The VERIFY® HPU Chemical Indicator is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 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, Flexible or Fast Non Lumen 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, Flexible, or Fast Non Lumen Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, or V-PRO maX 2 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 1C: VERIFY® HPU Chemical Indicator
Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
(Collectively referenced as the VERIFY® V-PRO Chemical Indicator)

The Version 1C: VERIFY® HPU Chemical Indicator is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.

The Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

AI/ML Overview

The STERIS VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label are Type 1 vaporized hydrogen peroxide sterilization process indicators designed to distinguish between processed and unprocessed units through a visible color change from magenta to yellow.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Type 1 Performance Testing	$\geq$ 90% Pass	100% Pass
V-PRO maX 2 Simulated Use Testing in Lumen, Non Lumen and Flexible Cycles	$\geq$ 90% Pass	100% Pass

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

The document mentions "Test of 6 Lots" for the Type 1 Performance Testing, indicating that 6 production lots of the chemical indicators were used for testing. However, the specific number of individual indicators or test units per lot is not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given that Albert Browne Ltd., a subsidiary of STERIS Corporation, is located in the United Kingdom and is involved in manufacturing, it is likely that parts of the testing or data generation might have occurred there or in other STERIS facilities.

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

This information is not provided in the document. As this is a chemical indicator with a visible color change, the "ground truth" for whether the indicator passed or failed is likely based on the color change as per the device specification, rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a chemical indicator (visible color change), the adjudication method might involve simple visual inspection against a reference, which may not explicitly require a complex adjudication process like 2+1 or 3+1.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. For a chemical indicator, the primary function is a direct color change, not an interpretive task for human readers that would be improved by AI assistance. The document confirms that the device is a "standalone" indicator.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The performance testing described in "Table 5-2. Verification Results Summary" directly assesses the chemical indicator's ability to change color in the specified sterilization cycles without human interaction influencing the indicator's performance. The "Study Result" column, showing 100% Pass, represents the standalone performance of the chemical indicators.

7. Type of Ground Truth Used

The ground truth used is the expected visible color change from magenta to yellow after exposure to specific sterilization conditions. This is an objective chemical reaction, not based on expert consensus, pathology, or outcomes data. The acceptance criteria specify that the indicator should "Pass" if it exhibits this color change to a certain percentage (e.g., $\geq$ 90%).

8. Sample Size for the Training Set

This information is not provided in the document. Chemical indicators usually don't involve a machine learning model that requires a "training set" in the traditional sense. Their performance is based on the chemical formulation and manufacturing consistency, which are validated through performance testing rather than training data.

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

Since there is no mention of a training set or machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device's performance is driven by its material composition and chemical reaction, which are verified through the outlined performance tests.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

February 9, 2018

STERIS Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K172746

Trade/Device Name: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH202 Process Indicator Adhesive Label Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 9, 2018 Received: January 10, 2018

Dear Bill 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.

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 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);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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) K172746

Device Name VERIFY® HPU Chemical Indicator

Indications for Use (Describe)

The VERIFY® HPU Chemical Indicator is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K172746

Device Name

VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Indications for Use (Describe)

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines that are light blue in color.

510(k) Summary For VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

K172746

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: January 23, 2018

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

2. Predicate Device

VERIFY® V-PRO Chemical Indicator (K140515)

3. Device Description

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

Version 1C: VERIFY® HPU Chemical Indicator ●
Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label ●

The Version 2C: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of

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

4. Indications for Use:

ട്. Technological Characteristics

The proposed and predicate devices are Type 1 single use process indicators in accordance with ISO 11140-1:2014 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 1B and 2B.

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	Proposed	K140515	Comparison
Feature	VERIFY® V-PRO ChemicalIndicator - V1C, V2C	VERIFY® V-PRO ChemicalIndicator - V1B, V2B
Intended use	The VERIFY® HPU ChemicalIndicator is a Type 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, Flexible or FastNon Lumen sterilization cycleof a V-PRO® LowTemperature SterilizationSystem.The VERIFY® VaporizedVH2O2 Process IndicatorAdhesive Label is a Type 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, Flexible or FastNon Lumen sterilization cycleof a V-PRO® LowTemperature SterilizationSystem.	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 Intended Usehas been modified inthe proposed devicein order to includethe Fast Non LumenCycle of the V-PROmaX 2 device.Also, the indicatorreference haschanged from Class1 to Type 1 basedupon updates to theguiding standard(ANSI/AAMI/ISO11140-2014).
Devicedesign -components	Indicator Ink printed onto spun-bonded polyolefin (Version 1C)and spun-bonded polyolefinwith an adhesive and a glassinebacking (Version 2C).	Indicator Ink printed onto spun-bonded polyolefin (Version 1B)and spun-bonded polyolefinwith an adhesive and a glassinebacking (Version 2B).	The proposed devicecontains the samecomponents forversions 1C and 2Cas versions 1B and2B of the predicatedevice, respectively.
Indicatoragent	Proprietary formulation	Proprietary formulation	The indicator agentis identical to thepredicate.
	Proposed	K140515	Comparison
Feature	VERIFY® V-PRO Chemical	VERIFY® V-PRO Chemical
	Indicator - V1C, V2C	Indicator - V1B, V2B
Sterilizationmethod andcycles	Vaporized Hydrogen Peroxidein the V-PRO 1, V-PRO 1Plus, V-PRO maX, V-PRO 60and V-PRO maX 2 LowTemperature Sterilizers	Vaporized Hydrogen Peroxidein the V-PRO 1 and V-PRO 1Plus, V-PRO maX and V-PRO60 Low TemperatureSterilizers	The sterilizationcycles for the V-PRO maX 2 arebeing added for theproposed device.
Mechanismof action	Proprietary	Proprietary	Mechanism ofaction is identical topredicate
Endpointspecifications	No Endpoint Specifications(Type 1 Process Indicator)	No Endpoint Specifications(Type 1 Process Indicator)	Same
Side by sidetesting withbiologicalindicators?	No	No	Same
Specification	Conforms toANSI/AAMI/ISO 11140-1:2014 requirements for aType 1 Hydrogen PeroxideChemical Indicator	Conforms toANSI/AAMI/ISO 11140-1:2005 requirements for aClass 1 Hydrogen PeroxideChemical Indicator	Proposed deviceconforms to themost recentstandard.

Table 5-1. Device Comparison Table

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K172746/S001 STERIS Response to 11/9/17 Request for Additional Information VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Performance Testing 6.

Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. 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 1C and Version 2C 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, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems.

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Test of 6 Lots	Acceptance Criteria		StudyResult
	FAIL	PASS
Type 1Performance Testing	100%	$\geq$ 90%	Pass
V-PRO maX 2 SimulatedUse Testing in Lumen,Non Lumen and FlexibleCycles	100%	$\geq$ 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.

7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device (K140515, Class II (21 CFR 880.2800), product code JOJ.

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).