(137 days)
Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.
The device is widely used for home healthcare, medical institutes and many other occasions.
The provided text describes the regulatory clearance of a Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) and details the testing done to prove its substantial equivalence to a predicate device. This is not an AI/ML device, and thus, many of the requested elements for AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not found in the provided document.
However, I can extract information related to the acceptance criteria and the study that proves the device meets (or is equivalent to) those criteria for a traditional medical device, specifically a thermometer.
Here's a breakdown of the requested information, adapted to the context of a thermometer and the provided document:
Acceptance Criteria and Device Performance for Non-contact Forehead Infrared Thermometer
1. Table of Acceptance Criteria and Reported Device Performance
For medical thermometers, the primary acceptance criteria revolve around measurement accuracy and clinical performance. The document refers to compliance with specific international standards.
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance (Reference) |
|---|---|
| Measurement Accuracy | |
| ISO 80601-2-56 compliance | The "Measuring accuracy" of the subject device (89.6°F-109.2°F (32.0°C-42.9°C)/±0.4°F/±0.2°C) is stated to be similar to the predicate device and both meet the requirement of ISO 80601-2-56. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. Based on the results, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023), which correlates to ISO 80601-2-56. |
| Clinical Performance | |
| ASTM E1965-98 (Reapproved 2016/2023) | Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016). Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023). |
| Electrical Safety and EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-56 is reported. |
| Biocompatibility | Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 and FDA guidance. |
| Software Function (if applicable) | Software documentation was provided in accordance with the FDA June 14, 2023 document "Content of Premarket Submissions for Device Software Functions". The software verification and validation test met the requirements, and performance testing shows compliance with performance standards. |
| Overall Substantial Equivalence | The device's technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to the predicate device. Differences (measuring range, measurement distance, memory, operating condition) do not raise new issues of safety or effectiveness and meet safety/performance standards. The software verification and validation test met requirements, and performance testing showed compliance with standards. The overall conclusion is that the device is substantially equivalent to the legally marketed predicate device. This is the overarching acceptance criterion for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A minimum of 143 subjects were used for the clinical study. These subjects were divided into three age groups:
- Group A1: 0 up to 3 months (Infant group)
- Group A2: 3 months up to 1 year (Infant group)
- Group C: Older than 1 to 5 years old (Child group)
- Group B and C: Above 5 years old (Adult group) - Note: The document lists B Child group (Older than 1 to 5 years old) and C group older than 5 years old. This seems to be a minor typo in the extract formatting, grouping A and B as infant and child, and then C as older. The key is that multiple age groups were tested.
- Data Provenance: The document does not explicitly state the country of origin of the clinical data. It states the study was a "randomization, simple blind homologous control, pairing design of clinical investigation." It is a prospective clinical study as it involved conducting tests with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the context of a non-contact infrared thermometer's clinical accuracy study. For such a device, a "ground truth" is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) as per the ASTM E1965 standard, rather than expert consensus on images or interpretations. The expertise required would be in the conduct of the clinical study itself, ensuring proper procedure and data collection.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers, common in diagnostic imaging. For a thermometer, the "ground truth" is a measured temperature value, not a subjective interpretation requiring adjudication among experts. The study design mentions "simple blind homologous control, pairing design."
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
This information is not applicable. The device is a Non-contact Forehead Infrared Thermometer, not an AI/ML-powered diagnostic imaging device involving human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an AI algorithm. The device itself is the "standalone" product, measuring temperature. Its performance is evaluated directly through non-clinical and clinical testing, not as an algorithm interpreting data for a human.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparative temperature measurements against a reference method (likely rectal or oral temperature, as per ASTM E1965-98 standards for clinical thermometers). The study assessed the device's accuracy in relation to these established body temperature measurements. It is explicitly stated that the study followed ASTM E1965-98, which is a standard for clinical accuracy of infrared thermometers.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The document describes a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is hardware-based, relying on infrared physics, not trained on a dataset of images or other input data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is not an AI/ML device with a "training set."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2025
Shenzhen Finicare Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K243136
Trade/Device Name: Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR202, FC-IR206, FC-IR207, FC-IR209) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 10, 2025 Received: January 15, 2025
Dear Boyle Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. 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
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Indications for Use
Submission Number (if known)
Device Name
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR202, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
Indications for Use (Describe)
Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
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
K243136
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Address: | 201, No.50, the 3rd Industrial Park, Houting Community,Shajing Street, Bao'an District, Shenzhen 518104 China |
| Tel: | 86-755-23013503 |
| Contact: | Chao Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 608, No. 738 Shangcheng Rd., Pudong Shanghai200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: February 14, 2025
2.0 Device Information
| Trade name: | Non-contact Forehead Infrared Thermometer(FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) |
|---|---|
| Common name: | Infrared Thermometer |
| Classification name: | Thermometer, Electronic, Clinical |
| Model(s): | FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209 |
| Production code: | FLL |
| Regulation number: | 21CFR 880.2910 |
| Classification: | Class II |
| Panel: | General Hospital |
3.0 Predicate Device Information
| Manufacturer: | Shenzhen Changkun Technology Co., Ltd. |
|---|---|
| Trade name: | Infrared Thermometer, Model Number CK-T1501, CK-T1502. |
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CK-T1503 510(k) number: K193253
4.0 Indication for Use Statement
Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
5.0 Device Description
The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.
The device is widely used for home healthcare, medical institutes and many other occasions.
6.0 Comparison to the Predicate Device
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Infrared Thermometer is substantially equivalent to the predicate devices referenced above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Item | Subject DeviceK243136 | Predicate DeviceK193253 | Remark |
|---|---|---|---|
| Manufacturer | Shenzhen Finicare Co., Ltd. | Shenzhen ChangkunTechnology Co., Ltd. | / |
| Product Name | Forehead Infrared Thermometer(Model FC-IR2000, FC-IR205,FC-IR202, FC-IR206, FC-IR207,FC-IR209) | Infrared Thermometer,model CK-T1501, CK-T1502,CK-T1503 | / |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| IntendedUse/Indicationfor Use | Infrared Thermometer is a non-sterile, reusable, non-contact andhandheld device. It can be usedby consumers in homecareenvironment and doctors in clinicas reference. It is intended formeasuring human bodytemperature of people over onemonth old by detecting infraredheat from the forehead. | Infrared Thermometer (model:CK-T1501, CK-T1502, CK-T1503) is a non-sterile,reusable, non-contact andhandheld device. It can beused by consumers inhomecare environment anddoctors in clinic as reference. Itis intended for measuringhuman body temperature ofpeople over one month old bydetecting infrared heat fromthe forehead | Same |
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| ThermometerType | Infrared Forehead Thermometer | Infrared ForeheadThermometer | Same |
|---|---|---|---|
| DisplayCircumference | LCD Digital Display | LCD Digital Display | Same |
| Measurementmethod | Forehead measure mode | Forehead measure mode | Same |
| Measuringrange | $32.0°C-42.9°C (89.6°F-109.2°F )$ | $32°C | Similar |
| Displayresolution | $0.1°C/0.1°F$ | $0.1°C/0.1°F$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measuringaccuracy | $89.6°F-109.2°F (32.0°C-42.9°C)/\pm0.4°F/\pm0.2°C$ | $32°C | Similar |
| Measurementdistance | 0-3cm | 3-5cm | Different |
| Memory | 35 sets. | 32 sets. | Different |
| Power source | DC1.5Vx2(2*AAA alkaline batteries) | DC 3V (2 of AA alkalinebatteries) | Same |
| Operatingcondition | 10°C-40°C (50°F-104°F);15-95%RH;86-106 kPa | 10°C ~ 40°C;15% ~ 85%RH;80kPa ~106kPa | Similar |
| PatientsContactingMaterials | Plastic Case / Key& BatteryCover: ABSLCD: PC | ABS | Same |
| Electric Safetyand EMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-56 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-56 | Same |
Analysis:
-
- The "measuring range", "Measurement distance" and "Measuring accuracy" of the subject device is similar with predicate device, both of them meet the requirement of safety and essential performance standard ISO 80601-2-56. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
-
- The "Memory" and "Operating condition" of subject device is similar with predicate device, the software verification and validation test met the requirements. The performance testing shows that the subject device complies with performance standard.
The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
7.0 Non-Clinical Test Conclusion
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Non-Clinical Performance Testing:
Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- · IEC 60601-1: 2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and essential performance
- · IEC 60601-1-2:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56: 2017+A1:2018 Medical electrical equipment Particular . requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- . IEC 60601-1-11:2020 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Biocompatibility Testing:
Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Document issued on: September 8, 2023.
Software Information:
Software documentation was provided in accordance with the FDA June 14,2023 document "Content of Premarket Submissions for Device Software Functions".
8.0 Clinical Test Conclusion
Clinical tests were conducted per ASTM E1965-98(Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 143 subjects which were divided into three group age ranges- A Infant group (Group A1- 0 up to 3 months; Group A2- 3 months up to 1 year), B Child group (Older than 1 to 5 years old) and C group older 5 years old (Above 5 years old). The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2023).
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Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023).
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device, cleared under K193253.
§ 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.