 SpO2Module with KS-AR01Probe | Thedifference ofSpO2 Sensordoes notraise anynewquestions ofsafety andeffectivenessand stillcomplieswith theISO80601-2-61 | |
| Application Site | Finger | Finger | Same | |
| Light Emitting | Red: 660 nmInfrared: 905nm | Red: 660 nmInfrared: 905nm | Same | |
| Display | 2.8-inch OLED and LED | 1.44" color TFT LCD | The displaysizedifferencedoes notraise anynewquestions ofsafety andeffectiveness. | |
| MeasuringMode | Spot-check andContinuous recording | Spot-check andContinuous recording | Same | |
| SpO2Measuring | 0%-100% | 0%-100% | Same | |
| Features | Subject Device | Predicate Device | Comparison | |
| Handheld Pulse Oximeter,WIT-S100, WIT-S300 | K201468Pulse Oximeter, AP-10 | |||
| Range | ||||
| SpO2Resolution | 1% | 1% | Same | |
| SpO2 Accuracy | 70~100%, ±2%.<70%, unspecified. | 70~100%, ±3%.<70%, unspecified; | The subjectdevices havebetter SpO2accuracy, andit conformswith ISO80601-2-61as thepredicate.Thedifferencedoes notraise anysafety andeffectivenessquestions. | |
| PR Range | 25 bmp – 250 bmp | 30 bmp – 250 bmp | The subjectdevices havelarger PRrange, and itconformswith ISO80601-2-61as thepredicate.Thedifferencedoes notraise anysafety andeffectivenessquestions. | |
| PR Resolution | 1 bpm | 1 bpm | Same | |
| PR Accuracy | ±3bpm | ±2bpm or ±2%(whichever is greater) | The subjectdevices have | |
| Features | Subject Device | Predicate Device | Comparison | |
| Handheld Pulse Oximeter,WIT-S100, WIT-S300 | K201468Pulse Oximeter, AP-10 | larger PRaccuracy, andit has beenverifiedaccording todeclaredrange andaccuracy.Thedifferencedoes notraise anysafety andeffectivenessquestions. | ||
| Power source | 3 AA batteries | Rechargeable Lithium-IonPolymer Battery(3.7V,500mAh) | The subjectdevices usedifferentpower sourcewhich meetsthe designrequirementand complieswith theapplicablestandards,includingIEC60601-1,IEC60601-1-2,etc | |
| Type ofProtection | Internal Powered | Internal Powered | Same | |
| IP degree | IP22 | IP22 | Same | |
| Degree ofProtection –sensor | Type BF - applied part | Type BF - applied part | Same | |
| Dimension(LxWxH) | 143(L) × 80(W) × 30(H) mm | Watch Case:D 56mm× W 44mm×H | The physicaldimension | |
| Features | Subject Device | Predicate DeviceK201468 | Comparison | |
| Handheld Pulse Oximeter,WIT-S100, WIT-S300 | Pulse Oximeter, AP-10 | |||
| 16mm | differencedoes notraise anynewquestions ofsafety andeffectiveness. | |||
| Weight | <0.5 kg (Excludingaccessories) | Net Weight: about 45g | The weightdifferencedoes notraise anynewquestions ofsafetyandeffectiveness | |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Same | |
| PatientContactingmaterial | Silicon for sensorABS for Handheld unitTPU for Connecting wire | Silicon for sensor | Somematerial ofthe predicatedevice is notavailable.However, thematerialsused inproposeddevice istested andpassed thebio-compatibilitytest, so thatthecontactingmaterial wasproven to besafe to be | |
| Features | Subject Device | Predicate Device | Comparison | |
| Handheld Pulse Oximeter,WIT-S100, WIT-S300 | K201468Pulse Oximeter, AP-10 | |||
| Operating | Temperature: 0°C~40°CRelative Humidity: 15% | Operating temperature: 5~40°COperating humidity: 15% | used.The operating condition difference does not raise any new questions of safety and effectiveness. | |
| Storage | Temperature: -20°C~+60°CRelative humidity: 10% | Ambient temperature: -20°C~60°C,Relative humidity 10% | The storage condition difference does not raise any new questions of safety and effectiveness |
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.
Biocompatibility testing
The biocompatibility evaluation for the Handheld 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 o
- Sensitization .
- Irritation ●
Section 5_510(k) Summary
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Non-clinical data
The Handheld 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 o 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 Handheld 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 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.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
§ 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).