MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q

K051100 · Microlife Intellectual Property GmbH · FLL · May 11, 2005 · General Hospital

Device Facts

• Record ID: K051100
• Device Name: MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
• Applicant: Microlife Intellectual Property GmbH
• Product Code: FLL · General Hospital
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Microlife MT1751Q Digital Pacifier Thermometer is a non-sterile, reusable rno miorolime intended for the determination of oral body temperature in infants to children five years of age.

Device Story

Battery-powered digital thermometer; pacifier form factor; thermistor sensor located within silicone nipple; ABS plastic body. Principle of operation: thermistor resistance changes proportional to temperature; resistance changes converted to frequency via R-C oscillator circuit; fixed hardware offset applied to accelerate measurement time. Device used by caregivers to measure infant/child oral temperature. Output displayed on liquid crystal display (LCD). Provides rapid, accurate temperature readings to assist in clinical assessment of fever.

Clinical Evidence

Controlled human clinical studies conducted. Data evaluated clinical bias, clinical uncertainty, and clinical repeatability per Microlife Clinical Test Protocol. Results demonstrated performance consistent with clinical requirements for electronic thermometers.

Technological Characteristics

Materials: medical silicone rubber (nipple), ABS plastic (body). Sensing: thermistor-based. Energy: battery-powered. Connectivity: none. Standards: ASTM E1112, IEC60601-1, IEC60601-1-2. Processing: R-C oscillator circuit with fixed hardware offset for measurement speed.

Indications for Use

Indicated for determination of oral body temperature in infants and children up to five years of age.

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

• Pro Check ™ Digital Pacifier Thermometer (K972259)

Submission Summary (Full Text)

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# EXHIBIT #1

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This outhinary of SE({{}, suirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:_K O S ! ! OO

#### Submitter's Identification: 1.

Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland

Contact: Mr. Gerhard Frick

Date Summary Prepared: April 27, 2005

#### Name of the Device: 2.

Microlife Digital pacifier Thermometer, Model MT1751Q

#### 3. Predicate Device Information:

Pro Check ™ Digital Pacifier Thermometer, K#972259, Micro Weiss Electronics

#### Device Description: 4.

The Microlife Digital Pacifier Thermometer, Model MT1751Q, is a batterypowered, liquid crystal display device using a thermistor inside the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable.

In addition, to speed up the measurement time, we have added the fixed offset into this thermometer, which is fulfilled by the hardware. With these characteristics, this thermometer can provide both a very high clinical accuracy and quick measurement time.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-Coscillator circuit, Therefore, temperature can be given by measuring the frequency of the oscillator.

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#### 5. Intended Use:

The Microlife MT1751Q Digital Pacifier Thermometer is a non-sterile, reusable rno miorolime intended for the determination of oral body temperature in infants to children five years of age.

#### Comparison to Predicate Devices: 6.

The Microlife Digital Pacifier Thermometer, Model MT1751Q, is identical to the Pro Check ™ Digital Pacifier Thermometer,K#972259, differing mostly in response time and, the position of the thermistor is fixed .

### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements.

Guidance documents included the "FDA Guidance on the Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".

#### Discussion of Clinical Tests Performed: 8.

Controlled human clinical studies were conducted using the Microlife Digital Pacifier Thermometer, Model MT1751Q. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.

#### റ്റ. Conclusions:

The Microlife Digital Pacifier Thermometer, Model MT1751Q, has the same intended use and similar technological characteristics as the predicate device, the Pro Check ™ Digital Pacifier Thermometer, K#972259. Moreover, bench testing contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Pacifier Thermometer, Model MT1751Q, is substantially equivalent to the predicate device.

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the serpent entwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2005

Microlife Intellectual Property GmbH C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K051100

Trade/Device Name: Microlife MT1751Q Digital Pacifier Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 27, 2005 Received: April 29, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your secures in ined 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 interstate commerce proc to tray as, seen reclassified in accordance with the provisions of Antichunches, or to do rough act (Act) that do not require approval of a premarket the rederal 1 00d; Drug, and Coou may, therefore, market the device, subject to the general approval application (1) = 1) = 1 = 1 = controls provisions of the restration, 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 If your device is classinod (soc ass 10) in a controls. Existing major regulations affecting (FMA), it may of Subject to Back and Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Bear nouncements concerning your device in the Federal Register.

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Page 2 -- Ms. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be auvisod that 1 Dr. o lostermination that your device complies with other requirements mean that I DA mas made a dotes and regulations administered by other Federal agencies. of the Act of ally I outer a base s requirements, including, but not limited to: registration 1 ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF Real vor), systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadiation 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) I mis letter will anow yourse organ finding of substantial equivalence of your device to a premarket notification of a 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), If you desire specific at 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 may other general Manufacturers, International and Consumer Assistance at its toll-free Drimber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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slloo lof

### Exhibit B

of Page _ 1

510(k) Number (if known): _

Device Name: Microlife MT1751Q Digital Pacifier Thermometer

Indications For Use:

The Microlife MT1751Q Digital Pacifier Thermometer is a non-sterile, reusable The Microllie WTTPO & Digitaronthation of oral body temperature in infants to children five years of age.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use X (21 CFR 807 Subpart C)

(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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