Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

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February 21, 2018 STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060 Re: K173626 Trade/Device Name: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 22, 2017 Received: November 24, 2017 Dear Anthony 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 of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K173626 ### Device Name CELERITY 20 Steam Process Challenge Device for Dynamic Air Removal Cycles ### Indications for Use (Describe) The Celerity™ 20 Steam Challenge Pack 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 (Prevac, SFPP) . - 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) . Type of Use (Select one or both, as applicable) 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Below the word "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves. # 510(k) Summary For Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles ### Sponsor Facility STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 ## Manufacturing Facility STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896 Contact: Anthony Piotrkowski Senior Manager Regulatory Affairs Telephone: (440) 392-7437 (440) 639-6258 Fax No: e-mail: tony_piotrkowski@steris.com Submission Date: January 23, 2018 Premarket Notification Number: K173626 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ ## K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles #### Device Name 1. | Trade Name: | Celerity 20 Steam Process Challenge Device for<br>Dynamic Air Removal Cycles | |------------------------|------------------------------------------------------------------------------| | Common/usual Name: | Biological Indicator Pack (PCD) | | Device Classification: | Class II | | Classification Name: | Sterilization Process Indicator<br>(21 CFR 880.2800, FRC) | #### 2. Predicate Device 3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593 Reference Device: Verify Assert Steam Process Challenge Device, K162945 #### 3. Description of Device The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (BI) and a VERIFY Steam Integrating Indicator - Short, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79. #### 4. Intended Use/ Indications for Use The Celerity™ 20 Steam Challenge Pack 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 (Prevac, SFPP) - 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) #### 5. Summary of Technical Characteristics A comparison of technical characteristics are summarized in Table 5-1. {5}------------------------------------------------ | Feature | Celerity PCD<br>(K173626) Proposed | Attest 41482V<br>(K121593) Predicate | Comparison | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use | The Celerity 20<br>STEAM Process<br>Challenge Device is<br>used for qualification,<br>routine microbial<br>monitoring, and load<br>monitoring of steam<br>sterilizers.<br>The validated steam<br>sterilization cycles<br>include:<br>• 270F (132°C), 4-<br>minute dynamic<br>air removal;<br>(Prevac, SFPP)<br>• 275F(135°C), 3-<br>minnute dynamic<br>air removal;<br>(Prevac, SFPP) | Use 3M Attest Super<br>Rapid 5 Steam-Plus<br>Challenge Pack in<br>conjunction with the<br>3M Attest Auto-<br>reader 490 to qualify<br>or monitor dynamic<br>air removal<br>(prevacuum) steam<br>sterilization cycles of<br>4 minutes at 270 F<br>(132 C) and 3 minutes<br>at 275 F (135 C).<br>The 3M Attest Super<br>Rapid Readout<br>Biological Indicator<br>contained within the<br>challenge pack<br>provides a final<br>fluorescent result in 1<br>hour. An optional<br>visual pH color<br>change result is<br>observed in 48 hours. | Both are intended for<br>monitoring 270F<br>(132C), 4-minute<br>dynamic air removal<br>275F(135C), 3-minnute<br>dynamic air removal,<br>steam sterilization<br>cycles. | | General<br>Design | Indicators are sealed<br>in plastic tray with<br>channel to limit steam<br>penetration/air<br>removal. | Layers of medical<br>index cards, some of<br>which are die-cut to<br>contain indicators,<br>overwrapped and<br>secured with a label. | Both the devices are<br>contained in a steam<br>barrier. Simulated use<br>testing demonstrated<br>equivalence | | Biological<br>Indicator | Celerity 20 Steam<br>Biological Indicator<br>(20-minute<br>fluorescent result) | Attest 1492V<br>Biological Indicator<br>(1-hour fluorescent<br>result) | Both contain 510(k)-<br>cleared Biological<br>Indicators with rapid<br>fluorescent results. | | Chemical<br>Integrator | VERIFY STEAM<br>Integrating Indicator-<br>Short | SteriGage Chemical<br>Integrator | Both contains 510(k)-<br>cleared chemical<br>integrators | | Means to<br>distinguish<br>processed<br>PCD from<br>unprocessed | Proposed device's<br>internal integrator is<br>visible through the<br>pack. | External process<br>indicator. Yellow to<br>brown color change<br>when exposed to<br>steam | Both have a means to<br>distinguish processed<br>PCD from unprocessed | ## Table 5-1. Summary of PCD Physical Description and Technological Properties {6}------------------------------------------------ ## K173626 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles is identical to the reference device VERIFY Assert Steam Process Challenge Device except for the biological indicator within the device. The difference in the biological indicator allows the Celerity BI to have a 20-minute read (versus 40-minutes for the reference device). The different BI also requires a different reader. #### 6. Summary of Nonclinical Tests Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below. | Test | Acceptance Criteria | Conclusion | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Simulated Use | • Performance of the BI in the PCD is equivalent to<br>the performance of the BI in the AAMI reference<br>pack in their respective sterilization processes | PASS | | | • Performance of the chemical integrator in the PCD<br>is equivalent to the performance of the chemical<br>integrator in AAMI reference pack in their<br>respective processes | PASS | | | • PCD provides an equivalent or greater challenge<br>than the AAMI standardized test pack | PASS | | BI in pack vs BI<br>outside of pack | PCD provides a greater challenge to the process than<br>the BI itself. | PASS | | CI in pack vs CI<br>outside of pack | PCD provides a greater challenge to the process than<br>the integrator by itself. | PASS | Table 5-2. Summary of Non-clinical Testing ### 7. Conclusion The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles has met the established performance criteria. The results of the studies performed demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as effective, and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, Product code FRC).