DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE

K051422 · Medisim, Ltd. · FLL · Sep 1, 2005 · General Hospital

Device Facts

• Record ID: K051422
• Device Name: DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is intended for determination of body temperature.

Device Story

Clinical electronic thermometer for body temperature determination; measures via forehead or axilla. Device uses probe to capture heat transfer data; mathematical algorithm calculates maximum temperature without waiting for thermal equilibrium. Measurement time 6-10 seconds; range 35.0°C to 42.0°C (95.5°F to 107.6°F). Used by patients or clinicians in home or clinical settings. Provides rapid temperature reading to assist in fever detection and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Electronic clinical thermometer; probe-based sensing; mathematical algorithm for predictive temperature calculation; measurement range 35.0°C-42.0°C; 6-10 second response time; reusable; non-sterile.

Indications for Use

Indicated for the determination of human body temperature via forehead or axilla measurement sites. Intended for 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

• Up-Grade Forehead Thermometer (K032362)
• M5T Instant Fever Thermometer (K012217)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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: [phone] Fax: [phone]

| 2. Device Name: | Dual Mode Up-Grade Forehead/ Underarm<br>Thermometer |
|--------------------------------|----------------------------------------------------------------------------------|
| Device trade/proprietary name: | Dual Mode Up-Grade Forehead/ Underarm<br>Thermometer (a.k.a. FHT2, UGFT-2, UGDM) |
| Common Name: | Electronic Thermometer |
| Classification Name: | Electronic Clinical Thermometer, Class II, 880.2910 |

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K05/422/51.
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#### 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.

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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 [phone]. 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 [phone] or [phone] 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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510(k) Number: K031422