UP-GRADE FOREHEAD THERMOMETER

K032362 · Medisim, Ltd. · FLL · Dec 4, 2003 · General Hospital

Device Facts

• Record ID: K032362
• Device Name: UP-GRADE FOREHEAD THERMOMETER
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

The Up-Grade Forehead Thermometer is a compact, reusable clinical thermometer for over-the-counter use. It measures human body temperature by detecting heat flow from the temporal artery at the forehead. The device utilizes a heat conduction principle combined with a predictive mathematical algorithm to calculate the maximum body temperature without requiring the probe to reach full thermal equilibrium with the body site. Measurement time is 6-10 seconds. The device provides a digital temperature reading to the user, facilitating clinical decision-making regarding fever management. It is intended for use by patients or caregivers in home or clinical settings.

Clinical Evidence

The device's safety and performance were established through non-clinical and clinical comparative testing against market-cleared devices. The device complies with ASTM E1112, IEC 60601-1, and EN 60601-1 standards.

Technological Characteristics

Electronic clinical thermometer; predictive measurement technology; temporal artery heat conduction sensing; measurement range 35.0°C to 42.0°C (95.5°F to 107.6°F); 6-10 second measurement time. Complies with ASTM E1112, IEC 60601-1, and EN 60601-1.

Indications for Use

Indicated for the determination of human body temperature via the forehead in patients of all ages. 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 Thermometer (K983887)
• M5T Instant Thermometer (K012217)
• Thermoteck IR Forehead Thermometer model 718F (K002712)
• Scanner (K011291)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

# Contact Person:

Dalia Givony Airport City 2A Hayarden str. 70151, Israel Tel: [phone] Fax: [phone] [e-mail]

### 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 [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/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

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