(240 days)
Not Found
No
The description focuses on standard infrared temperature measurement technology and signal processing, with no mention of AI/ML algorithms for interpretation or analysis. The Bluetooth feature is for data transmission, not AI/ML processing.
No
A therapeutic device is one that treats or manages a disease or condition. This device is an infrared thermometer, which is used for measurement and diagnosis, not for therapy.
No
The device is an infrared thermometer for measuring body temperature. While temperature can be an indicator of health, the device itself only measures a physiological parameter and does not provide a diagnosis of a disease or condition.
No
The device description explicitly lists hardware components such as infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, Fresnel lens, and batteries. It also mentions an ear cover and, for one model, Bluetooth technology for wireless transmission, indicating a physical device with integrated software, not a software-only device.
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 human body temperature by receiving infrared energy radiation from the forehead or ear. This is a direct measurement of a physiological parameter on the living body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "measurement of human body temperatures," which is a direct physiological measurement, not an in vitro diagnostic test.
Therefore, based on the provided information, the Infrared Thermometer is a medical device, but it falls under the category of a non-IVD device.
N/A
Intended Use / Indications for Use
The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
- The device is intended to be used in the home setting and medical institutes.
- The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.
- It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.
In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
forehead, ear
Indicated Patient Age Range
The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old.
Intended User / Care Setting
Home setting and medical institutes.
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)
Non-Clinical Data:
- Biocompatibility testing: The biocompatibility evaluation for the FC-IR series Infrared thermometer was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." The worst case of the whole system is considered tissue-contacting for a duration of less than 24 hours. The following tests were conducted: Cytotoxicity, Skin Sensitization, Skin Irritation.
- Reprocessing: Cleaning and Disinfection: The sterilization and shelf life information provided are acceptable because the subject devices are non-sterile devices. The validation testing results for cleaning and disinfection of the subject devices are adequate and acceptable.
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the FC-IR series Infrared thermometer device. consisting of all the modules and accessories in the system complies with ANSI/AAMI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11: 2010 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, and the 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 standard for EMC.
- Bench Testing: Bench testing was conducted on the FC-IR series Infrared thermometer device, consisting of all the accessories in the system. The system complies with ISO 80601-2-56: 2009 Medical electrical equipment -Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for performance effectiveness.
- Software Verification and Validation Testing: Software documentation including verification was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
- Risk Analysis: A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices - Application of risk management to medical devices.
Clinical data:
Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature. This clinical study was randomized, with a simple blind homologous control, which consisted of a minimum of 144 subjects with the various age groups as referenced in Section 201.102 of ISO 80601-2-56.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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January 2, 2019
Shenzhen Finicare Co., Ltd. Chao Li General Manager Room 201, A Building NO. 1 Qianwan Road Shengang Cooperative Zone, Qianhai Shenzhen, 518052 China
Re: K181215
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 17, 2018 Received: August 13, 2018
Dear Chao Li:
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 avare 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181215
Device Name
Infrared thermometer, models FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400
Indications for Use (Describe)
The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.
| 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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3
K181215
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Room 201, A Building, NO.1 Qianwan Road, Shengang Cooperative Zone, Qianhai, Shenzhen, | |
| China, 518052, Shenzhen, P.R. China | |
| Tel.: +86 -755-23013503 | |
| Fax: +86 -755-23574425 | |
| Contact | |
| Person: | Chao Li |
| Prepare | |
| date: | 2018-03-31 |
| 2. Device | |
| name and | |
| classification: | Device Name: Infrared Thermometer |
| Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400 | |
| Classification Name: | |
| 21 CFR 880.2910 | |
| Clinical Electronic Thermometers-Temperature Monitor with Probe | |
| Product code: FLL | |
| Regulatory Class: Class II | |
| 3. Reason for | |
| Submission | New Application. |
| 4. Predicate | |
| Device(s): | Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214 |
| 5. Device | |
| Description: | FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. |
| The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer. |
In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.
4
| Model(s)
| Configuration | FC-IR100 | FC-IR101 | FC-IR200 | FC-IR300 | FC-IR400 |
|---|---|---|---|---|---|
| Internal Battery | √ | √ | √ | √ | √ |
| °C/°F Transaction | √ | √ | √ | √ | √ |
| Forehead Measurement | √ | √ | √ | × | × |
| Tympanic | |||||
| Measurement | √ | √ | × | √ | √ |
| Ear Cover | √ | √ | × | √ | √ |
| Bluetooth | × | √ | × | × | × |
| High Temperature Hint | √ | √ | √ | √ | √ |
| Backlight | √ | √ | √ | √ | √ |
6. Indications for Use:
The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.
7. Predicate Device Comparison
In comparison to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.
Please refer to the following table that notes differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. No new questions are raised regarding effectiveness and safety.
| ITEM | Proposed Device
FC-IR series | Predicate Device
EFT-165/K171214 | Comparison
Result |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Finicare Co., Ltd. | Brav Electronic Technologies
Co., Ltd. | --- |
| Indications for
Use | The Infrared Thermometer is
intended for the measurement of
human body temperatures. The
forehead mode is indicated for
people of all ages and the
tympanic mode is indicated for
people above three months old.
The device can be used in the
home setting and medical
institutes. | The infrared thermometer is
intended for the measurement
and monitoring of human body
temperature by doctor or
customers in the hospital or
home. | Different |
| Operational Specifications | | | |
| Operational
Principle | Infrared radiation detection | Infrared radiation detection | Same |
| Measuring Mode | Forehead and ear | Forehead and ear | Same |
| | | | |
| Measurement
Range | $32.0°C42.9°C$109.2°F)$ | $32.0°C
$(89.6°F42.9°C$109.2°F)$ | Same |
$(89.6°F
| Measurement
Distance | 0 cm | 0 cm | Same |
| Accuracy | Body Mode: ±0.2°C(0.4°F) | Body Mode: ±0.2°C(0.4°F) | Same |
| Memory Data
Limit | memorize 20 measurements
automatically | memorize 20 measurements
automatically | Same |
| Product
configuration | It is mainly composed with
infrared sensor, signal receiving
processor, buttons, buzzer, LCD
display, battery and etc. | It is mainly composed with
infrared sensor, signal receiving
processor, buttons, buzzer, LCD
display, battery and etc. | Same |
| Temperature unit
and conversion | Dual temperature units “°C” and
“°F” optional, and the two units
can convert by the conversion
key automatically | Dual temperature units “°C” and
“°F” optional, and the two units
can convert by the conversion
key automatically | Same |
| Bluetooth
Compatible | YES (FC-IR 101 only) | YES | Same |
| Applicable
Standards | AAMI ANSI ES60601-1, IEC
60601-1-2, IEC 60601-1-11, and
ASTM E1965-98, ISO 10993-5,
ISO 10993-10 | AAMI ANSI ES60601-1, IEC
60601-1-2, IEC 60601-1-11, and
ASTM E1965-98, ISO 10993-5,
ISO 10993-10 | Same |
| Display | $0.1°C/°F$ , LCD | $0.1°C/°F$ , LCD | Same |
| Operating
Environment | 15°C ~ 35°C (59°F to 95 °F)