iHealth infrared Ear thermometer PT5

{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) | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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,<br>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<br>Thermoscan® PRO 4000 series Clinical Infrared Ear<br>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<br>(K103800)<br>Braun Thermoscan®<br>PRO 4000) | Comparison Result | |------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Device name | Infrared Ear Thermometer | Infrared Ear Thermometer | -------- | | Models | PT5 | Braun Thermoscan® IRT<br>4000 series and Braun<br>Thermoscan® PRO 4000<br>series Clinical Infrared<br>Ear Thermometer | -------- | | Product code | FLL | FLL | Same | | Regulation<br>number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Manufacturer<br>(legal) | Andon Health Co., Ltd | Kaz, USA Inc | -------- | | Indications for<br>Use | The Infrared Ear<br>thermometer is intended for<br>the intermittent<br>measurement of body<br>temperature from the ear<br>canal on people of all ages<br>except for babies under 3<br>months. It is suitable for<br>home use and healthcare<br>facilities use. | The Braun Thermoscan®<br>IRT 4000 series and Braun<br>Thermoscan®PRO 4000<br>series Clinical Infrared Ear<br>Thermometers is indicated<br>for the intermittent<br>measurement and<br>monitoring of human body<br>temperature by consumers<br>of all ages in a home<br>use/professional use<br>environment respectively.<br>The probe cover is used as a | See Note 1. | | | | sanitary barrier between the<br>infrared thermometer, and<br>the ear canal. | | | Sensor | Infrared | Infrared | Same | | Measurement<br>method | Infrared radiation detection | Infrared radiation detection | Same | | Dimensions | About<br>138mm×34mm×27mm<br>(5.43in x 1.34in x 2.24in) | 150mm x 45 mm x 30 mm | See Note 2 | | Measurement<br>range | 34- 42.9°C (93.2- 109.2°F) | 20- 42.2°C | See Note 3 | | Accuracy for<br>body<br>temperature<br>measurement | ±0.4°F (0.2°C) within<br>93.2~107.6°F (34~42°C),<br>±0.5°F (0.3°C) for other<br>range. | ±0.2°C within 35.5°C~42°C<br>±0.3°C for other range | See Note 4 | | Repeatability | <0.3 deg C | <0.3 deg C | Same | | Display<br>resolution | 0.1°F (0.1°C) | 0.1°F (0.1°C) | Same | | Operating<br>temperature | Temperature:<br>10°C-40°C (50°F-104°F)<br>Humidity: ≤95%RH,<br>non-condensing | 10- 42°C ambient and up to<br>95% RH | See Note 5 | | Display | LED | LCD | See Note 6 | | Response<br>Time | <3s | 2-3 sec | See Note 7 | | Signal input | Button, NTC and The<br>thermopile sensor | Button, NTC and The<br>thermopile sensor | Same | | Signal output | LED Display, buzzer and<br>probe heating signal | LCD Display, buzzer and<br>probe heating signal | Similar, see note 6 | | Presence of<br>heating feature | Yes, probe heat function | Yes, probe heat function | Same | | Mode of<br>operation | Adjusted mode | Adjusted mode | Same | | Reference<br>body Site | Oral | Oral | Same | | Power<br>requirements | 2X1.5V AAA battery | 2X1.5V AA battery or<br>custom rechargeable Nickel<br>Metal Hydride Battery Pack | See Note 8 | | Materials of<br>construction<br>for patient<br>contacting<br>component | Shell: ABS<br>Key/button: PMMA<br>Protective cover: PP<br>Probe: TPU | Common Materials<br>including an impact<br>resistant casing.<br>Biocompatible metals and<br>resins. | Similar - validated for<br>cytotoxicity per<br>ISO10993-5 and irritation<br>as well as sensitization per<br>ISO 10993-10, See Note 9 | | Temperature<br>unit | °C or °F | °C or °F | Same | | Accessory | Probe cover | Probe cover | Same | | Performance | Meets ASTM E 1965, and<br>ISO80601-2-56 | Meets ASTM E 1965 | All standards verified and<br>validated for test device<br>and met acceptance<br>criteria. | | Electrical<br>Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Same | | EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same | The following table is the summary of the technological characteristics of the proposed subject device and predicate device. {5}------------------------------------------------ {6}------------------------------------------------ # DISCUSSION OF DIFFERENCES: | Note No | Difference | Justification | |---------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Indications for Use | The scope of the applicable group of people has been narrowed down to<br>exclude babies under 3 months. The subject device has a narrower<br>intendedpopulation and it will not raise any new or different safety or<br>effectiveness risks. | | 2 | Dimensions | The software validation and clinical accuracy test demonstrated the<br>difference does not raise any new performance questions. | | 3 | Measurement range | The measurement range of the predicate device is different from that of the<br>subject device. The subject device measurement range is 34°C to 42.9°C.<br>Regarding the predicate's clinical measurement range of 34°C to 42.2°C, the<br>accuracy of the subject device and the predicate device are same or even<br>stricter than the predicate device. And the performance test and clinical<br>accuracy test showed that the subject device do not raise any new questions. | | 4 | Accuracy for body<br>temperature<br>measurement | The accuracy of subject device is same or even stricter than that of predicate<br>device.<br>For measurement range of 35.5°C~42°C, the accuracy of the subject device<br>and the predicate device are same, and for 34°C-35.5°C, the accuracy of the<br>subject device is stricter than that of predicate device, and the accuracy of<br>other ranges are same for subject device and predicate device.<br>And based on the testing, the subject device meets ASTM E1965-98, and ISO<br>80601-2-56 requirements. | | 5 | Operating<br>temperature | Our operating temperature and relative humidity are different from predicate<br>device, but we performed test according to ISO 80601-2-56 and ASTM<br>E1965-98, and it is demonstrated that it is substantially equivalent on<br>performance. | | 6 | Display | Different, the display component of the new device PT5 is changed from<br>LCD to LED, the software validation and performance test demonstrated the<br>difference does not raise any new performance questions. | | 7 | Response Time | Both subject device and the predicate device can get measurement within 3s, | | | | the software validation showed that the difference does not raise any new | | | | performance questions. | | 8 | Power requirements | Power supply of the subject device is different from the predicate device, the<br>electrical safety and EMC test demonstrated the difference does not raise any<br>new performance questions. | | 9 | Materials of<br>construction for<br>patient contacting<br>component | The materials used for subject device and predicate device are similar, and it<br>is validated for cytotoxicity per ISO10993-5 and irritation as well as<br>sensitization per ISO 10993-10, and it is demonstrated that the subject<br>device does not raise any new questions. | {7}------------------------------------------------ ## 8.0 Discussion of Non-Clinical & Clinical Testing 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. {8}------------------------------------------------ ## 9.0 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). ## 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).