MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1

K043110 · Microlife Intellectual Property GmbH · FLL · Dec 9, 2004 · General Hospital

Device Facts

• Record ID: K043110
• Device Name: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
• Applicant: Microlife Intellectual Property GmbH
• Product Code: FLL · General Hospital
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Microlife MT18I1 Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

Device Story

Digital electronic thermometer; utilizes predictive technology to estimate body temperature from initial temperature curve data; sensor detects temperature variations at oral, rectal, or axillary sites; physical model processes early-stage sensor data to provide rapid readings; intended for intermittent monitoring; used by clinicians or patients in home/clinical settings; provides immediate digital output for clinical decision-making regarding fever management.

Clinical Evidence

Controlled human clinical studies conducted; evaluated clinical bias, clinical uncertainty, and clinical repeatability per Microlife Clinical Test Protocol.

Technological Characteristics

Predictive digital electronic thermometer; fast probe sensor; ASTM E1112, IEC60601-1, and IEC60601-1-2 compliant; includes memory and waterproof features; battery-powered.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in adult and pediatric populations via oral, rectal, or axillary routes.

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

• Microlife Instant Digital Electronic Thermometer, Model QT1JA1 (K031958)

Submission Summary (Full Text)

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## DEC - 9 2004

## Exhibit #1

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# The assigned 510(k) number is: Kot 3 // O

#### 1. Submitter's Identification:

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

Date Summary Prepared: November 5th, 2004

#### 2. Name of the Device:

Microlife Instant Digital Electronic Thermometer, Model MT1811

#### 3. Predicate Device Information:

Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958,

#### 4. Device Description:

This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predictive technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.

With Microlife patented fast probe, others being equal, temperature curve of sensor varies with sites ( oral, underarm, rectal ) , this thermometer can use of temperature detected in the first few seconds to predict body temp using a well established physical model.

#### 5. Intended Use:

Microlife MT18I1 Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

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#### 6. Comparison to Predicate Devices:

The Microlife Instant Digital Electronic Thermometer, Model MT1811 is similar in design to the Microlife Instant Thermometer, Model QT1JA1, K#031958, differing mostly in response time, physical dimensions, power requirements, memory, waterproof, PCB layout, case material.

#### 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 Instant Digital Electronic Thermometer, Model MT1811. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.

#### 9. Conclusions:

The Microlife Instant Digital Electronic Thermometer, Model MT1811 has the same intended use and similar technological characteristics as the Microlife Instant Thermometer, Model QT1JA1. Moreover, bench testing contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Instant Digital Electronic Thermometer, Model MT1811 is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K043110

Trade/Device Name: Microlife MT1811 Instant Digital Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 5, 2004 Received: November 10, 2004

Dear Ms. Goldstein-Falk:

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 vour 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.

DEC - 9 2004

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Page 2 - Ms. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease of act result a made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the riot of arry I outs 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 and fibing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you acontact 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 yours,

Shao-Rune
fo Chiu Lin, Ph.D.

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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Exhibit B

Page _ 1

510(k) Number (if known): KO 273 11 (

Microlife MT18I1 Instant Digital Thermometer Device Name:

Indications For Use:

The Microlife MT 1811 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tim Vints

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k(a 43)/10