(124 days)
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an Infrared Forehead Thermometer intended for intermittent measurement of human body temperature. Its function is diagnostic (measurement), not therapeutic (treatment or healing).
No
Explanation: The device is described as a thermometer used for "intermittent measurement of human body temperature," which is a measurement function, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device description explicitly states it uses an "infrared sensor (thermopile)" and has an "LCD" for display, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infrared Forehead Thermometer measures the temperature of the human body externally by detecting infrared radiation from the forehead. It does not analyze any biological samples taken from the body.
Therefore, based on the provided information, the Infrared Forehead Thermometer FS-300&301 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.
Product codes
FLL
Device Description
The Infrared Forehead Thermometer, Modelfype FS-300&301 is an electronic thermometer using an infrared i sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces.
This product is an Infrared Forehead Thermometer with measuring room temperature and relative humidity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
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)
The Infrared Forehead Thermometer, FS-3008.301 has been manufactured and tested to meet the safety requirements of IEC. The Infrared Forehead Thermometer, FS-300&301 complies with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2001. Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
The performance tests demonstrated that The Infrared Forehead Thermometer. FS-3008301 is as safe, as effective and performs in a substantially equivalent manner to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sensor touch (K011291)
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
510(k) Summary న.
[as required by 807.92(c)]
A .- Applicant :-
-Company name: HuBDIC Co., Ltd
-Address: 195-42, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do, Korea (zip. 430-815)
TEL : +82-31-441-8637
► FAX : +82-31-442-4994
-Contact person: Peter Chung 412-687-3976
-Date: June 28th, 2010
B. Proprietary and Established Names:
Trade Name: The Infrared Forehead Thermometer, FS-300&301 Common Name: Clinical Electronic Thermometer Requiation Name: Clinical Electronic Thermometer Regulation Number:880.2910
NOV 1 0 2010
Regulatory Classification: II Product Code: FLL
C. Predicate device: Sensor touch (K011291)
D. Device Description
The Infrared Forehead Thermometer, Modelfype FS-300&301 is an electronic thermometer using an infrared i sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD.
Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces.
This product is an Infrared Forehead Thermometer with measuring room temperature and relative humidity.
E. Intended use
The Infrared Forehead Thermometer, FS-3008301 is internittent measurement of human body temperature in people of all ages.
F. Technological Characteristics:
To increase the accuracy, body temperature is measured 5,000 times in one second instantly and displays highest temperature on the LCD.
Purpose of measuring body temperature is to check body condition by measuring correct temperature in important part of body and both measured room temperature and relative humidity are to show environmental conditions.
In case of Forehead measurement, this product searches the highest temperature from the forehead to the temple. The temperature of the artery between the temple that emits thermal infrared from the inner shin to the exterior body is scanned continuously while the measurement button is pressed down
G. Performance (Safety and Effectiveness Information)
The Infrared Forehead Thermometer, FS-3008.301 has been manufactured and tested to meet the safety requirements of IEC. The Infrared Forehead Thermometer, FS-300&301 complies with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2001. Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
I. Conclusion:
The performance tests demonstrated that The Infrared Forehead Thermometer. FS-3008301 is as safe, as effective and performs in a substantially equivalent manner to the predicate device
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hubdic Company, Limited C/O Mr. Peter Chung 300 Atwood Pittsburgh, Pennsylvania 15213
NOV 1 0 2010
Re: K101912
Trade/Device Name: The Infrared Forehead Thermometer, FS-300&301 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 8. 2010 Received: October 20, 2010
Dear Mr. Chung:
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. 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.
2
Page 2- Mr. Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Parmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K101912 |
|---|---|
| Device Name: | The Infrared Forehead Thermometer, FS-300&301 |
Indications For Use:
The Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| --------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| 11/4/2010 | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | Page 1 of 1 |
| 510(k) Number: | K101912 |
NOV 10 2010
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