VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

• K Number: K140708
• Device Name: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
• Manufacturer: STERIS Corporation
• Date Cleared: 2014-06-16 ( 87 days)
• Product Code: FRC
• Regulation Number: 880.2800
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K083097 , K102330 , K073244 , K090514
• Predicate For: K172474

Intended Use

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
• Default Cycle of the STERRAD 100S Sterilizer ●
• Default Cycle of the STERRAD 200 Sterilizer .
• Standard and Advanced Cycles of the STERRAD NX Sterilizer .
• Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

Device Description

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System or STERRAD Sterilizer 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 °C for ≥ 24 hours. 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.

AI/ML Overview

The VERIFY® V24 Self-Contained Biological Indicator (SCBI) is intended to monitor specific cycles of V-PRO® Low Temperature Sterilization Systems and various STERRAD® Sterilizers. The acceptance criteria and supporting study are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

Test & Acceptance Criteria	Reported Device Performance
SCBI Half Cycle Performance SCBIs must be sterile after half-cycle testing.	Pass SCBIs were sterile in half-cycle testing.
SCBI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles No growth inhibition and no effect of the sterilization process on the media.	Pass There was no growth inhibition and no effect of the sterilization process on the media.
SCBI Simulated Use in the STERRAD Sterilizer Cycles Successful performance in simulated use.	Pass Simulated use performance has been successfully demonstrated.

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

The document does not specify the exact sample size (number of VERIFY V24 SCBIs) used for each of the performance tests (Half Cycle, Growth Inhibition, Simulated Use).

The data provenance is for testing the device's compatibility with STERRAD Sterilizers. The context implies that the testing was likely conducted in a controlled laboratory or clinical setting in the United States, given that the sponsor and manufacturing facilities are in Mentor, OH, USA, and the submission is to the FDA. The study appears to be prospective, specifically designed to demonstrate the device's performance with the new sterilizer indications.

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. For biological indicators, the ground truth is typically established by observing the growth or non-growth of the bacterial spores, which is a direct, objective biological outcome. It doesn't usually rely on expert interpretation in the same way an imaging diagnostic might.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. Given the nature of a biological indicator, where the outcome is a clear biological response (growth or no growth, indicated by a color change), an adjudication method by multiple experts is generally not applicable. The results are typically objectively measured.

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 and often AI assistance. The VERIFY V24 Self-Contained Biological Indicator is a direct biological indicator without a human-in-the-loop component for reading the primary outcome.

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

The device itself is a standalone indicator. Its performance is evaluated directly based on the biological outcome (spore inactivation and subsequent growth or no growth of Geobacillus stearothermophilus). This is essentially a standalone performance evaluation in that there is no "human-in-the-loop" for the primary interpretation of the device's result (color change or turbidity).

7. The type of ground truth used

The ground truth used is the biological outcome – specifically, the successful inactivation of Geobacillus stearothermophilus spores and the presence or absence of their growth after exposure to a sterilization process. This is determined by observing the color change of the media (orange to yellow) and/or turbidity, which indicates viable spores. The specification ranges for D-value, survival time, and kill time are also integral to establishing the efficacy (ground truth) of the indicator.

8. The sample size for the training set

The document does not detail a separate "training set" or its size, as this device is a biological indicator and not an AI/ML-based system that typically requires a training set. The existing biological indicator has been previously cleared, and the current submission focuses on extending its use to additional sterilizers.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this biological indicator. The existing performance characteristics of the Geobacillus stearothermophilus spores and the indicator's components (media, etc.) were established through previous studies (K073244, K090514) according to FDA guidance for biological indicators.

Summary

{0}------------------------------------------------

Image /page/0/Picture/15 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a large, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal wavy lines stacked on top of each other.

JUN | 6 2014

510(k) Summary for VERIFY® V24 Self-Contained Biological Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Manufacturing Facility

STERIS Corporation 9325 Pinecone Mentor, OH 44060

Contact:

Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: [phone] [phone] Fax No: e-mail: William [e-mail]

Submission Date:

March 20, 2014

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

!

5-1

{1}------------------------------------------------

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), Class II

2. Predicate Device

Verify Self-Contained Biological Indicator (SCBI) for Vaporized |VH2O2 Sterilization Processes (K073244) modified under K090514.

3. Description of Device

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System or STERRAD Sterilizer 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 °C for ≥ 24 hours. 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.

4. Intended Use

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

• Lumen. Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
• Default Cycle of the STERRAD 100S Sterilizer .
• Default Cycle of the STERRAD 200 Sterilizer .

{2}------------------------------------------------

• Standard and Advanced Cycles of the STERRAD NX Sterilizer .
• Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

5. Description of Safety and Substantial Equivalence

The VERIFY V24 Self-Contained Biological Indicator has the identical accessories, viable population, resistance characteristics, culture conditions, primary and secondary packaging, and storage conditions as compared to its predicate device, the Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2) Sterilization Processes (name changed in K090514). Testing submitted (Table 5-1) focused on qualification of the subject device for its proposed new indications for use in STERRAD Sterilizers as all other characteristics remain identical to the predicate device.

Table 5-1. Summary of Nonclinical Tests:

Fall Test &	and Result :
SCBI Half Cycle PerformanceEvaluation in the STERRAD SterilizerCycles	PassSCBIs were sterile in half-cycle testing.
SCBI Growth Inhibition FollowingExposure to STERRAD Sterilizer Cycles	PassThere was no growth inhibition and noeffect of the sterilization process on themedia.
SCBI Simulated Use in the STERRADSterilizer Cycles	PassSimulated use performance has beensuccessfully demonstrated.

All performance studies for the VERIFY V24 Self-Contained Biological Indicator recommended within FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions have been previously completed, submitted and cleared under K073244 and K090514. These studies and the results are summarized in the appropriate sections throughout this submission and include, but are not limited to:

• Viable Spore Population Assay .
• Resistance Characteristics ●
• Carrier and Primary Packaging Evaluation .
• Holding Time Assessment .
• . Recovery Methods
• Shelf Life .

Technological Characteristics 6.

Table 5-2 compares technological characteristics and specifications to the predicate device. The proposed biological indicator is identical in composition and has the same performance specifications as the predicate.

{3}------------------------------------------------

STERIS Traditional 510(k) PREMARKET NOTIFICATION

VERIFY® V24 Self-Contained Biological Indicator

Feature	Proposed DeviceVERIFY V24 Self-Contained BiologicalIndicator,	Predicate DeviceVerify Self-ContainedBiological Indicator(SCBI) for VaporizedVH2O2 SterilizationProcesses (K073244)modified under K090514	Comparison
Intended Use:Method ofMonitoringSterilizationProcess Parameters	The VERIFY® V24 Self-Contained BiologicalIndicator is intended forroutine monitoring of thefollowing sterilizers andcycles:• Lumen, Non Lumenand Flexible Cycles ofthe V-PRO® LowTemperatureSterilization Systems• Default Cycle of theSTERRAD 100SSterilizer• Default Cycle of theSTERRAD 200Sterilizer•Standard and AdvancedCycles of theSTERRAD NXSterilizer• Express, Standard andFlex Scope Cycles ofthe STERRAD 100NXSterilizer	A standard method forfrequent monitoring of theV-PRO 1 Low TemperatureSterilizer cycle	The device has beenpreviously cleared foruse with the V-PRO 1(K073244), V-PRO 1Plus (K083097) andV-PRO maX(K102330) LowTemperatureSterilization Systems.The proposed device isintended to add thelisted ASP STERRADSterilization systemcycles to the claims.
Labeling	• Vial Label• Certificate ofPerformance• Carton Label• Instructions for Use	• Vial Label• Certificate ofPerformance• Carton Label• Instructions for Use	Proposed andpredicate devices haveidentical labelingexcept that theinstructions for use ofthe proposed deviceinclude the listedSTERRAD Sterilizercycles.
Organism: Species& Strain	Geobacillusstearothermophilus ATCC7953 spores	Geobacillusstearothermophilus ATCC7953 spores	Same
Accessories	• VERIFY Incubator(Optional)• VERIFY Activator(Optional)• Throughput ProcessIndicator	• VERIFY Incubator(Optional)• VERIFY Activator(Optional)• Throughput ProcessIndicator	Same
Viable SporePopulation	The specification range for viable spore population is identical for the proposeddevice and predicate
Feature	Proposed DeviceVERIFY V24 Self-Contained BiologicalIndicator	Predicate DeviceVerify Self-ContainedBiological Indicator(SCBI) for VaporizedVH2O2 SterilizationProcesses (K073244)modified under K090514	Comparison
Resistancecharacteristics	The specification range for D-value, survival time and kill time are identical for theproposed device and predicate.
Culture Conditions	• V24 SCBI GrowthMedia• Incubation Temp: 55-60°C• Incubation Time: ≥24hours	• V24 SCBI GrowthMedia• Incubation Temp: 55-60°C• Incubation Time: ≥24hours	SamePlease note that thereduced incubationtime of 24 hours wascleared underK090514.
Carrier Materials	Polypropylene Vial	Polypropylene Vial	Same
Packaging:• Primary Pack• SecondaryPack	• Polypropylene Vial• 50 Indicators Suppliedin a Cardboard Box	• Polypropylene Vial• 50 Indicators Suppliedin a Cardboard Box	Same
Storage Conditions	16 - 25°C,30 - 60% RH	16 - 25°C,30 - 60% RH	Same
Shelf-life	The labeled shelf life is identical for the proposed device and predicate.

Table 5-2. VERIFY V24 Self-Contained Biological Indicator

·

{4}------------------------------------------------

STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY® V24 Self-Contained Biological Indicator

7. Conclusion

The VERIFY V24 Self-Contained Biological Indicator is identical in composition and has the same performance specifications as the predicate, therefore, it is substantially equivalent to the claimed predicate device since it is identical in design and performance characteristics and has been qualified for routine monitoring of the STERRAD 100S default cycle, STERRAD 200 default cycle, STERRAD NX Standard and Advanced cycles and STERRAD 100NX Express, Standard and Flex Scope cycles.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

June 16, 2014

STERIS Corporation William Brodbeck. Ph.D Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K140708

Trade/Device Name: VERIFY® V24 Self Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: II Product Code: FRC Dated: March 20, 2014 Received: March 21, 2014

Dear Dr. Brodbeck

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 conninered phorte with the provisions of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costhetic rior (110) that to nevice, subject to the general controls provisions of the Act. The I va may, alorely manns of the Act include requirements for annual registration, listing of general controls provisions of 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.

{6}------------------------------------------------

Page 2 - William Brodbeck, Ph.D

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 clectronic 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours. Teiashri Puro

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

K140708 510(k) Number (if known):

Device Name:

VERIFY® V24 Self-Contained Biological Indicator

Indications For Use:

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
• Default Cycle of the STERRAD 100S Sterilizer ●
• Default Cycle of the STERRAD 200 Sterilizer .
• Standard and Advanced Cycles of the STERRAD NX Sterilizer .
• Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

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)

Sreekanth
Gutala -S

Digitally signed by Sreekanth Gutala -S DN: c=US, o-U.S. Government, ou=HHS ou=FDA, ou=People, 0,9.2342.19200300.100.1.1=200054049 cn=Sreekanth Gutala -5 Date: 2014.06.16 11:31:27 -04'00'

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).