(126 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the UP-GRADE FOREHEAD THERMOMETER based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to compliance with voluntary standards, but does not explicitly state the specific acceptance criteria or provide a table of performance metrics. However, it does state that the device's acceptable performance was established through comparative testing with market-cleared devices and compliance with the following standards:
| Acceptance Criteria / Standard | Reported Device Performance (Implied) |
|---|---|
| ASTM E1112 | Complies (safe and effective performance established) |
| IEC 60601-1 | Complies (safe and effective performance established) |
| EN 60601-1 | Complies (safe and effective performance established) |
Note: The specific performance metrics (e.g., accuracy, repeatability) that would typically be detailed within compliance to ASTM E1112 are not explicitly listed in the summary. The summary only states that performance was "established" through testing and standard compliance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical or non-clinical test set. It mentions "comparative testing with market-cleared devices," implying a clinical validation, but provides no details on the number of subjects or the nature of the data (prospective/retrospective or country of origin).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study is mentioned in the 510(k) summary. The device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was effectively done. The device itself is an "algorithm only" in the sense that it uses a "mathematical algorithm" to calculate maximum temperature. The non-clinical and clinical tests performed were to establish the safe and effective performance of this device in a standalone manner, without human interpretation of its output beyond reading the displayed temperature.
7. The Type of Ground Truth Used
The document doesn't explicitly state the "ground truth" method. However, for clinical thermometers, the standard practice for establishing accuracy typically involves comparison against a reference thermometer (e.g., a rectal thermometer) considered the gold standard for core body temperature measurement in a clinical setting. Given the mention of "comparative testing with market-cleared devices" and compliance with ASTM E1112 (which defines accuracy requirements for electronic thermometers), it's highly probable that the ground truth was established by comparing the device's readings to those of a validated reference thermometer.
8. The Sample Size for the Training Set
The document does not specify any training set size. As a non-AI or machine learning-driven device in the modern sense, it likely does not have a "training set" in the way an image recognition algorithm would. Its "mathematical algorithm" for prediction would have been developed and validated, but not "trained" on a specific dataset in the typical AI/ML context.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the AI/ML context is implied or mentioned, the method for establishing its ground truth is not applicable or provided. The "mathematical algorithm" would have been designed based on heat transfer principles and validated against actual temperature measurements.
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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
8-6
§ 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.