(168 days)
The Wireless No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can transmit the temperature to a smart device with Bluetooth and can be used by consumers in the household environment and by healthcare providers.
The iHealth PT3SBT Wireless No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead skin temperature without touching patient's skin. Its operation is based on measuring the natural thermal radiation from the central forehead. Put the probe of the thermometer at a measurement distance less than or equal to 1.18 inch (3cm) without touching the skin at the center of the patient's forehead. It uses a thermopile sensor to measure the patient's forehead temperature and convert it to the oral equivalent. Pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display of the device. The thermometer can also be connected to a smart device through Bluetooth and display the measured temperature result on the smart device.
The provided text describes the regulatory clearance of a medical device, the "iHealth Wireless No-Touch Forehead Thermometer (model PT3SBT)", by the FDA. It details the device's characteristics, comparison to a predicate device, and the non-clinical and clinical tests performed to support its substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device can be inferred from the standards it claims to comply with and the performance characteristics stated. The primary acceptance criteria relate to accuracy, safety, and functionality.
| Acceptance Criteria Category | Specific Criteria (from standards/claims) | Reported Device Performance/Compliance |
|---|---|---|
| Accuracy | Specified Accuracy:$\pm$ 0.4°F (0.2°C) within 93.2°F-107.6°F (34°C-42°C)$\pm$ 0.5°F (0.3°C) for other temperature ranges. Clinical Accuracy: Compliance with ASTM E1965-98:2016 for clinical bias and uncertainties. | Stated Accuracy: $\pm$ 0.4°F (0.2°C) within 93.2°F-107.6°F (34°C-42°C)$\pm$ 0.5°F (0.3°C) for other temperature ranges. Clinical Test Results: "The clinical test report demonstrated that the clinical data, represented by clinical bias and uncertainties met the acceptance criteria of the clinical study protocol. The iHealth PT3 Infrared No-Touch Forehead Thermometer complies with the requirement of ASTM E1965-98 (2016)." |
| Electrical Safety | Compliance with IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) | "Electrical Safety test was performed according to IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)" |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2:2014 | "EMC test was performed according to 60601-1-2:2014" |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. | "Biocompatibility test (including cytotoxicity, sensitization, irritation) was performed according to (1) ISO 10993-1, (2)ISO 10993-5 and (3) ISO 10993-10." |
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005. | "Software verification and validation were conducted according to FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', dated May 11, 2005." "software validation demonstrated the difference does not raise any new performance questions." |
| Cybersecurity | Evaluated according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance. | "Cybersecurity testing has been evaluated according to guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'." |
| General Performance (Non-Clinical) | Compliance with ISO 80601-2-56:2017 [Including: Amendment 1 (2018)], "Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement." | "Performance test was performed according to ISO 80601-2-56:2017 ... is the applicable standards for this device." "the performance test complied with standards." |
| Usability/Operation Environment | Stated operational conditions (0-40° C, 15%-95% RH, 70-106kPa) and acceptable performance within these. | "the performance test complied with standards." (Implied acceptance within specified operating ranges). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The clinical investigation used a total of 130 subjects. This was broken down into:
- Infants: 40 subjects (0-1 year)
- Children: 40 subjects (1-5 years)
- Adults: 50 subjects (>5 years)
- Data Provenance: The document does not explicitly state the country of origin for the clinical test data. Given the manufacturer's address in Tianjin, China, it is highly probable the study was conducted there. The study appears to be prospective as it's described as a "clinical investigation" and "clinical test report".
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number or qualifications of experts used to establish the ground truth for human body temperature measurements in the clinical study. It refers to compliance with ASTM E1965-98 (2016), which is a standard specification for infrared thermometers, implying that the ground truth methodology would follow the requirements of this standard for comparison thermometers (e.g., rectal thermometers) and trained personnel for measurement.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth measurements. The ASTM E1965-98 standard typically involves comparing the test thermometer's readings against a reference (usually invasive, like rectal or oral) temperature obtained by trained personnel, rather than multiple expert adjudicators in the way an AI diagnostic image study might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
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Was it done? No, an MRMC study comparing human readers with and without AI assistance was not done. This device is a thermometer, not an AI-powered diagnostic imaging tool. Its primary function is direct measurement, not interpretation by human readers.
-
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
- The study primarily focuses on the device's direct measurement performance, which is inherently "standalone" in the sense that the thermometer provides a numerical output directly. While it can connect to a smart device via Bluetooth, the core temperature measurement capability is in the device itself, making its clinical accuracy evaluation a standalone performance assessment. The "algorithm" here is the embedded software that converts infrared radiation into a temperature reading.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy study was established by comparison to a reference method (likely an invasive, highly accurate thermometer like a rectal or oral thermometer) as specified by ASTM E1965-98 (2016). This standard outlines procedures for clinical accuracy assessment for body temperature measurement. The document states "clinical bias and uncertainties met the acceptance criteria of the clinical study protocol" in relation to this standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" sample size. For a medical device like a thermometer, the "training" usually refers to the internal calibration and development data rather than a separate dataset for training a machine learning algorithm in the way an AI diagnostic tool would have. The performance evaluation is based on the validation (test) set described in point 2.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for AI algorithm training is mentioned (as this is a thermometer, not an AI diagnostic model), the method of establishing ground truth for such a set is not detailed. For the internal development and calibration of the thermometer, standardized temperature sources and laboratory reference thermometers would be used to establish the ground truth for programming the device's measurement algorithm.
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March 8, 2021
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China
Re: K202753
Trade/Device Name: iHealth Wireless No-Touch Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: February 1, 2021 Received: February 5, 2021
Dear Liu Yi:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K202753
Device Name
iHealth Wireless No-Touch Forehead Thermometer (PT3SBT)
Indications for Use (Describe)
The Wireless No-Touch Forehead Thermometer is intenittent measurement of body temperature from the forehead on people of all ages. It can transmit the temperature to a smart device with Bluetooth and can be used by consumers in the household environment and by healthcare providers.
| Type of Use (Select one or both, as applicable) |
|---|
| Registration Use (Part 81 CFR 901 Subpart D) |
| Over-The-Counter Use (81 CFR 901 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K202753
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin,P.R. China |
| Phone number: | 86-22-87611660 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu, Yi |
| Date of Preparation: | 2/11/2021 |
2.0 Device information
| Trade name: | iHealth Wireless No-Touch Forehead Thermometer (model PT3SBT) |
|---|---|
| Common name: | Infrared forehead thermometer |
| Classification name: | Clinical Electronic Thermometer |
3.0 Classification
Production code: FLL Regulation number: 880.2910 Classification: II Panel: General Hospital
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd iHealth Infrared No-Touch Forehead Thermometer (Model: PT3) Device: 510(k) number: K200531
5.0 Indications for Use
The Wireless No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can transmit the temperature to a smart device with Bluetooth and can be used by consumers in the household environment and by healthcare providers.
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6.0 Device description
The iHealth PT3SBT Wireless No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead skin temperature without touching patient's skin. Its operation is based on measuring the natural thermal radiation from the central forehead. Put the probe of the thermometer at a measurement distance less than or equal to 1.18 inch (3cm) without touching the skin at the center of the patient's forehead. It uses a thermopile sensor to measure the patient's forehead temperature and convert it to the oral equivalent. Pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display of the device. The thermometer can also be connected to a smart device through Bluetooth and display the measured temperature result on the smart device.
| Item | Subject Device(K202753) | Predicate Device(K200531) | Comparison |
|---|---|---|---|
| Name and Model | iHealth Wireless No-TouchForehead ThermometerModel: PT3SBT | iHealth Infrared No-TouchForehead ThermometerModel: PT3 | --- |
| Product code | FLL | FLL | Same |
| Regulationnumber | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Manufacturer | Andon Health Co., Ltd | Andon Health Co., Ltd | Same |
| Indications forUse | The Wireless No-TouchForehead Thermometer isintended for the intermittentmeasurement of bodytemperature from theforehead on people of allages. It can transmit thetemperature to a smart devicewith Bluetooth and can beused by consumers in thehousehold environment andby healthcare providers. | The Infrared No-TouchForehead Thermometer isintended for the intermittentmeasurement of bodytemperature from theforehead on people of allages. It can be used byconsumers in thehousehold environment andby healthcare providers. | Different 1 |
| Probe contacttype | Non-contact;measurement distance: ≤1.18 in(3 cm) | Non-contact;measurement distance: ≤1.18 in(3 cm) | Same |
| Sensor | Thermopile | Thermopile | Same |
| Measurementmethod | Infrared radiation detection | Infrared radiation detection | Same |
| Display type | LED | LED | Same |
| Other feature | 1. Vibration when getmeasurement2. Can connect to a smartdevice and display measuredtemperature result on a smartdevice. | 1. Vibration when getmeasurement | Different 2 |
| APP name andfeature | iHealth My Vitals Pro AppStore and show data receivedfrom the thermometer throughBluetooth | No App related | Different 3 |
| Measuring range | 32- 42.9° C (89.6- 109.2° F) | 32- 42.9° C (89.6- 109.2° F) | Same |
| Accuracy | $\pm$ 0.4°F( $\pm$ 0.2°C) within93.2°F-107.6°F(34°C-42°C),and $\pm$ 0.5°F( $\pm$ 0.3°C) for othertemperature ranges. | $\pm$ 0.4°F (0.2°C) within95 | Different 4 |
| Measuringresponse time | 1 second | 1 second | Same |
| Low batteryindicator | Indicated on LED | Indicated on LED | Same |
| Temperature unit | °C or °F | °C or °F | Same |
| Display resolution | 0.1 °F (0.1 °C) | 0.1 °F (0.1 °C) | Same |
| Powerrequirements | 2X1.5V AAA battery | 2X1.5V AAA battery | Same |
| Operationenvironment | 0-40° C, 15%-95% RH,70-106kPa | 15-40° C, 15%-95% RH,70-106kPa | Different 5 |
| Storageenvironment | -20-55° C, 15%-95% RH,70-106kPa | -20-55° C, 10%-95% RH,70-106kPa | Different 6 |
| Materials ofskin-contactingcomponents | ABS and PMMA | ABS and PMMA | Same |
| biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Same |
| electrical safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC andperformancetesting | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Wirelesscommunication | Bluetooth low energy | NA | Different 7 |
7.0 Summary comparing technological characteristics with predicate device
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Different 1: The indication for use of the proposed device is slightly different, because it can transmit the temperature to a smart device with Bluetooth. The performance test and the clinical accuracy test complied with standards. The difference does not raise any new performance questions.
Different 2-3: There is App on smart device for the subject device, test result displayed on the thermometer can also be transmited to App on smart device through bluetooth. The software validation demonstrated the difference does not raise any new performance questions.
Different 4: The accuracy of the proposed device is different from the predicate device, the performance test and the clinical accuracy test complied with standards. The difference does not raise any new performance questions.
Different 5: The operation temperature range of the proposed device PT3SBT is different from the predicate device, but the performance test complied with standards. The difference does not raise any new performance questions.
Different 6: The storage humidity range of the proposed device PT3SBT is different from the predicate device, but the performance test complied with standards. The difference does not raise any new performance questions.
Different 7: There is wireless communication with bluetooth low energy on the subject device, the software validation and performance test demonstrated the difference does not raise any new performance questions.
8.0 Discussion of non-clinical and clinical test performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device.
Non-clinical Tests
Electrical Safety test was performed according to IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
EMC test was performed according to 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.
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Performance test was performed according to ISO 80601-2-56:2017 , Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. is the applicable standards for this device.
Biocompatibility test (including cytotoxicity, sensitization, irritation) was performed according to (1) ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, (2)ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and (3) ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Software verification and validation were conducted according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005. Cybersecurity testing has been evaluated according to guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Clinical Tests
Clinical investigation and data analysis were performed according to ASTM E1965-98:2016. The test was conducted for 40 subjects in infants group (0-1 year), 40 subjects in children group (1-5 years) and 50 subjects in adults group (>5 years) (Total 130 subjects). The clinical test report demonstrated that the clinical data, represented by clinical bias and uncertainties met the acceptance criteria of the clinical study protocol. The iHealth PT3 Infrared No-Touch Forehead Thermometer complies with the requirement of ASTM E1965-98 (2016).
9.0 Conclusion
Basing on the performance testing, comparison and analysis, the subject device iHealth PT3SBT Wireless No-Touch Forehead Thermometer is substantially equivalent to the predicate device .
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.