The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.

The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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.

Device Description

The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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 provided document is a 510(k) Premarket Notification for a chemical indicator. It explicitly states in section 6, "No new testing was performed for this submission." Therefore, it does not contain the information requested regarding acceptance criteria and performance studies.

The submission is for a modification to an existing device (predicate K173428), primarily revising the product's name, indications for use, and labeling to list specific liquid chemical processing systems where the Chemical Indicator (CI) can be used. The FDA's determination of substantial equivalence is based on the argument that these changes "raise no new questions of safety or effectiveness."

To answer your request, here's what can be extracted and what cannot:

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

This information is not provided in the document because no new performance testing was conducted for this specific submission. The document relies on the performance of the predicate device. However, the document does describe the performance characteristics of the device if new testing had been conducted.

Acceptance Criteria (Inferred from intended use)	Reported Device Performance (Inferred from device description, not new testing)
Color Change Threshold: Indicator changes color when exposed to ≥1820 ppm (mg/L) peracetic acid (PAA) in S40 use dilution.	Color Change Performance: Changes color from blue, through intermediate beige, to pink endpoint when exposed to >1820 ppm (mg/L) peracetic acid in S40 use dilution. The indicator may become more pink with higher PAA concentrations.
Exposure Conditions: Color change occurs during a controlled 6-minute exposure at 45.5 - 60°C in STERIS automated liquid chemical sterilant processors (SYSTEM 1E® and SYSTEM 1® endo).	Exposure Conditions Performance: Color change occurs under the specified conditions (6-minute exposure at 45.5 - 60°C) within the SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems.
Initial Color: Unprocessed indicator is blue.	Initial Color Performance: The unprocessed Chemical Indicator is blue.
Shelf-life: 2 years.	Shelf-life Performance: 2 years (Identical to predicate).
Open bottle shelf-life: 6 months.	Open bottle shelf-life Performance: 6 months (Identical to predicate).
Mechanism of Action: Bleaching of lissamin green B dye as a result of oxidation, leading to blue to beige/pink color change. (This is a design characteristic rather than an acceptance criterion in the traditional sense, but important for its function)	Mechanism of Action Performance: Achieved through bleaching of lissamine green B dye as a result of oxidation (Identical to predicate).

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

This information is not provided as no new testing was performed.

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 provided as no new testing was performed.

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

This information is not provided as no new testing was performed.

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 is not applicable. The device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a chemical indicator, not an algorithm. Its "standalone" performance would be its ability to change color correctly, which is the basis of its function. The document states its performance is identical to the predicate device.

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

This information is not explicitly provided for new testing, as no new testing was performed. For the original predicate device, the "ground truth" for a chemical indicator would typically be established by precise analytical measurements of peracetic acid concentration in the sterilant solution, confirmed by laboratory methods (e.g., titration or spectrophotometry), and correlated with the visual color change of the indicator.

8. The sample size for the training set

This information is not provided as no new testing was performed. The device is a chemical indicator, not a machine learning model that requires a training set in the typical sense.

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

This information is not provided as no new testing was performed and it's not a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

December 8, 2023

Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060

Re: K233654

Trade/Device Name: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 14, 2023 Received: November 14, 2023

Dear Anthony 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233654

Device Name

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

Indications for Use (Describe)

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

510(k) Summary For VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Tony Piotrkowski Contact: Director, Regulatory Affairs (440) 392-7437 Telephone: Email: tony piotrkowski@steris.com

Submission Date: December 7, 2023

Premarket Notification Number; K233654

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

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

1. Device Name

Trade Name:	VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM1® endo Liquid Chemical Sterilant Processing Systems
Models:	LCC016
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 (K173428)

3. Device Description

4. Intended Use/Indications for Use:

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ડ. Description of Technological Characteristics

The proposed device and its predicate are physically identical. The more descriptive intended use statement will identify use of the Chemical Indicator in specific STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate. This includes the indicator's intended use in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.

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.

Feature	Proposed VERIFY® ChemicalIndicator for SYSTEM 1E® andSYSTEM 1® endo Liquid ChemicalSterilant Processing Systems	Predicate K173428VERIFY Chemical Indicator forS40 Sterilant	Comparison
Intended use	The VERIFY® Chemical Indicator forSYSTEM 1E® and SYSTEM 1® endoLiquid Chemical Sterilant ProcessingSystems is a peracetic acid concentrationindicator for routine monitoring of SYSTEM1E® and SYSTEM 1® endo LiquidChemical Sterilant Processing Systems thatemploy S40 Sterilant Concentrate in acontrolled cycle.The unprocessed Chemical Indicator forSYSTEM 1E® and SYSTEM 1® endoLiquid Chemical Sterilant ProcessingSystems is blue. When exposed in a STERISautomated liquid chemical sterilant processorto a concentration of >1820 ppm (mg/L)peracetic acid found in the S40 use dilutionduring a controlled 6-minute exposure at45.5 - 60℃, the indicator changes colorfrom blue through an intermediate beige andthen to the endpoint color, pink. Theindicator may become more pink whenexposed to higher peracetic acidconcentrations in S40 sterilant use dilution.	The VERIFY® Chemical Indicator forS40 Sterilant is a peracetic acidconcentration indicator for routinemonitoring of STERIS automated liquidchemical sterilant processing systemsthat employ S40 Sterilant Concentratein a controlled cycle.The unprocessed VERIFY® ChemicalIndicator for S40 Sterilant is blue.When exposed in a STERIS automatedliquid chemical sterilant processor to aconcentration of >1820 ppm (mg/L)peracetic acid found in the S40 usedilution during a controlled 6-minuteexposure at 45.5 - 60°C, the indicatorchanges color from blue through anintermediate beige and then to theendpoint color, pink. The indicator maybecome more pink when exposed tohigher peracetic acid concentrations inS40 sterilant use dilution.	The proposedrewordingfocuses on thespecificprocessorswhich the CIis intended tomonitor.

Table 1. Device Comparison Table for Modified Chemical Indicator and Predicate

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

Feature	Proposed VERIFY® ChemicalIndicator for SYSTEM 1E® andSYSTEM 1® endo Liquid ChemicalSterilant Processing Systems	Predicate K173428VERIFY Chemical Indicator forS40 Sterilant	Comparison
Device design -components	Printed indicator ink printed ontopolypropylene overlaid with a clear,permeable laminate	Printed indicator ink printed ontopolypropylene overlaid with a clear,permeable laminate	Identical
Indicator agent	Lissamine green B (active dye) and savinylorange (background dye)	Lissamine green B (active dye) andsavinyl orange (background dye)	Identical
Mechanism ofaction	Bleaching of lissamine green B dye as aresult of oxidation, resulting in blue tobeige/pink color change.	Bleaching of lissamine green B dye as aresult of oxidation, resulting in blue tobeige/pink color change.	Identical
Peracetic acidconcentrationfor the endpointcolor change	> 1820 mg/L PAA	> 1820 mg/L PAA	Identical
Disposable	Yes	Yes	Identical
Shelf-life	2 years	2 years	Identical
Open bottleshelf life	6 months	6 months	Identical

6. Performance Testing

No new testing was performed for this submission. This submission revises the product's name, indications for use and, consequently, labeling to list specific liquid chemical processing systems where the CI can be used, changes that raise no new questions of safety or effectiveness.

7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K173428), 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).