The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.

The validated steam sterilization cycles include:

· 250°F (121°C) 30-minute gravity
· 270°F (132°C) 15-minute gravity

The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.

Device Description

The VERIFY"" Assert" |STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.

AI/ML Overview

The STERIS VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles does not involve AI or human readers, therefore, many of the requested categories are not applicable.

Here's a summary of the acceptance criteria and study information for this device:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes. Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes. PCD provides an equivalent or greater challenge than the AAMI standardized test pack.	PASS
BI in pack vs BI outside pack	PCD provides a greater challenge to the process than the BI itself.	PASS
CI in pack vs CI outside pack	PCD provides a greater challenge to the process than the integrator by itself.	PASS
Chemical Integrator	Chemical integrator does not reach endpoint before BI is inactivated.	PASS

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

The document does not specify the exact sample sizes used for each test. However, it indicates "Simulated use testing was done side-by-side with the predicate device". The data provenance is derived from these non-clinical tests conducted by STERIS Corporation. The data is prospective as it describes testing specifically designed for the device's clearance.

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

Not applicable. This device is a sterilization process challenge device, not a diagnostic or AI-powered medical device requiring expert interpretation of results. The "ground truth" is based on the inactivation of biological indicators and the chemical changes in integrators under controlled sterilization conditions, in comparison to an established standard (AAMI reference pack).

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

Not applicable. The tests involve quantifiable outcomes (e.g., biological indicator inactivation, chemical integrator endpoint attainment) rather than subjective 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 is not an AI-powered device or a device involving human readers.

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

The device's performance is inherently "standalone" in the sense that it functions to indicate sterilization efficacy without human interpretation of complex data or algorithms. Its results (fluorescent or non-fluorescent, chemical change) are read by an automated incubator/reader for the BI and visually for the chemical integrator.

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

The ground truth is established based on:

Biological Inactivation: The complete inactivation of Geobacillus stearothermophilus spores within the biological indicator, as confirmed by the absence of fluorescence after incubation. This aligns with standard microbiological principles for sterilization efficacy.
Chemical Integrator Response: The visible change in the chemical integrator, indicating exposure to specific sterilization parameters (time, temperature, steam).
Comparison to AAMI Reference Pack: The performance of the VERIFY™ Assert™ PCD is compared against the "standard 16-towel test pack described in ANSI/AAMI ST79," which serves as a recognized gold standard for validating sterilization processes.

Essentially, the "ground truth" is a set of established physical and biological parameters for effective steam sterilization.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. No training set was used.

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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol. The logo is black and white.

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

April 28, 2017

STERIS Corporation Mr. Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060

Re: K170070

Trade/Device Name: VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles Regulation Number: 21 CFR 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 28, 2017 Received: March 29, 2017

Dear Mr. Anthony 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

forth in the quality systems (OS) 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/Resourcesfor You/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) K170070

Device Name

VERIFY Assert STEAM Process Challenge Device for Gravity Cycles

Indications for Use (Describe)

The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.

The validated steam sterilization cycles include:

· 250°F (121°C) 30-minute gravity
· 270°F (132°C) 15-minute gravity

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

Image /page/3/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, black letters at the top of the image, with a small registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal blue lines that are slightly curved, resembling waves.

510(k) Summary For VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles

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: Tony Piotrkowski

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

April 28, 2017 Submission Date:

Premarket Notification Number: K170070

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

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

K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert " STEAM Process Challenge Device for Gravity Cycles

Device Name 1.

Trade Name:	VERIFYTM AssertTM STEAM Process Challenge Devicefor Gravity Cycles
Common/usual Name:	Biological Indicator Pack (PCD)
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593

3. Description of Device

4. Intended Use/ Indications for Use

The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.

The validated steam sterilization cycles include:

· 250°F (121°C) 30-minute gravity
· 270°F (132°C) 15-minute gravity

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

K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles

Summary of Technical Characteristics ട.

Feature	Assert Gravity PCD	Attest 41482V	Comparison
	(proposed)	(K121593) Predicate
IntendedUse	The VERIFY™Assert™ STEAMProcess ChallengeDevice (PCD) is usedfor qualification, routinemicrobial monitoring,and load monitoring ofsteam sterilizers.270F (132°C), 15-minute gravity;250F (121°C), 30-minute gravityWhen used inconjunction with theVERIFY Incubator forAssert Self ContainedBiological Indicators,the VERIFY AssertSelf-ContainedIndicator within theProcess challengedevice provides afluorescent result within40 minutes	Use 3M Attest SuperRapid 5 Steam-PlusChallenge Pack inconjunction with the 3MAttest Auto-reader 490to qualify or monitordynamic air removal(prevacuum) steamsterilization cycles of 4minutes at 270 F (132C) and 3 minutes at 275F (135 C).The 3M Attest SuperRapid ReadoutBiological Indicatorcontained within thechallenge pack providesa final fluorescent resultin 1 hour. An optionalvisual pH color changeresult is observed in 48hours.	Both are intended formonitoring steamsterilization cycles.Testing to demonstrateperformance in theclaimed cycles has beencompleted.
GeneralDesign	Indicators are sealed inplastic tray with channelto limit steampenetration/air removal.	Layers of medical indexcards, some of whichare die-cut to containindicators, overwrappedand secured with alabel.	Both the devices arecontained in a steambarrier. Testing todemonstrate equivalencehas been completed.
BiologicalIndicator	Verify Assert SelfContained BiologicalIndicator (40-minutefluorescent result)	Attest 1492V BiologicalIndicator (1-hourfluorescent result)	Both contain 510(k)-cleared BiologicalIndicators with rapidfluorescent results.
ChemicalIntegrator	Non-commercialChemical Integrator	SteriGage ChemicalIntegrator	Both contain chemicalintegrators
Means todistinguishprocessedPCD fromunprocessed	Proposed device'sinternal integrator isvisible through thepack.	External processindicator. Yellow tobrown color changewhen exposed to steam	Both have a means todistinguish processedPCD from unprocessed
Feature	Assert SCBI(K162701)	Attest 1492V(K121484)	Comparison
Indicatororganism	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	Same criteria
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
Accessories	Automated incubator /reader (K1635870)• 40 minute incubationtime• Holds temperaturerange throughoutincubation time.	Automated incubator /reader• 60 minute incubationtime• Holds temperaturerange throughoutincubation time.	RIT testing performed withthe proposedincubator/reader cleareduner K163587. Inubatorreaders meet criterion ofFDA BI 510(k) guidance.
Viable sporepopulation	1.0 - 4.0 x 106 spore/SCBI	≥ 1.0 x 106 spore/SCBI	Both proposed and predicatemeet criteria of ISO 11138-3and FDA guidance
Resistance	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	D132 ≥ 10 sD135 ≥ 8 s
CultureConditions	55- 59 °C, media includedin SCBI, 40 minuteincubation time.	55- 59 °C, media includedin SCBI, 60 minuteincubation time.	RIT Testing and ISO 11138media testing verifiesperformance
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Inoculated paper in plasticvial with cap and glassampoule with recoverymedia in capped vial.	Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatorand sterilization process

A comparison of technical characteristics of the PCD are in Table 3-1. Table 3-1 Summary of PCD Physical Description and Technological Properties

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

K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert™ STEAM Process Challenge Device for Gravity Cycles

A comparison of technical characteristics BI components of the PCD are in Table 3-2.

Table 5-2 Summary of SCBI Components of the PCD Physical Description and Technological Properties

Any differences between the predicate and proposed device as noted above are addressed through testing summarized below or submitted as part of the cleared 510(k): K162701 for the BI component and K163587 for the incubator.

6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3-3 below. Simulated use testing was done side-by-side with the predicate device and all other testing demonstrates the PCD meets the criteria of the FDA guidances for CI and BI as they pertain to PCD.

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

K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert™ |STEAM Process Challenge Device for Gravity Cycles

Test	Acceptance Criteria	Conclusion
Simulated Use	Performance of the BI in the PCD is equivalent to theperformance of the BI in the AAMI reference pack intheir respective sterilization processes Performance of the chemical integrator in the PCD isequivalent to the performance of the chemical integratorin AAMI reference pack in their respective processes PCD provides an equivalent or greater challenge thanthe AAMI standardized test pack	PASS
BI in pack vs BIoutside of pack	PCD provides a greater challenge to the process thanthe BI itself.	PASS
CI in pack vs CIoutside of pack	PCD provides a greater challenge to the process thanthe integrator by itself.	PASS
Chemical Integrator	Chemical integrator does not reach endpoint before BIis inactivated.	PASS

Table 3-3. Summary of Non-clinical Testing vs Predicate

"PASS" indicates that acceptance criteria were met and that the proposed pack performed at least as effectively as the predicate device.

7. Conclusion

The VERIFY Assert |STEAM Process Challenge Device for Gravity Cycles 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 at least as safely and effectively as the legally marketed predicate device, 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).