The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

Device Description

The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60℃ for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "VERIFY Spore Test Strip for S40 Sterilant Concentrate." This submission is for a device that already has a predicate (K180553) and the main change is an expansion of its indications for use to include a new processing system, the "enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS)."

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to demonstrate that the expanded use of the spore test strip in the new system is safe and effective, performing as well as the previous approved uses.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful outcomes ("PASS") of the performance tests, demonstrating that the device functions appropriately under the new use conditions. The "performance" is the conclusion that the device passed these tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Population Wash Off Stability: Evaluate the population of the spores remaining on the STS after processing without sterilant.	PASS (Demonstrated that the population of spores remaining on the STS after processing without sterilant was acceptable.)
Simulated Use: Demonstrate the STS functions appropriately in the enspire CLCSPS.	PASS (Demonstrated that the STS functions appropriately in the enspire CLCSPS.)
Bacteriostasis: Ensure no inhibitory effects on the outgrowth of a low number of spores.	PASS (Demonstrated no inhibitory effects on the outgrowth of a low number of spores.)

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes (e.g., number of strips, number of runs) used for each of the performance tests (Population Wash Off Stability, Simulated Use, Bacteriostasis).

Data Provenance: The study was conducted by STERIS Corporation, an American company (Mentor, Ohio). Given the context of a 510(k) submission to the FDA, the data would have been generated in a controlled environment to meet regulatory standards. The document does not specify whether the data was retrospective or prospective, but performance testing for a 510(k) generally involves prospective testing of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of device (spore test strip for sterilant efficacy) does not typically involve human expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. Ground truth is established through laboratory methods (e.g., microbial growth/no growth, quantitative spore counts). Therefore, the concept of "experts" for ground truth establishment in the human-in-the-loop sense, or their qualifications, is not applicable directly to this device. Competent laboratory personnel would conduct and interpret the tests according to established protocols.

4. Adjudication method for the test set

Adjudication methods (like 2+1, 3+1) are common in clinical studies involving human interpretation or subjective assessments. For a biological indicator like a spore test strip, the results (growth/no growth, quantitative counts) are objective, and adjudication is not typically applied in the same manner. The outcome is determined by the presence or absence of growth and quantitative measurements.

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

An MRMC study is not applicable to this device. This is not an AI diagnostic device that assists human readers. It is a biological indicator for sterilization processes.

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

The device itself is a standalone biological indicator. It provides a result (growth/no growth) based on a biological process (spore killing by sterilant and subsequent incubation). There is no "algorithm" in the sense of artificial intelligence. The device's performance is its ability to accurately reflect the 5-log kill of spores under specified conditions. The performance tests ("Population Wash Off Stability," "Simulated Use," "Bacteriostasis") directly evaluate this standalone performance.

7. The type of ground truth used

The ground truth for this device is based on biological and chemical efficacy.

Biological Efficacy: The primary ground truth is the presence or absence of Geobacillus stearothermophilus growth after exposure to the sterilant and incubation, indicating whether a 5-log reduction of spores has occurred. This is a direct measure of microbial inactivation.
Chemical/Physical Parameters: The ground truth also relates to the specific conditions of the sterilization process (e.g., PAA concentration, temperature, time) as defined for the sterilant and the processing systems.

8. The sample size for the training set

This device does not involve machine learning or AI, and therefore, there is no "training set" in the typical sense for algorithms. The "training" of the product's design would be based on historical data, prior knowledge of sterilant efficacy, and established microbiological methods for biological indicators, rather than a data set used to train a predictive model.

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

As there is no training set for an AI algorithm, this question is not applicable. The underlying scientific principles for spore test strips and sterilization efficacy are well-established through decades of microbiological and chemical research. The "ground truth" for the development of such a device is rooted in these scientific principles and standard test methods (e.g., those from AAMI, ISO).

Summary

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September 11, 2023

Steris Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Rd Mentor, Ohio 44060

Re: K231746

Trade/Device Name: VERIFY Spore Test Strip for S40 Sterilant Concentrate Regulation Number: 21 CFR 880.6887 Regulation Name: Spore Test Strip Regulatory Class: Class II Product Code: OVY Dated: June 15, 2023 Received: June 15, 2023

Dear Gregory Land:

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. 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 located 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.

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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231746

Device Name VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE

Indications for Use (Describe)

The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

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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510(k) Summary For VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE K231746

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Gregory Land Lead Regulatory Affairs Specialist (440) 392-7424 Telephone: Email: greg land@steris.com

Submission Date: June 15, 2023

Submission Number: K231746

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

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT

Device Name 1.

Trade Name:	VERIFY Spore Test Strip for S40 Sterilant Concentrate
Models:	N/A
Common Name:	Spore Test Strip
Classification Name:	Liquid Chemical Processing System
Classification	21 CFR 880.6887
Product Code	OVY

2. Predicate Device

VERIFY Spore Test Strip for S40 Sterilant - K180553

3. Device Description

There are no changes to the strip itself for this submission: only the indications for use and consequently, labeling are changing to include the Spore Test Strip's use in the STERIS enspire CLCSPS, which uses S40 Sterilant Concentrate.

4. Intended Use/Indications for Use:

The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant Concentrate use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process

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achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

ട്. Description of Technological Similarities and Differences

The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical. Table 1 summarizes the predicate and subject device comparison in tabular format.

The revised indications for use statement will enable use of the VERIFY Spore Test Strip for S40 Sterilant Concentrate in the enspire CLCSPS which uses S40 Sterilant Concentrate with critical parameters identical to those in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, previously cleared for use with the STS.

Feature	ProposedVERIFY Spore Test Strip for S40Sterilant Concentrate	Predicate K180553VERIFY Spore Test Strip for S40	Comparison
Intendeduse/Indicationsfor Use	The VERIFY Spore Test Strip for S40Sterilant Concentrate is intended toprovide users with a means to assessspore kill by S40 Sterilant Concentrateuse dilution in the STERIS automatedLiquid Chemical Sterilant ProcessingSystems (SYSTEM 1E and SYSTEM1®endo Liquid Chemical SterilantProcessing Systems and enspire 3000Series Cleaning and Liquid ChemicalSterilant Processing System). A “nogrowth” result from the VERIFY SporeTest Strip for S40 Sterilant Concentrateafter 24 hours of incubation indicates thatthe liquid chemical sterilization processachieved the conditions necessary to killat least 1 x $10^5$ viable spores (5 logs) onthe spore test strip (STS). It does notconfirm the expected full performance ofthe liquid chemical sterilization cycle.	The VERIFY® Spore Test Strip forS40 Sterilant is intended to provideusers with a means to assess spore killby S40 sterilant use dilution in theSTERIS automated Liquid ChemicalSterilant Processing Systems(SYSTEM 1E Liquid ChemicalSterilant Processing System andSYSTEM 1 endo Liquid ChemicalSterilant Processing System). A "nogrowth" result from the VERIFYSpore Test Strip for S40 Sterilant after24 hours of incubation indicates thatthe liquid chemical sterilizationprocess achieved the conditionsnecessary to kill at least 1 x 10E5viable spores (5 logs) on the test strip.It does not confirm the expected fullperformance of the liquid chemicalsterilization cycle.	The proposedIndications foruse are expandedto include theenspireCLCSPS. TheIndications havebeen altered toinclude theenspireprocessor as wellas the previouslyclearedprocessors. Thewords"Concentrate"and "spore" areinserted into theproposedIndications toensure precisionincommunication.
Organism	Geobacillus stearothermophilus 7953spores	Geobacillus stearothermophilus 7953spores	Identical

Table 1. Device Comparison Table

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION
VERIFY® SPORE TEST STRIP FOR S40 STERILANT

Feature	ProposedVERIFY Spore Test Strip for S40Sterilant Concentrate	Predicate K180553VERIFY Spore Test Strip for S40	Comparison
ViableSporePopulation	At manufacture: ≥1.5 x 105 CFUPost-Builders: ≥ 1.0 x 105 CFU	At manufacture: ≥1.5 x 105 CFUPost-Builders: ≥ 1.0 x 105 CFU	Identical
Resistancecharacteristics	At 1635 ppm PAA:• D-value 12 – 26 seconds• Survival Time ≥ 38 seconds• Kill Time ≥ 239 seconds	At 1635 ppm PAA:• D-value 12 – 26 seconds• Survival Time ≥ 38 seconds• Kill Time ≥ 239 seconds	Identical
LCSPScycleparameters	• >1820 mg/L PAA• 6 minutes• 45.5 – 60°C	• >1820 mg/L PAA• 6 minutes• 45.5 - 60°C	Identical
CultureConditions	• Trypticase Soy Broth Based Media• Incubation Temp.: 55-60°C• Incubation Time: 24 hours minimum;up to 7 days	• Trypticase Soy Broth Based Media• Incubation Temp: 55-60°C• Incubation Time: 24 hoursminimum; up to 7 days	Identical
CarrierMaterial	Filter paper	Filter paper	Identical
PrimaryPackaging	• 20 BIs in Glassine• 20 Media Vials	• 20 BIs in Glassine• 20 Media Vials	Identical
Shelf Life	12 months	12 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.

This submission revises the product's indications for use and consequently, labeling, expanding its indications for use to include the enspire CLCSPS that provides identical S40 Sterilant Concentrate exposure conditions in a unique flow pattern.

7. Performance Testing

While the sterilant exposure conditions in the enspire are identical to the sterilant exposure conditions in the previously cleared processors, the flow rates the STS are exposed to are different. Testing, described in this submission, was undertaken to ensure safety and efficacy in the enspire CLCSPS. Refer to Table 2.

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Testing	Summary	Conclusion
Population Wash OffStability	Evaluate the population of the sporesremaining on the STS after processingwithout sterilant.	PASS
Simulated Use	Demonstrate the STS functions appropriatelyin the enspire CLSPS.	PASS
Bacteriostasis	Ensure no inhibitory effects on the outgrowthof a low number of spores.	PASS

Table 2. Performance Testing on Subject Device

Conclusion 8.

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 well as the legally marketed predicate device (K180553), Class II (CFR 880.6887), product code OVY.

Regulation Number and Section

§ 880.6887 Spore test strip.

(a)
Identification. The spore test strip consists of a carrier or strip with a known number of spores, at least 5 log10 per strip, of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip after the specified predetermined incubation period indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores on the test strip which is 5 log10 spores/strip; it does not confirm the expected full performance of the liquid chemical sterilant processing cycle because full performance is a 6 log10 spore kill in a full liquid chemical sterilization cycle.(b)
Classification. Class II (special controls). The special controls for this device are:(1)
Spore strip characterization. (i) Population of viable spores on strip shall be a minimum of 5 log10 after physical wash off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.(ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.
(iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated.
(iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.
(2)
Simulated Use Testing. Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.(3)
Labeling. Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a “no growth” result.