(165 days)
No
The description mentions a "built-in correction algorithm" and "calculation," but there is no mention of AI, ML, or related concepts like training sets or complex data processing that would indicate the use of such technologies. The performance studies focus on standard medical device testing and clinical accuracy validation.
No.
A therapeutic device is used for treating or curing a disease or condition, whereas this device is an ear thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is an infrared ear thermometer intended for the intermittent measurement of body temperature. Measuring body temperature is a diagnostic process as it provides information about a person's health status, such as the presence of fever.
No
The device description explicitly states it is a "hand-held, reusable, battery operated device" and describes physical components like a probe, activation button, and LED display, indicating it is a hardware device with embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The iHealth PT5 Infrared Ear Thermometer measures body temperature directly from the ear canal. It does not analyze any biological specimens taken from the body.
Therefore, based on the provided information, the device 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 Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.
Product codes
FLL
Device Description
The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, 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. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear canal
Indicated Patient Age Range
all ages except for babies under 3 months
Intended User / Care Setting
home use and healthcare facilities use.
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
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 tests were 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)].
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 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.
Clinical Accuracy Validation Test:
Clinical testing have performed according to ASTM F1965-98. The clinical accuracy validation test report included temperature readings of 129 subjects divided into three group age ranges- Infant group (3 months up to 1 year), Children group (1-5 years) and Over 5 years old ( > 5 years). Based on the result, it is demonstrated the the clinical performance of iHealth PT5 Infrared Ear Thermometer complies with the requirement of ASTM E1965-98 (2016).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
January 28, 2022
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street. Ya An Road. Nankai District Tianjin, 300190 China
Re: K212598
Trade/Device Name: iHealth infrared Ear thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 17, 2021 Received: December 29, 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,
Payal Patel 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) K212598
Device Name iHealth Infrared Ear Thermometer (PT5)
Indications for Use (Describe)
The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.
| 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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3
K212598 510(K) SUMMARY
(In accordance with 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, |
| 300190, P.R. China | |
| Phone Number: | 86-22-87611660 |
| Fax Number: | 86-22-87612379 |
| Contact: | Mr. Liu Yi |
| Date of Preparation: | November 15, 2021 |
2.0 Device Information
| Device Name: | iHealth PT5 Infrared Ear Thermometer |
|---|---|
| Common Name: | Infrared Ear Thermometer |
| Classification Name: | Clinical Electronic Thermometer |
3.0 Classification
| Product Code: | FLL |
|---|---|
| Regulation Number: | 21 CFR880.2910 |
| Classification: | II |
| Review Panel: | General Hospital |
4.0 Predicate Device Information
| Manufacturer: | Kaz USA, Inc. |
|---|---|
| Device: | Braun Thermoscan® IRT 4000 series and Braun |
| Thermoscan® PRO 4000 series Clinical Infrared Ear | |
| Thermometer | |
| 510(k) Number: | K103800 |
| Classification | II |
| Product Code | FLL |
5.0 Intended Use
The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.
4
6.0 Device Descrintion
The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, 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. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.
7.0 Comparison of Technological Characteristics with Predicate Device
| Item | Subject Device | Predicate Device
(K103800)
Braun Thermoscan®
PRO 4000) | Comparison Result |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Infrared Ear Thermometer | Infrared Ear Thermometer | -------- |
| Models | PT5 | Braun Thermoscan® IRT
4000 series and Braun
Thermoscan® PRO 4000
series Clinical Infrared
Ear Thermometer | -------- |
| Product code | FLL | FLL | Same |
| Regulation
number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Manufacturer
(legal) | Andon Health Co., Ltd | Kaz, USA Inc | -------- |
| Indications for
Use | The Infrared Ear
thermometer is intended for
the intermittent
measurement of body
temperature from the ear
canal on people of all ages
except for babies under 3
months. It is suitable for
home use and healthcare
facilities use. | The Braun Thermoscan®
IRT 4000 series and Braun
Thermoscan®PRO 4000
series Clinical Infrared Ear
Thermometers is indicated
for the intermittent
measurement and
monitoring of human body
temperature by consumers
of all ages in a home
use/professional use
environment respectively.
The probe cover is used as a | See Note 1. |
| | | sanitary barrier between the
infrared thermometer, and
the ear canal. | |
| Sensor | Infrared | Infrared | Same |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same |
| Dimensions | About
138mm×34mm×27mm
(5.43in x 1.34in x 2.24in) | 150mm x 45 mm x 30 mm | See Note 2 |
| Measurement
range | 34- 42.9°C (93.2- 109.2°F) | 20- 42.2°C | See Note 3 |
| Accuracy for
body
temperature
measurement | ±0.4°F (0.2°C) within
93.2107.6°F (3442°C),
±0.5°F (0.3°C) for other
range. | ±0.2°C within 35.5°C~42°C
±0.3°C for other range | See Note 4 |
| Repeatability | 5 years). Based on the result, it is demonstrated the the clinical performance of iHealth PT5 Infrared Ear Thermometer complies with the requirement of ASTM E1965-98 (2016).
10. Comparison to the Predicate Device and Conclusion
The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device Infrared Ear Thermometer is very similar with its predicate device in the intended use, design principle, performance and applicable standards. And the tests in this submission demonstrate that the differences compared to the predicate device do not raise any new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the legally marketed predicate device (K103800).