Celerity 5 HP Biological Indicator (LCB052), Celerity 5 HP Challenge Pack (LCB059), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Challenge Pack (LCB045)

Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterlizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chad is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non-Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chaded. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Device Description

Celerity 5 HP BI

The product 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, STERIS Celerity Incubator, within 5 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.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

Celerity 20 HP BI

The product 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, STERIS Celerity Incubator, 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.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

AI/ML Overview

The provided document is a 510(k) summary for STERIS Corporation's Celerity 5 HP and Celerity 20 HP Biological Indicators and Challenge Packs. It details non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human readers or AI algorithms for diagnostic purposes.

Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the-loop performance) was done," are not applicable to the information contained in this document. This document describes the performance of a physical medical device (Biological Indicator) intended to monitor sterilization cycles, not a software-based diagnostic tool or AI.

However, I can extract and present the relevant acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

The document presents non-clinical performance testing for two sets of devices: Celerity 5 HP Biological Indicator/Challenge Pack and Celerity 20 HP Biological Indicator/Challenge Pack. The tables below combine the acceptance criteria and results for both, as they largely follow similar testing methodologies.

Celerity 5 HP Biological Indicator and Challenge Pack (Table 3)

Test	Acceptance Criteria	Reported Device Performance (Result)
Reduced Incubation Time Testing	All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5-minutes.	PASS
Simulated Use Testing	All processed BIs shall be sterile following full cycle exposure sterilizer cycles.	PASS
Bacteriostasis Testing	All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth.	PASS
Cap Media Testing	All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Stability Testing	Population: The mean initial population at the start of the stability study must be 1.0-4.0 x 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.D-value: D-value between 6 and 20 seconds.Survival/Kill: Demonstration of one all survive time and one all kill time point.RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5 minutes.Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Specialty Cycle	All BIs will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.	PASS
Hold Time Testing	The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).	72 Hour Hold Time Established

Celerity 20 HP Biological Indicator and Challenge Pack (Table 6)

Test	Acceptance Criteria	Reported Device Performance (Result)
Reduced Incubation Time Testing	All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.	PASS
Simulated Use Testing	All processed BIs shall be sterile following full cycle exposure sterilizer cycles.	PASS
Bacteriostasis Testing	All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth.	PASS
Cap Media Testing	All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Stability Testing	Population: The mean initial population at the start of the stability study must be 1.0-4.0 x 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.D-value: D-value between 6 and 20 seconds.Survival/Kill: Demonstration of one all survive time and one all kill time point.RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Specialty Cycle	All BIs will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.	Pass
Hold Time Testing	The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).	72 Hour Hold Time Established

Study Details (Based on available information)

As noted, many elements of the request are not applicable as this document pertains to a physical biological indicator, not an AI or imaging diagnostic device.

Sample size used for the test set and the data provenance: The document uses terms like "All BI lots" and refers to testing of the biological indicators themselves rather than a "test set" of patient data. Specific sample sizes for each non-clinical test are not explicitly stated in this summary. The data provenance is from non-clinical laboratory testing performed by STERIS Corporation. There is no indication of country of origin of data or whether it was retrospective/prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biological indicators in sterilization involves laboratory-based microbiology (e.g., presence or absence of spore growth in controlled environments), not expert human interpretation like radiologists for images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a non-clinical device performance study, not a human reader study requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical biological indicator. The performance is assessed in a laboratory setting. The "Celerity Incubator" detects the fluorescent signal, but this is a device accessory, not an AI algorithm.
The type of ground truth used: The ground truth for the biological indicators is based on the viability of Geobacillus stearothermophilus spores, determined by their ability to grow and produce a fluorescent signal (or lack thereof) under specific, controlled laboratory conditions after exposure to sterilization processes. This is a direct microbiological assessment.
The sample size for the training set: Not applicable. This is a physical device that undergoes performance testing, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable. As above, there is no "training set" in the context of this device.

Summary

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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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 6, 2025

STERIS Corporation Logan Persons Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K250044

Trade/Device Name: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 8, 2025 Received: January 10, 2025

Dear Logan Persons:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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-regulatory

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assistance/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,

Stephen A. Anisko -S

Digitally signed by Stephen A. Anisko -S Date: 2025.02.06 17:36:11 -05'00'

for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K250044

Device Name

Celerity 5 HP Biological Indicator (LCB052), Celerity 5 HP Challenge Pack (LCB059), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Challenge Pack (LCB045)

Indications for Use (Describe) Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterlizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

Celerity 20 HP Biological Indicator

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non-Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear

Celerity 20 HP Challenge Pack

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/5/Picture/1 description: The image shows the logo for STERIS corporation. The logo consists of the word "STERIS" in a large, bold, sans-serif font, with the registered trademark symbol to the right of the "S". Below the word "STERIS" is a graphic of several horizontal, wavy lines in a light blue color. The lines are stacked on top of each other, creating a visual effect of water waves.

510(k) Summary For Celerity 5 HP Biological Indicator and Challenge Pack

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax:

Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax: (440) 392-7896

Contact

Logan Persons Regulatory Affairs Specialist Phone: (440) 352-7325 Fax: (440) 357-9198 Email: Logan Persons(@steris.com

Submission Date:

January 10, 2025

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Image /page/6/Picture/2 description: The image shows a blue logo with a series of horizontal, wavy lines stacked on top of each other. There are five lines in total, and they are all the same color. The lines are arranged in a way that creates a sense of depth and movement. The logo is simple and modern, and the blue color gives it a clean and professional look.

1. Device Name

Trade Name:	Celerity 5 HP Biological Indicator (LCB052)
Common/usual Name:	Biological Indicator
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]
Trade Name:	Celerity 5 HP Challenge Pack (LCB059)
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

2. Predicate Device

Proprietary Name	Celerity 5 HP Biological Indicator
Common/usual Name	Biological indicator
Classification Name:	Indicator, Biological Sterilization Process
510(k) Submitter/Holder	STERIS Corporation
510(k) Number:	K223717
Proprietary Name	Celerity 5 HP Challenge Pack
Common/usual Name	Biological indicator Challenge Pack
Classification Name:	Indicator, Biological Sterilization Process
510(k) Submitter/Holder	STERIS Corporation
510(k) Number:	K223717

3. Description of Device

Celerity 5 HP BI

Celerity 5 HP Challenge Pack

4. Intended Use/Indications for Use Celerity 5 HP BI

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Image /page/7/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same light blue color. The lines are not perfectly straight, but rather have a gentle, undulating curve, resembling waves or contours. The logo is simple and abstract, with a clean and modern aesthetic.

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO ● 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without . ALLClear®
. Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

5. Summary of Technical Characteristics

Table 1. BI Subject Device Comparison to the Predicate Device (Celerity 5 HP)

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S STE

Image /page/8/Picture/2 description: The image shows a blue icon with a series of horizontal lines that curve up and down, resembling waves. There are six lines in total, stacked vertically on top of each other. The lines are evenly spaced and have a consistent thickness. The icon is simple and abstract, likely representing water or a similar concept.

Table 2. Challenge Pack Comparison to Predicate Device (Celerity 5 HP)

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STEI

Image /page/9/Picture/2 description: The image shows a blue logo with a series of horizontal, wavy lines stacked on top of each other. There are five lines in total, each slightly curved to create a wave-like pattern. The lines are evenly spaced and appear to be of uniform thickness. The logo is simple and abstract, suggesting movement or fluidity.

6. Summary of Non-clinical Tests

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 3.

Table 3. Performance Testing

Test	Acceptance Criteria	Result
ReducedIncubation TimeTesting	All BI lots will demonstrate 97% or greater positive growthresults at 7 days as compared to the fluorescent result atless than or equal to 5-minutes	PASS
Simulated UseTesting	All processed Bis shall be sterile following full cycleexposure sterilizer cycles.	PASS
BacteriostasisTesting	All BIs inoculated with 10-100 Geobacillusstearothermophilus spores will demonstrate growth	PASS
Cap MediaTesting	All BIs will demonstrate a positive fluorescent signal in thefluorescent incubators.	PASS
Stability Testing	PopulationThe mean initial population at the start of the stabilitystudy must be 1.0-4.0 x 106 CFU/BI. At each subsequenttime point, the mean population shall be 50-300% of theinitial mean population.D-valueD-value between 6 and 20 seconds.Survival/KillDemonstration of one all survive time and one all kill timepoint.RITAll BI lots will demonstrate 97% or greater positive growthresults at 7 days as compared to the fluorescent result atless than or equal to 5 minutes.Media TestingAll BIs will demonstrate a positive fluorescent signal in thefluorescent incubators.	PASS
	Specialty Cycle		All Bis will demonstrate a positive signal and growth afterexposure to a sublethal cycle and a 20 hour aeration phase.	PASS
	Hold TimeTesting		The hold time will be established using the longest holdtime where there is no statistical or practical differencefrom the initial hold time (time 0).	72 HourHold TimeEstablished

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STERIS®

Image /page/10/Picture/2 description: The image shows a blue icon with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same color. The lines are arranged in a way that creates a sense of depth and movement. The icon is simple and clean, and it could be used to represent a variety of things, such as water, waves, or sound.

7. Conclusion

The Celerity 5 HP Biological Indicator and Challenge Pack have met the established performance criteria. Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective, and performs as well as

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STERIS®

the legally marketed predicate device (K223717), Class II (21 CFR 880.2800), product code FRC.

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Image /page/12/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is written in large, bold, black letters at the top of the logo, with a small "®" symbol in the upper right corner. Below the word "STERIS" is a graphic of several horizontal, wavy blue lines, resembling water.

510(k) Summary For Celerity 20 HP Biological Indicator and Challenge Pack

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax:

Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 (440) 392-7896 Fax:

Contact

Logan Persons Regulatory Affairs Specialist Phone: (440) 352-7325 Fax: (440) 357-9198 Email: Logan Persons(@steris.com

Submission Date:

January 10, 2025

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Image /page/13/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a pattern that resembles waves or ripples. The logo is simple and abstract, with no text or other elements included.

8. Device Name

Trade Name:	Celerity 20 HP Biological Indicator (LCB044)
Common/usual Name:	Biological Indicator
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process [21 CFR 880.2800(a),FRC]
Trade Name:	Celerity 20 HP Challenge Pack (LCB045)
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process [21 CFR 880.2800(a),FRC]

9. Predicate Device

Proprietary Name	Celerity 20 HP Biological Indicator
Common/usual Name	Biological indicator
Classification Name:	Indicator, Biological Sterilization Process
510(k) Submitter/Holder	STERIS Corporation
510(k) Number:	K183294
Proprietary Name	Celerity 20 HP Challenge Pack
Common/usual Name	Biological indicator Challenge Pack
Classification Name:	Indicator, Biological Sterilization Process
510(k) Submitter/Holder	STERIS Corporation
510(k) Number:	K183294

10. Description of Device

Celerity 20 HP BI

The product 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, STERIS Celerity Incubator, 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.

Celerity 20 HP Challenge Pack

11. Intended Use/Indications for Use Celerity 20 HP BI

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Image /page/14/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same light blue color. The lines are arranged in a way that creates a sense of depth and movement. The logo is simple and modern, and the blue color gives it a calming and refreshing feel.

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO ● 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without . ALLClear®
. Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

12. Summary of Technical Characteristics

Table 4. BI Subject Device Comparison to the Predicate Device (Celerity 20 HP)

Feature	Celerity 20 HP BI(proposed)	Celerity 20 HP BIPredicate (K183294)	Comparison
Intended Use	The Celerity 20 HPBiological Indicator(BI) is intended forroutine monitoring ofthe following sterilizercycles:• Lumen, Non• Lumen, Fast Non• Lumen, Fast,Flexible, andSpecialty Cycles ofthe V-PRO: 1, 1Plus, maX, maX2,60 and s2 LowTemperature	The Celerity 20 HPBiological Indicator(BI) is intended forroutine monitoring ofthe following sterilizercycles:• Lumen, Non• Lumen, Fast Non• Lumen, Fast,Flexible, andSpecialty Cycles ofthe V-PRO: 1, 1Plus, maX, maX2,60 and s2 LowTemperature	Similar. Proposed devicewill remove STERRAD100S Standard Cycle
Feature	Celerity 20 HP BI(proposed)	Celerity 20 HP BIPredicate (K183294)	Comparison
	SterilizationSystems.• Standard andAdvanced Cycles ofthe STERRAD®NX Sterilizer withor withoutALLClear• Standard, FLEX,Express and DUOCycles of theSTERRAD®100NX Sterilizerwith or withoutALLClearWhen used inconjunction with theCelerity® Incubator, theIncubator provides afluorescent result within20 minutes.	SterilizationSystems.• Standard Cycle ofthe STERRAD®100S• Standard andAdvanced Cycles ofthe STERRAD®NX Sterilizer withor withoutALLClear• Standard, FLEX,Express and DUOCycles of theSTERRAD®100NX Sterilizerwith or withoutALLClearWhen used inconjunction with theCelerity HP Incubator,the Celerity 20 HP BIprovides a fluorescentresult within 20 minutes.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanismof action	An enzyme, which isproduced by theorganism, reacts with afluorogenic substratewithin the definednutrient media toproduce a fluorescentmoiety	An enzyme, which isproduced by theorganism, reacts with afluorogenic substratewithin the definednutrient media toproduce a fluorescentmoiety	Same
Accessories	Celerity Incubator	Celerity Incubator	Same
Viable sporepopulation	1.0 – 4.0 x 106 spore/BI	1.0 – 4.0 x 106 spore/BI	Same
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 9.1 mg/LH2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Same
Feature	Celerity 20 HP BI(proposed)	Celerity 20 HP BIPredicate (K183294)	Comparison
CultureConditions	55- 59°C, mediaincluded in BI, 20-minute incubation time.	55- 59°C, mediaincluded in BI, 20-minute incubation time.	Same
PrimaryPackaging	Direct inoculum onplastic vial, cap withrecovery media.	Direct inoculum onplastic vial, cap withrecovery media.	Same
Processindicator	Celerity HP Indicator(K231488); magenta toyellow color change.	Celerity HP Indicator(K231488); magenta toyellow color change.	Same
Shelf-life	3 months (with target of24 months)	10 Months	Similar

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STERIS®

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S STE

Image /page/16/Picture/2 description: The image shows a logo with a series of horizontal, curved lines stacked on top of each other. The lines are all the same color, a light blue, and they create a wave-like pattern. The overall effect is reminiscent of water or sound waves, giving the logo a sense of movement and fluidity.

Table 5. Challenge Pack Comparison to Predicate Device (Celerity 20 HP)

Feature	Celerity 20 HP Challenge packProposed	Celerity 20 HP Challenge pack(K183294) Predicate	Comparison
The Celerity 20 HP ChallengePack is intended forqualification testing of the V-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.	The Celerity 20 HPChallenge Pack is intendedfor qualification testing of theV-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.
Intended Use/ Indicationfor Use	The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers.	The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers.	Same

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STI

Image /page/17/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a pattern that resembles waves or contours. The logo is simple and abstract, with no text or other elements present.

Feature	Celerity 20 HP ChallengepackProposed	Celerity 20 HP Challengepack(K183294) Predicate	Comparison
GeneralDesign	Sealed sterilization pouchcontaining BI, CI and barriermaterial.	Sealed sterilization pouchcontaining BI, CI and barriermaterial.	Same
BiologicalIndicator	Celerity 20 HP BiologicalIndicator	Celerity 20 HP BiologicalIndicator	Same
ChemicalIndicator	Celerity HP ChemicalIndicator	Celerity HP ChemicalIndicator	Same
Means todistinguishprocessedpack fromunprocessed	Proposed device's internalindicator is visible through thepack.	Proposed device's internalindicator is visible throughthe pack.	Same
Requiredaccessories	Celerity Incubator (Subject ofa concurrent submission)	Celerity Incubator (Subject ofa concurrent submission)	Same

13. Summary of Non-clinical Tests

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 6.

Test	Acceptance Criteria	Result
ReducedIncubation TimeTesting	All BI lots will demonstrate 97% or greater positive growthresults at 7 days as compared to the fluorescent result atless than or equal to 20 minutes	PASS
Simulated UseTesting	All processed Bis shall be sterile following full cycleexposure sterilizer cycles.	PASS
BacteriostasisTesting	All BIs inoculated with 10-100 Geobacillusstearothermophilus spores will demonstrate growth	PASS
Cap MediaTesting	All BIs will demonstrate a positive fluorescent signal in thefluorescent incubators.	PASS
Stability Testing	PopulationThe mean initial population at the start of the stabilitystudy must be 1.0-4.0 x $10^6$ CFU/BI. At each subsequent	PASS

Table 6. Performance Testing

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	time point, the mean population shall be 50-300% of the initial mean population.
	D-value
	D-value between 6 and 20 seconds.
	Survival/Kill
	Demonstration of one all survive time and one all kill time point.
	RIT
	All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.
	Media Testing
	All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.
Specialty Cycle	All Bis will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.	Pass
Hold TimeTesting	The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).	72 HourHold TimeEstablished

14. Conclusion

The Celerity 20 HP Biological Indicator and Challenge Pack have met the established performance criteria. Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K183294), Class II (21 CFR 880.2800), product code FRC.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).

Feature	Celerity 5 HP BI(proposed)	Celerity 5 HP BIPredicate (K223717)	Comparison
Intended Use	The Celerity 5 HPBiological Indicator (BI) isintended for routinemonitoring of thefollowing sterilizer cycles:Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, andSpecialty Cycles ofthe V-PRO: 1, 1 Plus,maX, maX2, 60 ands2 Low TemperatureSterilization Systems. Standard andAdvanced Cycles ofthe STERRAD® NX	The Celerity 5 HPBiological Indicator (BI) isintended for routinemonitoring of thefollowing sterilizer cycles:Lumen, Non Lumen, Fast Non Lumen, Fast, and FlexibleCycles of the V-PRO:1, 1 Plus, maX, maX260 and s2 LowTemperatureSterilization Systems. Standard Cycle of theSTERRAD® 100S Standard andAdvanced Cycles of	Similar. Proposed devicewill add the Specialty Cycleand remove the STERRAD100S Standard Cycle
Feature	Celerity 5 HP BI (proposed)	Celerity 5 HP BI Predicate (K223717)	Comparison
	Sterilizer with orwithout ALLClearStandard, FLEX,Express and DUOCycles of theSTERRAD® 100NXSterilizer with orwithout ALLClearWhen used in conjunctionwith the Celerity®Incubator, the Incubatorprovides a fluorescentresult within 5 minutes.	the STERRAD® NXSterilizer with orwithout ALLClearStandard, FLEX,Express and DUOCycles of theSTERRAD® 100NXSterilizer with orwithout ALLClearWhen used in conjunctionwith the Celerity®Incubator, the Incubatorprovides a fluorescentresult within 5 minutes.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanism ofaction	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety	Same
Accessories	Celerity Incubator	Celerity Incubator	Same
Viable sporepopulation	1.0 - 4.0 x 106 spore/BI	1.0 - 4.0 x 106 spore/BI	Same
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 9.1 mg/LH2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Same
	CultureConditions	55- 59°C, media includedin BI, 20-minuteincubation time.	55- 59°C, media includedin BI, 20-minuteincubation time.	Same
		PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, cap with recoverymedia.
Processindicator	Celerity HP Indicator(K231488); magenta toyellow color change.		Celerity HP Indicator(K231488); magenta toyellow color change.	Same
Shelf-life	3 months (with target of24 months)		10 Months	Similar
Feature	Celerity 5 HP Challenge packProposed	Celerity 5 HP Challenge pack(K223717) Predicate	Comparison
Intended Use /Indication forUse	The Celerity 5 HP ChallengePack is intended for qualificationtesting of the V-PRO LowTemperature Sterilization Systemfollowing installation, relocation,malfunctions or major repairs andfor routine requalification testing.	The Celerity 5 HP ChallengePack is intended for qualificationtesting of the V-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.	Same
	The Challenge Pack is placed inan otherwise empty sterilizerchamber; a hospital-definedchallenge load isnot included.	The Challenge Pack is placed inan otherwise empty sterilizerchamber; a hospital-definedchallenge load isnot included.	Same
	The challenge pack is notintended for routine monitoring ofthe V-PRO Sterilizers. It has beentested and validated solely for usein periodic testing of thesterilizers.	The challenge pack is notintended for routine monitoringof the V-PRO Sterilizers. It hasbeen tested and validated solelyfor use in periodic testing of thesterilizers.	Same
GeneralDesign	Sealed sterilization pouchcontaining BI, CI and barriermaterial.	Sealed sterilization pouchcontaining BI, CI and barriermaterial.	Same
BiologicalIndicator	Celerity 5 HP BiologicalIndicator	Celerity 5 HP BiologicalIndicator	Same
ChemicalIndicator	Celerity HP Chemical Indicator	Celerity HP Chemical Indicator	Same
Means todistinguishprocessed packfromunprocessed	Proposed device's internalindicator is visible through thepack.	Proposed device's internalindicator is visible through thepack.	Same
Requiredaccessories	Celerity Incubator (Subject of aconcurrent submission)	Celerity Incubator (Subject of aconcurrent submission)	Same