(137 days)
Not Found
No
The description of the device components (shell, LCD, button, beeper, infrared sensor, microprocessor) and the performance testing (standardized clinical tests per ASTM and ISO) do not indicate the use of AI or ML. There is no mention of algorithms that learn or adapt from data.
No
The device is described as an Infrared Thermometer intended for measuring human body temperature, which is a diagnostic function, not a therapeutic one.
Yes
The device is an Infrared Thermometer intended for measuring human body temperature, which is a diagnostic indicator.
No
The device description explicitly lists hardware components such as a shell, LCD, measure button, beeper, infrared temperature sensor, and microprocessor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Infrared Thermometer described measures body temperature by detecting infrared heat emitted from the forehead. This is a measurement taken directly from the body (in vivo), not from a sample taken from the body.
Therefore, based on the intended use and device description, this infrared thermometer falls under the category of a general medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
people over one month old
Intended User / Care Setting
consumers in homecare environment and doctors in clinic
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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). Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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"
1
(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).
2
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
3
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)
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."
4
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 Shanghai |
| 200120 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. |
5
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 Device
K243136 | Predicate Device
K193253 | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Manufacturer | Shenzhen Finicare Co., Ltd. | Shenzhen Changkun
Technology 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 |
| Intended
Use/Indication
for Use | 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. | Infrared Thermometer (model:
CK-T1501, CK-T1502, CK-
T1503) 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 | Same |
6
| Thermometer
Type | Infrared Forehead Thermometer | Infrared Forehead
Thermometer | Same |
|-------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Display
Circumference | LCD Digital Display | LCD Digital Display | Same |
| Measurement
method | Forehead measure mode | Forehead measure mode | Same |
| Measuring
range | $32.0°C-42.9°C (89.6°F-109.2°F )$ | $32°C 42.5°C (89.6°F108.5°F)$ | Similar |
| Display
resolution | $0.1°C/0.1°F$ | $0.1°C/0.1°F$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measuring
accuracy | $89.6°F-109.2°F (32.0°C-42.9°C)/\pm0.4°F/\pm0.2°C$ | $32°C34.9°C \pm 0.3°C/89.6 °F94.8°F \pm0.5°F35°C42°C \pm0.2°C/95.0°F107.6°F \pm0.4°F42.1°C42.5°C \pm0.3°C/107.8°F108.5°F \pm0.5°F$ | Similar |
| Measurement
distance | 0-3cm | 3-5cm | Different |
| Memory | 35 sets. | 32 sets. | Different |
| Power source | DC1.5Vx2
(2*AAA alkaline batteries) | DC 3V (2 of AA alkaline
batteries) | Same |
| Operating
condition | 10°C-40°C (50°F-104°F);
15-95%RH;
86-106 kPa | 10°C ~ 40°C;
15% ~ 85%RH;
80kPa ~106kPa | Similar |
| Patients
Contacting
Materials | Plastic Case / Key& Battery
Cover: ABS
LCD: PC | ABS | Same |
| Electric Safety
and EMC | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-56 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 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
7
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).
8
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.