RAVEN PROTEST - STEAM

{0}------------------------------------------------ K041386 ## 510(k) Summary #### 510(k) Notification ProTest - Steam Biological Indicator | Submitted by: | Raven Biological Laboratories<br>8607 Park Drive<br>Omaha, NE 68127 | |-------------------|----------------------------------------------------------------------------------------------------------------------| | Contact: | Wendy Royalty-Hann<br>Quality Assurance/Regulatory Affairs Manager | | | Or | | | Robert V. Dwyer, Jr.<br>President | | | Phone: (402) 593-0781<br>Fax: (402) 593-0921 | | Prepared on: | May 19, 2004 | | Device: | Trade name: ProTest - Steam<br>Biological Indicator<br>Common name: Self-contained Biological<br>Indicator for Steam | | Classification: | Class II | | Predicate Device: | SGM EZTest® - Steam (K963841) | #### DESCRIPTION The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. #### OPERATIONAL PRINCIPALS The ProTest - Steam Biological Indicator is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The unit is then removed and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 55-60℃ for 24 hours. {1}------------------------------------------------ - During incubation, the available food supply (Tryptic Soy Broth) and temperature During incubation, the available lood Supply (Trypts es germinate and consume the media promote grown of any viable spores. TAS viable speres sing the acidity of the media provided nutrients waste products are released, increasing the acidity of the media provided nuthents waste products are reterange from purple to yellow. Evidence of growth by color change and/or turbidity within 24 hours should be Evidence of growth by color onango undrer takensy for sterilizations, provided signs of growth are present in the control unit. # STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE ProTest – Steam is similar in composition and function to the legally marketed predicate device EZTest - Steam. - o Both are intended for use in monitoring steam sterilization cycles from 121℃ to 135°C. - Utilize the same strain of bacterial spores. - ם Utilize the same carrier material. - o Virtually the same size and shape. - a Activated in the same manner. #### DESCRIPTION OF TESTING Testing was performed in accordance with AAMI ST59:1999 to validate the labeled claims and performance characteristics of ProTest - Steam. Three separate lots of product manufactured from three different primary spore crops I hree separate foto of production, recovery of low numbers of injured spores, were tested for resistante, opors population, For all lots tested, the above parameters and a readood moubation penonitoring routine steam sterilization cycles has been demonstrated. ## STATEMENT OF SAFETY AND EFFECTIVENESS Based on the similar claims, design and results from the above mentioned testing, the Dasod on the entillar of indicator has been demonstrated to be substantially r rollest - Gtoum Blerogical masafe and effect as, the legally marketed device EZTest -Steam. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## AUG - 9 2004 Ms. Wendy Royalty-Hann Quality Assurance, Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127 Re: K041386 R041500 Trade/Device Name: Raven ProTest Self-Contained Biological Indicator for Steam Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: FRC Dated: May 20, 2004 Received: May 25, 2004 Dear Ms. Royalty-Hann: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in the device is substantially equivalent (for the referenced above and have decemblied and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisece prior to frid, 20, 10, 10, 10, 10, 10, 20, 10, 2011, 10, 2011, 10, 2019, 10, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendinents, or to devroos and navic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmen's , therefore, market the device, subject to the general approval application (1 MIT). 1 Car een controls provisions of the Act include Controls provisions of the Fea. "The girling 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 If your device is classified (see as 10) inn a controls. Existing major regulations affecting (PMA), It may be subject to such adaltions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements 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 (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 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, Chiu-Lin, Ph.D. 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)<br>Number | K041386 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Raven ProTest - Steam | | Indications for<br>Use | Raven ProTest - Steam is a self-contained Biological Indicator<br>inoculated with viable Geobacillus stearothermophilus bacterial<br>spores and is intended for monitoring the efficacy of steam<br>sterilization cycles (121°C gravity displacement and 121°C - 135°C<br>prevacuum cycles). Raven ProTest - Steam has a validated<br>reduced incubation time of 24 hours. | Prescription Use (Part 21 CFR 801 Subpart D) ... AND/OR Over-The-Counter Use (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) Kei Mulvey (Division Sign-Off) (UNIsion of Anesthesiology, General Hospital, Infection Control, Dental Devi Page 1 of 1 510(k) Number: K041386