The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.

Device Description

The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.

AI/ML Overview

The VERIFY Chemical Indicator for S40 Sterilant is a device designed to monitor peracetic acid concentration in STERIS automated liquid chemical sterilant processing systems. Its primary function is to change color from blue to pink (through an intermediate beige) when exposed to a specific concentration of peracetic acid for a set duration and temperature.

Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Targeted Performance)	Reported Device Performance
Color change from blue through intermediate beige to pink when exposed to >1820 ppm (mg/L) peracetic acid in S40 use dilution.	The indicator changes color from blue through an intermediate beige and then to the endpoint color, pink, when exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C. The indicator may become more pink with higher concentrations.
Controlled 6-minute exposure at 45.5 - 60°C.	The indicator is designed for a controlled 6-minute exposure at 45.5 - 60°C.
Effectively monitors peracetic acid concentration for routine monitoring of STERIS automated liquid chemical sterilant processing systems.	The device passed performance tests including Comparative Sensitivity and Specificity, Analytic Specificity, and Simulated Use Testing, demonstrating its effectiveness in monitoring.
Shelf-life of 24 months.	Passed Shelf Life for 24 months testing.
Open bottle stability for 6 months.	Passed Open Bottle Stability for 6 months testing.
Robustness against environmental factors and contaminants.	Passed UV Study, Effects of Aggressive Chemicals, and Effects of Contaminants testing.
Readability of color change.	Passed Color Read Time and Blind Reader testing.

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

The document states that the performance testing was "non-clinical." It does not specify the exact sample sizes used for each test. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing as part of the 510(k) submission process. The testing appears to be retrospective due to the use of "identical predicate device" data.

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

The document mentions "Blind Reader" testing. However, it does not specify the number of experts (readers) used, nor their qualifications (e.g., years of experience, specific professional titles).

4. Adjudication Method for the Test Set:

The document does not describe the adjudication method used for the "Blind Reader" test or any other test where subjective interpretation might be involved.

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:

This device is a chemical indicator, not an AI-powered diagnostic tool for human interpretation. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

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

The VERIFY Chemical Indicator is a standalone device in the sense that its color change is a direct chemical reaction and does not involve an algorithm or human-in-the-loop for its fundamental operation. Its "performance" (color change) is inherent to the device itself. The "Blind Reader" test assesses human interpretation of this standalone indicator.

7. The Type of Ground Truth Used:

The ground truth for the performance testing appears to be based on:

Known Peracetic Acid Concentrations: Precisely controlled concentrations of peracetic acid (e.g., >1820 ppm) were used to test the indicator's color change.
Controlled Exposure Parameters: The specified temperature (45.5 - 60°C) and time (6 minutes) were controlled during testing.
Established Chemical Reactions: The mechanism of action is described as ink ingredients changing color due to oxidation.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here as the device is a chemical indicator, not a machine learning algorithm. Its performance is based on chemical properties, not learned patterns from data.

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

As there is no training set for this type of device, this question is not applicable. The device's color-changing chemistry is its inherent "mechanism."

Summary

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May 18, 2018

STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060

Re: K173428

Trade/Device Name: VERIFY Chemical Indicator for S40 Sterilant Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 31, 2018 Received: February, 2018

Dear Marcia Benedict:

This letter corrects our substantially equivalent letter of March 2, 2018.

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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Page 2 - Marcia Benedict

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); manufaceaning 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 medical devices and radiation-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/CDRHLeam). 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,

Tina Kiang
-S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173428

Device Name

VERIFY® Chemical Indicator for S40® Sterilant

Indications for Use (Describe)

The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.

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)

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Image /page/3/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and is above a symbol that looks like several horizontal wavy lines stacked on top of each other. The registered trademark symbol is to the right of the word STERIS.

510(k) Summary For VERIFY® Chemical Indicator for S40 Sterilant

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Marcia L. Benedict Senior Director, Regulatory Affairs (440) 392-7063 Telephone: (440) 357-9198 Fax No:

February 6, 2018 Submission Date:

Premarket Notification Number: K173428

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

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Device Name 1.

Trade Name:	VERIFY® Chemical Indicator for S40 Sterilant
Models:	N/A
Common Name:	Chemical Indicator.
Classification Name:	Physical/chemical sterilization process indicator
Classification	21 CFR 880.2800
Product Code	JOJ

2. Predicate Device

VERIFY® Chemical Indicator for SYSTEM 1E Processor (K102217)

3. Device Description

The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end.

The subject device is physically identical to the predicate device.

The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.

4. Intended Use

The VERIFY® Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of STERIS automated liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.

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Description of Technological Similarities and Differences ડ.

The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical.

The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of peracetic acid greater than 1820 ppm at 45.5 - 60°C during the liquid chemical sterilant processing system's standard cycle.

The more descriptive intended use statement will enable use of the VERIFY Chemical Indicator for S40 Sterilant in STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate and provide the same specific described and validated liquid chemical sterilant exposure parameters in a controlled automated cycle.

Feature	K173428 - ProposedVERIFY® ChemicalIndicator for S40 Sterilant	K102217 - PredicateVERIFY® ChemicalIndicator for SYSTEM 1EProcessor	Comparison
Intended use	The VERIFY ChemicalIndicator for S40 Sterilant is aperacetic acid concentrationindicator for routine monitoringof STERIS automated liquidchemical sterilant processingsystems that employ S40Sterilant Concentrate in acontrolled cycle.The unprocessed VERIFYChemical Indicator for S40Sterilant is blue. When exposedin a STERIS automated liquidchemical sterilant processor to aconcentration of >1820 ppm(mg/L) peracetic acid found inthe S40 use dilution during acontrolled 6-minute exposure at45.5 - 60°C, the indicatorchanges color from blue throughan intermediate beige and then tothe endpoint color, pink. Theindicator may become more pinkwhen exposed to higherperacetic acid concentrations inS40 sterilant use dilution.	The VERIFY SYSTEM 1EChemical Indicator (SYSTEM1E Chemical Indicator) is aperacetic acid concentrationindicator for routine monitoringof the SYSTEM 1E LiquidChemical Sterilant ProcessingSystem employing S40 SterilantConcentrate.The unprocessed VerifySYSTEM 1E Chemical Indicatoris blue. When exposed to aconcentration of >1820 ppm(mg/L) peracetic acid found inthe S40 use dilution, theindicator changes color fromblue through an intermediatebeige and then to the endpointcolor pink. The indicator maybecome more pink whenexposed to higher peracetic acidconcentrations in S40 usedilution.	The proposeddescriptivewordingfocuses on theS40 sterilantand the liquidchemicalsterilizationcycle exposureparametersmonitoredrather than ona specificprocessingsystem name.

Table 1. Device Comparison Table

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K173428/S001 STERIS Response to 12/29/17 Request for Additional Information VERIFY Chemical Indicator for S40 Sterilant

Feature	K173428 - ProposedVERIFY® ChemicalIndicator for S40 Sterilant	K102217 - PredicateVERIFY® ChemicalIndicator for SYSTEM 1EProcessor	Comparison
Devicedesign -components	Printed indicator ink printed ontopolypropylene overlaid with aclear, permeable laminate	Printed indicator ink printed ontopolypropylene overlaid with aclear, permeable laminate	Identical
Sterilizationmethod andcycles	Used in a liquid chemicalsterilant processing systememploying S40 SterilantConcentrate to form a usedilution concentration of ≥1820ppm (mg/L) peracetic acid andprovide 6 minutes exposure at45.5 - 60°C.	Used in a liquid chemicalsterilant processing systememploying S40 SterilantConcentrate to form a usedilution concentration of ≥1820ppm (mg/L) peracetic acid andprovide 6 minutes exposure at45.5 - 60°C.	Identical
Mechanismof action	Ink ingredients change color as aresult of oxidation, resulting inblue to beige/pink color change.	Ink ingredients change color as aresult of oxidation, resulting inblue to beige/pink color change.	Identical
Peraceticacid concen-tration forthe endpointcolor change	> 1820 mg/L PAA	> 1820 mg/L PAA	Identical
Disposable	Yes	Yes	Identical
Shelf-life	15 months;pending change to 2 years	15 months;pending change to 2 years	Identical
Open bottleshelf life	6 months	6 months	Identical

Description of Safety and Substantial Equivalence 6.

The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored by the strip are identical.

7. Performance Testing

The following table summarizes the non-clinical performance testing of the identical predicate device that has demonstrated that the product is safe and

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effective. This submission revises the product's name and its indications for use description, changes that raise no new questions of safety or effectiveness.

Testing	Results
Comparative Sensitivity and Specificity	PASS
Color Read Time	PASS
Analytic Specificity	PASS
Blind Reader	PASS
Simulated Use Testing	PASS
UV Study	PASS
Shelf Life for 24 months	PASS
Effects of Aggressive Chemicals	PASS
Effects of Contaminants	PASS
Open Bottle Stability for 6 months	PASS

8. Conclusion

The VERIFY Chemical Indicator for S40 Sterilant has met the established performance criteria. Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K102217), Class II (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).