(197 days)
No
The device description and performance studies focus on standard infrared thermometry technology and do not mention any AI or ML components. The software validation is based on a 2005 guidance document, which predates widespread AI/ML in medical devices.
No
The device is intended for measurement, not for treatment or therapy. It measures body temperature, which is a diagnostic function, not a therapeutic one.
No
The device is intended for the measurement of body temperature, which is a physiological parameter, but does not provide a diagnosis of a disease or condition.
No
The device description explicitly states it is a "hand-held, reusable, battery operated device" that uses a "thermopile sensor" and has an "LCD display," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 Infrared Digital No-Touch Thermometer measures body temperature by detecting infrared radiation emitted from the forehead. This is a direct measurement of a physiological parameter on the body, not an analysis of a specimen 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 monitoring a vital sign, not an IVD.
Therefore, while it is a medical device, it falls under the category of a general medical device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Digital No-Touch 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.
Product codes
FLL
Device Description
The iHealth PT2L Infrared Digital No-Touch 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 LCD 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
Clinical investigation and data analysis have performed according to ASTM F1965-98. 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 group (>5 years) (Total 130 subjects) are within acceptable range. Based on the test results, it demonstrates the iHealth PT2L Infrared Digital No-Touch Thermometer complies with the requirement of ASTM E1965-98 (2016).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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October 1, 2020
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 China
Re: K200710
Trade/Device Name: Infrared PT2L Digital No-Touch Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: August 24, 2020 Received: September 1, 2020
Dear Liu Yi:
We have reviewed vour 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
1
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 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 medical devices and radiation-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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200710
Device Name
iHealth PT2L Infrared Digital No-Touch Thermometer
Indications for Use (Describe)
The Infrared Digital No-Touch Thermometer is intennittent 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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510(k) Summary-K200710
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 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: | 8/21/2020 |
2.0 Device information
Trade name: iHealth PT2L Infrared Digital No-Touch Thermometer Infrared forehead thermometer Common name: Regulation 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: Guangzhou Berrcom Medical Device Co., Ltd. Device: Infrared Thermometer Model MD-H30 510(k) number: K191570
5.0 Indications for Use
The Infrared Digital No-Touch 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 PT2L Infrared Digital No-Touch 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 LCD display.
| Item | Subject Device
(K200710) | Predicate Device
(K191570) | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Models | PT2L | 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 Digital No-Touch
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: ≤ 1.18
in(3 cm) | Skin contacting | Different |
| Sensor | Thermopile | Thermopile | Same |
| Measurement method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement Site | Forehead | Forehead or Ear | Different |
| Reference site | Oral | Oral | Same |
7.0 Summary comparing technological characteristics with predicate device
5
| Display type | LCD | LCD | Same |
|---|---|---|---|
| Dimension | 141mm×32mm×48mm | Not known | different |
| Other feature | Beep when get measurement | ||
| colored screen indicates the | |||
| temperature is outside of | |||
| 'normal' or 'high' temperature | |||
| ranges | Beep when get | ||
| measurement | |||
| Probe cover provided | different | ||
| Measuring range | 34-43° C (93.2-109.4° F) | 32- 43° C (89.6- 109.4° F) | different |
| Accuracy | ±0.5°F (±0.3°C) for 34- | ||
| 43° C (93.2- 109.4° F) | ±0.4° F (±0.2° C) within | ||
| 95 | |||
| ±0.5°F (±0.3° C) for | |||
| other range. | Different | ||
| 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, ≤95%RH, | ||
| 70-106kPa | 10°C~40°C; ≤95% RH | Different, | |
| Storage | |||
| environment | -25-55°C, ≤95%RH, | ||
| 70-106kPa | -20~55°C; ≤95%RH | Different, | |
| Materials of | |||
| skin-contacting | |||
| components | ABS and PMMA | ABS | Different |
| 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 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | 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 indication for use because the subject device only take measurement from the forehead skin while the predicate device take measurement from both forehead skin and auditory canal. Moreover, the predicate device is skin contacting when taking measurement while the subject device is non-contact device. The software validation and clinical accuracy test demonstrated the difference does not raise any new performance questions.
Dimension of the subject device is different from the predicate device, but the electrical safety and EMC test and the performance test demonstrated the difference does not raise any new performance questions.
The subject device has no probe cover provided, while the predicate device will provide probe cover, and the subject device has function of flashing/colored screen that indicates the temperature is outside of 'normal' or
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'high' temperature ranges, but the performance test of the subject device demonstrated the difference does not raise any new performance questions.
The Measuring range and accuracy 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 measuring range and accuracy is within the ASTM 1965-98 standard for Skin IR thermometers.
The operation temperature range of the proposed device PT2L is narrow than the predicate device, and the storage humidity range of the proposed device PT2L is also wide 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 confirms 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.
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Biocompatibility test (including cytotoxicity, sensitization, irritation) was leveraged from their own reference device K 2 0 0 5 3 1 . The tests performed on the reference device 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.
Reprocessing: Cleaning and Disinfection
The subject device is a non-sterile device. The cleaning validation was performed according to the Instructions for Use.
Clinical Accuracy Validation Test
Clinical investigation and data analysis have performed according to ASTM F1965-98. 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 group (>5 years) (Total 130 subjects) are within acceptable range. Based on the test results, it demonstrates the iHealth PT2L Infrared Digital No-Touch Thermometer complies with the requirement of ASTM E1965-98 (2016).
9.0 Comparison to the predicate device and the conclusion
Basing on the performance testing, comparison and analysis above, the subject device iHealth PT2L Infrared Digital No-Touch Thermometer is substantially equivalent to the predicate device .