(168 days)
Not Found
No
The description details a standard infrared thermometer operation based on thermal radiation measurement and electrical signal processing, with no mention of AI or ML techniques.
No.
The device is a thermometer used for measuring body temperature, not for treating or rehabilitating a medical condition.
No
The device is intended for the intermittent measurement of body temperature, which is a physiological measurement, not a diagnostic one. While temperature can be an indicator of illness, the device itself does not diagnose any condition.
No
The device description clearly states it is a "hand-held, reusable, battery operated device" that uses a "thermopile sensor" and has an "LED display". While it can transmit data to a smart device via Bluetooth, the core temperature measurement is performed by the physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device function: The iHealth PT3SBT Wireless No-Touch Forehead Thermometer measures body temperature by detecting infrared radiation from the forehead. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is for "intermittent measurement of body temperature from the forehead." This aligns with a general medical device for physiological measurement, not an IVD.
Therefore, the device falls under the category of a general medical device, specifically a thermometer, rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
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)
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.4 degree F (+/- 0.2 degree C) within 93.2 degree F-107.6 degree F (34 degree C-42 degree C), and +/- 0.5 degree F (+/- 0.3 degree C) for other temperature ranges.
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.
0
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
1
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
2
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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3
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.
4
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-Touch
Forehead Thermometer
Model: PT3SBT | iHealth Infrared No-Touch
Forehead Thermometer
Model: PT3 | --- |
| Product code | FLL | FLL | Same |
| Regulation
number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Manufacturer | Andon Health Co., Ltd | Andon Health Co., Ltd | Same |
| 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. | 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. | Different 1 |
| Probe contact
type | Non-contact;
measurement distance: ≤
1.18 in(3 cm) | Non-contact;
measurement distance: ≤
1.18 in(3 cm) | Same |
| Sensor | Thermopile | Thermopile | Same |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same |
| Display type | LED | LED | Same |
| Other feature | 1. Vibration when get
measurement
2. Can connect to a smart
device and display measured
temperature result on a smart
device. | 1. Vibration when get
measurement | Different 2 |
| APP name and
feature | iHealth My Vitals Pro App
Store and show data received
from the thermometer through
Bluetooth | 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) within
93.2°F-107.6°F(34°C-42°C),
and $\pm$ 0.5°F( $\pm$ 0.3°C) for other
temperature ranges. | $\pm$ 0.4°F (0.2°C) within
95107.6°F (3542°C),
$\pm$ 0.5°F (0.3°C) for other
range. | Different 4 |
| Measuring
response time | 1 second | 1 second | Same |
| Low battery
indicator | 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 |
| Power
requirements | 2X1.5V AAA battery | 2X1.5V AAA battery | Same |
| Operation
environment | 0-40° C, 15%-95% RH,
70-106kPa | 15-40° C, 15%-95% RH,
70-106kPa | Different 5 |
| Storage
environment | -20-55° C, 15%-95% RH,
70-106kPa | -20-55° C, 10%-95% RH,
70-106kPa | Different 6 |
| Materials of
skin-contacting
components | 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 and
performance
testing | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Wireless
communication | Bluetooth low energy | NA | Different 7 |
7.0 Summary comparing technological characteristics with predicate device
5
6
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.
7
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 .