MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1

K034023 · Microlife Intellectual Property GmbH · FLL · Jan 15, 2004 · General Hospital

Device Facts

• Record ID: K034023
• Device Name: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
• Applicant: Microlife Intellectual Property GmbH
• Product Code: FLL · General Hospital
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting. This device is used probe cover free.

Device Story

Electronic infrared ear thermometer; detects thermal radiation from tympanic membrane and auditory canal via thermopile sensor. Operates in 1-second 'normal mode'. Used in home setting by patients or caregivers. Device components include IR thermopile sensor, ASIC, E2 PROM IC, LCD with backlight, and buzzer. Output is digital temperature reading displayed on LCD. Probe cover-free design. Clinical decision-making supported by providing rapid, non-invasive temperature monitoring.

Clinical Evidence

Controlled human clinical studies conducted to validate effectiveness of use without a probe cover. Bench testing performed for compliance with ASTM E-1965-98, IEC 60601-1, and IEC 60601-1-2.

Technological Characteristics

Infrared thermopile sensor; ASIC and E2 PROM IC processing; LCD display with backlight; buzzer. Operates in 1-second mode. Probe cover-free. Complies with ASTM E-1965-98, IEC 60601-1, and IEC 60601-1-2. PCB layout modified from predicate.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for measuring body temperature via the auditory canal in a home setting.

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 Digital Infrared Ear Thermometer, Model IR1DE1 (K020725)

Submission Summary (Full Text)

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# JAN 1 5 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:_KO34073

#### 1. Submitter's Identification:

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

Date Summary Prepared: December 23, 2003

Contact: Mr. Gerhard Frick

#### 2. Name of the Device:

Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1

#### 3. Information for the 510(k) Cleared Device (Predicate Device):

Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725

#### 4. Device Description:

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:

- IR Thermopile Sensor a)
- b) ASIC
- E2 PROM IC C)

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- LCD and Blacklight d)
- Key "2, Buzzer" 1 e)

#### 5. Intended Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

This device is used probe cover free.

#### Comparison to the 510(k) Cleared Device (Predicate Device): 6.

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is substantially equivalent to the original Microlife Digital Infrared Ear Thermometer, Model IR1DE1.

The new model, IR1DE1-1, has the same intended use and is similar in design to the 510(k) cleared device.

The IR1DE1-1 is identical in functionality and performance, with the only difference being that the device is to be used probe cover free, and, the PCB layout of the device. The working environmental specification of 5-40 degree C, temperature measurements algorithm and its software codes of the modified devices remains unchanged.

The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. The Microlife IR1DE1-1 device works with a only a 1-second called a "normal mode".

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

Compliance to applicable voluntary standards includes ASTM E-1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements.

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Guidance documents included the "FDA Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers", "Deciding When to Submit a 510(k) for a Change to An Existing Devices", and, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

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

Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer modified devices to validate the effectiveness of use without a probe cover.

#### 9. Conclusions:

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 has the same intended use and technological characteristics as the unmodified model IR1DE1. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. These engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

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: K034023

Trade/Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1 Regulation Number: CFR 21 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 23, 2003 Received: December 29, 2003

Dear Ms. 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 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. Falk

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. or the rice or ally i vith all the Act's requirements, including, but not limited to: registration 1 od intilet comply would and (21 CFR Part 801); good manufacturing practice and instills (21 OF real 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadion 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) rms retet 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), 11 you don't 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 maj con 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,

Chas. L. Dees

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 of 1

510(k) Number (if known): _ 034023

Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1

Indications For Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Qur

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

510(k) Number _ KO3 4023