The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Aunsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO max (Lumen, Non Lumen and Flexible Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers.

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the following cycles.

Sterilization Cycle	Sterilant/Injection(g)	#Injections	SterilantExposure Time(min)
Amsco V-PRO I Cycle
Amsco V-PRO 1 Plus Lumen Cycle	2.1	4	32
Amsco V-PRO maX Lumen Cycle
Amsco V-PRO 1 Plus Non Lumen Cycle
Amsco V-PRO maX Non Lumen Cycle	2.1	4	12
Amsco V-PRO maX Flexible Cycle	2.1	4	12

Device Description

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is used by healthcare providers for qualification testing of the Amsco V-PROTM 1 Low Temperature Sterilization System, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen Cycles) and the V-PROT maX (Flexible, Lumen and Non Lumen Cycles) following installation, relocation, 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 Biological Indicator Challenge Pack into the Amsco V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the Verify V-PRO Chemical Indicator (CI) and the Verify V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is accessed 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 media ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

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

AI/ML Overview

The provided text describes the 510(k) summary for the STERIS Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes, specifically focusing on its qualification for the V-PRO maX Sterilizer Flexible Cycle. The document serves as a regulatory submission to the FDA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Resistance Characterization	Challenge Pack resistance should be equivalent or greater than the biological model used to validate the sterilizer cycles (Lumen and Non Lumen Cycles of the V-PRO 1 Plus Low Temperature Sterilization System, and Flexible Cycle of the V-PRO maX Low Temperature Sterilization System). This implies the BI should represent a sufficient challenge to the sterilization process.	Pass. Challenge Pack resistance is equivalent or greater than the biological model used to validate the Lumen and Non Lumen Cycles of the V-PRO 1 Plus Low Temperature Sterilization System. Challenge Pack resistance is equivalent or greater than the biological model used to validate the Flexible Cycle of the V-PRO maX Low Temperature Sterilization System.
Simulated Use Evaluation	The Verify V-PRO Chemical Indicator (CI) and Verify V24 Self-Contained Biological Indicator (SCBI) should consistently yield "passing results" under worst-case simulated use conditions, indicating effective sterilization.	Pass. The Verify V-PRO CI and Verify V24 SCBI yielded passing results when evaluated under worst case simulated use conditions.
Process Indicator Performance Evaluation	The Process Indicator (CI) in the Challenge Pack must demonstrate a complete color change under "Pass" (sterilization successful) conditions and an incomplete or no color change under "Fail" (sterilization unsuccessful) conditions.	Pass. The Process Indicator in the Challenge Pack demonstrated a complete color change under "Pass" conditions and an incomplete color change under "Fail" conditions.

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

The document does not explicitly state the specific sample sizes (number of challenge packs, number of tests run) used for the "Resistance Characterization," "Simulated Use Evaluation," and "Process Indicator Performance Evaluation." It only states "Pass" for each test.

Regarding data provenance: The studies were conducted by STERIS Corporation for their 510(k) submission to the FDA in the USA. This suggests the data is likely retrospective, as it's being submitted for device clearance. There is no mention of country of origin for the data other than the company's location in Mentor, Ohio, USA.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. The nature of the device (biological indicator) suggests that "ground truth" is typically established by observing the growth or non-growth of microorganisms after exposure to sterilization cycles, rather than expert interpretation of images or clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify any adjudication method involving multiple human readers for the test set. Given that this is a biological indicator and chemical indicator, the evaluation is based on scientific measurement (microbial growth/no growth, color change) rather than 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images with or without AI assistance. The STERI Verify Biological Indicator is a device that provides a direct biological or chemical indication of sterilization effectiveness, not a diagnostic imaging device requiring human interpretation in this context. There is no AI component mentioned with human-in-the-loop.

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

This question is not applicable to the device described. The device is a physical biological and chemical indicator. It does not involve an algorithm or AI that operates in a standalone manner without human intervention. The "human-in-the-loop" here is the user who activates the BI and interprets the color change or growth media.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the ground truth is established through:

Microbiological viability: For Biological Indicators (BIs), the ground truth is determined by whether the test microorganisms (e.g., Geobacillus stearothermophilus) survive (growth, indicated by color change to yellow and/or turbidity) or are killed (no growth, media remains orange and non-turbid) after exposure to the sterilization process. This is a direct measure of sterilization efficacy.
Chemical reaction: For Chemical Indicators (CIs), the ground truth is a specific and predictable color change in response to exposure to sterilant conditions (e.g., hydrogen peroxide).

The "biological model" mentioned in the "Resistance Characterization" implicitly refers to these established microbiological and chemical principles of sterilization assessment.

8. The Sample Size for the Training Set

The document does not mention a training set. This concept is typically associated with machine learning or AI models, which are not components of this biological indicator device. The device's performance is demonstrated through validation testing against established microbiological and chemical criteria.

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 an AI or machine learning model.

Summary

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SEP - 1 2011

STERIS®

510(k) Summary For Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

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

Contact:

Robert F. Sullivan. Senior Director, FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198

Summary Date:

January 28, 2011

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

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1. Device Name

Trade Name:	Verify® Biological Indicator Challenge Pack forVaporized VH2O2 Sterilization Processes
Common/usual Name:	Biological Indicator (BI) Process Challenge Device
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes, K092906, December 30, 2009.

3. Description of Device

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

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4. Intended Use

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1, the Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906) and the V-PRO100 maX (Flexible, Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes is intended for qualification testing of the following cycles.

Sterilization Cycle	Sterilant/Injection(g)	#Injections	SterilantExposure Time(min)
Amsco V-PRO 1 CycleAmsco V-PRO 1 Plus Lumen CycleAmsco V-PRO maX Lumen Cycle	2.1	4	32
Amsco V-PRO 1 Plus Non Lumen CycleAmsco V-PRO maX Non Lumen Cycle	2.1	4	12
Amsco V-PRO maX Flexible Cycle	2.1	4	12

ട്. Description of Safety and Substantial Equivalence

No substantial changes were made to the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes design, cleared in K092906, for qualification in the V-PRO maX Sterilizer Flexible Cycle. The Verify Biological Indicator Challenge Pack for Vaporized |VH2O2 Sterilization Processes does not raise any new issues of safety and effectiveness. The performance data obtained through nonclinical tests and outlined below demonstrates the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes substantial equivalence to the predicate device.

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K103331/S001 STERIS Response to 1/10/11 Request for Additional Informa Verify® Biological Indicator Challenge Pack for Vaporized [VH2O2 Sterilization Processes

Summary of Nonclinical Tests:

Test	Result
ResistanceCharacterization	PassChallenge Pack resistance is equivalent or greater than the biologicalmodel used to validate the Lumen and Non Lumen Cycles of theV-PRO 1 Plus Low Temperature Sterilization System.Challenge Pack resistance is equivalent or greater than the biologicalmodel used to validate the Flexible Cycle of the V-PRO maX LowTemperature Sterilization System
Simulated UseEvaluation	PassThe Verify V-PRO CI and Verify V24 SCBI yielded passing resultswhen evaluated under worst case simulated use conditions.
ProcessIndicatorPerformanceEvaluation	PassThe Process Indicator in the Challenge Pack demonstrated acomplete color change under "Pass" conditions and an incompletecolor change under "Fail" conditions

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Image /page/4/Picture/1 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 seal is a stylized symbol featuring three parallel lines that curve and converge, resembling a stylized human figure or a bird in flight.

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

Mr. Robert F. Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

EP - 1 2011

Re: K103331

Trade/Device Name: Verify® Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 25, 2011 Received: August 26, 2011

Dear Mr. Sullivan:

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.

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Page 2 - Mr. Sullivan

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm ! 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

L. Schultheis for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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® Biological Indicator Challenge Pack for Vaporized WH2O2 Sterilization Processes

Indications For Use:

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the following cycles.

Sterilization Cycle	Sterilant/Injection(g)	#Injections	SterilantExposure Time(min)
Amsco V-PRO I Cycle
Amsco V-PRO 1 Plus Lumen Cycle	2.1	4	32
Amsco V-PRO maX Lumen Cycle
Amsco V-PRO 1 Plus Non Lumen Cycle
Amsco V-PRO maX Non Lumen Cycle	2.1	4	12
Amsco V-PRO maX Flexible Cycle	2.1	4	12

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103331

Page 1 of 1

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).