← Product Code [OWP](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP) · K162945 # VERIFY ASSERT STEAM Process Challenge Device (K162945) _STERIS Corporation · OWP · Apr 28, 2017 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/K162945 ## Device Facts - **Applicant:** STERIS Corporation - **Product Code:** [OWP](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP.md) - **Decision Date:** Apr 28, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2805 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: - · 270°F (132°C) 4-minute dynamic air removal • 275°F (135°C) 3-minute dynamic air removal ## Device Story VERIFY Assert STEAM Process Challenge Device (PCD) functions as a biological indicator challenge pack for steam sterilization monitoring. Device placed within steam sterilizer load to simulate resistance of actual medical instruments. PCD contains biological indicator; exposure to steam sterilization cycle challenges indicator viability. Following cycle, indicator processed to determine sterilization efficacy. Used by healthcare personnel in clinical settings to verify sterilizer performance and ensure load sterility. Provides objective evidence of sterilization cycle success; failure indicates potential non-sterile load, preventing use of contaminated instruments on patients. ## Clinical Evidence No clinical data. Bench testing only. ## Technological Characteristics Biological indicator-based process challenge device. Designed for dynamic air removal steam sterilization cycles at 270°F (132°C) and 275°F (135°C). ## Regulatory Identification A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single, flowing shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 28, 2017 Steris Corporation Anthony M. Piotrkowski Senior Manager, Reguloatory Affairs 5976 Heisley Rd Mentor, Ohio 44060 Re: K162945 Trade/Device Name: Verify Assert Steam Process Challenge Device Regulation Number: 21 CFR 880.2805 Regulation Name: Recombinant Biological Indicator Regulatory Class: Class II Product Code: OWP Dated: March 24, 2017 Received: March 27, 2017 Dear Anthony M. Piotrkowski: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162945 #### Device Name VERIFY Assert STEAM Process Challenge Device Indications for Use (Describe) The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: - · 270°F (132°C) 4-minute dynamic air removal • 275°F (135°C) 3-minute dynamic air removal Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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