MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1

{0}------------------------------------------------ # FEB 2 3 2004 Exhibit #1 ## 510(K) SUMMARY This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________ ## Submitter's Identification: 1. Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland Date Summary Prepared: December 8, 2003 Contact: Mr. Gerhard Frick ## 2. Name of the Device: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 ### Predicate Device Information: 3. Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725 ### Device Description: 4. The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is an ectronic thermometer using an infrared sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. The Microlife Digital Infrared Forehead Thermometer, consists mainly of five parts: - a) IR Thermopile Sensor - b) ASIC - c) E2PROM IC {1}------------------------------------------------ - d) LCD and Blacklight - e) Kev*2, Buzzer*1 ### 5. Intended Use: The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. ## Comparison to Predicate Devices: 6. The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is substantially equivalent to the original Microlife Digital Ear Thermometer, Model IR1DE1 in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., The major difference between the Microlife Infrared Forehead Thermometer and the predicate device is the measuring site. The predicate device is measuring ear temperature while the subject device is measuring forehead temperature. ## Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1965-98, 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 Infrared forehead thermometer FR1DM1. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer. ## 9. Conclusions: The Microlife Infrared Forehead Thermometer, Model FR1DM1, has the same intended use and similar technological characteristics as the Microlife Infrared Ear thermometer Model IR1DE1. Moreover, bench testing contained in this {2}------------------------------------------------ submission supplied demonstrate that any differences in their characteristics do submission suppliod aomenstate of safety or effectiveness. Thus, the Microlife not raise any new questions of our oneously of onvolvalentially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 3 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: K033820 Trade/Device Name: Microlife Digital Infrared Forchead Thermometer, Model FR1DM1 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 8, 2003 Received: December 9, 2003 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 Amendinents, or to act result Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 wr ), it nay of be actions in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ ## Page 2 - Ms. Falk Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and regarents, including, but not limited to: registration You must comply with an the Act 3 requirements art 801); good manufacturing practice and ifsing (21 CFR Fall 807), laboring (21 CFR Particles), 1 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bjocchs (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) This letter will anow your of other of substantial equivalence of your device to a premarket notification. The I Dr Intention or cassification 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 auvice for your de at (301) 594-4618. 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 outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Small Manufacturer (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Carl 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 {5}------------------------------------------------ Exhibit B Page ___ 1 __ of ___ 1 __ KO33820 510(k) Number (if known): # Device Name: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 ## Indications For Use: The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is The Microllie Digital mirarou Forencement and monitoring of human body Intended for the mermikont model of or use by people of all ages in the home. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |---------------------------------------------------------------------------------|---------| | Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | | | 510(k) Number: | K033820 | | Prescription Use<br>(Per 21 CFR 801.109) | Over-The Counter Use<br>(Optional Format 1-2-96) | |------------------------------------------|--------------------------------------------------| |------------------------------------------|--------------------------------------------------| OR