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

· STERRAD® 100S Sterilizer (Default Cycle)

· STERRAD® 200 Sterilizer (Default Cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with ALLClear® Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.

The Celerity 20 HP Biological indicator is intended for the 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 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology

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

Device Description

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP 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.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 SCBI into the V-PRO® Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

AI/ML Overview

This document is a 510(k) premarket notification for two biological indicators: the Celerity 20 HP Biological Indicator and the VERIFY V24 Self-Contained Biological Indicator, both manufactured by STERIS Corporation. The purpose of the submission is to obtain clearance for these devices to routinely monitor additional sterilizer cycles, specifically the "Specialty Cycle" of the V-PRO® maX 2 Low Temperature Sterilization System, as well as several other specified STERRAD® cycles.

It's important to note that this document is for a sterilization process indicator, not a medical device in the typical sense (e.g., a diagnostic AI tool). Therefore, many of the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like MRMC studies, expert consensus for imaging, etc.) do not apply here. This is a technical performance study for a biological measurement device, focusing on its ability to accurately reflect sterilization efficacy.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them for each of the two devices mentioned:

For the Celerity 20 HP Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Performance (Conclusion)
Verification of Celerity HP BI Performance after V-PRO Specialty Cycle Extended Aeration	Celerity BIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle.	Pass
Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle	The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in the provided text. The term "Celerity BIs" and "SCBIs" are used, implying multiple biological indicators were tested, but the exact number is not given.
Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation. The location (Mentor, OH) of the manufacturing and sponsor facility would suggest the studies were conducted in the USA. The data appears to be prospective as it's specifically for a new cycle qualification.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable in the context of this device. Ground truth for a biological indicator is typically established by the physical inactivation of bacterial spores under controlled, validated sterilization conditions, and the subsequent growth/no-growth determination. This is a direct measurement of sterility, not an interpretation of an image or signal that would require human expert consensus in the medical imaging sense.

4. Adjudication Method for the Test Set:

Not applicable as this is a direct biological and physical process validation, not a diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images) with and without AI assistance. This device is a sterility indicator; its performance is measured by its biological response to sterilization, not by how humans interpret its output in a diagnostic scenario.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the Celerity 20 HP BI is performed by the Celerity HP Incubator which detects a fluorescent signal within 20 minutes to confirm viability. While an instrument is involved, it's not an "algorithm" in the AI sense, but rather a direct measurement device. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.

7. The Type of Ground Truth Used:

Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (or lack thereof) of the Geobacillus stearothermophilus spores under specific culture conditions, which then produces a fluorescent moiety if growth occurs. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.

8. The Sample Size for the Training Set:

Not applicable. Biological indicators are not "trained" in the machine learning sense. Their function relies on the pre-defined biological characteristics of the Geobacillus stearothermophilus spores and the biochemical reaction designed into the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (See #8)

For the VERIFY V24 Self-Contained Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Performance (Conclusion)
Verification of V24 SCBI Performance after V-PRO Specialty Cycle Extended Aeration	SCBIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle.	Pass
Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle	The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. Similar to the Celerity BI, "SCBIs" (Self-Contained Biological Indicators) are mentioned, implying multiple units were tested, but the exact count is not provided.
Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation (likely in the USA). The data appears to be prospective for the new cycle qualification.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for a biological indicator is typically established by the direct biological response of the bacterial spores to sterilization. While there's a visual detection of growth (color change/turbidity), this is a direct observation of a biological event, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the VERIFY V24 SCBI involves visual detection of growth (media color change/turbidity) after incubation. While this involves human observation, it's observing a biological fact (growth/no growth), not interpreting an image or signal in a diagnostic sense. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.

7. The Type of Ground Truth Used:

Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (color change from orange to yellow and/or turbidity) or no-growth (media remains orange and non-turbid) of the Geobacillus stearothermophilus spores after incubation. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.

8. The Sample Size for the Training Set:

Not applicable. Biological indicators are not "trained."

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

August 7, 2023

STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K231490

Trade/Device Name: Celerity 20 HP Biological Indicator; V24 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: Mav 22, 2023 Received: May 23, 2023

Dear Gregory Land:

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. 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 located 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.

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Christopher K. Dugard -S

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231490

Device Name

VERIFY V24 Self-Contained Biological Indicator

Indications for Use (Describe)

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

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

· STERRAD® 100S Sterilizer (Default Cycle)

· STERRAD® 200 Sterilizer (Default Cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with ALLClear® Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.

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. 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."

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Indications for Use

510(k) Number (if known) K231490

Device Name Celerity 20 HP Biological Indicator

Indications for Use (Describe)

The Celerity 20 HP Biological indicator is intended for the 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 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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.

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."

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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, sans-serif font at the top of the image. Below the word is a graphic of several horizontal, curved lines that resemble waves. The lines are blue, and the background is white.

510(K) Summary For K231490 Celerity 20 HP Biological Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax: (440)357-9198

Manufacturing Facility

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

Contact

Gregory Land Lead Regulatory Affairs Specialist Phone: (440) 352-7424 Fax: (440) 357-9198 Email: greg land(@steris.com

Submission Date:

May 22, 2023

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Device Name 1

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

2 Predicate Device

Proprietary Name Common/usual Name Classification Name: 510(k) Submitter/Holder 510(k) Number:

Celerity 20 HP Biological Indicator Biological indicator Indicator, Biological Sterilization Process STERIS Corporation K183294

3 Description of Device

ব Intended Use/Indications for Use

The Celerity 20 HP Biological indicator is intended for the 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
STERRAD® 100S Sterilizer (Default Cycle)
Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® . Technology
Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or ● without ALLClear® Technology

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

5 Summary of Technical Characteristics

Feature	CELRITY 20 HP BiologicalIndicator(proposed)	Celerity 20 HP BiologicalIndicator (K183294)	Comparison
Intended Use	The Celerity 20 HP BiologicalIndicator is intended for	The Celerity 20 HP BiologicalIndicator is intended for	The proposed andpredicate devices areidentical. The
Feature	CELRITY 20 HP BiologicalIndicator(proposed)	Celerity 20 HP BiologicalIndicator (K183294)	Comparison
	routine monitoring of thefollowing sterilizer cycles:• Lumen, Non Lumen, FastNon Lumen, Fast, Flexibleand Specialty Cycles of theV-PRO 1, 1 Plus, maX, maX2, 60 and s2 LowTemperature SterilizationSystems.• STERRAD® 100S Sterilizer(Default Cycle)• Standard and AdvancedCycles of the STERRAD®	routine monitoring of thefollowing sterilizer cycles:• Lumen, Non Lumen, FastNon Lumen, Fast andFlexible Cycles of the V-PRO: 1, 1 Plus, maX, maX2and s2 Low TemperatureSterilization Systems.• STERRAD® 100S Sterilizer(Default Cycle)• Standard and AdvancedCycles of the STERRAD®NX Sterilizer with orwithout ALLClear• Standard, Flex Scope,Express and DUO Cycles ofthe STERRAD® 100NXSterilizer with or withoutALLClearWhen used in conjunctionwith the Celerity HPIncubator, the Celerity 20 HPBI provides a fluorescentresult within 20 minutes.	Specialty Cycle is anew cycle in the V-PRO maX 2 LowTemperatureSterilizer, which hasbeen submitted in thispremarket notification.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanism ofaction	An enzyme, which is producedby the organism, reacts with afluorogenic substrate withinthe defined nutrient media toproduce a fluorescent moiety.	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety.	Same
Accessories	Automated incubator / reader	Automated incubator / reader	Same
Viable sporepopulation	1.0 – 4.0 x 106 spore/BI	1.0 - 4.0 x 106 spore/BI	Same
Resistance	Resistance @ 9.1 mg/L H2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 7 min	Resistance @ 9.1 mg/L H2O2:• D-value > 6 sec• Survival Time ≥ 4 sec• Kill Time ≤ 7 min	Same
Feature	CELRITY 20 HP BiologicalIndicator(proposed)	Celerity 20 HP BiologicalIndicator (K183294)	Comparison
CultureConditions	55-59°C, media included inBI, 20-minute incubation time.	55-59°C, media included inBI, 20-minute incubation time.	Same
PrimaryPackaging	Direct inoculum on plasticvial, cap with recovery media.	Direct inoculum on plasticvial, cap with recovery media.	Same
Process indicator	VERIFY V-PRO ChemicalIndicator (K140515); magentato yellow color change.	VERIFY V-PRO ChemicalIndicator (K140515); magentato yellow color change.	Same
Shelf-life	10 months	10 months	Same

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

6 Summary of Non-clinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

Test	Acceptance Criteria	Conclusion
Verification of Celerity HP BIPerformance after V-PRO SpecialtyCycle Extended Aeration	Celerity BIs exposed to the SpecialtyCycle demonstrate essentiallyequivalent or not significantlydifferent resistance as compared toSCBIs exposed to the 136L V-PROSterilizer Fast Non Lumen Cycle	Pass
Final Process Qualification of theVPRO maX2 Sterilizer SpecialtyCycle	The V-PRO maX 2 SterilizerSpecialty Cycle final processqualification was successful.	Pass

Table 5-3. Summary of Non-clinical Testing

7 Conclusion

Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the Celerity 20 HP Biological Indicator, K183294 Class II [21 CFR 880.2800(a)], product code FRC.

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Image /page/8/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.

510(K) Summary For K231490 VERIFY V24 Self-Contained Biological Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax: (440)357-9198

Manufacturing Facility

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

Contact

Gregory Land Lead Regulatory Affairs Specialist Phone: (440) 352-7424 Fax: (440) 357-9198 Email: greg land(@steris.com

Submission Date:

May 22, 2023

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY V24 Self-Contained Biological Indicator

Device Name 8

Trade Name:	VERIFY V24 Self-Contained Biological Indicator
Common/usual Name:	Biological Indicator
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

の Predicate Device

Proprietary Name: VERIFY V24 Self-Contained Biological Indicator Common/usual Name Biological indicator Classification Name: Indicator, Biological Sterilization Process 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K183300

10 Description of Device

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

11 Intended Use/Indications for Use

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, ● 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
STERRAD® 100S Sterilizer (Default Cycle)
STERRAD® 200 Sterilizer (Default Cycle) ●
Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with . ALLClear® Technology
. Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology

12 Summary of Technical Characteristics

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Feature	VERIFY V24 SCBI(proposed)	VERIFY V24 SCBI Predicate(K183300)	Comparison
Intended Use	The VERIFY® V24 Self-Contained BiologicalIndicator is intended forroutine monitoring of thefollowing sterilizer cycles:• Lumen, Non Lumen,• Flexible, Fast, Fast NonLumen and SpecialtyCycles of the V-PRO® 1,• 1 Plus, maX, maX 2, 60and s2 Sterilizers• STERRAD® 100SSterilizer (Default Cycle)• STERRAD® 200Sterilizer (Default Cycle)• Standard and AdvancedCycles of theSTERRAD® NXSterilizer to includesterilizers withALLClear® Technology• Express, Flex Scope andStandard Cycles of theSTERRAD® 100NXSterilizer to includesterilizers withALLClear® technology.	The VERIFY® V24 Self-Contained Biological Indicatoris intended for routinemonitoring of the followingsterilizer cycles:• Lumen, Non Lumen,• Flexible, Fast and Fast NonLumen Cycles of the V-PRO® 1, 1 Plus, maX, maX2, 60 and s2 Sterilizers• STERRAD® 100SSterilizer (Default Cycle)• STERRAD® 200 Sterilizer(Default Cycle)• Standard and AdvancedCycles of the STERRAD®NX Sterilizer to includesterilizers with ALLClear®Technology• Express, Flex Scope andStandard Cycles of theSTERRAD® 100NXSterilizer to includesterilizers with ALLClear®technology.	The proposed andpredicate devices areidentical. The SpecialtyCycle is a new cycle inthe V-PRO maX 2 LowTemperature Sterilizer,which has beensubmitted in thispremarket notification.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanism ofaction	Visual detection of growthbased on media color changein the presence of survivingindicator organisms.	Visual detection of growthbased on media color changein the presence of survivingindicator organisms.	Same
Accessories	VERIFY Incubator andVERIFY SCBI HP Activator(optional)	VERIFY Incubator andVERIFY SCBI HP Activator(optional)	Same
Viable sporepopulation	2.0 - 3.4 x 106 spore/BI	2.0 - 3.4 x 106 spore/BI	Same
Resistancecharacteristics	Resistance @ 2.7 mg/L H2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min	Resistance @ 2.7 mg/L H2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min	Same
CultureConditions	55- 60°C, media included inSCBI, 24 hour incubationtime.	55- 60°C, media included inSCBI, 24 hour incubationtime.	Same
PrimaryPackaging	Direct inoculum on plasticvial, glass ampoule withrecovery media.	Direct inoculum on plasticvial, glass ampoule withrecovery media.	Same
Process indicator	VERIFY V24 Self-ContainedBiological Indicator Vial	VERIFY V24 Self-ContainedBiological Indicator Vial	Same
Feature	VERIFY V24 SCBI(proposed)	VERIFY V24 SCBI Predicate(K183300)	Comparison
	Label; magenta toorange/yellow color change.	Label; magenta toorange/yellow color change.
Shelf-life	15 Months	15 Months	Same

12.1 YERIFY V24 Self-Contained Biological Indicator

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13 Summary of Non-clinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

Test	Acceptance Criteria	Conclusion
Verification of V24 SCBIPerformance after V-PRO SpecialtyCycle Extended Aeration	SCBIs exposed to the Specialty Cycledemonstrate essentially equivalent ornot significantly different resistanceas compared to SCBIs exposed to the136L V-PRO Sterilizer Fast NonLumen Cycle	Pass
	Final Process Qualification of theVPRO maX2 Sterilizer SpecialtyCycle		The V-PRO maX 2 SterilizerSpecialty Cycle final processqualification was successful.	Pass

Table 5-3. Summary of Non-clinical Testing

14 Conclusion

Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the VERIFY V24 Self-Contained Biological Indicator, K183300 Class II [21 CFR 880.2800(a)], 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).

For the Celerity 20 HP Biological Indicator:

For the VERIFY V24 Self-Contained Biological Indicator:

Re: K231490

Indications for Use

Device Name

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Indications for Use

Indications for Use (Describe)

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510(K) Summary For K231490 Celerity 20 HP Biological Indicator

Sponsor Facility

Manufacturing Facility

Contact

Submission Date:

Device Name 1

2 Predicate Device

3 Description of Device

ব Intended Use/Indications for Use

5 Summary of Technical Characteristics

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

6 Summary of Non-clinical Tests

7 Conclusion

510(K) Summary For K231490 VERIFY V24 Self-Contained Biological Indicator

Sponsor Facility

Manufacturing Facility

Contact

Submission Date:

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY V24 Self-Contained Biological Indicator

Device Name 8

の Predicate Device

10 Description of Device

11 Intended Use/Indications for Use

12 Summary of Technical Characteristics

12.1 YERIFY V24 Self-Contained Biological Indicator

13 Summary of Non-clinical Tests

14 Conclusion

§ 880.2800 Sterilization process indicator.

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