Who is the manufacturer of Celerity 20 HP Biological Indicator?

STERIS Corporation filed the 510(k) submission for Celerity 20 HP Biological Indicator (K172474).

What is the FDA product code for Celerity 20 HP Biological Indicator?

FRC. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Celerity 20 HP Biological Indicator?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Celerity 20 HP Biological Indicator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Celerity 20 HP Biological Indicator

Q: What are the predicate devices for Celerity 20 HP Biological Indicator?

VERIFY® V24 Self-Contained Biological Indicator (K140708).

K172474 · STERIS Corporation · FRC · Dec 29, 2017 · General Hospital

Device Facts

Record ID	K172474
Device Name	Celerity 20 HP Biological Indicator
Applicant	STERIS Corporation
Product Code	FRC · General Hospital
Decision Date	Dec 29, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Indications for Use

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems. STERRAD® 100S Sterilizer (Default Cycle) Standard and Advanced Cycles of the STERRAD® NX Sterilizer Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Device Story

Biological indicator (BI) for monitoring vaporized hydrogen peroxide (VHP) sterilization cycles; consists of Geobacillus stearothermophilus spores and nutrient media in a plastic vial. Device placed in sterilizer; after cycle, BI inserted into Celerity HP Incubator. Reporter enzyme produced by surviving spores reacts with fluorogenic substrate in media to produce fluorescent signal. Incubator detects fluorescence within 20 minutes. Used by healthcare personnel to confirm sterilization efficacy. Output provides binary result (growth/no growth) to verify sterilization process success; enables rapid release of sterilized instruments.

Clinical Evidence

Bench testing only. Performance validated via RIT testing (meeting >97% alignment with 7-day conventional incubation), resistance testing (D-value, survival/kill times), and simulated use testing in V-PRO and STERRAD cycles. All tests met acceptance criteria for growth inhibition and sterilization monitoring.

Technological Characteristics

Self-contained biological indicator; Geobacillus stearothermophilus spores (1.0-4.0 x 10^6/BI); fluorogenic enzyme-substrate detection system. Plastic vial packaging. Requires Celerity HP Incubator for automated fluorescence detection. Operates at 55-59°C. Includes VHP-sensitive chemical indicator ink.

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization cycles in healthcare facilities using V-PRO and STERRAD sterilization systems.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

VERIFY® V24 Self-Contained Biological Indicator (K140708)

Reference Devices

3M Attest™ Rapid Readout Biological Indicator 1295 (K160546)
VERIFY V-PRO Chemical Indicator (K140515)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a black square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in bold black letters. The word "ADMINISTRATION" is on the second line. January 26, 2018 STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060 Re: K172474 Trade/Device Name: CELERITY 20 HP Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 16, 2017 Received: November 17, 2017 Dear Mr. Piotrkowski: This letter corrects our substantially equivalent letter of December 29, 2017. 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1}------------------------------------------------ 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. 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLeam). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K172474 Device Name CELERITY 20 HP Biological Indicator Indications for Use (Describe) The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: · Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems. · STERRAD® 100S Sterilizer (Default Cycle) · Standard and Advanced Cycles of the STERRAD® NX Sterilizer · Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes. Type of Use (Select one or both, as applicable) J Prescription Use (Part 21 CFR 801 Subpart D) 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # STERIS® # 510(k) Summary For CELERITY 20 HP Biological Indicator # 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 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com Submission Date: December 5, 2017 Premarket Notification Number: K172474 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ ### 1. Device Name | Trade Name: | CELERITY 20 HP Biological Indicator | |------------------------|-----------------------------------------------------------------------| | Common/usual Name: | Biological Indicator (BI) | | Device Classification: | Class II | | Classification Name: | Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) | ### 2. Predicate Device VERIFY® V24 Self-Contained Biological Indicator, K140708 # Reference Devices 3M Attest™ Rapid Readout Biological Indicator 1295, K160546 ### 3. Description of Device The subject device is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader. CELERITY Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles. ### Intended Use/ Indications for Use 4. The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: - Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems. - . STERRAD® 100S Sterilizer (Default Cycle) - Standard and Advanced Cycles of the STERRAD® NX Sterilizer ● - Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX ● Sterilizer {5}------------------------------------------------ When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes. ### ડાં Summary of Technical Characteristics A comparison of technical characteristics versus the predicate is summarized in Table 5-1 and versus the reference device in Table 5-2. # Table 5-1 BI Physical Description and Technological Properties vs the Predicate Device | Feature | Celerity VH2O2 BI (proposed) K172474 | VERIFY V24 SCBI Predicate (K140708) | Comparison | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems. • STERRAD® 100S Sterilizer (Default Cycle) • Standard and Advanced Cycles of the STERRAD® NX Sterilizer • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes. | The VERIFY® V24 Self Contained Biological Indicator is intended for routine monitoring of the following sterilization cycles in healthcare facilities: • Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems • Default Cycle of the STERRAD 100S Sterilizer • Default Cycle of the STERRAD 200 Sterilizer • Standard and Advanced Cycles of the STERRAD NX Sterilizer • Express, Standard and Flex Scope Cycles of the STERRAD 100 NX Sterilizer | The intended cycles for the proposed and predicate are the same with the following exceptions: • Use of the proposed device in the Default Cycle of the STERRAD 200 Sterilizer - the STERRAD 200 Sterilizer is no longer on the market. • Use of the predicate device in the Duo Cycle of the STERRAD 100NX - the Duo Cycle had not yet been cleared for use when the predicate was submitted for clearance. • V-PRO sterilizer claims were cleared in K171504 The proposed indications for use include information about the incubator/reader and read time that are supported through testing in accordance with FDA guidance for BI 510(k). | | | Indicator organism | Geobacillus stearothermophilus | Geobacillus stearothermophilus | Same | | | | Celerity VH2O2 BI | VERIFY V24 SCBI | | | | Feature | (proposed) K172474 | Predicate (K140708) | Comparison | | | Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. | Visual detection of growth based on media color change in the presence of surviving indicator organisms. | Both devices indicate survival of indicator organisms after sterilization. The mechanism of the proposed device is more similar to the reference device (see table 5-2). Resistance testing and simulated use testing demonstrate appropriate monitoring of indicated sterilization cycles. | | | Accessories | Automated incubator / reader | None | This accessory is more similar to the reference device (see table 5-2) than to the predicate device. RIT testing and simulated use testing demonstrate appropriate monitoring of indicated sterilization cycles. | | | Viable spore population | 1.0 - 4.0 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Both contain greater than 106 spores/BI. | | | Resistance characteristics | Resistance @ 9.1 mg/L H2O2: • D-value > 3 sec • Survival Time ≥ 4 sec • Kill Time ≤ 6 min | Resistance @ 2.7 mg/L H2O2: • D-value 4.0 - 8.0 sec • Survival Time 4 - 30 sec • Kill Time ≤ 16 min | Resistance testing for proposed device at a higher H2O2 concentration. Simulated use testing verifies suitability for use in claimed cycles. | | | Culture Conditions | 55- 59°C, media included in BI, 20-minute incubation time. | 55- 59°C, media included in SCBI, 24h incubation time. | RIT Testing and ISO 11138-1 media testing verifies performance | | | Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Direct inoculum on plastic vial, glass ampule with recovery media. | Similar configuration. Component testing per ISO 11138-1 Annex B demonstrates packaging is compatible with indicator and sterilization process. | | | Process indicator | VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change. | VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change. | Same chemical indicator on both BI. | | | Shelf-life | Currently 3 months Target of 13 months | 18 months | Real-time testing ongoing | | | Feature | Celerity VH2O2 BI (proposed) K172474 | Attest 1295 Reference (K160546) | Comparison | | | Intended Use | The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems. • STERRAD® 100S Sterilizer (Default Cycle) • Standard and Advanced Cycles of the STERRAD® NX Sterilizer • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes. | Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems. | Intended cycles for both reference and proposed devices include the same STERRAD cycles. Both require an automated incubator/reader for results. V-PRO sterilizer claims for the proposed device were cleared under K171504. | | | Indicator organism | Geobacillus stearothermophilus | Geobacillus stearothermophilus | Same | | | Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. | Same mechanism of action | | | | Accessories | Automated incubator / reader | Automated incubator / reader | This accessory is similar to the reference. RIT testing and simulated use testing demonstrate appropriate monitoring of indicated sterilization cycles. | | Viable spore population | | $1.0 - 4.0 \times 10^6$ spore/BI | $\ge 1.0 \times 10^6$ spore/BI | Both contain greater than $10^6$ spore/BI | | Feature | | Celerity VH2O2 BI (proposed) K172474 | Attest 1295 Reference (K160546) | Comparison | | Resistance characteristics | | Resistance @ 9.1 mg/L H2O2: • D-value > 3 sec • Survival Time ≥ 4 sec • Kill Time ≤ 6 min | Resistance @ 10 mg/L H2O2: • D-value > 1 sec • Survival Time ≥ 5 sec • Kill Time = 7 min | Resistance values are similar for both devices. Simulated use testing verifies suitability for use in claimed cycles. | | Culture Conditions | 55- 59°C, media included in BI, 20-minute incubation time. | 60 +/- 2°C; media included in SCBI, 4-hour incubation time. | RIT Testing and ISO 11138-1 media testing verifies performance. | | | Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Inoculation on plastic disc within vial, ampoule of recovery medium. | Similar configuration. Component testing per ISO 11138-1 Annex B demonstrates packaging is compatible with indicator organism and sterilization process. | | | Process indicator | VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change. | H2O2 sensitive ink: appears blue until processed, then appears pink | Both contain a VH2O2 CI to distinguish processed BI from unprocessed BI. | | | Shelf-life | Currently 3 months Target of 13 months | 18 months | Real-time testing ongoing | | {6}------------------------------------------------ Note: The BI is identical to that provided in K171504 only the name and indications have been changed. {7}------------------------------------------------ # Table 5-2 BI Physical Description and Technological Properties vs the Reference Device {8}------------------------------------------------ ### 6. Summary of Nonclinical Tests Performance testing to demonstrate substantial equivalence to the predicate in STERRAD Sterilizers has been completed and is summarized in Table 5-3 below. | | Table 5-3. Summary of Non-clinical Testing | | |--|--------------------------------------------|--| | | | | | Test | Acceptance Criteria | Conclusion | |-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------| | BI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles | All BIs processed in half cycle will be negative for growth. | PASS | | BI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles | All BIs inoculated with low numbers of Geobacillus stearothermophilus spores will demonstrate growth. | PASS | | BI Simulated Use in the STERRAD Sterilizer Cycles | All BIs processed in full cycles will be negative for growth. | PASS | Performance testing to demonstrate substantial equivalence to the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-4. | Table 5-4. Summary of Non-clinical Testing Previously Submitted in K171504 | | |----------------------------------------------------------------------------|--| |----------------------------------------------------------------------------|--| | Test | Acceptance Criteria | Conclusion | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------| | Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS | {9}------------------------------------------------ | Test | Acceptance Criteria | Conclusion | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------| | Viable spore population | 1.0 - 4.0 x 106 spore/SCBI | PASS | | Resistance | D-value > 3 sec | PASS | | Survival Time | Survival Time ≥ 4 sec | PASS | | Kill Time | Kill Time ≤ 6 min | PASS | | Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst case VHP exposure | PASS | | Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS | | Simulated Use | Demonstrate no growth when exposed to worst- case cycles | PASS | ## 7. Conclusion The Celerity 20 HP Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed pril book device, VERIFY V24 Self-Contained Biological Indicator cleared in K140708, (21 CFR 880.2800, Product code FRC).

Celerity 20 HP Biological Indicator

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Reference Devices

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Celerity 20 HP Biological Indicator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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