PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007

{0}------------------------------------------------ K012974 ### 510(k) SUMMARY of SAFETY and EFFECTIVENESS #### I. GENERAL INFORMATION | Trade or (Proprietary) Name: | Prizm Medical, Inc. ThermoTrace™ Infrared<br>Thermometer Models 15004 and 15007 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Common or usual name: | Thermometer, electronic, clinical | | Classification Name: | FDA has classified thermometer, electronic, clinical as<br>Class II devices. (21 C.F.R. § 880.2910) | | Submitter's Name<br>And Address: | Cathryn N. Cambria<br>for Prizm Medical, Inc.<br>Regulatory Resources Group<br>5536 Trowbridge Drive<br>Dunwoody, GA 30338 | | Submission Date: | September 4, 2001 | | Legally Marketed Device | | To Which Claim Substantial J & J Engineering, Inc. Thermistor Thermometer Equivalence: Exergen Corporation DermaTemp DT 1001 #### II. INDICATIONS FOR USE The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages. #### III. DEVICE DESCRIPTION The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages. Please refer to the Operations Manual (Exhibit A) for photographs and a more thorough description of the device. The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages. The primary function of {1}------------------------------------------------ the ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are the same as the J & J Engineering, Inc. Thermistor Thermometer and the Exergen Corporation DermaTemp DT 1001 and raises no new questions of safety and effectiveness. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or faces, stacked one behind the other, with the foremost profile being the most distinct. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 3 2002 Prizm Medical, Incorporated C/O Ms. Cathryn N. Cambria Regulatory Resources Group, Incorporated 5536 Trowbridge Drive Dunwoody. Georgia 30338 Re: K012974 Trade/Device Name: Prizm Medical Inc. Thermotrace™ Infrared Thermometer. Models 15004 and 15007 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 3, 2002 Received: July 10, 2002 Dear Ms. Cambria: 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. {3}------------------------------------------------ ### Page 2 - Ms. Cambria 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 (OS) regulation (21 CFR Part 820); and if applicable, the 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 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 21 CFR 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ M II MICHINUN Prizm Medical, Inc. Page 1 of 1. 510(k) Number (if known): Device Name: Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 ## Indications for Use: The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument intended for use in clinical settings for the intermittent measurement and monitoring of skin temperature variations of the wml and a son people of all ages. 1012974 wint # (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use er Use Patucia Cucero (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ Page 21 of 23