AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER

{0}------------------------------------------------ # SEP 1 0 2001 ## 510(K) SUMMARY K 012136 his summary of 510(k) safety and effectiveness information is being submitted in.accordance with the requirements of SMDA and 21 CFR §807.92 | 1.0 | Submitter's Name: | AVITA International Corp | |-------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Address: | 9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan, R.O.C. | | | Phone: | 001-886-2-85121568 | | | Fax: | 001-886-2-85121347 | | | Contact: | Mr. Geo Lin, General Manager | | 2.0 Device Name: | | AVITA Agil IT101 Instant Digital Thermometer | | 3.0 | Classification: | Class II | | 4.0 Predicate Device: | | Microlife IT2CA1 Digital 4-Sec. Predicative Thermometer (K990168) | | 5.0 Device Description: | | AVITA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile,<br>reusable clinical thermometer and is designed to instantly take the body<br>temperature orally, rectally or under the arm. With its rapidity and<br>precisemenss, Agil IT101 gives a temperature reading in merely 4 seconds orally<br>and 6 seconds rectally and under the arm respectively. | | 6.0 | Intended Use: | The AVITA Agil IT101 Instant Digital Thermometer is intended for the<br>intermittent measurement and monitoring of human body temperature, in either<br>Rapid mode (4-seconds orally, 6-seconds rectally and under the arm --<br>Predicative Temperature), or standard mode(actual determination of<br>temperature), orally, rectally and under the arm , by consumers in the home. | | 7.0 | Performance<br>Summary: | In terms of operating specification, Safety & EMC requirements, the device<br>conforms to applicable standards included ASTM E1112-98, PrEN 12470-3,<br>IEC 60601-1 and IEC 60601-1-2 requirements. | #### 8. Conclusions: : he AVITA Agil 1T101 Instant Digital Thermometer have the same intended use and similar technological characteristics as the Microlife IT2CA1 Digital 4-Sec. Predicative Thermometer (K990168). Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVTA Agil 1T101 Instant Digital Thermometer, is substantially equivalent to the predicate device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its wings and head. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 1 8 2001 AViTA International Corporation Mr. Allen Reich Harvest Consulting Corporation 900 North Switzer Canyon Drive, #142 Flaggstaff, Arizona 86001 Re: K012136 Trade/Device Name: AViTA Agil IT101 Instant Digital Thermometer Regulation Number: 880.2910 Regulation Name: Thermometer, Electronicthermometer, Predictive Thermometer Regulatory Class: II Product Codc: FLL Dated: September 10, 2001 Received: July 9, 2001 Dear Mr. Reich: This letter corrects our substantially equivalent letter of September 10, 2001 regarding the trade name. 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). 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 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. {2}------------------------------------------------ Page 2 - Mr. Reich 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. You must comply with 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue 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 your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | Page | 1 of 1 | |------|--------| |------|--------| NUMBER (IF KNOWN): 510 (k) DEVICE NAME: AViTA Agil IT101 Instant Digital Thermometer AVITA International Corp. ## INDICATIONS FOR USE: A ViTA Agil IT101 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature , orally, rectally and under the arm, by consumers in the home. AviTA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either rapid mode (4-seconds orally, 6-seconds rectally and under the arm -- Predicative Temperature), or standard mode(actual determination of temperature), The device is to used and installed by people exception of handicapped persons and children. The device is to used in the ENVIRONMENT of room temperature & normal environment condition. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter<br>(Optional Format) | V | |------------------------------------------|----|---------------------------------------|---| |------------------------------------------|----|---------------------------------------|---| | (Division Sign-Off) | | |------------------------------------------------------------------------|---------| | Division of Dental, Infection Control,<br>and General Hospital Devices | | | 510(k) Number | K012136 | 510(k) Number _