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) and Amsco V-PRO 1 Plus (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 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 and V-PRO 1 Plus Sterilizers.

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 Cycle	2.1	4	32
Amsco V-PRO 1 Plus Lumen Cycle	2.1	4
Amsco V-PRO 1 Plus Non Lumen 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-PRO1M 1 Low Temperature Sterilization System and the Amsco® V-PROTM 1 Plus Low Temperature Sterilization System (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

Acceptance Criteria and Device Performance Study for Verify® Biological Indicator Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Resistance Characterization	Not explicitly stated as a separate acceptance criterion, but implied that resistance should be "equivalent or greater than the biological model used to validate the Non Lumen Cycle."	Pass: Challenge Pack resistance is equivalent or greater than the biological model used to validate the Non Lumen Cycle of the V-PRO 1 Plus Low Temperature Sterilization System.
Simulated Use Evaluation	Not explicitly stated as a separate acceptance criterion, but implied that the Chemical Indicator (CI) should yield a passing color change and the Self-Contained Biological Indicator (SCBI) should yield passing results under worst-case simulated use conditions.	Pass: The Verify V-PRO CI and Verify V24 SCBI yielded passing results when evaluated under worst case simulated use conditions.

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

The document does not explicitly state the specific sample sizes for the "Resistance Characterization" or "Simulated Use Evaluation" tests.

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) summary for a medical device submitted to the FDA, these tests are typically conducted prospectively as part of the device validation process.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications for the tests conducted. The "ground truth" for a biological indicator challenge pack is typically based on the known lethality of the sterilization cycle and the viability of the biological indicator organism.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test results. The assessment of "Pass" for both tests suggests a binary outcome based on predefined criteria (e.g., specific color change for CI, absence of growth for SCBI).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted, as this device (a biological indicator challenge pack) does not involve human interpretation in the same way an imaging or diagnostic AI device would. The assessment of the biological indicator's performance is typically an objective read (color change, turbidity).

6. Standalone Performance Study

Yes, standalone performance studies were implicitly done. The "Resistance Characterization" and "Simulated Use Evaluation" tests evaluate the device's performance (the challenge pack and its components) independently to ensure it functions as intended without direct human intervention in the interpretation of the biological indicator's results (though human action is required to activate and incubate the SCBI). The chemical indicator is read by a human, but the document does not specify its standalone performance from the SCBI.

7. Type of Ground Truth Used

The ground truth used for these tests would be based on:

Resistance Characterization: The known biological model used to validate the V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle. This typically involves established D-value (decimal reduction time) and Z-value (temperature change required to alter D-value by a factor of 10) for the indicator organism (e.g., Geobacillus stearothermophilus) under defined sterilization conditions.
Simulated Use Evaluation: The expected outcome of effective sterilization (no growth of microorganisms in the biological indicator, specific color change in the chemical indicator) under "worst case simulated use conditions" (which would be defined to represent the most challenging scenario for sterilization).

8. Sample Size for the Training Set

The document does not mention any training set. This device is not an AI/ML-based system that requires a machine learning training set. Its performance is based on the biological and chemical properties of its components and their interaction with the sterilization process.

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

Not applicable, as there is no training set for this type of device.

Summary

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K092906

510(k) Summary For

Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

DEC 30 "300

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Contact:

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

Submission Date:

December 28, 2009

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

December 28, 2009

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Verify" Biological Indicator Challenge Pack for Vaporized MH2O2 Sterilization Processes

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 | VH2O2 Sterilization Processes, K073618, January 7, 2009. Cleared as Verify Sirius Biological Indicator Challenge Pack.

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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Intended Use 4.

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PROM 1 (cleared under K073618) and Amsco V-PRO 1 Plus (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 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 and V-PRO 1 Plus 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 1 Cycle,Amsco V-PRO 1 Plus Lumen Cycle	2.1	4	32
Amsco V-PRO 1 Plus Non Lumen Cycle	2.1	4	12

ર. 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 K073618, for qualification in the V-PRO 1 Plus Sterilizer Non Lumen Cycle. The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes does not raise any new issues of safety and efficacy.

Summary of Nonclinical Tests:

Test	Result
ResistanceCharacterization	PassChallenge Pack resistance is equivalent or greater than the biologicalmodel used to validate the Non Lumen Cycle of the V-PRO 1 PlusLow Temperature Sterilization System.
Simulated UseEvaluation	PassThe Verify V-PRO CI and Verify V24 SCBI yielded passing resultswhen evaluated under worst case simulated use conditions.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor, Ohio 44060

DEC 3 0 2009

Re: K092906

Trade/Device Name: Verify® Biological Indicator challenge Pack for Vaporized VH2O2 Sterilization Processes Regulation Number: 21CFR 880.2800

Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: December 16, 2009 Received: December 17, 2009

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.

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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hh fo.

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): K092906

Device Name: Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

Indications For Use:

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) and Amsco V-PRO 1 Plus (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 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 and V-PRO 1 Plus Sterilizers.

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 In Vitro Diagnostic Devices (OIVD)

gnostic Devices (OVD)

Elizabet F. Claverie-Will

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)

510(k) Number: K092906

Page 1 of 2

A-2

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Indications for Use (continued)

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 Cycle	2.1	4	32
Amsco V-PRO 1 Plus Lumen Cycle	2.1	4
Amsco V-PRO 1 Plus Non Lumen Cycle	2.1	4	12

Page 2 of 2

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).