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 VERIFY™ VH2O2 Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterlizers
· 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 provided document is a 510(k) summary for the VERIFY™ VH2O2 Indicator Tape, a Class II medical device (Sterilization Process Indicator). It details the device's characteristics and compares it to a predicate device (VERIFY™ VH2O2 Indicator Tape, K160485) to demonstrate substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of formal acceptance criteria with specific numerical targets. However, it implies acceptance based on compliance with standards and successful performance in specific tests. The key performance indicators evaluated are:

Acceptance Criteria (Implied)	Reported Device Performance
Conforms to ISO 11140-1:2014 Type 1 requirements	"Proprietary - conforms with ISO 11140-1:2014 Type 1 requirements"
Distinguishes between processed and unprocessed units	"color change from the start color (pink) to peach, yellow or lighter"
Maintains performance in "Fast Non Lumen Cycle" of V-PRO maX 2	"Simulated Use Testing in Fast Non Lumen Cycle" resulted in "Pass"
Maintains performance over an 18-month shelf-life	"Stability Testing for 18 month Shelf Life" resulted in "Pass"
Consistent adhesive performance	"Testing included in this submission demonstrating" (adhesive performance)
Endpoint color stability	"endpoint color stability" tested during shelf-life
Biocompatibility	Referenced from predicate device (K160485)
Light stability	Referenced from predicate device (K160485)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes (e.g., number of indicator tapes tested) for the simulated use testing or stability testing. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

The testing for the current submission focused on:

"performance was tested in the V-PRO maX 2's Fast Non Lumen Cycle with loads under simulated use conditions under pass and fail conditions."
"Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014, endpoint color stability and tape adhesion after various times of storage within the labeled storage conditions."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the VERIFY™ VH2O2 Indicator Tape. This device is a chemical indicator that undergoes a physical color change. Its performance is evaluated objectively against chemical parameters and color charts, not through expert interpretation of complex medical images or diagnoses. Therefore, there's no mention of experts establishing a "ground truth" in the way it would be for a diagnostic AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the device's performance is based on a direct chemical reaction resulting in a color change, which is evaluated against established physical criteria (e.g., an industry standard color chart or specific chemical exposure levels), rather than subjective interpretation requiring adjudication.

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

Not applicable. The VERIFY™ VH2O2 Indicator Tape is a standalone chemical indicator, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

The device is inherently a "standalone" indicator. Its performance is entirely determined by its chemical reaction to hydrogen peroxide and the resulting color change, without any human-in-the-loop interaction beyond observation. The reported "Simulated Use Testing" and "Stability Testing" are essentially standalone performance evaluations of the indicator tape itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance relies on objective chemical and physical parameters as defined by:

ANSI/AAMI/ISO 11140-1:2014 Type 1 requirements: This standard defines the performance characteristics for process indicators, including the specific conditions (e.g., concentration of sterilant, temperature) under which the indicator must change color, and the expected color change.
Sterilization cycle parameters: The device is tested against the actual sterilization cycles of specific sterlizers (e.g., V-PRO maX 2, STERRAD 100S, STERRAD NX, STERRAD 100 NX) under "pass and fail conditions." The "ground truth" here is whether the sterilization process itself was successful or not, based on the validated parameters of the sterilizer, and whether the indicator accurately reflected that state.
Visual color change: The ground truth for distinguishing processed from unprocessed units is the observed color change from pink to peach, yellow, or lighter. This is a direct physical observable.

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not a machine learning or AI algorithm that requires a "training set." Its design and performance are based on chemical engineering and adherence to international standards, not data-driven learning.

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

Not applicable, for the same reason as point 8.

Summary

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February 9, 2018

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

Re: K172753

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: January 9, 2017 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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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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) K172753

Device Name VERIFY VH2O2 Indicator Tape

Indications for Use (Describe)

The tape may be used in the following sterilization cycles:

Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterlizers
· 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)

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STERIS®

Image /page/3/Picture/2 description: The image shows a blue graphic of six horizontal lines that are curved. The lines are stacked on top of each other, with the top line having the smallest curve and the bottom line having the largest curve. The lines are all the same thickness and color, and they are evenly spaced apart.

510(k) Summary for VERIFY™ VH2O2 Indicator Tape K172753

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

Contact: Bill Brodbeck Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198 E-mail: William_brodbeck@steris.com

Submission Date: September 11, 2017

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

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

Device Name 1.

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

Predicate Device 2.

VERIFYTM VH2O2 Indicator Tape (K160485)

3. Description of Device

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

Intended Use/ Indications for Use 4.

The tape may be used in the following sterilization cycles:

Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 . Plus, maX, 60 and maX 2 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

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

Table 5.1 Indications for Use Comparison
Proposed	Predicate (K160485)	Comparison
VERIFY VH2O2 Indicator Tape	VERIFY VH2O2 Indicator Tape
The VERIFYTM VH2O2 IndicatorTape is intended to secure itemswrapped in synthetic wrap materialsuntil used and to distinguishbetween processed and unprocessedunits through a color change fromthe start color (pink) to peach,yellow or lighter. The VERIFYTMVH2O2 Indicator Tape is alsointended to be used as an externalprocess indicator when applied tosynthetic wrap materials and/orTyvek pouches.The tape may be used in thefollowing sterilization cycles:Non Lumen, Flexible, Lumenand Fast Non Lumen Cycles ofthe V-PRO 1, 1 Plus, maX, 60and maX 2 Sterilizers Standard Cycle of theSTERRAD® 100S Sterilizer Standard and Advanced Cyclesof the STERRAD® NXSterilizer Express, Flex Scope, Duo andStandard Cycles of theSTERRAD® 100 NX Sterilizer	The VERIFY VH2O2 Indicator Tape isintended to secure items wrapped insynthetic wrap materials until used andto distinguish between processed andunprocessed units through a colorchange from the start color (pink) topeach, yellow or lighter.The tape may be used in the followingsterilization cycles:Non Lumen, Flexible and LumenCycles of the V-PRO 1, 1 Plus, maXand 60 Low Temperature Sterilizers Standard Cycle of the STERRAD®100S Sterilizer Standard and Advanced Cycles of theSTERRAD® NX Sterilizer Express,Flex Scope, Duo and StandardCycles of the STERRAD® 100 NXSterilizer	The Indications forUse has beenmodified in theproposed device inorder to include theFast Non LumenCycle of the V-PROmaX 2 device.The proposed devicealso includes thestatement that theVERIFYTM VH2O2Indicator Tape isalso intended to beused as an externalprocess indicatorwhen applied tosynthetic wrapmaterials and/orTyvek pouches.

5. Description of Safety and Substantial Equivalence

The VERIFY VH2O2 Indicator Tape has equivalent characteristics as compared to its predicate device. 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 ISO11140-1:2014 Type1 requirements	Proprietary -conforms with ISO11140-1:2014 Type1 requirements	Same
Adhesive	Proprietary	Proprietary	Testing included in thissubmissiondemonstrating

Table 5.2 Device Comparison

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

Characteristic	Proposed	Predicate	Comparison
			performance (See Table5.3).
Color Change	Pink toPeach/Yellow	Pink toPeach/Yellow	Same
Detection	hydrogenperoxide dose	hydrogen peroxidedose	Same
Shelf-life	18 months	18 months	Same
Storage Conditions	16 - 24°C,30 - 60% RH	16 - 24°C30 - 60% RH	Testing included in thissubmission to supportproposed device's shelflife when stored underlabeled conditions (SeeTable 5.3).

Since the VERIFY | VH2O2 Indicator Tape is identical to the predicate device, prior nonclinical testing (K160485) is referenced in this submission to support performance of the chemical indicator in accordance to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. Furthermore, since the proposed device is identical to the proposed device, testing was provided in K160485 addresses endpoint stability, light stability, biocompatibility and adhesion. To demonstrate that the CI performs appropriately according to the proposed device's expanded claims, performance was tested in the V-PRO maX 2's Fast Non Lumen Cycle with loads under simulated use conditions under pass and fail conditions. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014, endpoint color stability and tape adhesion after various times of storage within the labeled storage conditions. Table 5.3 summarizes the testing performed in the current submission.

Table 5.3 Summary of Nonclinical Tests:

Test	Result
Simulated Use Testing in Fast Non Lumen Cycle	Pass
Stability Testing for 18 month Shelf Life	Pass

6. 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 K160485, 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).