(102 days)
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.
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.
The provided 510(k) summary for the Medisim Ltd. Up-Grade Electrical Thermometer does not contain specific acceptance criteria, detailed study results, or the other requested information regarding sample sizes, expert qualifications, and ground truth establishment in the level of detail typically associated with medical device studies.
However, based on the limited information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) states that the device conforms to "acceptable voluntary standards" and that "safety and efficacy performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices." It also explicitly mentions compliance with ASTM E1112 and IEC 601-1. These voluntary standards would contain the specific acceptance criteria for accuracy and performance of an electronic thermometer.
Without the actual standards document or a detailed study report, the precise numerical acceptance criteria are not available in this 510(k) submission. However, assuming compliance with these standards, the reported device performance implicitly meets those criteria.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Accuracy / Measurement Range: | |
| (Defined by ASTM E1112 for clinical electronic thermometers) | Temperature reading range: 35.5℃ to 42.0℃ (95.5℉ to 107.6℉) |
| Measurement Time: | |
| (Defined by ASTM E1112 for predictive thermometers) | Measurement time: 4 to 6 seconds |
| Safety and Electrical Standards: | |
| (Defined by IEC 601-1) | Conforms to IEC 601-1 |
| Clinical Performance: | |
| (Performance comparable to predicate devices for oral, rectal, and axillary use) | "safety and efficacy performance... established through comparative testing with market-cleared devices." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. It's unclear if the data was collected in Israel (where the applicant is located) or elsewhere, nor if it was prospective or retrospective.
3. Number of Experts and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not applicable for this device. A clinical thermometer measures a direct physiological parameter and does not involve human readers interpreting complex images or data in a diagnostic context that would typically necessitate an MRMC study. Its performance is evaluated against reference standards or predicate devices.
6. Standalone Performance Study
- Standalone Performance Study: Yes, implicitly. The statement "The Up-Grade Electrical Thermometer conforms with the following voluntary standards: ASTM E1112 and IEC 601-1" and "safety and efficacy performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices" indicates that the device's performance was evaluated on its own merits against established standards and other similar devices. The comparison "with market-cleared devices" serves as the clinical data point for substantial equivalence.
7. Type of Ground Truth Used
- Ground Truth: For a clinical thermometer, the "ground truth" would typically be established by highly accurate reference thermometers (e.g., traceable to national standards) or by the performance of the predicate devices themselves in comparative studies. The focus would be on accuracy, precision, and response time.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a predictive clinical thermometer, using a "mathematical algorithm" to predict temperature. The development of such an algorithm would involve data for calibration and optimization, which could be considered an internal "training set." However, the 510(k) does not provide details on the size or nature of this data. The submission focuses on the validation against standards and predicate devices.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified. For a predictive thermometer, the "ground truth" for developing its algorithm would be actual body temperatures measured with a highly accurate, often slower, reference thermometer over a wide range of conditions and body sites, against which the predictive model is trained to correlate its rapid measurements.
{0}------------------------------------------------
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
{4}------------------------------------------------
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)
§ 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.