Q-TIPS, FAICHNEY, PRIVATE LABEL

{0} K962497 OCT - 8 1996 # faichney ## MEDICAL September 23, 1996 Food & Drug Administration Center for Devices and Radiological Health Document Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850 510(k) #: K962497 Received: 26-JUN-96 Product: Q-TIPS®, FAICHNEY®, & PRIVATE LABEL CLINICAL ELECTRONIC THERMOMETER ## 510(k) SUMMARY Name of Applicant: Faichney Medical Company, a division of Conopco, Inc. Contact Person: M. James Davis General Manager Faichney Medical Company 17159 Surrey View Drive Chesterfield, MO 63005 Telephone: (314) 530-0077 Facsimile: (314) 530-9948 ## Device Identification Trade Name: Q-tips®, Faichney®, Private Label Common Name: Clinical Electronic Thermometer Establishment Registration Number: 1933255 Classification: Class II (21 CFR 880.2910) Panel: Panel 80, General Hospital and Personal Use Device Section of the General Medical Devices Panel Procode: FLL -- thermometer, electronic, clinical Faichney Medical Company 17159 Surrey View Drive • Chesterfield, Missouri 63005 Phone (314) 530-0077 • Fax (314) 530-9948 ATTACHMENT #1 {1} Faichney Medical Company 510(k) Summary September 23, 1996 Page 2 of 3 Performance Standard: Performance standards have not been adopted by the FDA for clinical electronic thermometers. This thermometer is compliant with the standards established by the American Society for Testing and Materials (ASTM), Designation E1112-86. The disposable probe cover for this thermometer is compliant with standards established by ASTM, Designation E1104-86. The specification is under the jurisdiction of ASTM Committee E-20 on Temperature Measurement and the direct responsibility of the ASTM Subcommittee E20.80 on Medical Thermometry. ## Comparable Device This device is substantially equivalent to other digital thermometers in commercial distribution such as the Becton-Dickinson Digital Fever Thermometer. The 510(k) Document Control Number for the Becton-Dickinson Digital Fever Thermometer. is K852954. ## Description of Device and Intended Use The Faichney Medical Company and Becton-dickinson digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites. There are no technological differences between these thermometers. The Becton-Dickinson digital thermometer is a Class II, Panel code 80 FLL, device approved for commercial market. ## Summary of Bench Data Laboratory tests of the Faichney digital fever thermometer were conducted by an independent testing house. Regarding "Accuracy" the temperature Range, Mean & Standard Deviation of the digital thermometer is better than that of the mercury-in-glass thermometer (Reference Table #1 and Table #2, Attachment #6a). The investigator concluded that..."it may be stated with a confidence interval of 89 percent that the accuracy of the electronic thermometers (both with and without probe covers) is within 0.1°F of the accuracy of the glass stem product or better at every range but the 96.4°F to 98.0°F." Regarding "Response Time", as expected, there is a slight increase in the time required for the digital thermometer to reach Peak Temperature. The investigator concluded that..."When tested without probe covers, the product averaged 26 seconds to register peak temperature. The same units, when tested with probe covers, averaged 28 seconds to register peak temperature. {2} Faichney Medical Company 510(k) Summary September 23, 1996 Page 3 of 3 ## Conclusions Regarding Safety and Effectiveness The Faichney Medical Company digital thermometer, which is substantially equivalent to the Becton-Dickinson digital thermometer, is safe and effective for its intended use. Sincerely, Faichney Medical Company By:  M. James Davis, General Manager Enclosures