(102 days)
Not Found
No
The description mentions a "mathematical algorithm" for temperature prediction, which is a standard approach for predictive thermometers and does not necessarily imply AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is a thermometer, which is used for measurement and diagnosis, not treatment.
Yes
Explanation: The device is a clinical thermometer used for determining body temperature, which is a diagnostic measurement.
No
The device description explicitly states it is a "compact predictive clinical thermometer" that measures temperature by detecting heat using the heat conduction principle and prediction, indicating it is a physical device with hardware components (probe tip, heat detection mechanism).
Based on the provided information, the Up-Grade 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.
- Up-Grade's function: The Up-Grade is a clinical thermometer that measures body temperature directly from the human body (oral, rectal, and axillary). It does not analyze samples taken from the body.
Therefore, the Up-Grade falls under the category of a clinical thermometer, which is a medical device used for direct measurement of a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
Product codes
FLL
Device Description
The Up-Grade is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction. The device is designed to calculate the maximum temperature of probe tip 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 35.5℃ to 42.0℃ (95.5℃ to 107.6℃F) and the time of measurement varies between 4 to 6 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal, and axillary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
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 safety and efficacy 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)
SureTemp™ Thermometer System, (K964643), B-D Flexible Thermometer (K902624)
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.
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2/12/99
983887
page 1 of 2
510(k) Summary Medisim Ltd. Up-Grade Electrical Thermometer 510(k) Number K
Applicant's Name:
Medisim Ltd. The Technology Park Manhat Jerusalem 38900, Israel Tel: 972-2-679-9204 Fax: 972-2-679-9198
Contact Person:
Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: (202) 637-5794 Fax: (202) 637-5910
Date Prepared: November 2, 1998
Trade Name:
Up-Grade Electrical Thermometer
Classification Name:
Clinical Electronic Thermometer
Common Name:
Electronic Thermometer
Classification:
Clinical Electronic Thermometers are class II devices (product code 80 FLL) and are reviewed by the General Hospital Division.
1
Indication for Use:
The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
Predicate Device:
The Up-Grade is substantially equivalent to Diatek Instruments, Inc.'s SureTemp™ Thermometer System, (K964643) and Becton Dickinson and Company's B-D Flexible Thermometer (K902624).
Device Description:
The Up-Grade is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction. The device is designed to calculate the maximum temperature of probe tip 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 35.5℃ to 42.0℃ (95.5℃ to 107.6℃F) and the time of measurement varies between 4 to 6 seconds.
Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:
The Up-Grade Electrical Thermometer conforms with the following voluntary standards: ASTM E1112 and IEC 601-1. Additionally, the safety and efficacy 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 over-the-counter Up-Grade Electrical Thermometer is substantially equivalent to its predicate devices and the device does not raise new questions of safety and efficacy.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Medisim Ltd. C/O Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109
K983887 Re : Trade Name: Up-Grade Regulatory Class: II Product Code: FLL Dated: December 28, 1998 December 28, 1998 Received:
Dear Mr. Kahan
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Paqe 2 - Mr. Kahan
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-204f1 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Up-Grade Electrical Thermometer
Indications For Use:
The Up-Grade is an over-the-counter, non-sterile, reusable clinical The op-Grade Is an Over the Councer) non Becaoral, rectal, and axillary body temperature determination in humans.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, Office of Device I
Prescription Use Per 21 CFR 801.109)
Patricia Cassenbe
(Division Sign-Off)
Over-The-Counter Use X
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K
: .
(Optional Format 1-2-96)