The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

Device Description

The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen. Non-Lumen or Flexible Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, or V-PRO 60 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.

The VERIFY® V-PRO Chemical Indicator is provided as two formats:

Version 1B: VERIFY® HPU Chemical Indicator .
Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive . Label

The Version 1B: VERIFY® HPU Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.

The Version 2B: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the STERIS® VERIFY® V-PRO Chemical Indicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test of 6 Lots	Acceptance Criteria (FAIL)	Acceptance Criteria (PASS)	Reported Device Performance	Study Result
Class 1 Performance Testing	100%	≥ 90%	Not explicitly stated	Pass
V-PRO 60 Simulated Use Testing in Lumen, Non Lumen, and Flexible Cycles	100%	≥ 90%	Not explicitly stated	Pass
V-PRO maX Simulated Use Testing in Lumen, Non-Lumen, and Flexible Cycles	100%	≥ 90%	Not explicitly stated	Pass

Note: The "Reported Device Performance" column is not explicitly detailed with numerical percentages for each test in the provided text. The document states that the studies "confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria." and "The results... demonstrate that both formats... perform as intended." which implies they met or exceeded the "PASS" criteria.

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

The document mentions "Test of 6 Lots" for the performance testing. This indicates that at least 6 lots of the VERIFY® V-PRO Chemical Indicator were included in the testing.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, the manufacturing facility is in Leicester, United Kingdom, and the sponsor facility is in Mentor, OH, USA. The testing was conducted internally by STERIS Corporation. There is no information to suggest it was a retrospective study; it is implied to be a prospective verification study for premarket notification.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.

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

The document does not specify an adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

This section is not applicable. The device is a chemical indicator for sterilization processes, not an AI-assisted diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable as the device is a chemical indicator, not an algorithm or software. The "performance" of the device is its ability to change color when exposed to sterilization conditions, which is inherently a standalone function.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance testing is based on the objective physical/chemical change of the indicator in response to defined sterilization conditions. The acceptance criteria are tied to the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. This standard dictates the expected color change (magenta to yellow) under specific conditions. Therefore, the ground truth is established by the physical and chemical properties of the indicator and its adherence to an established international standard.

8. The Sample Size for the Training Set

The document does not discuss any "training set" in the context of an AI/machine learning model. The device is a physical chemical indicator, not an AI or software device that would require training data.

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

This section is not applicable as the device does not involve a "training set."

Summary

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STERIS®

JUL 1 7 2014

510(k) Summary For VERIFY® V-PRO Chemical Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Contact:

Bill Brodbeck Director, Regulatory Affairs

Telephone: (440) 392-7690 Fax No: (440) 357-9198 William brodbeck@steris.com

Submission Date:

July 16, 2014

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

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1. Device Name

Trade Name:	VERIFY® HPU Chemical Indicator andVERIFY® Vaporized VH2O2 Process Indicator AdhesiveLabel
Models:	Version 1B: VERIFY® HPU Chemical IndicatorVersion 2B: VERIFY® Vaporized VH2O2 Process IndicatorAdhesive Label(Collectively referenced as the VERIFY® V-PRO ChemicalIndicator)
Common Name:	Chemical Indicator
Class:	II
Classification Name:	Physical/chemical sterilization process indicator (21 CFR880.2800, Product Code JOJ)

2. Predicate Device

Verify® V-PRO Chemical Indicator - Version 1A and 2A (K091174)

3. Device Description

The VERIFY® V-PRO Chemical Indicator is provided as two formats:

Version 1B: VERIFY® HPU Chemical Indicator .
Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive . Label

The Version 2B: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of

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K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

4. Indications for Use:

The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

ડ. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use process indicators for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The differences between the proposed V-PRO Chemical Indicator - Versions 1B and 2B and the predicate VERIFY® V-PRO Chemical Indicator - Version 1A and 2A device are limited to minor physical differences as well as expanding the indications for use statement to include use in the V-PRO 60 Low Temperature Sterilization System. Testing included in this submission demonstrates that the proposed device performs as intended and is substantially equivalent to the predicate device.

6. Technological Characteristics

The proposed and predicate devices are Class 1 single use process indicators in accordance with ISO 11140-1:2005 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The ink, mechanism of action, and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow.

Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label to the predicate Verify® V-PRO Chemical Indicator - Version 1A and 2A.

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K140515 STERIS ABBREVIATED 510(K) PREMARKET NOTIFICATION

VERIFY® V-PRO CHEMICAL INDICATOR

Feature	ProposedVERIFY® V-PRO ChemicalIndicator - V1B, V2B	K091174Verify® V-PRO ChemicalIndicator - V1A, V2A	Comparison
Intended use	The VERIFY® HPU ChemicalIndicator is a Class 1vaporized hydrogen peroxidesterilization process indicator.It is designed to distinguishbetween processed andunprocessed units when placedwithin packs to be sterilized toindicate, through a visiblechange from magenta toyellow, when the device hasbeen exposed to the Lumen,Non Lumen or Flexiblesterilization cycle of a V-PRO® Low TemperatureSterilization System.The VERIFY® VaporizedVH2O2 Process IndicatorAdhesive Label is a Class 1vaporized hydrogen peroxidesterilization process indicator.It is designed to distinguishbetween processed andunprocessed units, whenaffixed to packs to besterilized, through a visiblecolor change from magenta toyellow, when the pack hasbeen exposed to the Lumen,Non Lumen or Flexiblesterilization cycle of a V-PRO® Low TemperatureSterilization System.	The Verify® V-PROChemical Indicator (Version1A) and the Verify® V-PROChemical Indicator AdhesiveLabel (Version 2A) are Class1 vaporized hydrogenperoxide sterilization processindicators that conform toANSI/AAMI/ISO 11140-1:2005. They are designed todistinguish between processedand unprocessed units whenplaced within (Version 1A) oraffixed to (Version 2A)sterilization wraps, trays orpouches to indicate, through avisible change from magentato yellow, when the device(Version 1A) or pack (Version2A) has been exposed to a V-PRO 1 Low Temperaturesterilization process (LumenCycle) or V-PRO 1 Plus LowTemperature sterilizationprocess (Lumen or Non-Lumen cycle). This product isdesigned for use exclusively inthe Amsco V-PRO 1 LowTemperature SterilizationSystem and Amsco V-PRO 1Plus Low TemperatureSterilization System at 50 °Cusing Vaprox™ HC Sterilant.The Verify® V-PROChemical Indicator (Version1A) and the Verify® V-PROChemical Indicator AdhesiveLabel (Version 2A) intendedfor use in vaporized hydrogenperoxide sterilizationprocesses. The Verify® V-PRO Chemical Indicator(Version 1A) and the Verify®V-PRO Chemical IndicatorAdhesive Label (Version 2A)change color from magenta toyellow when exposed to theappropriate cycle conditions oftemperature, sterilant	The intended usestatement has beenrearranged forsimplicity for theproposed device butconveys a similarintended use. Theproposed device isintended to monitorLumen, Non Lumenand Flexible Cyclesof V-PRO 1, 1 Plusand maX LowTemperatureSterilizationSystems as with thepredicate devicewith the addition ofadding the claim ofuse in the V-PRO 60Low TemperatureSterilization System.
Feature	ProposedVERIFY® V-PRO ChemicalIndicator - V1B, V2B	K091174Verify® V-PRO ChemicalIndicator - V1A, V2A	Comparison
Devicedesign -components	Indicator Ink printed onto spun-bonded polyolefin (Versions 1Band 2B)	Indicator Ink printed ontoPolypropylene (Version 1A) orspun-bonded polyolefin(Version 2A)	The proposed devicecontains the samecomponents forversions 2A and 2Bas version IB of thepredicate device.
Indicatoragent	Proprietary formulation	Proprietary formulation	The indicator agentis identical to thepredicate.
Sterilizationmethod andcycles	Vaporized Hydrogen Peroxidein the V-PRO 1, V-PRO 1Plus, V-PRO maX and V-PRO60 Low TemperatureSterilizers	Vaporized Hydrogen Peroxidein the Amsco V-PRO 1 andAmsco V-PRO 1 Plus LowTemperature Sterilizers	The sterilizationcycles for the V-PRO maX and V-PRO 60 are beingadded for theproposed device.
Mechanismof action	Proprietary	Proprietary	Mechanism ofaction is identical topredicate
Endpointspecifications	No Endpoint Specifications(Class 1 Process Indicator)	No Endpoint Specifications(Class 1 Process Indicator)	Same
Side by sidetesting withbiologicalindicators?	No	No	Same
Specification	Conforms toANSI/AAMI/ISO 11140-1:2005 requirements for aClass I Hydrogen PeroxideChemical Indicator	Conforms toANSI/AAMI/ISO 11140-1:2005 requirements for aClass I Hydrogen PeroxideChemical Indicator	Same

Table 5-1. Device Comparison Table

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K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

7. Performance Testing

Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications.

Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® V-PRO Chemical Indicator - Version 1B and Version 2B is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems.

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K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

Test of 6 Lots	Acceptance Criteria		Study
	FAIL	PASS	Result
Class 1Performance Testing	100%	$\u2265$ 90%	Pass
V-PRO 60 Simulated UseTesting in Lumen, NonLumen and Flexible Cycles	100%	$\u2265$ 90%	Pass
V-PRO maX SimulatedUse Testing in Lumen,Non-Lumen and FlexibleCycles	100%	$\u2265$ 90%	Pass

Table 5-2. Verification Results Summary

The results of the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.

8. Conclusion

The proposed device contains the same indicator agent on the same substrate with the minor addition of the adhesive on the VERIFY® Vaporized (VH2O2) Process Indicator Adhesive Label. The indications for use vary only in the addition of claims for a new sterilizer. Testing included in this submission demonstrates that the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 17, 2014

STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060

Re: K140515

Trade/Device Name: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label Regulation Number: 21 CFR 880.2800 Regulation Name: Process Indicators Regulatory Class: II Product Code: JOJ Dated: June 19, 2014 Received: June 20, 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 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 - Dr. Brodbeck

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR

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

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Indications for Use

510(k) Number (if known): K140515

VERIFY® HPU Chemical Indicator and Device Name: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Indications For Use:

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)

Elizabeth F. Claverie -

Digitally signed by Elizabeth F. Claverie -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA. ou=People, 0.9.2342.19200300.100.1.1=1300055864, cn=Elizabeth F. Claverie -S Date: 2014.07.15 19:14:13 -04'00'

Page I of I

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).