The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator 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 indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert VH2O2 Self-Contained Biological Indicator, 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.

AI/ML Overview

The provided text describes the acceptance criteria and the summary of non-clinical tests for the "VERIFY Assert VH2O2 Self-Contained Biological Indicator". However, it's important to note that this document is for a biological indicator used in sterilization processes, not an AI/ML powered medical device for diagnostic purposes. As such, some of the requested information (like MRMC study, human reader improvement with AI, ground truth for training AI, etc.) is not applicable to this type of device.

Here's the information extracted and adapted where possible:

1. Table of Acceptance Criteria and the Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Reduced Incubation Time (RIT) Testing	Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days	PASS
Viable spore population	1.0 - 4.0 x 10^6 spore/SCBI	PASS
Resistance	D-value > 3 sec	PASS
Survival Time	Survival Time ≥ 4 sec	PASS
Kill Time	Kill Time ≤ 6 min	PASS
Carrier growth inhibition / media growth promotion	Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure	PASS
Hold Time	Performance not affected if incubated within 72 hours of exposure to VHP sterilization	PASS
Simulated Use	Demonstrate no growth when exposed to worst-case cycles	PASS

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

The document summarizes "non-clinical tests" but does not explicitly state the specific sample sizes for each test in the acceptance criteria table. It refers to "testing in accordance with FDA guidance for BI 510(k)" and "ISO 11138–1 media testing," which would imply standardized testing protocols that define sample sizes. Without further details of these specific tests, the exact sample sizes cannot be determined from the provided text.

The data provenance is not specified in terms of country of origin or explicit retrospective/prospective design. However, the tests are laboratory-based and conducted by the manufacturer, STERIS Corporation, in the US.

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

This information is not applicable to a biological indicator. The "ground truth" for a biological indicator is determined by the survival or inactivation of Geobacillus stearothermophilus spores under specific sterilization conditions, which is a microbiological and chemical measurement, not an expert human interpretation.

4. Adjudication method for the test set:

Not applicable, as the evaluation is based on objective microbiological and chemical results, not expert 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 device is a biological indicator for sterilization, not an AI-powered diagnostic tool requiring human reader studies.

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

The device itself is a "self-contained biological indicator" that produces a fluorescent result, which is then detected by an "automated incubator/reader." In this sense, the "algorithm" equivalent is the biological and chemical reaction within the indicator, and its detection by the automated reader. The performance described in the acceptance criteria is essentially its standalone performance in various conditions. There's no "human-in-the-loop" for the primary result generation, only for interpreting the automated reader's output.

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

The ground truth used for testing this biological indicator is based on:

Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
Chemical/Biological reactions: The enzyme reaction with a fluorogenic substrate to produce a fluorescent moiety, detected by the incubator.
Standardized testing methods: Adherence to FDA guidance for BI 510(k) and ISO 11138–1 standards, which define the expected biological and chemical responses under controlled conditions (e.g., D-value, survival time, kill time).

8. The sample size for the training set:

Not applicable in the context of an AI/ML training set. This is a physical device, and its "performance" is inherent to its design and manufacture, validated through a series of non-clinical tests.

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

Not applicable in the context of an AI/ML training set. The "ground truth" for the device's development (if one were to call it that) would come from established principles of microbiology and sterilization science, as well as the performance characteristics of its constituent materials and biological components.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 22, 2017

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060

Re: K171504

Trade/Device Name: VERIFY Assert VH2O2 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: July 31, 2017 Received: August 1, 2017

Dear Mr. Piotrkowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 device

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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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Tara A. Ryan -S

for

Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171504

Device Name

VERIFY Assert VH2O2 Self-Contained Biological Indicator

Indications for Use (Describe)

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator 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)

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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue.

510(k) Summary For VERIFY Assert VH2O2 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

Tony Piotrkowski Contact: Senior Manager, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com

Submission Date: August 21, 2017

Premarket Notification Number: K171504

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

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Device Name 1.

Trade Name:	VERIFY Assert VH2O2 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

Reference Devices

3M Attest™ Rapid Readout Biological Indicator 1295, K160546

3. Description of Device

Intended Use/ Indications for Use 4.

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

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5. Summary of Technical Characteristics

A comparison of technical characteristics versus the predicate is summarized in Table 5-1 and versus the reference device in Table 5-2.

Feature	Assert VH202 SCBI	VERIFY V24 SCBI	Comparison
	(proposed)	Predicate (K140499)
Intended Use	The VERIFY AssertVH2O2 Self-ContainedBiological Indicator isused for routinemonitoring, andqualification of NonLumen, Flexible andLumen Cycles of the V-PRO 1, 1 Plus, maX, and60 Low TemperatureSterilizers in healthcarefacilities.	The VERIFY® V24 Self-Contained BiologicalIndicator is intended forroutine monitoring of theLumen, Non Lumen andFlexible cycles of V-PRO®Low TemperatureSterilization Systems.	Intended cycles are the samefor both predicate andproposed. The proposedindications for use includeinformation about theincubator/reader and readtime that are supportedthrough testing inaccordance with FDAguidance for BI 510(k).
	When used in conjunctionwith the VERIFYIncubator for AssertVH2O2 SCBI, theVERIFY Assert Self-Contained Indicatorprovides a fluorescentresult within 20 minutes.
Indicator	Geobacillus	Geobacillus	Same
organism	stearothermophilus	stearothermophilus
Mechanismof action	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety.	Visual detection of growthbased on media colorchange in the presence ofsurviving indicatororganisms.	Both devices indicatesurvival of indicatororganisms after sterilization.The mechanism of theproposed device is moresimilar to the referencedevice (see table 5-2).Resistance testing andsimulated use testingdemonstrate appropriatemonitoring of indicatedsterilization cycles.
Accessories	Automated incubator /reader	None	This accessory is moresimilar to the referencedevice (see table 5-2) than tothe predicate device. RITtesting and simulated usetesting demonstrateappropriate monitoring ofindicated sterilizationcycles.
Feature	Assert VH2O2 SCBI(proposed)	VERIFY V24 SCBIPredicate (K140499)	Comparison
Viable sporepopulation	$1.0 – 4.0 \times 10^6$ spore/BI	$2.0 – 3.4 \times 10^6$ spore/BI	Both contain greater than$10^6$ spores/BI.
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 2.7 mg/LH2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min	Resistance testing forproposed device at a higherH2O2 concentration.Simulated use testingverifies suitability for use inclaimed cycles.
CultureConditions	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	55- 59 °C, media includedin SCBI, 24h incubationtime.	RIT Testing and ISO 11138–1media testing verifiesperformance
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, glass ampule withrecovery media.	Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatorand sterilization process.
Processindicator	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change.	Same
Shelf-life	Currently 3 monthsTarget of 13 months	18 months	Real-time testing ongoing

Table 5-1 SCBI Physical Description and Technological Properties vs the Predicate Device

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Table 5-2 SCBI Physical Description and Technological Properties vs the Reference Device

Feature	Assert VH2O2 SCBI(proposed)	Attest 1295Reference (K160546)	Comparison
Intended Use	The VERIFY AssertVH2O2 Self-ContainedBiological Indicator isused for routinemonitoring, andqualification of NonLumen, Flexible andLumen Cycles of the V-PRO 1, 1 Plus, maX, and60 Low TemperatureSterilizers in healthcarefacilities.When used in conjunctionwith the VERIFYIncubator for AssertVH2O2 SCBI, theVERIFY Assert Self-Contained Indicatorprovides a fluorescentresult within 20 minutes.	Use the 3MTM AttestTMRapid Readout BiologicalIndicator 1295 inconjunction with the 3MAttestTM Auto reader 490Has a standard method ofroutine monitoring ofvaporized hydrogenperoxide sterilizationprocesses in the Amsco®V-PRO® maX LowTemperature SterilizationSystem (Lumen, NonLumen, and Flexiblecycles), and inSTERRAD® 100S,STERRAD® NX(Standard and Advancedcycles) and 100NX(Standard, Flex, Expressand Duo cycles) systems.	Intended cycles for bothreference and proposeddevices include V-PROsterilizer cycles.Both require an automatedincubator/reader for results.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same

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Feature	Assert VH2O2 SCBI(proposed)	Attest 1295Reference (K160546)	Comparison
Mechanismof action	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 mechanism of action
Accessories	Automated incubator /reader	Automated incubator /reader	This accessory is similar tothe reference. RIT testingand simulated use testingdemonstrate appropriatemonitoring of indicatedsterilization cycles.
Viable sporepopulation	1.0 - 4.0 x 106 spore/BI	≥ 1.0 x 106 spore/BI	Both contain greater than106 spores/BI.
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min	Resistance @ 10 mg/LH2O2:• D-value > 1 sec• Survival Time ≥ 5 sec• Kill Time = 7 min	Resistance values are similarfor both devices. Simulateduse testing verifiessuitability for use in claimedcycles.
CultureConditions	55- 59 °C, media includedin SCBI, 20-minuteincubation time.	60 +/- 2 °C; mediaincluded in SCBI, 4-hourincubation time.	RIT Testing and ISO 11138-1media testing verifiesperformance
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Inoculation on plastic discwithin vial, ampoule ofrecovery medium.	Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatororganism and sterilizationprocess.
Processindicator	VERIFY V-PROChemical Indicator(K091174); magenta toyellow color change.	H2O2 sensitive ink;appears blue untilprocessed, then appearspink	Both contain a VH2O2 CI todistinguish processed SCBIfrom unprocessed SCBI.
Shelf-life	Currently 3 monthsTarget of 13 months	18 months	Real-time testing ongoing

Summary of Nonclinical Tests 6.

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

Test	Acceptance Criteria	Conclusion
Reduced IncubationTime (RIT) Testing	Meets FDA's requirement of > 97% alignment of the20-minute results with the conventional incubationtime of 7 days	PASS
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	PASS

Table 5-3. Summary of Non-clinical Testing

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Test	Acceptance Criteria	Conclusion
Resistance	D-value > 3 sec	PASS
Survival Time	Survival Time ≥ 4 sec	PASS
Kill Time	Kill Time ≤ 6 min	PASS
Carrier growth inhibition / media growth promotion	Positive growth of less than 100 spores after primary packaging and media are subject to worst case VHP exposure	PASS
Hold Time	Performance not affected if incubated within 72 hours of exposure to VHP sterilization	PASS
Simulated Use	Demonstrate no growth when exposed to worst-case cycles	PASS

7. Conclusion

The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed predicate device, 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).