(126 days)
No
The description mentions a "mathematical algorithm" for temperature prediction, but there is no mention of AI, ML, or related concepts like training/test sets, which are typical indicators of AI/ML use in medical devices.
No
The device is a thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
The device is a thermometer, used to measure body temperature. While temperature can be an indicator of health status, the device itself simply measures a physiological parameter and does not diagnose a disease or condition. Its intended use is for "determination of human's body temperature," not for diagnosing.
No
The device description explicitly states it is a "compact predictive clinical thermometer" that measures temperature by "detecting heat flow from the temporal artery" and uses a "probe in contact with the body site." This indicates a physical hardware component is involved in the measurement process, not just software.
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 (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The UP-GRADE FOREHEAD THERMOMETER measures body temperature by detecting heat from the forehead. This is a measurement taken directly from the body ("in vivo").
- Intended Use: The intended use is for "determination of human's body temperature using the forehead as measurement site." This clearly describes an in vivo measurement.
The description of the device and its intended use aligns with a standard clinical thermometer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Up-Grade Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.
Product codes
FLL
Device Description
The over-the-counter Up-Grade Forehead Thermometer is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat flow from the temporal artery, by using the heat conduction principle and prediction.
The over-the-counter Up-Grade Forehead Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site. without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.0ºC to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
Not Found
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
The Up-Grade Forehead Thermometer is an electronic thermometer complies with the following voluntary standards: ASTM E1112, IEC 60601-1 and EN 60601-1. Additionally, the safe and effective performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices.
Key Metrics
Not Found
Predicate Device(s)
K983887, K012217, K002712, 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
Medisim Ltd.
UP-GRADE FOREHEAD THERMOMETER
510(k) Number KO32367
Applicant's Name:
Medisim Ltd. Airport City 2A Hayarden str. 70151, Israel Tel: 972-3 9795560 Fax: 972-3 9795541
Contact Person:
Dalia Givony Airport City 2A Hayarden str. 70151, Israel Tel: 972-3 9795560 Fax: 972-3 9795541 dalia@medisim.co.il
Trade Name:
UP-GRADE FOREHEAD THERMOMETER
Classification Name:
Clinical Electronic Thermometer
Classification:
Clinical Electronic Thermometers are class II devices (product code 80 FLL) and are reviewed by the General Hospital Division.
Indication for Use:
The Up-Grade Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.
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Predicate Devices:
The Up-Grade Forehead Thermometer is substantially equivalent in intended use, technology characteristics, and performance characteristics to the:
- UP-Grade Thermometer (Medisim LTD.) cleared under K983887 צ
- 트 M5T Instant Thermometer (Medisim LTD.) cleared under K012217
- 트 Thermoteck (SAAT Ltd.) IR Forehead Thermometer model 718F cleared under K002712.
- 트 Scanner (Exergen Co.) Cleared under K011291.
Device Description:
The over-the-counter Up-Grade Forehead Thermometer is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat flow from the temporal artery, by using the heat conduction principle and prediction.
The over-the-counter Up-Grade Forehead Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site. without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.0ºC to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.
Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:
The Up-Grade Forehead Thermometer is an electronic thermometer complies with the following voluntary standards: ASTM E1112, IEC 60601-1 and EN 60601-1. Additionally, the safe and effective performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices.
Conclusion:
Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the Up-Grade Forehead Thermometer is substantially equivalent to its predicate devices cited above and does not raise any new safety and/or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, represented by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2003
Ms. Dalia Givony Clinical &Regulatory Manager Medisim Limited Airport City, 2A Hayarden Str. ISRAEL 70151
Re: K032362
Trade/Device Name: Up-Grade Forehead Thermometer Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 30, 2003 Received: September 15, 2003
Dear Ms. Givony:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 -Ms. Givony
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runnes
& Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
No 32362
UP-GRADE FOREHEAD THERMOMETER Device Name:
Indications for Use:
The UP-GRADE FOREHEAD THERMOMETER is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
Patuxa Cucente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K032362
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