Celerity 20 Steam Biological Indicator for IUSS

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January 8, 2021 STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060 Re: K202721 Trade/Device Name: Celerity 20 Steam Biological Indicator for IUSS Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 10, 2020 Received: December 11, 2020 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). 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202721 ### Device Name Celerity 20 STEAM Biological Indicator for IUSS Indications for Use (Describe) The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes. When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes. | 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. # 510(k) Summary For Celerity 20 Steam Biological Indicator for IUSS ### 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: Tony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com Submission Date: January 8, 2021 Premarket Notification number: K202721 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | Celerity 20 Steam Biological Indicator for IUSS | |------------------------|-----------------------------------------------------------------------| | Common/usual Name: | Biological Indicator (BI, SCBI) | | Device Classification: | Class II | | Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) | #### 2. Predicate Device 3M Attest 1491 Super Rapid Readout Biological Indicator, K103277 #### 3. Reference Device Celerity 20 Steam Biological Indicator, cleared under K173634 and modified under K181686 #### 4. Description of Device The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. #### Intended Use/ Indications for Use ട്. The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: - Gravity 270°F (132°C) 3 minutes ● - Gravity 270°F (132°C) 10 minutes ● - Gravity 275°F (135°C) 3 minutes ● - Gravity 275°F (135°C) 10 minutes. When used in conjunction with the Celerity STEAM Incubator, the Incubator provides a fluorescent result within 20 minutes. {5}------------------------------------------------ ### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS #### Summary of Technical Characteristics 6. A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-1. | | Celerity SCBI for IUSS<br>(proposed) | K103277 Attest 1491<br>(Predicate) | Comparison | Feature | Celerity SCBI for IUSS<br>(proposed) | K173634 Celerity 20<br>Steam BI (Reference) | Comparison | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | Intended<br>Use | The Celerity 20 STEAM<br>Biological Indicator for<br>IUSS is used for monitoring<br>and qualification testing of<br>the following steam<br>sterilization cycles:<br>Gravity 270°F (132°C) 3<br>minutes<br>Gravity 270°F (132°C) 10<br>minutes<br>Gravity 275°F (135°C) 3<br>minutes<br>Gravity 275°F (135°C) 10<br>minutes.<br><br>When used in conjunction<br>with the Celerity STEAM<br>Incubator, the Incubator<br>provides a fluorescent result<br>within 20 minutes. | The Celerity 20 Steam<br>Biological Indicator (BI) is<br>for routine monitoring,<br>qualification testing and<br>product testing of the<br>following steam<br>sterilization processes:<br>270F, 4-minute dynamic<br>air removal; 275F, 3-<br>minute dynamic air<br>removal; 250 F, 30-minute<br>gravity; 270, 15-minutes<br>gravity.<br><br>When used in conjunction<br>with the Celerity 20 Steam<br>Incubator, the Celerity 20<br>Steam Biological Indicator<br>provides a fluorescent<br>result within 20 minutes. | Both are intended for<br>monitoring steam<br>sterilization cycles.<br><br>The Celerity BI for IUSS is<br>specifically for gravity IUSS<br>cycles. Testing is provided<br>in this 510(k) to demonstrate<br>suitable performance in<br>gravity IUSS cycles. | | Intended<br>Use | The Celerity 20 STEAM<br>Biological Indicator for<br>IUSS is used for monitoring<br>and qualification testing of<br>the following steam<br>sterilization cycles:<br>Gravity 270°F (132°C) 3<br>minutes<br>Gravity 270°F (132°C) 10<br>minutes<br>Gravity 275°F (135°C) 3<br>minutes<br>Gravity 275°F (135°C) 10<br>minutes.<br>When used in conjunction<br>with the Celerity STEAM<br>Incubator, the Incubator<br>provides a fluorescent result<br>within 20 minutes. | Use 3M Attest 1491 Super<br>Rapid Read Biological<br>Indicator in conjunction<br>with the 3M Attest Auto-<br>reader 490 to monitor the<br>cycles below.<br>Gravity Displacement<br>IUSS (Flash):<br>270°F(132°C) 3 minutes;<br>270°F(132°C) 10 minutes;<br>275°F(135°C) 3 minutes;<br>275°F(135°C) 10 minutes.<br>The 3M Attest 1491 Super<br>Rapid Readout Biological<br>Indicator provides a final<br>fluorescent result in 30<br>minutes. An optional visual<br>pH color change result is<br>observed in 24 hours. | Both are intended for<br>monitoring the same steam<br>sterilization cycles.<br><br>The Celerity BI has a shorter<br>claimed readout time.<br>Reduced Incubation Time<br>(RIT) testing per the FDA<br>guidance demonstrates the<br>read time is appropriate. | Indicator<br>organism | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | Identical | | Indicator<br>organism | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | Same criteria | Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | Identical | | Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | Same mechanism | Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | Both use the same reader | | Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | RIT testing performed with<br>the proposed<br>incubator/reader. | Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | 1.0 - 4.0 x 106 spore/SCBI | Identical | | Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | ≥ 1.0 x 106 spore/SCBI | Both proposed and predicate<br>meet criteria of the FDA | Resistance | D132 ≥ 10 s<br>D135 ≥ 8 s | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | Identical at the two<br>temperatures for which the<br>proposed device is indicated | | Resistance | D132 ≥ 10 s<br>D135 ≥ 8 s | D132 ≥ 10 s<br>D135 ≥ 8 s | guidance on Biological<br>Indicator 510(k) | Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | Identical | | Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 30 minute<br>incubation time. | RIT Testing and ISO 11138<br>media testing verifies<br>performance | Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Identical | | Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Inoculated paper in plastic<br>vial with cap and glass<br>ampoule with recovery<br>media in capped vial. | Similar configuration.<br>Component testing per ISO<br>11138-1 Annex B<br>demonstrates packaging is<br>compatible with indicator<br>and sterilization process. | | | | | ## Table 5-1. Proposed vs Predicate Physical Description and Technological Properties {6}------------------------------------------------ ### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-2. ### Table 5-2. Proposed vs Reference Physical Description and Technological Properties {7}------------------------------------------------ #### 7. Summary of Nonclinical Tests Performance testing has been completed and is summarized in Table 5-2 below. | Test | Acceptance Criteria | Conclusion | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Reduced<br>Incubation Time<br>(RIT) Testing | Meets FDA's requirement of $>$ 97%<br>alignment of the 20-minute results with the<br>conventional incubation time of 7 days | PASS | | Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | PASS | | Resistance | $D_{132} ≥ 10 s$<br>$D_{135} ≥ 8 s$ | PASS | | Survival Time | Meets FDA requirements | $132 C ≥ 1 min$<br>$135 C ≥ 0.667 min$ | | Carrier growth<br>inhibition / media<br>growth promotion | Positive growth of less than 100 spores after<br>primary packaging and media are subject to<br>worst case steam exposure | PASS | | Hold Time | Performance not affected if incubated within<br>8 hours of exposure to steam sterilization | PASS | | Simulated Use | Demonstrate growth when exposed to<br>abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growth<br>Full cycle - no growth | | Shelf-life | Population, resistance, RIT and media must<br>meet above criteria at each stability time<br>point | PASS at 3 months<br>(ongoing) | ### Table 5-2. Summary of Non-clinical Testing #### 7. Conclusion The conclusion drawn from the nonclinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K103277 Class II (21 CFR 880.2800, Product code FRC).