The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.

The tape may be used in the following sterilization cycles:

· Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
· Standard Cycle of the STERRAD® 100S Sterilizer
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

Device Description

The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.

The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.

AI/ML Overview

The medical device is the VERIFY™ VH2O2 Indicator Tape, which is a chemical sterilization process indicator.

Here's an analysis of the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Result)
ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide Process Indicator Performance Testing	Pass
Simulated Use: Pass Performance Testing (in V-Pro and STERRAD sterilizers with loads)	Pass
Simulated Use: Fail Performance Testing (in V-Pro and STERRAD sterilizers with loads)	Pass
Endpoint Stability (color of processed tape at various time points)	Pass
Light Stability after Removal from Packaging (before exposure to sterilization)	Pass
Adhesion Evaluation (ASTM adhesion standard and simulated use)	Pass
Shelf Life Evaluation (CI performance and tape adhesion)	Pass
Hydrogen Peroxide Residual Testing	Pass
Off-set (transference) Performance Testing	Pass

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

The document does not explicitly state the specific sample sizes for each test in the test set. It mentions tests being conducted "in an ANSI/AAMI/ISO 18472:2006-conforming resistometer" and "in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions." The provenance of the data is not explicitly stated as country of origin, but it is implied to be from the manufacturer's (STERIS Corporation) testing, which is based in Mentor, Ohio, USA. The testing appears to be prospective as it was conducted to demonstrate the performance of the new device.

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

This information is not provided in the document. For chemical indicators like this, ground truth is typically established by physical/chemical properties and standardized tests, not by human expert interpretation in the same way an imaging AI might be evaluated. The "Pass" results are against established standards (ANSI/AAMI/ISO).

4. Adjudication Method for the Test Set

This information is not applicable in the traditional sense for a chemical indicator. The "Pass" or "Fail" of the tests is determined by adherence to predefined measurable criteria set forth in the ISO standards and internal performance specifications, rather than by a panel of human adjudicators reviewing outputs.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human interpretation of results is involved, and the AI's impact on human performance is being assessed. The VERIFY™ VH2O2 Indicator Tape is a chemical indicator that provides a direct visual color change, not an interpretive diagnostic.

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

Yes, the testing performed can be considered "standalone" in the sense that the device's performance (color change, adhesion, stability) was evaluated directly against scientific and industry standards without a human-in-the-loop component for the device's core function. The device itself is designed to provide a clear, unambiguous signal (color change) that indicates processing. The evaluation focuses on whether this signal occurs accurately and reliably under specified conditions.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and physical/chemical properties. This includes:

ANSI/AAMI/ISO 11140-1:2014: This standard defines the requirements for chemical indicators for sterilization.
ANSI/AAMI/ISO 18472:2006: This standard relates to resistometers, which are used to evaluate sterilization processes and indicators.
ASTM adhesion standard: Used for evaluating tape adhesion.
Measurable parameters for color change (from pink to peach/yellow or lighter) under defined sterilization conditions (pass conditions) and no change under fail conditions.
Shelf-life stability of the indicator.
Residual chemical levels (hydrogen peroxide).

8. The Sample Size for the Training Set

This document describes a physical device, a chemical indicator tape, not an algorithm that requires a "training set" in the context of machine learning or AI. Therefore, the concept of a training set sample size does not apply.

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

As explained above, this device does not utilize a training set in the AI sense. Ground truth relates to the performance standards and physical/chemical characteristics of the indicator itself, established by international and industry standards, and verified through laboratory and simulated-use testing.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.

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

June 1, 2016

Steris Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K160485

Trade/Device Name: VERIFY™ VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: April 29, 2016 Received: May 2, 2016

Dear Mr. Piotrkowski:

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 (reporting of medical devicerelated 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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

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

Indications for Use

510(k) Number (if known) K160485

Device Name VERIFY™ VH2O2 Indicator Tape

Indications for Use (Describe)

The tape may be used in the following sterilization cycles:

· Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
· Standard Cycle of the STERRAD® 100S Sterilizer
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Drug 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."

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

Image /page/3/Picture/1 description: The image shows the word "STERIS" in a bold, serif typeface. A registered trademark symbol is located to the upper right of the final "S". The text is black against a white background.

Image /page/3/Picture/2 description: The image shows a logo with a series of horizontal, curved lines stacked on top of each other. The lines are all the same color, a light blue, and they create a wave-like pattern. The logo is simple and abstract, with no text or other elements present.

510(k) Summary for VERIFY™ VH2O2 Indicator Tape

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

Anthony Piotrkowski Contact: Sr. Manager, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com

Submission Date: May 28, 2016

K160485

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

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape

Device Name 1.

Trade Name:	VERIFYTM VH2O2 Indicator Tape
Common/Usual Name:	Chemical Sterilization Process Indicator
Classification Name:	Sterilization Process Indicator(21 CFR 880.2800, JOJ)

2. Predicate Device

STERRAD® Sealsure™ Chemical Indicator Tape (K111519)

Description of Device 3.

The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.

4. Intended Use/ Indications for Use

The tape may be used in the following sterilization cycles:

. Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
Standard Cycle of the STERRAD® 100S Sterilizer ●
Standard and Advanced Cycles of the STERRAD® NX Sterilizer ●
Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX ● Sterilizer

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape

Proposed	Predicate (K111519) STERRADSEALSURE Chemical Indicator Tape	Comparison
VERIFY VH2O2 Indicator Tape
The VERIFY VH2O2 Indicator Tapeis intended to secure items wrappedin synthetic wrap materials until usedand to distinguish between processedand unprocessed units through acolor change from the start color(pink) to peach, yellow or lighter.The tape may be used in thefollowing sterilization cycles:• Non Lumen, Flexible and LumenCycles of the V-PRO 1, 1 Plus,maX and 60 Low TemperatureSterilizers• Standard Cycle of theSTERRAD® 100S Sterilizer• Standard and Advanced Cycles ofthe STERRAD® NX Sterilizer• Express, Flex Scope, Duo andStandard Cycles of the	STERRAD SEALSURE ChemicalIndicator Tape (PN 14202) is a processindicator (ISO 11140-1:2205) intendedfor use by healthcare providers to securenon-woven sterilization packs and wrapsto be sterilized in the STERRADSterilization Systems.• Standard Cycle of STERRAD 100S• Standard Cycle of STERRAD 50• Standard Cycle of STERRAD 200• Standard and Advanced Cycles ofSTERRAD NX• Standard, Flex, DUO and EXPRESSCycles of STERRAD 100NXThe color of the STERRAD SEALSUREChemical Indicator Tape changes fromred to gold (or lighter) when exposed tohydrogen peroxide and is intended todifferentiate between processed andunprocessed loads.	Both devices arechemical indicatortapes used to securepacks forsterilization inhydrogen peroxidesterilizers and toindicate through acolor change that thepacks have beenexposed to hydrogenperoxide. Testing isincluded in thissubmission todemonstrate safe andeffectiveperformance of theproposed device inthe indicated cycles.

5. Description of Safety and Substantial Equivalence

The VERIFY VH2O2 Indicator Tape has equivalent characteristics as compared to its predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Table 5.2 compares the proposed device's design to the predicate.

Characteristic	Proposed	Predicate	Comparison
Substrate	Crepe Paper	Crepe Paper	Same
Indicator	Proprietary - conformswith ISO 11140-1:2014Type 1 requirements	Proprietary - conformswith ISO 11140-1:2005Class 1 requirements	Testing included in thissubmission demonstratingperformance (See Table5.3).
Adhesive	Proprietary	Proprietary	Testing included in thissubmission demonstratingperformance (See Table5.3).
Color Change	Pink to Peach/Yellow	Red to Gold	Similar start and endpointcolors
Detection	hydrogen peroxide dose	hydrogen peroxide dose	Same
Shelf-life	3 months to beextended as real timedata allows to aprojected 24 months	22 months	Testing included in thissubmission to supportproposed device's shelf lifewhen stored under labeledconditions (See Table 5.3).
StorageConditions	16 - 24°C,30 - 60% RH	15 - 30°C,Dry Conditions

Table 5.2 Device Comparison

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape

The VERIFY VH2O2 Indicator Tape was tested in nonclinical testing. Performance of the chemical indicator, CI, was demonstrated by testing in an ANSI/AAMI/ISO 18472:2006-conforming resistometer according to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. CI performance was also tested in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions under pass and fail conditions. Endpoint stability was tested by evaluating the color of processed tape at various time points when stored at room temperature. Light stability was demonstrated by evaluating the tape after storage outside its packaging before exposure to peroxide sterilization. Tape adhesion was evaluated using ASTM adhesion standard and under simulated use conditions on wrapped loads processed through the sterilizer. Biocompatibility was demonstrated by testing peroxide residual levels of processed tape samples and Off-set testing per ANSI/AAMI/ISO 11140-1:2014. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014 and tape adhesion after various times of storage within the labeled storage conditions. Table 5.3 summarizes the testing performed to demonstrate substantial equivalence.

Test	Result
ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide ProcessIndicator Performance Testing	Pass
Simulated Use: Pass Performance Testing	Pass
Simulated Use: Fail Performance Testing	Pass
Endpoint Stability	Pass
Light Stability after Removal from Packaging	Pass
Adhesion Evaluation	Pass
Shelf Life Evaluation	Pass
Hydrogen Peroxide Residual Testing	Pass
Off-set (transference) Performance Testing	Pass

		Table 5.3 Summary of Nonclinical Tests:
--	--	-----------------------------------------	--

6. Conclusion

The VERIFY | VH2O2 Indicator Tape is substantially equivalent to the predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Based on the performance testing provided in this submission and summarized above, the subject device is as safe and as effective as the legally marketed, claimed predicate device.

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).