M5T INSTANT FEVER THERMOMETER

K012217 · Medisim, Ltd. · FLL · Aug 1, 2001 · General Hospital

Device Facts

• Record ID: K012217
• Device Name: M5T INSTANT FEVER THERMOMETER
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

Device Story

M5T is a compact, portable, predictive clinical thermometer; measures human body temperature via heat conduction from axillary, rectal, or oral sites. Device uses a probe to contact body site; microprocessor calculates maximum temperature based on heat conduction and predictive algorithms. Measurement time ranges from 8 to 10 seconds. Device includes LCD, push button, battery, and PCB in a single housing. Operated by clinicians or patients for temperature monitoring; output displayed on LCD. Predictive technology allows rapid temperature determination, facilitating clinical decision-making regarding fever management.

Clinical Evidence

A clinical study was performed to evaluate the safety and performance of the M5T following the removal of the heater component. Results demonstrated the device is safe and effective for its intended use.

Technological Characteristics

Predictive clinical thermometer; heat conduction sensing principle. Temperature range: 35.0°C to 42.0°C (95.5°F to 107.6°F). Measurement time: 8-10 seconds. Components: LCD, push button, battery, microprocessor, PCB. Portable, compact, lightweight housing. Non-sterile, reusable.

Indications for Use

Indicated for the determination of oral, rectal, and axillary body temperature in humans of all ages.

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
• Up-Grade Pro Thermometer

Submission Summary (Full Text)

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#### AUG 1 2001

K012217

## 510(K) SUMMARY

# M5T Instant Fever Thermometer

### Applicant's Name:

Medisim Ltd. The Technology Park Manhat Jerusalem 96251, Israel Tel: [phone] Fax: [phone]

# Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone]

## Date Prepared:

July, 2001

### Trade Name:

M5T Instant Fever Thermometer

### Classification Name:

Thermometer, Electronic, Clinical

### Classification:

Class II; Product Code 80FLL; Regulation No. 880.2910.

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#### Statement of Substantial Equivalence:

The is substantially equivalent in all aspects, MST e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Up-Grade and Up-Grade Pro Thermometer. The changes between the two thermometers include removal of the heater, the preheating control and overheating protection, prolonged measuring time, and subsequently slight change in the thermometer design.

#### Device Description:

The M5T 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 M5T is designed to calculate the maximum temperature of a probe in contact with the body site. The temperature reading range is from 35.0℃ to 42.0℃ (95.5°F to 107.6°F) and the time of measurement varies between 8 to 10 seconds.

The LCD, push button, battery, microprocessor and the PCB are located in one housing, which includes upper cover, lower cover and the battery cover. The entire device is compact, lightweight, small in size, easy to use and portable,

### Indications:

The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

#### Performance Data:

A clinical study was performed in order to evaluate the safety and performance of the M5T following the heater removal. The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

#### 1 2001 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medisim Limited C/O Ms. Dorin Teich Quality Assurance Manager Push-med Limited 117 Ahuzah Street Ra'ananna , ISREAL

K012217 Re : M5T Instant Fever Thermometer Trade/Device Name: 880.2910 Requlation Number: Requlatory Class: II Product Code: FLL July 10, 201 Dated: Received: July 16, 2001

Dear Ms. Teich:

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 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). 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Teich

In addition, FDA may publish further announcements action. 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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" (21CFR 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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): K012217

Device Name:

M5T Instant Fever Thermometer

Indications for Use:

The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

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510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use

Patricio Ciuenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________