UP-GRADE AND UP-GRADE PRO

K983887 · Medisim, Ltd. · FLL · Feb 12, 1999 · General Hospital

Device Facts

• Record ID: K983887
• Device Name: UP-GRADE AND UP-GRADE PRO
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Up-Grade is a compact, reusable, predictive clinical thermometer for oral, rectal, and axillary temperature measurement. Device uses heat conduction principle to detect temperature at probe tip. Mathematical algorithm processes heat transfer data to calculate maximum body temperature without waiting for thermal equilibrium. Measurement time: 4-6 seconds. Intended for OTC use by patients or caregivers. Output is a digital temperature reading. Benefits include rapid, accurate temperature determination for clinical or home monitoring.

Clinical Evidence

Safety and efficacy established through non-clinical and clinical comparative testing against market-cleared devices. Device conforms to ASTM E1112 and IEC 601-1 standards.

Technological Characteristics

Predictive clinical thermometer; heat conduction sensing; temperature range 35.5°C to 42.0°C (95.5°F to 107.6°F); measurement time 4-6 seconds. Conforms to ASTM E1112 and IEC 601-1 standards.

Indications for Use

Indicated for oral, rectal, and axillary body temperature measurement in humans of all ages. Over-the-counter use.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• SureTemp™ Thermometer System (K964643)
• B-D Flexible Thermometer (K902624)

Submission Summary (Full Text)

{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: [phone] Fax: [phone]

#### Contact Person:

Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: [phone] Fax: [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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)