· Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
· Standard Cycle of the STERRAD® 100S Sterilizer
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer

The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

Device Description

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites 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 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator 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 VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.

The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and 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°C 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 describes the acceptance criteria and study proving the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Challenge Pack meet these criteria.

VERIFY® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance/Conclusion
1/4, 1/2 & 3/4 Cycle Performance	Partial positive results obtained in 1/4 and 1/2 cycles; all negative results obtained in 3/4 cycle evaluations.	PASS
Growth Inhibition	Uninoculated VERIFY V24 SCBIs processed in a Fast Non Lumen Cycle and inoculated with low numbers (<100 CFU) of Geobacillus stearothermophilus should all exhibit growth.	All tested SCBIs exhibited growth. PASS
Simulated Use	VERIFY V24 SCBIs processed in the Fast Non Lumen Cycle under simulated use conditions should result in: All processed SCBIs exhibit negative growth results; All processed SCBI Label PIs exhibit a “pass” result; All processed CIs exhibit a “pass” result.	PASS
Reduced Incubation Time (RIT) Testing	30 – 80% survival of exposed BI with a ≥ 97% correspondence between the 24-hour results and the conventional incubation time of 7 days.	PASS
Viable Spore Population	2.0 – 3.4 x 10^6 spore/SCBI	PASS (met the range)
D-value	4-8 seconds (at 2.7 mg/L H₂O₂)	PASS (met the range)
Survival Time	4-30 seconds (at 2.7 mg/L H₂O₂)	PASS (met the range)
Kill Time	≤ 16 minutes (at 2.7 mg/L H₂O₂)	PASS (met the criteria)
Hold Time	Performance of VERIFY V24 SCBIs held for 72 hours after exposure to VHP was evaluated.	PASS

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer. The information does not specify country of origin for specific data sets, but the company is located in the USA. The studies appear to be prospective, designed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for a biological indicator and its performance characteristics (like D-value, survival time, kill time, and growth/no-growth) are established through microbiological laboratory methods and adherence to recognized standards (e.g., FDA guidance on BI submissions, ISO 11138-1), not through expert consensus in the same way an AI diagnostic tool might be. The interpretation of results (growth/no growth, color change) is objective.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a scientific and objective assessment of a biological and chemical indicator's performance against defined quantifiable metrics, not a subjective human interpretation requiring adjudication.

5. 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 diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a biological indicator that provides a visual readout.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines. This includes:
- Direct enumeration of viable spores.
- Controlled exposure to the sterilant (H₂O₂ at specific concentrations and times) to determine D-value, survival time, and kill time.
- Incubation under controlled conditions to observe microbial growth (turbidity, color change) as an indicator of sterilization failure.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

VERIFY® V24 Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance/Conclusion
Comparative Dose Response to Biological Model	The VERIFY V24 Challenge Pack shall demonstrate equal or greater resistance as compared to the worst-case biological model in the Fast Non Lumen Cycle.	PASS
Simulated Use	VERIFY V24 Challenge Packs processed in the Fast Non Lumen Cycle under simulated use conditions should result in: All processed SCBIs exhibit negative growth results; All processed SCBI Label PIs exhibit a “pass” result; All processed CIs exhibit a “pass” result.	PASS

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, in the USA. The studies appear to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Similar to the SCBI, the ground truth for the challenge pack's performance is based on objective microbiological and chemical indicator principles, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. 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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines for process challenge devices. This includes:
- Comparison to a "worst-case biological model" to ensure adequate challenge.
- Observation of growth/no-growth for the contained SCBI and color change for chemical indicators after exposure to sterilization cycles.

8. The sample size for the training set:

Not applicable.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2018

STERIS Corporation Ms. Jennifer Nalenka Senior Regulatory Affairs Specialist 5960 Heisley Rd. Mentor, Ohio 44060

Re: K172748

Trade/Device Name: VERIFY @ V24 Self-Contained Biological Indicator VERIFY® V24 Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: Class II Product Code: FRC Dated: January 09, 2018 Received: January 10, 2018

Dear Ms. Jennifer Nalepka :

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 (reporting of medical

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

device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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}------------------------------------------------

Indications for Use

510(k) Number (if known) K172748

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 sterilizers and cycles:

· Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
· Standard Cycle of the STERRAD® 100S Sterilizer
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer

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."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known)

K172748

Device Name VERIFY V24 Challenge Pack

Indications for Use (Describe)

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

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.

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."

{4}------------------------------------------------

510(k) Summary For VERIFY® V24 Self-Contained 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: Jennifer Nalepka Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com

Submission Date: January 9, 2018

Premarket Notification Number: K172748

{5}------------------------------------------------

1. Device Name

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

2. Predicate Device

VERIFY® V24 Self-Contained Biological Indicator, K140499

3. Description of Device

{6}------------------------------------------------

4. Intended Use/ Indications for Use

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

· Non Lumen, Flexible, Lumen and Fast Non Lumen of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
· Standard Cycle of the STERRAD® 100S Sterilizer
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer

ട. Summary of Technical Characteristics

A comparison of technical characteristics versus the predicate is summarized in Table 5-1.

Table 5-1. VERIFY V24 Self-Contained Biological Indicator Physical Description and
Technological Properties vs the Predicate Device

Feature	VERIFY V24 Self-Contained BiologicalIndicator(Proposed, K172748)	VERIFY V24 Self-Contained BiologicalIndicator(Predicate, K140499)	Comparison
Intended Use	The VERIFY V24 Self-Contained BiologicalIndicator is intended forroutine monitoring of thefollowing sterilizers andcycles:• Non Lumen, Flexible,Lumen and Fast NonLumen Cycles of the V-PRO 1, 1 Plus, maX, 60and maX 2 Sterilizers• Standard Cycle of theSTERRAD 100SSterilizer• Standard and AdvancedCycles of theSTERRAD NXSterilizer• Express, Flex Scope andStandard Cycles of theSTERRAD 100 NXSterilizer	The VERIFY V24 Self-Contained BiologicalIndicator is intended forroutine monitoring of thefollowing sterilizers andcycles:• Lumen, Non Lumen andFlexible Cycles of theV-PRO 1, 1 Plus, maXand 60 Sterilizers• Standard Cycle of theSTERRAD 100SSterilizer• Standard and AdvancedCycles of theSTERRAD NXSterilizer• Express, Flex Scope andStandard Cycles of theSTERRAD 100 NXSterilizer.	The proposed and predicatedevices are identical. TheFast Non Lumen Cycle is anew cycle in the V-PROmaX 2 Low TemperatureSterilizer, which has beensubmitted in a separatepremarket notification.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanism ofaction	Visual detection of growthbased on media colorchange in the presence of	Visual detection of growthbased on media colorchange in the presence of	Same. Resistance testingand simulated use testingdemonstrate appropriate

{7}------------------------------------------------

Feature	VERIFY V24 Self-Contained BiologicalIndicator(Proposed, K172748)	VERIFY V24 Self-Contained BiologicalIndicator(Predicate, K140499)	Comparison
	surviving indicatororganisms.	surviving indicatororganisms.	monitoring of indicatedsterilization cycles.
Accessories	VERIFY Incubator andVERIFY SCBI HPActivator (optional)	VERIFY Incubator andVERIFY SCBI HPActivator (optional)	Same
Viable sporepopulation	2.0 – 3.4 x 106 spore/BI	2.0 – 3.4 x 106 spore/BI	Same. Both contain greaterthan 106 spores/BI.
Resistancecharacteristics	Resistance @ 2.7 mg/LH2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min	Resistance @ 2.7 mg/LH2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min	Same. Simulated use testingverifies suitability for use inclaimed cycles.
CultureConditions	55- 60°C, media includedin the VERIFY V24 Self-Contained BiologicalIndicator, 24 hourincubation time.	55-60°C, media includedin the VERIFY V24 Self-Contained BiologicalIndicator, 24 hourincubation time.	Same. RIT Testing and ISO11138-1 media testingverifies performance
PrimaryPackaging	Direct inoculum on plasticvial, glass ampoule withrecovery media.	Direct inoculum on plasticvial, glass ampule withrecovery media.	Same
Processindicator	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	Same
Shelf-life	9 months: An 18-monthshelf life is established forthe SCBI however thethroughput processindicator (K140515) has ashelf life of 9 months sothe maximum labeledshelf life for the SCBI is 9months	9 months: An 18-monthshelf life is established forthe SCBI however thethroughput processindicator (K140515) has ashelf life of 9 months sothe maximum labeledshelf life for the SCBI is 9months	Same

Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
1/4, 1/2 & 3/4 CyclePerformance	The performance of the VERIFY V24 Self-Contained Biological Indicator in 1/4, 1/2 or 3/4 cycleswas evaluated. Partial positive results were obtained inthe 1/4 and 1/2 cycles and all negative results wereobtained in the 3/4 cycle evaluations.	PASS
Growth Inhibition	Uninoculated VERIFY V24 Self-Contained BiologicalIndicators were processed in a Fast Non Lumen Cycle	PASS

Table 5-2. Summary of Non-clinical Testing

{8}------------------------------------------------

Test	Acceptance Criteria	Conclusion
	and inoculated with low numbers (<100 CFU) ofGeobacillus stearothermophilus. All tested theVERIFY V24 Self-Contained Biological Indicatorsexhibited growth.
	Simulated Use		VERIFY V24 Self-Contained Biological Indicatorswere processed in the Fast Non Lumen Cycle undersimulated use conditions with the following results:• All processed SCBIs exhibit negative growth results• All processed SCBI Label PIs exhibit a “pass” result• All processed CIs exhibit a “pass” result	PASS

Table 5-3. Summary of Testing Previously Submitted for VERIFY V24 Self-Contained
Biological Indicator (K140499)

Test	Acceptance Criteria	Conclusion
Reduced IncubationTime (RIT) Testing	RIT testing performed per the FDA guidance on BIsubmissions is done to obtain 30 – 80% survival ofexposed BI with a ≥ 97% correspondence between the24-hour results and the conventional incubation timeof 7 days.	PASS
Viable sporepopulation	The viable spore population found in the VERIFYV24 Self-Contained Biological indicator must fallbetween 2.0 – 3.4 x $10^6$ spore/SCBI	PASS
D-value	D-value testing was performed per the FDA guidanceon BI submissions. For the VERIFY V24 Self-Contained Biological Indicator, the D-value must be4-8 seconds.	PASS
Survival Time	Survial time testing was performed per the FDAguidance on BI submissions. For the VERIFY V24Self-Contained Biological Indicator, the survival timemust be 4-30 seconds.	PASS
Kill Time	Kill time testing was performed per the FDAguidance on BI submissions. For the VERIFY V24Self-Contained Biological Indicator, the kill timemust be ≤ 16 min.	PASS
Hold Time	The performance of VERIFY V24 Self-ContainedBiological Indicators held for 72 hours after exposureto VHP was evaluated.	PASS

7. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, VERIFY V24 Self-Contained Biological Indicator (cleared in K140499), Class II (21 CFR 880.2800) product code FRC.

{9}------------------------------------------------

510(k) Summary For VERIFY® V24 Challenge Pack

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: Jennifer Nalepka Senior Regulatory Affairs Specialist

(440) 392-7458 Telephone: Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com

Submission Date: January 8, 2018

Premarket Notification Number: K172748

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{10}------------------------------------------------

8. Device Name

Trade Name:	VERIFY® V24 Challenge Pack
Common/usual Name:	Biological Indicator (BI) Process Challenge Device
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

9. Predicate Device

VERIFY® V24 Challenge Pack, K140499

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.

Intended Use/ Indications for Use 11.

{11}------------------------------------------------

The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in Sterilizer qualification.

12. Summary of Technical Characteristics

A comparison of technical characteristics versus the predicate is summarized in Table 5-1.

Table 5-1. VERIFY V24 Challenge Pack Physical Description and Technological
Properties vs the Predicate Device

	VERIFY V24 ChallengePack(proposed K172748)	VERIFY V24 ChallengePredicate (K140499)	Comparison
Feature
Intended Use	The VERIFY V24Challenge Pack is used forqualification testing of theNon Lumen, Flexible,Lumen and Fast NonLumen cycles of the V-PRO Low TemperatureSterilization Systemsfollowing installation,relocation, malfunctions ormajor repairs in healthcarefacilities.	The VERIFY® V24Challenge Pack is intendedfor qualification testing ofthe Lumen, Non Lumenand Flexible cycles of V-PRO® Low TemperatureSterilization Systemsfollowing installation,relocation, malfunctions ormajor repairs.	The proposed and predicatedevices are identical. TheFast Non Lumen Cycle is anew cycle in the V-PROmaX 2 Low TemperatureSterilizer, which has beensubmitted in a separatepremarket notification.
	The VERIFY V24Challenge Pack is placedin an otherwise emptysterilizer chamber; ahospital-defined challengeload is not included.	The challenge pack isplaced in an otherwiseempty sterilizer chamber; ahospital-defined challengeload is not included.
	The VERIFY V24Challenge Pack is notintended for routinemonitoring of V-PROSterilizers. It has beentested and validated solelyfor use in Sterilizerqualification testing.	The challenge pack is notintended for routinemonitoring of V-PROSterilizers. It has beentested and validated solelyfor use in Sterilizerqualification testing.

{12}------------------------------------------------

Feature	VERIFY V24 ChallengePack(proposed K172748)	VERIFY V24 ChallengePackPredicate (K140499)	Comparison
BiologicalIndicator	VERIFY V24 Self-Contained BiologicalIndicator (subject of thissubmission)	VERIFY V24 Self-Contained BiologicalIndicator	Same
Class 1ChemicalIndicator	The VERIFY HPUChemical Indicator(subject of a separatePremarket Notification) isplaced inside the pouch.A throughput processindicator is also located onthe VERIFY V24 SCBIlabel.	The VERIFY HPUChemical Indicator isplaced inside the pouch.A throughput processindicator is also located onthe VERIFY V24 SCBIlabel.	Same
Means todistinguishprocessedfromunprocessed	Chemical indicator ofproposed device visiblethrough the pack.	Chemical indicator ofproposed device visiblethrough the pack.	Same

13. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
Comparitive DoseResponse toBiological Model	The VERIFY V24 Challenge Pack was compared tothe worst case biological model in the Fast Non LumenCycle. The challenge pack shall demonstrate equal orgreater resistance as compared to the worst casebiological model.	PASS
Simulated Use	VERIFY V24 Challenge Pack were processed in theFast Non Lumen Cycle under simulated use conditionswith the following results:• All processed SCBIs exhibit negative growth results• All processed SCBI Label PIs exhibit a “pass” result• All processed CIs exhibit a “pass” result	PASS

Table 5-2. Summary of Non-clinical Testing

14. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, VERIFY V24 Challenge Pack (cleared in K140499), 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).