The Verify® V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 1 Low Temperature Sterilization System.

Device Description

The Verify V24 Self-Contained Biological Indicator (SCBI) 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 V24 SCBI 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 orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid. The modified Verify V24 Self-Contained Biological Indicator is identical in design to the original K073244 device with exception of the media formulation. It is identical with respect to performance specifications with exception of the incubation time.

AI/ML Overview

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

Acceptance Criteria and Device Performance for Verify® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Growth Inhibition Testing & Effect of Sterilization Process on Recovery Media	No growth inhibition, no adverse effect of sterilization process on media.	Pass (No growth inhibition, no effect on media).
Incubation Time Validation	Achieve full and accurate results within 24 hours.	Pass (24 hour Incubation).
Media Performance Evaluations (Viability Control SCBIs)	All viability control SCBIs display growth within the specified incubation time and maintain yellow color.	Pass (All viability control SCBIs displayed growth within 24 hrs. Media was present and the color remained yellow for 7 days).
Media Performance Evaluations (Uninoculated SCBIs)	All uninoculated SCBIs remain sterile and maintain orange color.	Pass (All uninoculated SCBIs were sterile and the media remained orange for 7 days).
Media Stability Evaluation	Maintain performance characteristics over time.	Pass (On-Going Stability Evaluation).

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

The document does not explicitly state the specific sample sizes used for each individual test (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability). It reports results in a summary format ("Pass").

The data provenance is not explicitly stated in terms of country of origin. Given the submission is to the US FDA, it is highly likely the studies were conducted in the US or under US regulatory standards. The studies are non-clinical tests conducted to confirm the performance of the modified culture media, implying they are prospective experimental studies designed to evaluate the modified device.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical or diagnostic evaluations. The testing described focuses on the intrinsic performance of the biological indicator (e.g., microbial growth, color change, stability) under controlled laboratory conditions, rather than interpreting complex human-generated data. Therefore, the concept of qualified experts establishing ground truth as in a diagnostic imaging study is not applicable here.

4. Adjudication Method for the Test Set:

No adjudication method is described. The tests are laboratory-based and likely involve objective measurements (e.g., observation of color change, presence/absence of growth, incubation time).

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

No MRMC study was done, as this is a biological indicator designed to provide a direct readout of sterilization efficacy, not to be interpreted by human readers for diagnostic purposes where human variability would be a factor.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance evaluation was conducted. The described tests (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability) are all objective, laboratory-based assessments of the biological indicator's performance without human interpretation or intervention in the result generation process. The device itself changes color or fails to change color as its "output," which is then directly observed.

7. Type of Ground Truth Used:

The ground truth for these tests is based on controlled experimental conditions and objective biological/chemical outcomes. For example:

Sterility: Absence of microbial growth in uninoculated controls.
Viability/Growth: Presence of microbial growth in inoculated controls.
Incubation Time: Observed time to positive growth.
Media Stability: Maintenance of expected performance over time.
These are not based on expert consensus, pathology, or outcomes data in a clinical sense, but rather on established microbiological and chemical principles.

8. Sample Size for the Training Set:

The document does not mention a "training set" as this device does not utilize machine learning or AI that would require such a dataset. The biological indicator's function is based on a direct biological response, not a learned pattern.

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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MAR 1 6 2009

1. Device Name

Trade Name:	Verify® V24 Self-Contained Biological Indicator
Common/usual Name:	Biological Indicator (BI)
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC).

2. Predicate Device

Verify® Sclf-Contained Biological Indicator for Vaporized VH2O2 트 Sterilization Processes, K073244, May 28, 2008
STERRAD® Cyclesure™ Biological Indicator, K994055, Feb 13, 2002 트
STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 ■
STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007 트

3. Description of Device

The user places the packaged Verify V24 SCBI 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 orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The modified Verify V24 Self-Contained Biological Indicator is identical in design to the original K073244 device with exception of the media formulation. It is identical with respect to performance specifications with exception of the incubation time.

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Intended Use 4.

The Verify V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco V-PRO 1 Low Temperature Sterilization System.

5. Description of Modification

The culture media has been modified to achieve a 24 hour incubation time and the device labeling has been modified to reflect the change in incubation period as well as a change in the media color.

6. Description of Safety and Substantial Equivalence

The Verify V24 Self-Contained Biological Indicator 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 devices the Verify® Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes and STERRAD CycleSure Biological Indicator.

Summary of nonclinical tests performed to confirm the performance of the modified culture media:

Test	Result
Growth Inhibition Testing & Effect ofSterilization Process on RecoveryMedia	PassThere was no growth inhibition and noeffect of the sterilization process on themedia.
Incubation Time Validation	Pass24 hour Incubation
Media Performance Evaluations	PassAll viability control SCBIs displayedgrowth within 24 hrs. Media waspresent and the color remained yellowfor 7 days.All uninoculated SCBIs were sterile andthe media remained orange for 7 days
Media Stability Evaluation	PassOn Going Stability Evaluation

The test results indicate that the proposed Verify V24 Self-Contained Biological Indicator is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

MAR 1 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Robert (Jack) Scoville, Jr Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K090514

Trade/Device Name: Verify® V24 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: February 25, 2009 Received: February 26, 2009

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 electronic product radiation control provisions 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sutte Y. Michael Dms.

Ginette Y. Michaud, M.D. Acting 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): K090514

Device Name:

Verify® V24 Self-Contained Biological Indicator

Indications For Use:

The Verify® V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 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)

Shule M. Murphy, MD

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

510(k) Number: _

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).