RAVEN BACTERIAL SPORE STRIPS

{0}------------------------------------------------ K 020026 # SUMMARY OF RAVEN BACTERIAL SPORE STRIPS # JAN 3 0 2002 | Submitter: | Raven Biological Laboratories, Inc.<br>8607 Park Drive<br>Omaha, NE 68127<br>(402) 593-0781<br>(402) 593-0921 Fax | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Contact: | Robert Dwyer<br>President | | | Wendy Royalty-Hann<br>Quality Assurance/Regulatory Affairs Manager | | Prepared on: | January 2, 2002 | | Device name: | Raven Bacterial Spore Strip | | Classification: | Class II medical device, General hospital | | Predicate Devices (legally marketed): | Raven Bacterial Spore Strip | | Predicate Device 510(k) number: | Pre-amendment device | Description: Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch. ### Operational Principles: The bacterial spore strip is exposed in the glassine pouch to a Steam sterilization cycle rice baotenairepens B. stearothermophilus or dual species. The spore strip is intended for (Single Spooler D. Stourother of the sterilization process and should be placed in the use in determining the onealy the load. Upon cycle completion, the spore strip should most unficult to stomics and aseptically transferred into an appropriate growth media. The media should then be incubated at 55-60°C. Media should be monitored daily for growth and results recorded. When used in conjunction with Raven's Modified Tryptic g row aroth with Bromocresol Purple, a reduced incubation time for Steam has been validated at 48 hours. Growth will be indicated by a change in color from purple to/towards yellow and/or by turbidity. Detection of a failed sterilization cycle is facilitated by the use of the Raven Bacterial Spore Strip. {1}------------------------------------------------ # Statement of Similarity to Legally Marketed Predicate Device The Raven Bacterial Spore Strip has the following similarities to the legally marketed Pre-amendment Raven Bacterial Spore Strip. - Have the same indicated use - Incorporate the same materials - Have the same shelf life, and - Are packaged using the same materials and processes. ## Description of Testing: Per FDA guidance for validation of reduced incubation of biological indicators, testing Performed for the Steam sterilization process using three lots each of newly was performed for the Gloum Stelliar nearing expiry, newly manufactured Modified manufactured spore strips, opere stipe neal MTSB w/ BCP) and MTSB w/ BCP nearing rryptic Soy Broth with Bromovious i upic (w and media was tested. For all explity. Each Combination of new and noal Siphy sterilization was demonstrated when fols lested, 40 hour reddod in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple. ## Conclusion The Raven Bacterial Spore Strip is substantially equivalent in composition and function The Raven Dacterial Opero Only is Suice, Pre-amendment Raven Bacterial Spore Strip, to the Legally Manicitou produced creduced incubation period of 48 hours for montoning Occam Stormization of Systems Modified Tryptic Soy Broth with Bromocresol Purple. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 0 2002 Ms. Wendy Royalty-Hann QA/RA Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127 Re: K020026 Trade/Device Name: Raven Bacterial Spore Strips for Steam Sterilization Regulation Number: 880.2800 Regulation Name: Biological Indicators Regulatory Class: II Product Code: FRC Dated: January 23, 2002 Received: January 4, 2002 Dear Ms. Hann: We have reviewed your Section 510(k) premarket notification of intent to market the device we nate fortened your and have determined the device is substantially equivalent (for the indications muleations for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sales in the encreases , 15 the enactment date of the Medical Device Amendments, commerce pror to may as nay lassified in accordance with the provisions of the Federal or to devices and Cosmetic Act (Act) that do not require approval of a premarket approval 1 000, Brug, and Connectore, market the device, subject to the general controls application (1 Mr.) - 1 ou experal controls provisions of the Act include requirements for provisions of ation, 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 (1 will), it indy of budget of Federal Regulations, Title 21, Parts 800 to 898. In your device anay publish further announcements concerning your device in the Federal Register. 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 {3}------------------------------------------------ #### Page 2 - Ms. Hann of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registereds, including, but not limited to: registration 1 ou must comply with and Hovering (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), laceling (21 CFR Pat 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 This icity will and w you to began interest of substantial equivalence of your device to 310(K) premarket notification. I rice 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 If you desire specific at not 2017 your in vitro diagnostic devices), please contact the allo auditionally 21 OF N 2 at 1 and 1 and 1 and tionally, for questions on the promotion and Office of Comphance at (e please contact the Office of Compliance at (301) 594-4639. ad veraling or your working entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother in the relation of Small Manufacturers, International and the Act may be obtained from the enumber (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 A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Attachment 2 # Indications for Use Statement 510(k) Number K020026 **Number** Device Name Raven Bacterial Spore Strips The Raven Bacterial Spore Strip (single species B. Indications for stearothermophilus ATCC#7953 or dual species B. Use stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple. ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ### Concurrence of CDRH, Office of Device Evaluation (ODE) Olin S. Lahn (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K020026