The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.

Device Description

The Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes is used by healthcare providers to monitor the Amsco V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer. The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, 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 medium 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 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.

AI/ML Overview

The provided text describes the STERIS Verify® Self-Contained Biological Indicator (SCBI) for Vaporized VH2O2 Sterilization Processes. It outlines various nonclinical tests performed to demonstrate safety and substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria values (e.g., minimum population reduction thresholds, specific D-values, or sterility assurance levels) or detailed study results that explicitly prove the device meets numerical acceptance criteria in a comparative table for each characteristic.

Instead, the document primarily lists a series of nonclinical tests and their qualitative "Pass" results, indicating the device performed within expectations or specifications for each test. It doesn't present a formalized table of acceptance criteria vs. device performance with quantitative metrics.

Therefore, many of the requested elements for a detailed study description are not available in the provided text. I will answer based on the information that is present.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

As noted, the document doesn't provide a table with quantitative acceptance criteria and their corresponding reported device performance values. It lists tests and their qualitative "Pass" results.

Test	Acceptance Criteria (Not Quantified)	Reported Device Performance
Viable Population Assay	Within Specification	Pass (Within Specification)
Resistance	Within Specification	Pass (Within Specification)
Growth Inhibition by Carrier and Pack Materials	No Inhibition	Pass (No Inhibition)
Holding Time Assessment	Established Hold Time	Pass (72 Hour Hold Time Established)
Effect of Media Additives	No Effect of Additives	Pass (No Effect of Additives)
Incubation Time Validation	Validated Incubation Time	Pass (4 day Incubation)
Effect of Sterilization Process on Recovery Media	No Affect	Pass (No Affect)
Stability of Biological Read	Stable for a specified duration	Pass (Stable for 7 Days)
Controls	Viability and Media Sterility Demonstrated	Pass (Viability and Media Sterility Demonstrated)
Media Volume	Adequate Volume for Incubation Conditions	Pass (Adequate Volume for Incubation Conditions)
Throughput Indicator Color Change	Color Change Demonstrated under Worst Case Exposure Conditions	Pass (Color Change Demonstrated under Worst Case Exposure Conditions)
Stability Evaluation	Ongoing Stability Evaluation	Pass (On Going Stability Evaluation)
Worst Case Location In V-PRO Sterilization Chamber	Identification of Worst Case Location	Pass (Middle of Top Shelf is the Worst Case Location)

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

The document does not specify the sample sizes used for each of the nonclinical tests listed. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for a biological indicator would typically be determined by microbiological assays and physical/chemical tests, rather than expert interpretation in the same way as, for example, medical images.

4. Adjudication method for the test set

This information is not applicable and not provided in the document for the type of nonclinical tests described for a biological indicator. Adjudication methods like "2+1" typically apply to diagnostic studies involving human readers.

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

This is not applicable to the device described. The device is a biological indicator, a consumable product used to monitor sterilization processes, not an AI-assisted diagnostic tool that would involve human readers.

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

This is not applicable to the device described. The device is a biological indicator, not an algorithm. Its performance is evaluated through its biological response to sterilization conditions.

7. The type of ground truth used

For the biological indicator, the "ground truth" for assessing its performance is based on established microbiological principles, such as:

Microbiological viability assays: Determining the initial population of spores.
Resistance profiling: Measuring the D-value (decimal reduction time) or Z-value (temperature coefficient) of the Geobacillus stearothermophilus spores against the sterilant.
Growth/no-growth observations: Observing the physical change of the media (color change, turbidity) after incubation to indicate the survival or inactivation of spores.
Sterility testing: For media sterility and package integrity.

The document implicitly refers to these types of ground truths through tests like "Viable Population Assay," "Resistance," and "Controls (Viability and Media Sterility Demonstrated)."

8. The sample size for the training set

This information is not applicable to the nonclinical studies of a biological indicator and is not provided. There is no "training set" in the context of an algorithm.

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

This information is not applicable, as there is no "training set" for an algorithm.

Summary

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Image /page/0/Picture/12 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the "S". Below the word "STERIS" is a graphic of several horizontal, wavy lines stacked on top of each other.

510(k) Summary For

MAY 2 8 2008

Verify® Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes

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

Contact:

John R. Scoville. Fellow Regulatory Affairs Telephone: (440) 392-7330 Fax No: (440) 357-9198

May 16, 2008 Submission Date:

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

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1. Device Name

Trade Name:	Verify® Self-Contained Biological Indicator forVaporized VH2O2 Sterilization Processes
Common/usual Name:	Biological Indicator (BI)
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC).

2. Predicate Device

STERRAD® Cyclesure™ Biological Indicator, K994055, Feb 13, 2002 STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007

3. Description of Device

The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, 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 medium 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 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.

4. Intended Use

The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PRO 1 Low Temperature Sterilization System.

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Description of Safety and Substantial Equivalence 5.

The Verify SCBI for VH2O2 has the same or similar intended use, accessories, viable population, resistance characteristics, culture conditions, primary and secondary packaging, and storage conditions as compared to its predicate device the STERRAD CycleSure Biological Indicator.

Summary of Nonclinical Tests:

Test	Result
Viable Population Assay	PassWithin Specification
Resistance	PassWithin Specification
Growth Inhibition by Carrier andPack Materials	PassNo Inhibition
Holding Time Assessment	Pass72 Hour Hold Time Established
Effect of Media Additives	PassNo Effect of Additives
Incubation Time Validation	Pass4 day Incubation
Effect of Sterilization Process onRecovery Media	PassNo Affect
Stability of Biological Read	PassStable for 7 Days
Controls	PassViability and Media Sterility Demonstrated
Media Volume	PassAdequate Volume for Incubation Conditions
Throughput Indicator ColorChange	PassColor Change Demonstrated under WorstCase Exposure Conditions
Stability Evaluation	PassOn Going Stability Evaluation
Worst Case Location In V-PROSterilization Chamber	PassMiddle of Top Shelf is the Worst CaseLocation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Scoville Fellow, Regulatory Affairs STERIS, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

MAY 2 8 2008

Re: K073244

Trade/Device Name: Verify Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 30, 2008 Received: May 1, 2008

Dear Mr. Scoville:

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 such 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. Scoville

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

K073244 510(k) Number (if known):

Device Name:

Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes

Indications For Use:

The Verify Self-Contained Biological Indicator for Vaporized | VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.

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)

Shula A. Murphy, MD

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

510(k) Number: K073244

Page 1 of 1

CONFIDENTIAL

May 16, 2008

C-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).