The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

· 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
· 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
· Celerity 20 Steam Biological Indicator
· VERIFY STEAM Integrating Indicator
· VERIFY SixCess MF4 STEAM Emulating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°P/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

The VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

Device Description

The VERIFY All-in-One STEAM Reusable Test Pack consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity Xtend 10 Assembly containing the Celerity 20 STEAM Biological Indicator and the Celerity 10 STEAM Chemical Indicator.

The Celerity Xtend 10 Assembly consists of a tube and cap design, comprised of one (1) polypropylene tube and one (1) silicone rubber cap containing one (1) Celerity 20 STEAM Biological Indicator and one (1) Celerity 10 STEAM Chemical Indicator and can only be used with the VERIFY A11-in-One STEAM Reusable Test Pack. The Celerity Xtend 10 Assembly has a tamper evident seal that will be broken once the assembly has been opened after use. A broken tamper evident seal will indicate to the user that it cannot be reused. The Celerity Xtend 10 Assembly is a single use device used for routine monitoring of 10-minute 270°F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The Celerity 20 STEAM Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity STEAM Incubator, in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 STEAM Biological Indicator has been cleared under K173634 and K181429 and the Incubator has been cleared under K173670.

The Celerity 10 STEAM Chemical Indicator is a single-use device used to monitor a 10-minute 270°F/132°C dynamic air removal steam sterilization cycle and is subject of a concurrent premarket notification.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VERIFY All-In-One STEAM Reusable Test Pack, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria	Reported Device Performance
Simulated Use	Performance of the Biological Indicator (BI) in the Reusable Test Pack is equivalent to the performance of the predicate.	PASS
Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack	Reusable Test Pack containing the Celerity Xtend 10 Assembly provides a greater challenge to the process than the Celerity Xtend 10 Assembly itself.	PASS

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

The document does not explicitly state the sample sizes used for the "Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack" tests. The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. This type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis), which is not the primary focus of this device (a sterilization process indicator).

4. Adjudication Method for the Test Set:

The document does not mention an adjudication method for the test set. Given the nature of the device (a pass/fail indicator for sterilization), an adjudication method relying on multiple human readers is typically not applicable. The “ground truth” for effectiveness of sterilization indicators is typically objective, based on microbiological culture or physical/chemical changes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a sterilization process indicator and does not involve AI assistance or human reader interpretation in the context of diagnostic decision-making.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

The performance studies described ("Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack") appear to be evaluating the standalone performance of the device (the VERIFY All-In-One STEAM Reusable Test Pack in conjunction with its indicators). The "pass" conclusions suggest acceptable standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For sterilization indicators like this device, the ground truth is typically based on:

Microbiological Culture: For biological indicators (BI), "pass" means the BI did not grow microorganisms after sterilization, indicating effective sterilization. "Fail" means growth, indicating ineffective sterilization.
Physical/Chemical Changes: For chemical indicators (CI) like the Celerity 10 STEAM Chemical Indicator, the ground truth is based on a specific, observable color change (e.g., yellow to blue/purple) which correlates with exposure to critical sterilization parameters.
Reference Standards: Comparison against established and validated sterilization process challenges (e.g., ANSI/AAMI/ISO standards for temperature differences or air removal efficiency).

The document mentions "conditions are met and proper vacuum is achieved" and "2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature," suggesting a ground truth based on physical parameters validated against international standards for sterilization and microbiological efficacy.

8. The Sample Size for the Training Set:

The document does not provide information about a "training set" in the context of machine learning or AI. This device is a physical indicator system, not an AI/algorithm-based device that would typically use a training set. The development of such devices relies on engineering, material science, and microbiology, with validation studies rather than training sets.

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

This question is not applicable as there is no mention of a training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 20, 2018

Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K182931

Trade/Device Name: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 19, 2018 Received: October 22, 2018

Dear 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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -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

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Indications for Use

510(k) Number (if known)

Device Name

VERIFY All-In-One STEAM Reusable Test Pack

Indications for Use (Describe)

· 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
· 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
· Celerity 20 Steam Biological Indicator
· VERIFY STEAM Integrating Indicator
· VERIFY SixCess MF4 STEAM Emulating Indicator

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary For VERIFY™ All-in-One STEAM Reusable Test Pack

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Manufacturing Facility

STERIS Corporation Franklin Park Facility 11457 Melrose Ave. Franklin Park, IL 60131 Phone: (847) 455-2881

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 Fax No: (440) 357-9189 e-mail: jennifer_nalepka@steris.com

Submission Date: October 19, 2018

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

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1. Device Name

Trade Name:	VERIFY™ All-in-One STEAM Reusable Test Pack
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

VERIFY All-in-One STEAM Reusable Test Pack K173633

3. Description of Device

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The user will place the Celerity Xtend 10 Assembly inside the VERIFY All-in-One STEAM Reusable Test Pack and screw on the lid. The user will place the VERIFY All-in-One STEAM Reusable Test Pack into the sterilizer chamber and perform a 10-minute 270°F dynamic air removal steam sterilization cycle.

At the end of the cycle, the user will remove the Celerity Xtend 10 Assembly from the pack. The Celerity 10 STEAM Chemical Indicator can be evaluated for a pass or fail prior to opening the assembly. The Celerity 10 STEAM Chemical Indicator indicates a pass by a color change of yellow to blue/purple. If there is no color change or an incomplete color change, the Celerity 10 STEAM Chemical Indicator indicates a fail.

If the CI indicates a pass, the Celerity 20 STEAM Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.

4. Intended Use/ Indications for Use

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of prevacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 1140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

. 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
3M ATTEST Super Rapid Read Biological Indicators catalog number ● 1492V manufactured by 3M Company
Smart-Read EZTest Self Contained Biological Indicators for steam ● manufactured by MesaLabs, Inc.

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Celerity 20 STEAM Biological Indicator ●
VERIFY STEAM Integrating Indicator ●
. VERIFY SixCess MF4 |STEAM Emulating Indicator

The VERIFY All-In-One STEAM Reusable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The VERIFY All-in-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10-Minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

5. Technical Characteristics Comparison Table

A comparison of technical characteristics are summarized in Table 6-1.

Feature	VERIFY All-In-OneSTEAM Reusable TestPack(proposed)	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Comparison
Intended Use /Indication forUse	The VERIFY All-In-OneSTEAM Reusable TestPack, when used with aVERIFY Bowie DickIndicator Strip, is designedfor testing the air removalefficiency of pre-vacuumsteam sterilizers. Theindicator will demonstratecomplete dye migrationwhen proper sterilizationconditions are met andproper vacuum isachieved. If there is	The VERIFY All-In-OneSTEAM Reusable TestPack, when used with aVERIFY Bowie DickIndicator Strip, is designedfor testing the air removalefficiency of pre-vacuumsteam sterilizers. Theindicator will demonstratecomplete dye migrationwhen proper sterilizationconditions are met andproper vacuum isachieved. If there is	The proposed and predicatedevices are identical. Thecurrent premarketnotification is to add the useof the Celerity 10 XtendAssembly for routinemonitoring and qualificationof 10-minute 270°F/132°Cprevacuum steamsterilization cycles in theVERIFY All-In-OneSTEAM Reusable TestPack.
Feature	VERIFY All-In-OneSTEAM Reusable TestPack(proposed)	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Comparison
	inadequate vacuum suchthat would result in a 2°C(+1°C/-0°C) temperaturedifference between thecenter of theANSI/AAMI/ISO 1140-5:2007 Standard Test Packand the drain temperatureat the beginning of thefinal minute of a three anda half minute cycle, theindicator will demonstrateincomplete dye migration(incomplete color changein the indicator window).The test parameters usedfor validating this devicewere 134°C for 3.5minutes with a 2 minutedry time.	inadequate vacuum suchthat would result in a 2°C(+1°C/-0°C) temperaturedifference between thecenter of theANSI/AAMI/ISO 1140-5:2007 Standard Test Packand the drain temperatureat the beginning of thefinal minute of a three anda half minute cycle, theindicator will demonstrateincomplete dye migration(incomplete color changein the indicator window).The test parameters usedfor validating this devicewere 134°C for 3.5minutes with a 2 minutedry time.	The following claims for useof the VERIFY All-In-OneReusable Test Pack havebeen previously cleared:Bowie Dick Indicator whenused with the VERIFYBowie Dick Indicator Strip(K120592)Routine Monitoring of a 4-minute 270°F/132°C pre-vacuum steam sterilizationcycle when used with:• 3M ATTEST Rapid ReadBiological Indicatorscatalog number 1292manufactured by 3MCompany (K092944)• Smart-Read EZTest SelfContained BiologicalIndicators for steammanufactured byMesaLabs, Inc.(K130135)• VERIFY STEAMIntegrating Indicator(K102761)• Celerity 20 STEAMBiological Indicator(K173633)• VERIFY SixCess MF4STEAM EmulatingIndicator (K110253)o The VERIFY SixCessMF4 STEAMEmulating Indicatorwas inadvertently leftout of the Indicationsfor Use in the previousclearance for theReusable Test Packdue to a typographicalerror.Routine Monitoring of a 10-minute 270°F/132°C pre-vacuum steam sterilizationcycle when used with theadditional polypropylene
	VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cyclesutilizing a biologicalindicator, integratingindicator or both abiological and integratingindicator from thefollowing list.• 3M ATTEST RapidRead BiologicalIndicators catalognumber 1292manufactured by 3MCompany• 3M ATTEST SuperRapid Read BiologicalIndicators catalognumber 1492V	VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cyclesutilizing a biologicalindicator, integratingindicator or both abiological and integratingindicator from thefollowing list.• 3M ATTEST RapidRead BiologicalIndicators catalognumber 1292manufactured by 3MCompany• 3M ATTEST SuperRapid Read BiologicalIndicators catalognumber 1492V
Feature	VERIFY All-In-OneSTEAM Reusable TestPack(proposed)	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Comparison
	manufactured by 3MCompany• Smart-Read EZTestSelf ContainedBiological Indicatorsfor steam manufacturedby MesaLabs, Inc.• Celerity 20 SteamBiological Indicator• VERIFY STEAMIntegrating Indicator• VERIFY SixCess MF4STEAM EmulatingIndicator	manufactured by 3MCompany• Smart-Read EZTestSelf ContainedBiological Indicatorsfor steam manufacturedby MesaLabs, Inc.• Celerity 20 SteamBiological Indicator• VERIFY STEAMIntegrating Indicator	ATTEST Rapid ReadoutBiological Indicator catalognumber 1292 (K103321)NOTE: In previoussubmissions, the VERIFYAll-In-One STEAMReusable Pack was referredto as the Dana Reusable TestPack, the VERIFY STEAMIntegrating Integrator wascalled the SteriScanIntegrator and the VERIFYSixCess MF4 STEAMEmulating Indicator wascalled the Dana EmulatingIndicator.
	VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge the steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cycleswith the VERIFYSTEAM IntegratingIndicator.	VERIFY All-In-OneSTEAM Reusable TestPack is designed tochallenge the steamsterilization process inhealthcare facilities. It isintended to be used forroutine monitoring of pre-vacuum steam sterilizationcycles. It is validated tobe used in 4-minute270°F/132°C pre-vacuumsteam sterilization cycleswith the VERIFY STEAMIntegrating Indicator.
	The VERIFY All-In-OneSTEAM Reusable TestPack employing the All-in-One PV10 Assembly (adisposable polypropylenesleeve assembly) with a3M ATTEST RapidReadout BiologicalIndicator catalog number1292 can be used forroutine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilizationcycles. The polypropylenesleeve assembly isintended to be used onlywith the VERIFY All-In-One STEAM Reusable	The VERIFY All-In-OneSTEAM Reusable TestPack employing the All-in-One PV10 Assembly (adisposable polypropylenesleeve assembly) with a3M ATTEST RapidReadout BiologicalIndicator catalog number1292 can be used forroutine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilizationcycles. The polypropylenesleeve assembly isintended to be used onlywith the VERIFY All-In-One STEAM Reusable
Feature	VERIFY All-In-OneSTEAM Reusable TestPack(proposed)	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)	Comparison
	The VERIFY All-in-OneSTEAM Reusable TestPack employing theCelerity Xtend 10Assembly with a Celerity20 STEAM BiologicalIndicator and a Celerity 10STEAM ChemicalIndicator can be used forroutine monitoring of 10-Minute 270°F/132°C pre-vacuum steamsterilization cycles. Thesleeve assembly isintended to be used onlywith the VERIFY All-In-One STEAM ReusableTest Pack.
GeneralDesign	Aluminum chamber thatcan be sealed at one endusing a removablealuminum plug. The otherend has a permanentlypressed in aluminum capwith a precision machinedspiral that provides atortuous path for airremoval. The aluminumchamber is large enough tocontain a biologicalindicator and chemicalindicator.	Aluminum chamber thatcan be sealed at one endusing a removablealuminum plug. The otherend has a permanentlypressed in aluminum capwith a precision machinedspiral that provides atortuous path for airremoval. The aluminumchamber is large enough tocontain a biologicalindicator and chemicalindicator.	Identical configuration

Table 6-1 Summary of pack Physical Description and Technological Properties

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	VERIFY All-In-OneSTEAM Reusable TestPack(proposed)	VERIFY All-In-OneSTEAM Reusable TestPack(K173633)
Feature			Comparison
BiologicalIndicator	3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc. Celerity 20 STEAM Biological Indicator	3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc. Celerity 20 STEAM Biological Indicator	Identical
ChemicalIndicator	VERIFY STEAM Integrating Indicator	VERIFY STEAM Integrating Indicator	Identical
ExtendedCycleAssemblies	PV10 Assembly with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 Celerity Xtend 10 Assembly containing a Celerity 20 STEAM Biological Indicator and Celerity 10 STEAM Chemical Indicator	PV10 Assembly with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292	The proposed and predicate devices are identical. The current premarket notification is to add the use of the Celerity 10 Xtend Assembly for routine monitoring and qualification of 10-minute 270°F/132°C prevacuum steam sterilization cycles in the VERIFY All-In-One STEAM Reusable Test Pack.

6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 6-2 below.

Test	Acceptance Criteria	Conclusion
Simulated Use	Performance of the BI in the Reusable Test Pack isequivalent to the performance of the predicate	PASS
Celerity Xtend 10Assembly in pack vsCelerity Xtend 10Assembly outside ofpack	Reusable Test Pack containing the Celerity Xtend 10Assembly provides a greater challenge to the processthan the Celerity Xtend 10 Assembly itself.	PASS

Table 6-2. Summary of Non-clinical Testing

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7. Conclusion

The VERIFY All-in-One STEAM Reusable Test Pack has met the established performance criteria. Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (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).