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°C 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.

There are no changes to the strip itself for this submission; only an expansion to the exposure time to the chemical sterilant.

AI/ML Overview

The provided document, an FDA 510(k) Premarket Notification summary for the "VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE," details the acceptance criteria and the study proving the device meets these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and the Reported Device Performance:

The primary acceptance criteria for this device revolve around demonstrating its continued performance as a spore test strip, specifically that the expansion of contact time with the liquid chemical sterilant does not negatively impact its ability to accurately assess spore kill.

Test	Acceptance Criteria	Result
Population Wash Off Testing	The modification does not affect the performance of the device.	Pass
Bacteriostasis Testing	The modification does not affect the performance of the device.	Pass
Implied Performance Criteria (from Intended Use & Predicate Comparison):
Ability to indicate ≥ 5 logs kill of Geobacillus stearothermophilus spores	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).	Demonstrated as substantially equivalent to predicate, which has this capability.
Shelf Life	12 months	Identical to predicate.
Resistance Characteristics (at 1635 ppm PAA)	D-value 12 – 26 seconds; Survival Time ≥ 38 seconds; Kill Time ≥ 239 seconds	Identical to predicate.

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

The document does not explicitly state the numerical sample size for the "Population Wash Off Testing" and "Bacteriostasis Testing." It only indicates that these tests were performed and passed.

The data provenance is implied to be prospective testing conducted by the manufacturer, STERIS Corporation, in support of this 510(k) submission. The country of origin of the data is not specified, but given that STERIS Corporation is based in Mentor, Ohio, USA, it is highly probable the testing was conducted in the USA.

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

This information is not provided in the document. The nature of these tests (Population Wash Off and Bacteriostasis Testing for a biological indicator) suggests laboratory-based assessments rather than expert interpretation of complex medical images, therefore, detailed information on expert consensus is not typically required or provided for this type of device.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For the type of testing described (objective laboratory assays), an adjudication method like 2+1 or 3+1 for human readers is not applicable. The results are likely determined by predefined laboratory protocols and measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images. The device in question is a biological indicator for sterilization monitoring, not a diagnostic imaging device.

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

Yes, in essence. The "Population Wash Off Testing" and "Bacteriostasis Testing" are standalone tests of the device's physical and biological integrity and performance characteristics, independent of human interpretation beyond reading the final culture results (growth/no growth). The device itself functions as a standalone indicator of sterilization efficacy.

7. The Type of Ground Truth Used:

The ground truth for the performance of this device is established by:

Laboratory Testing: Directly measuring the Population Wash Off (the number of viable spores remaining on the strip after specified processing) and Bacteriostasis (the absence of inhibitory substances affecting subsequent bacterial growth).
Biological Efficacy: The ultimate ground truth for a spore test strip is its ability to accurately reflect the killing of the specified 5 logs of Geobacillus stearothermophilus spores, as confirmed by standard microbiological culture methods (absence of growth after incubation).

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a biological indicator, not a machine learning or AI model that requires training data.

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

This information is not applicable. As stated above, this device does not involve a training set as it is not an AI/ML model.

Summary

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December 15, 2023

STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K233682

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: November 16, 2023 Received: November 16, 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 (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.

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233682

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 liguid chemical sterilization cvcle.

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."

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510(k) Summary For K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE

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

Gregory Land Contact Lead Regulatory Affairs Specialist (440) 392-7424

Summary Date December 13, 2023

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

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1. Device Name

Trade Name:

Device Classification: Common Name: Classification Name: Classification Panel: Classification Number: Product Code

VERIFY Spore Test Strip for S40 Sterilant Concentrate II Spore Test Strip Liquid Chemical Processing System General Hospital and Personal Use Devices Panel 21 CFR 880.6887 OVY

2. Predicate Device

VERIFY Spore Test Strip for S40 Sterilant - K231746

Device Description 3.

There are no changes to the strip itself for this submission; only an expansion to the exposure time to the chemical sterilant.

4. Intended 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 achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on

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the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

ട. Technological Characteristic Comparison Table

The modified device and its predicate are physically identical. The only difference is the modified device has an expanded contact time with the liquid chemical sterilant. Table 1 summarizes the predicate and subject device comparison in tabular format.

Table 1. Device Comparison Table
Feature	ModifiedVERIFY Spore Test Strip forS40 Sterilant Concentrate	Predicate K231746VERIFY Spore Test Strip forS40 Sterilant Concentrate	Comparison
Intendeduse	The VERIFY Spore Test Strip forS40 Sterilant Concentrate isintended to provide users with ameans to assess spore kill by S40Sterilant use dilution in theSTERIS automated LiquidChemical Sterilant ProcessingSystems (SYSTEM 1E andSYSTEM 1®endo LiquidChemical Sterilant ProcessingSystems and enspire 3000 SeriesCleaning and Liquid ChemicalSterilant Processing System). A"no growth" result from theVERIFY Spore Test Strip for S40Sterilant Concentrate after 24hours of incubation indicates thatthe liquid chemical sterilizationprocess achieved the conditionsnecessary to kill at least 1 x 105viable spores (5 logs) on the sporetest strip (STS). It does notconfirm the expected fullperformance of the liquid chemicalsterilization cycle.	The VERIFY Spore Test Strip forS40 Sterilant Concentrate isintended to provide users with ameans to assess spore kill by S40Sterilant use dilution in theSTERIS automated LiquidChemical Sterilant ProcessingSystems (SYSTEM 1E andSYSTEM 1®endo LiquidChemical Sterilant ProcessingSystems and enspire 3000 SeriesCleaning and Liquid ChemicalSterilant Processing System). A"no growth" result from theVERIFY Spore Test Strip for S40Sterilant Concentrate after 24hours of incubation indicates thatthe liquid chemical sterilizationprocess achieved the conditionsnecessary to kill at least 1 x 105viable spores (5 logs) on the sporetest strip (STS). It does notconfirm the expected fullperformance of the liquid chemicalsterilization cycle.	Identical
Organism	Geobacillus stearothermophilus7953 spores	Geobacillus stearothermophilus7953 spores	Identical
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

Table 1. Device Comparison Table

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

Feature	ModifiedVERIFY Spore Test Strip forS40 Sterilant Concentrate	Predicate K231746VERIFY Spore Test Strip forS40 Sterilant Concentrate	Comparison
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 (+ up to 9 minute and30 second Warm/Mix Phase)• 45.5 - 60°C	• >1820 mg/L PAA• 6 minutes• 45.5-60°C	Similar
CultureConditions	• Trypticase Soy Broth BasedMedia• Incubation Temp.: 55-60°C• Incubation Time: 24 hoursminimum; up to 7 days	• Trypticase Soy Broth BasedMedia• 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

6. Summary of Non-Clinical Testing

Shown in Table 2 is the new testing which was performed to evaluate the modified device.

Table 2. Summary of verification activities.

Test	Acceptance Criteria	Result
Population Wash OffTesting	The modification does not affect theperformance of the device.	Pass
Bacteriostasis Testing	The modification does not affect theperformance of the device.	Pass

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K231746), Class II (21 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.