(92 days)
Not Found
No
The description mentions a "mathematical algorithm" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC).
No
The device is a thermometer, used for diagnosis by measuring body temperature, not for treating a condition.
No
The device is a thermometer, which measures body temperature. While temperature can be an indicator for health conditions, the device's intended use is solely for "determination of body temperature" and it does not interpret or diagnose any disease or condition based on that measurement.
No
The device description explicitly states it is a "clinical electronic thermometer" and describes a "probe in contact with the body site," indicating it is a hardware device with a physical component for temperature measurement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Dual Mode Up-Grade Forehead/ Underarm Thermometer measures body temperature by being placed on the forehead or under the arm. This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body.
Therefore, based on the provided information, this device falls under the category of a clinical thermometer used for direct body temperature measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is intended for determination of body temperature.
The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and axilla as measurement sites.
Product codes
FLL
Device Description
The Dual Mode Up-Grade Forehead/ Underarm Thermometer is a clinical electronic thermometer used for determination of body temperature. The over-the-counter Dual Mode Up-Grade Forehead/ Underarm 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 35.0°C 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 and axilla
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
510(K) Summary
SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS
SEP - 1 2005
(Premarket Notification [510(k)] Number)
K051472/51
1. Applicant
Medisim Ltd. Kenes International Bldg. 2a Hayarden St. Airport City, 70151 ISRAEL Tel: +972-3-9795560-4 Fax: +972-3-9795565
Corresponding Official:
Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
| 2. Device Name: | Dual Mode Up-Grade Forehead/ Underarm
Thermometer |
|--------------------------------|----------------------------------------------------------------------------------|
| Device trade/proprietary name: | Dual Mode Up-Grade Forehead/ Underarm
Thermometer (a.k.a. FHT2, UGFT-2, UGDM) |
| Common Name: | Electronic Thermometer |
| Classification Name: | Electronic Clinical Thermometer, Class II, 880.2910 |
1
K05/422/51.
2 of 2
3. Predicate Devices
The Dual Mode Up-Grade Forehead/ Underarm Thermometer is substantially equivalent to the following devices:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| Up-Grade Forehead Thermometer | Medisim Ltd. | K032362 |
| M5T Instant Fever Thermometer | Medisim Ltd. | K012217 |
4. Intended Use
The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is intended for determination of body temperature.
5. Description of the Device
The Dual Mode Up-Grade Forehead/ Underarm Thermometer is a clinical electronic thermometer used for determination of body temperature. The over-the-counter Dual Mode Up-Grade Forehead/ Underarm 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 35.0°C to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.
6. Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Dual Mode Up-Grade Forehead/ Underarm Thermometer device are substantially equivalent to the predicate devices cited above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wing-like shapes and a stylized body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2005
Medisim Limited C/O Ms. Ahava M. Stein Regulatory Affairs Consultant Beit Hapa amon Box 124 20 Hata'as St. 44425 Kfar Saba ISRAEL 44225
Re: K051422
Trade/Device Name: Dual Mode Up-Grade ForeHead/Underarm Thermometer Device Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 17, 2005 Received: August 24, 2005
Dear Ms. Stein:
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. Iisting 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. Stein
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Supt. Y. M'chain Oms.
Chu 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 Statement
510(k) Number (if known): _________________
Dual Mode Up-Grade Forehead/ Underarm Thermometer device Device Name:
Indications for use: The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and axilla as measurement sites..
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use V (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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for CSC
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510(k) Number: K031422