(292 days)
Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.
The provided document is a 510(k) summary for an Infrared Forehead Thermometer (Model FR200). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets general acceptance criteria for a novel AI/software medical device.
Therefore, much of the requested information regarding acceptance criteria and study details for an AI/software device is not available in this document because it pertains to a different type of medical device (a thermometer) and regulatory pathway (substantial equivalence of a hardware device incorporating standard technology).
However, I can extract the information that is present and point out where the requested information is absent or not applicable given the context.
Here's a breakdown of what can be inferred or directly stated from the document:
Device Type: Infrared Forehead Thermometer (hardware device, not an AI/software image analysis device).
Regulatory Pathway: 510(k) - demonstrating substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a general table of "acceptance criteria" for an AI/software device, as it is a thermometer. However, it does list performance specifications and testing standards that serve as benchmarks for this type of device.
| Acceptance Criteria (Performance Specifications/Standards) | Reported Device Performance (Compliance) |
|---|---|
| Measurement Accuracy: | Subject Device (K202741): |
| - $±0.2°C: 34.0°C \sim 43.0°C$ | $±0.2°C (±0.4°F): 34.0°C \sim 43.0°C (93.2°F \sim 109.4°F)$ |
| (Note 1 states the difference in accuracy with the predicate does not affect performance/accuracy evaluated by ISO 80601-2-56 and ASTM E1965-98) | (Complies based on evaluation) |
| Measurement Range: | $34.0°C \sim 43.0°C (93.2°F \sim 109.4°F)$ |
| Display Resolution: | $0.1°C (0.1°F)$ |
| Electromagnetic Compatibility & Electrical Safety: | Passed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Biocompatibility: | Passed ISO 10993-5, ISO 10993-10 |
| Performance Test-Bench: | Passed ISO 80601-2-56, ASTM E1965-98 |
| Clinical Accuracy (Repeatability): | Met the acceptance criteria of the clinical study protocol. (Specific numerical criteria for repeatability are not provided in this summary, but are stated as met). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the Clinical Accuracy study, the document states: "a clinical study was carried out on 160 subjects for all ages of population" (Page 7) and "consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults" (Page 8). There is a discrepancy in the total number of subjects (160 vs 180). Assuming 60 per age group (infants, children, adults), 180 seems more consistent.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation" (Page 8), indicating it was a prospective study specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/available. This device is a thermometer. Its "ground truth" for temperature measurement is typically established by comparing readings against a reference thermometer (e.g., a rectal thermometer or other highly accurate standard) in a clinical setting, not through expert consensus on images. The document refers to meeting "acceptance criteria of the clinical study protocol" for repeatability, which would involve quantitative comparisons to a reference.
4. Adjudication method for the test set
Not applicable/available. Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments, like image reading, where multiple experts interpret data. For a thermometer, objective measurement comparisons are used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device. It's a standalone thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device functions as a "standalone" measurement tool. Its performance is evaluated intrinsically (how accurately it measures temperature), not in conjunction with human interpretation of complex data. The clinical accuracy study assesses the device's direct measurement capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "Clinical Accuracy," the ground truth would be established by simultaneous measurements using a recognized reference standard thermometer (e.g., a rectal thermometer, an oral thermometer, or a highly accurate laboratory-grade thermometer) according to the ASTM E1965-98 and ISO 80601-2-56 standards. The document doesn't explicitly name the reference method used within the clinical study, but these standards prescribe such methods. It's an objective, quantitative comparison rather than subjective consensus.
8. The sample size for the training set
Not applicable. This is a traditional infrared thermometer, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI model.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
July 7, 2021
Shenzhen Combei Technology Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K202741
Trade/Device Name: Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 24, 2021 Received: June 7, 2021
Dear Yoyo Chen:
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 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) K202741
Device Name Infrared Forehead Thermometer, Model:FR200
Indications for Use (Describe)
Infrared Forehead Thermometer is intentermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
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)
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}------------------------------------------------
510K Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| The date the summarywas prepared | May 24, 2021 |
|---|---|
| Manufacturerinformation | Shenzhen Combei Technology Co., Ltd.Address:Floor 3, Bldg. B, Jinxiongda Technology Park, No.105,Huanguan South Road, Dahe Community, Guanlan, Long HuaDistrict, Shenzhen, Guangdong, China, 518110Contact person: Kevin FongTEL: 086-755-29588956E-Mail: kevin.fong@combei.cn |
| SubmissionCorrespondent | Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Ms. Yoyo ChenTel: +86(755)86069197E-Mail: yoyo@cefda.com; field@cefda.com |
| Image: Logo | |
| Establishmentregistration number | 3013561145 |
2. Device Information
| Device Name: | Infrared Forehead Thermometer |
|---|---|
| Model: | FR200 |
| Common name: | Clinical Electronic Thermometer (Infrared Thermometer) |
| Classification Name: | Thermometer, Electronic, Clinical |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
{4}------------------------------------------------
3. Predicate Device
| Manufacturer | Microlife Intellectual Property GmbH |
|---|---|
| Device name | Microlife Non-Contact Infrared Forehead Thermometer |
| Model | FR1DG1 (NC200) |
| 510(K) Number: | K191829 |
| Regulation Number: | 880.2910 |
| Device Class: | Class II |
| Product Code | FLL |
4. Device Description
The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home.
After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead. The features of the thermometer are as follow:
-
- This device can be used for measuring the body temperature and object temperature
-
- Measurement in a matter of seconds;
- Switching between ℃ and ℃ F; 3)
- Automatic range selection; resolution is 0.1°C (0.1 °F); 4)
- Body mode and object mode switching 5)
-
- Low battery indication, and auto shut-down;
-
- With a high and low temperature alarm function (color and sound indication);
- Multiple reading recall (30 sets data could be stored and recalled); 8)
-
- Two color backlight display:
-
- Ambient detection
5. Indication for Use
Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
6. Comparison with Predicate Device
The subject devices are substantially equivalent to the predicate device (K191829). The comparison of technological characteristics between the subject device and predicate device is listed as follows:
| Items | Subject Device(K202741) | Predicate Device(K191829) | Comparison |
|---|---|---|---|
| Product code | FLL | FLL | Same |
| Regulation number | 880.2910 | 880.2910 | Same |
| Items | Subject Device(K202741) | Predicate Device(K191829) | Comparison |
| Device class | 2 | 2 | Same |
| Intended use | Infrared Forehead Thermometer isintended for the intermittentmeasurement and monitoring offorehead temperature. The device isindicated for use by people of all agesin the home. | The Microlife Non-ContactInfrared ForeheadThermometer, ModelFR1DG1 (NC200) is intended for theintermittent measurement andmonitoring of human bodytemperature.The device is indicated for use bypeople of all ages in the home. | Same |
| Thermometer type | Infrared thermometerNon-contact | Infrared thermometerNon-contact | Same |
| DeviceMeasurementTechnology | Infrared radiation detection | Infrared radiation detection | Same |
| Measurementlocation | Forehead | Forehead | Same |
| MeasurementRange | $34.0°C~43.0°C (93.2°F ~ 109.4° F);$ | $34.0°C -43.0 °C (93.2-109.4 °F);$ | Same |
| Measurementaccuracy | $±0.2°C (±0.4°F): 34.0°C ~ 43.0°C(93.2°F ~ 109.4°F);$ | $±0.2 °C: 35.0 ~ 42.0 °C$$±0.3 °C: 34°C ~ 34.9°C, 42.1°C$$~43°C,$$±0.4 °F: 95.0 ~ 107.6 °F,$$±0.5 °F: 93.2 | Different(Note 1) |
| TemperatureMeasurementdistance | 3cm~5cm | Appropriate within 5 cm | Similar |
| Display Type | LCD Display | LCD Display | Same |
| Display resolution | $0.1°C (0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| Power supply | d.c.3.0V (2pcs AAA batteries) | d.c.3.0V (2pcs AAA batteries) | Same |
| Measurement datamemories | 30 sets memories | 30 sets memories | Same |
| Backlight | Green and red backlight according tothe measured temperature; | Green and red backlight according tothe measured temperature; | Same |
| Auto-off time | Approx. 1 minute after lastmeasurement has been taken | Approx. 1 minute after lastmeasurement has been taken | Same |
| OperationCondition | Temperature:$16-40.0 °C (60.8-104.0 °F)$Humidity: 15-95%RH, non-condensing | Ambient Temperature:$15°C | Different(Note 2) |
| Items | Subject Device(K202741) | Predicate Device(K191829) | Comparison |
| Storage andtransportationcondition | Temperature: -20 °C to +50 °C (-4 °Fto 122 °F)Humidity:15-95 % relative maximumhumidity(non-condensing) | Ambient Temperature: -25°C | Different(Note 2) |
| Protection againstelectric shock | Internally power supply, Type BF | Internally power supply, Type BF | Same |
| IP Class | IP22 | IP22 | Same |
| High temperaturealarm | Yes | Yes | Same |
| Auto measurement | No | The device can take ameasurement automaticallywhen the device detects thedistance is appropriate within5 cm. | Different(Note 3) |
| Sensor type | Thermopile | Thermopile | Same |
| Housing material | ABS/ PA-757 | ABS/PA 707 | Different(Note 4) |
| Patient-contactbutton material | ABS/ PA-757 | PMMA | Different(Note 4) |
| Display case | PMMA/CM-203 | unknown | Different(Note 4) |
| PhysicalDimensions | 145 x 36 x 33 mm | 156.74347 mm | Similar |
| Weight | 62g (without battery) | 68.5 g (Battery excluded) | Similar |
| Expected ServiceLife | 5 year | 5 year | Same |
| Safety &Performance | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;ISO 80601-2-56;ASTM E1965-98. | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;ISO 80601-2-56;ASTM E1965-98. | Same |
| Biocompatibility | Cytotoxicity, ISO 10993-5Skin Irritation, ISO 10993-10Skin Sensitization,ISO 10993-10 | Cytotoxicity, ISO 10993-5Skin Irritation, ISO 10993-10Skin Sensitization,ISO 10993-10 | Same |
| Clinical AccuracySupport | Yes | Yes | Same |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
Note 1 Measurement accuracy
The measurement accuracy for the subject device is different with the predicate device. But The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98. The different will not arise new safety and effectiveness issue.
Note 2 Operation Condition, Storage, and transportation condition
The subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1, IEC60601-1-11, and ASTM E1965-98 standard. The difference does not raise new issues on the device safety and effectiveness.
Note 3 Auto measurement
The predicate device can take a measurement automatically when the device the distance is appropriate within 5 cm. The purpose of auto measurement is to obtain the body temperature. However, for the subject device, the user can read the body temperature by aim the probe at the center of the forehead and keep distance of no more than 3~5cm and press measurement button. The measurement function has been verified during software verification. Otherwise, a clinical study was carried out on 160 subjects for all ages of population, it is demonstrating the subject device clinically safe and effective with all age groups. The difference does not raise new issues on the device safety and effectiveness.
Note 4 Housing material. Patient-contact button material and Display case
Although the patient contact materials for subject device and predicate device are different, but they are all compliance with the biocompatibility standards ISO 10993-5 and ISO 10993-10. The difference does not raise new issues on the device safety and effectiveness.
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject devices have passed safety testing in according to following standards.
- IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment Part 1: General requirements for basic 1) safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety 3) and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
7.2. Biocompatibility Test
The subject devices have passed biocompatibility tests in according to following standards.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 1)
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject devices have passed performance testing in according to following standard.
{8}------------------------------------------------
- ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety 1) and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent 2) Determination of Patient Temperature
7.4. Software verification and validation
Software documentation consistent with moderate level of concern was submitted in this 510(k) in according to FDA guidance - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
8. Clinical Accuracy
Clinical accuracy testing was conducted in according to ASTM E1965-98(Reapproved 2016) and ISO 80601-2-56:2017. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults (NOTE: Infants--newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical test report demonstrated that the clinical data, represented by clinical repeatability met the acceptance criteria of the clinical study protocol.
9. Conclusion
The Infrared Forehead Thermometer (Model FR200) is substantially equivalent to the predicate device (K191829). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.
§ 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.