PROCHEM EXT CHEMICAL INTEGRATOR

{0}------------------------------------------------ K062651 # 510(k) Summary of Safety and Effectiveness ## 510(k) Notification ProChem EXT - Chemical Integrator | Submitted by: | Raven Biological Laboratories<br>8607 Park Drive<br>Omaha, NE 68127 | MAR 15 200 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Contact: | Wendy Royalty-Hann<br>Quality Assurance/Regulatory Affairs Manager<br><br>Or<br><br>Robert V. Dwyer, Jr.<br>President<br><br>Phone: (402) 593-0781<br>Fax: (402) 593-0921 | | | Prepared on: | May 3, 2006 | | | Device: | Trade name: ProChem EXT Chemical Integrator<br>Common name: Physical/chemical sterilization<br>process indicator | | | Classification: | Class II | | | Predicate Device: | TST Control Integrator for Steam Autoclave<br>510(k) #K965154, K002937 & K902958 | | ## DEVICE DESCRIPTION ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color. #### INTENDED USE ProChem EXT is an integrating indicator that changes color from green to black when exposed to the following conditions: - 121ºC, 20 min., steam sterilizers � - 132ºC, 8.5 min., steam sterilizers � - 134°C, 7.5 min., steam sterilizers . - 135°C, 7 min., steam sterilizers ● {1}------------------------------------------------ #### TECHNOLOGICAL CHARACTERISTICS The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process. #### PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE Performance testing was conducted in accordance with ANSI/AAMI ST 60 - 1996 in an AAMI compliant steam resistometer using 3 separate production lots of chemical integrators. The performance of the ProChem EXT was equivalent to that of the predicate device and meets the requirements of Class 5 indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60:1996. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 5 2007 Ms. Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127 Re: K062651 Trade/Device Name: ProChem EXT Chemical Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process Indicator Regulatory Class: II Product Code: JOJ Dated: February 26, 2007 Received: February 27, 2007 Dear Ms. Royalty-Hann: 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. Royalty-Hann 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 (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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Cuvls 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 {4}------------------------------------------------ # Indications for Use Statement 510(k) Number K062651 ProChem EXT Chemical Integrator Device Name - Raven ProChem EXT chemical integrator is an integrating Indications for chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121℃, 20 minutes; 132℃, 8.5 minutes; 134℃, 7.5 minutes and 135℃, 7 minutes. AND/OR Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Shula t Murphy, 10 K062651