(135 days)
Not Found
No
The device description details a standard thermopile sensor and electrical circuit for amplification and calculation, with no mention of AI or ML. The performance studies focus on clinical accuracy based on standard temperature measurement protocols.
No.
A therapeutic device is one that treats or heals a condition. This device is a thermometer, which is a diagnostic tool used for measuring temperature, not for treatment.
Yes
Explanation: The device measures body temperature, which is a physiological parameter often used to help determine a medical condition or disease, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "hand-held, reusable, battery operated device" that uses a "thermopile sensor" and has a "LED display," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states the device measures "body temperature from the forehead" by measuring "natural thermal radiation from the central forehead." This is a direct measurement of a physiological parameter from the body itself, not an analysis of a specimen taken from the body (like blood, urine, tissue, etc.).
- The intended use is for measuring body temperature. While body temperature can be an indicator of health status, the device's function is solely to measure this physical parameter. It does not perform any analysis or testing on biological samples.
Therefore, the iHealth PT3 Infrared No-Touch Forehead Thermometer falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The iHealth PT3 Infrared No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead 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 time from start of measurement to display of temperature reading is about 1 second. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages.
Intended User / Care Setting
consumers in the household environment and by healthcare providers.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Data Accuracy Validation Test:
Clinical investigation and data analysis have performed according to ASTM E1965-98. The test report shows result of 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) are within acceptable range. Based on the test results, it demonstrates the clinical accuracy of ±0.4°F (0.2°C) within 95107.6°F (3542°C), and ±0.5°F (0.3°C) for other range. The iHealth PT3 Infrared No-Touch Forehead Thermometer complies with the requirement of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.4°F (0.2°C) within 95107.6°F (3542°C), ±0.5°F (0.3°C) for other range.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2020
Andon Health Co., Ltd. Mr. Liu Yi President No. 3 Jinping Street, Ya An Road, Nankai District Tianjin, 300190 China
Re: K200531
Trade/Device Name: iHealth Infrared No-Touch Forehead Thermometer, Model: PT3 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 10, 2020 Received: June 15, 2020
Dear Mr. 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 Actinclude 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
1
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 (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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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, Sapana Patel -S
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) K200531
Device Name
iHealth Infrared No-Touch Forehead Thermometer (Model: PT3)
Indications for Use (Describe)
The Infrared No-Touch Forehead Thermometer is intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K200531
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, Tianji n, |
| P.R. China | |
| Phone number: | 86-22-87611660 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 7/14/2020 |
2.0 Device information
Trade name: iHealth Infrared No-Touch Forehead Thermometer (model: PT3) Infrared forehead thermometer Common name: 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
Guangzhou Berrcom Medical Device Co., Ltd. Manufacturer: Infrared Thermometer Model MD-H30 Device: 510(k) number: K191570
5.0 Indications for Use
The Infrared No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
4
6.0 Device description
The iHealth PT3 Infrared No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead 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. lt 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 time from start of measurement to display of temperature reading is about 1 second. 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.
| 7.0 Summary comparing technological characteristics with predicate | |||
|---|---|---|---|
| device |
| Item | Subject Device
(K200531) | Predicate Device
(K191570) | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Models | PT3 | MD-H30 | Different |
| Product code | FLL | FLL | Same |
| Regulation
number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Manufacturer | Andon Health Co., Ltd | Guangzhou Berrcom
Medical Device Co., Ltd. | Different |
| Indications for
Use | The Infrared No-Touch
Forehead Thermometer is
intended for the intermittent
measurement of body
temperature from the
forehead on people of all
ages. It can be used by
consumers in the household
environment and by
healthcare providers. | The infrared thermometer is
intended for the intermittent
measurement of body
temperature from the
auditory canal or central
forehead skin surface on
people of all ages. It can be
used by consumers in the
household environment and
by healthcare providers. | Different |
| Probe contact
type | Non-contact;
measurement distance: $\leq$
1.18 in(3 cm) | Skin contacting | Different |
| Sensor | Thermopile | Thermopile | Same |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same |
| Display type | LED | LCD | Different |
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| Other feature | Vibration when get
measurement | Beep when get
measurement
Probe cover provided | Different |
|-----------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------|
| Measuring range | 32- 42.9° C (89.6- 109.2°
F) | 32- 43° C (89.6- 109.4° F) | different |
| Accuracy | ±0.4°F (0.2°C) within
95107.6°F (3542°C),
±0.5°F (0.3°C) for other
range. | ±0.4°F (0.2°C) within
95107.6°F (3542°C),
±0.5°F (0.3°C) for other
range. | 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 |
| Power
requirements | 2X1.5V AAA battery | 2X1.5V AAA battery | Same |
| Operation
environment | 15-40° C, 15%-95% RH,
70-106kPa | 10°C40°C; ≤95% RH | Different, |55°C; ≤95%RH | |
| Storage
environment | -20-55° C, 10%-95% RH,
70-106kPa | -20
| Materials of
skin-contacting
components | ABS and PMMA | ABS | Different. |
| biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Same |
The manufacturer of the subject device is different from the predicate device, so the model is also different, there is slightly difference in the indications for use because the subject device only takes measurement from the forehead while the predicate device takes measurement from both forehead skin and auditory canal. Moreover, the predicate device is skin contacting when taking forehead temperature measurement while the subject device is non-contact device. Both subject and predicate devices detect the infrared radiation from forehead. The software validation, laboratory accuracy test and clinical accuracy test demonstrated the difference does not raise any new performance questions.
The display component of the new device PT3 is changed from LCD to LED, the software validation and performance test demonstrated the difference does not raise any new performance questions.
When measurement completed, the device with results displayed on LED, while the predicate will beep when completed measurement. This feature is different, but the software validation demonstrated the difference does not raise any new performance questions.
The subject device is non-contact when taking measurement, which is different from the predicate device, the performance study and clinical accuracy test
6
demonstrated the difference does not raise any new performance questions.
The Measuring range is different from the predicate device, the performance test and the clinical accuracy test demonstrated the difference does not raise any new performance questions.
The operation temperature range of the proposed device PT3 is narrow than the predicate device, and the storage humidity range of the proposed device PT3 is also narrow than the predicate device, but the performance test demonstrated the difference does not raise any new performance questions.
The material of skin-contacting components is different, the biocompatibility report conforms that there is no new risk for the proposed device.
8.0 Discussion of non-clinical and clinical test performed
Non-clinical tests were conducted to verify that the proposed device meet 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
Performance test was performed according to 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. [Including: Amendment 1 (2018)]. is the applicable standards for this device.
The 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.
Biocompatibility test (including cytotoxicity, sensitization, irritation) was performed according to (1) ISO 10993-1 Fifth edition 2018-08 Biological
7
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.
Reprocessing: Cleaning and Disinfection
The subject device is a non-sterile device. The cleaning validation was performed according to the Instructions for Use.
Clinical Data Accuracy Validation Test
Clinical investigation and data analysis have performed according to ASTM E1965-98. The test report shows result of 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) are within acceptable range. Based on the test results, it demonstrates the clinical accuracy of ±0.4°F (0.2°C) within 95107.6°F (3542°C), and ±0.5°F (0.3°C) for other range. 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 above, the subject device i Health PT3 Infrared No-Touch Forehead Thermometer is substantially equivalent to the predicate device .