The VERIFY® Spore Test Strip for S40 Sterilant 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 Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.

Device Description

The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends.

For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. 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 Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.

The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the VERIFY® Spore Test Strip for S40® Sterilant. This device is a biological indicator designed to assess the effectiveness of liquid chemical sterilization processes. It is important to note that this is not an AI/ML device, and therefore, several requested categories are not applicable.

Here's the breakdown based on the provided document:

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

Acceptance Criteria	Reported Device Performance (Table 1 & 2)
Population
• At manufacture	$\geq$ 1.5 x 105 cfu/strip
• After wash-off (end of cycle)	$\geq$ 1.0 x 105 cfu/strip
Resistance (at 1635 ppm PAA)
• D-value	12-26 sec
• Survival Time	$\geq$ 38 seconds
• Kill Time	$\leq$ 239 seconds
Reduced Incubation Time	24 hours
Simulated Use	PASS
Stability of Media Color	PASS
Shelf Life	PASS (for 12 months)

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

The document indicates that non-clinical testing was performed for "Simulated Use", "Stability of Media Color", "Reduced Incubation Time", and "Shelf Life for 12 months." However, the specific sample sizes used for these tests are not provided in the document.

Regarding data provenance:

Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA by STERIS Corporation located in Mentor, Ohio, USA. It can be inferred that the testing likely occurred in the USA.
Retrospective or Prospective: The testing described (simulated use, stability, reduced incubation time, shelf life) appears to be prospective laboratory-based testing designed to validate the device's performance characteristics.

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

This device is a biological indicator, not an AI/ML diagnostic device that requires expert interpretation of images or other complex data. The "ground truth" for its performance is established through microbiological methods and chemical analysis of the sterilant's effect on spores, rather than expert consensus on complex medical data.

Therefore, this question is not applicable in the context of this device.

4. Adjudication method for the test set

As the "ground truth" for this device is based on objective microbiological and chemical measurements (e.g., spore kill, population counts, D-values, color change indicating growth), an adjudication method involving multiple human experts is not applicable or described. The results (PASS/FAIL, numerical values) are determined by laboratory assays.

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 question pertains to AI/ML devices involving human readers. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device.

Therefore, this question is not applicable.

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

This question pertains to AI/ML devices. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device. While its performance is "standalone" in the sense of being an automated indicator, it does not involve an algorithm generating a diagnostic output without human input in the way a medical AI would. Users visually interpret the media color.

Therefore, this question is not applicable in the context of an AI algorithm.

7. The type of ground truth used

The ground truth used for this device is based on microbiological viability testing and chemical resistance characteristics.

Spore Kill: Demonstrated by the absence of growth (no color change) in the culture medium, indicating that the targeted 5-log reduction of Geobacillus stearothermophilus spores was achieved.
Population Counts: Directly measured in colony-forming units (CFU/strip).
Resistance Characteristics (D-value, Survival Time, Kill Time): These are experimentally determined values that quantify how resistant the spores on the strip are to the sterilant under specific conditions.
Stability of Media Color: Objective observation of the indicator color over time.

8. The sample size for the training set

This device is not an AI/ML device that requires a training set. Its performance characteristics are inherent to its biological and chemical design, validated through laboratory experiments.

Therefore, this question is not applicable.

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

This device is not an AI/ML device that requires a training set.

Therefore, this question is not applicable.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 29, 2018

Steris Corporation Marcia Benedict Senior Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K180553

Trade/Device Name: VERIFY Spore Test Strip for S40 Sterilant Regulation Number: 21 CFR 880.6887 Regulation Name: Spore Test Strip Regulatory Class: Class II Product Code: OVY Dated: February 28, 2018 Received: March 1, 2018

Dear Marcia Benedict:

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,

Geeta K. Pamidimukkala -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) K180553

Device Name VERIFY® Spore Test Strip for S40® Sterilant

Indications for Use (Describe)

The VERIFY® Spore Test Strip for S40 Sterilant 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 Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "ho growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. 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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STEF

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

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

Contact:

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

Submission Date: May 22, 2018

Premarket Notification Number: K180553

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

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1. Device Name

Trade Name:	VERIFY® Spore Test Strip for S40 Sterilant
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 – DEN110002 (K100049)

3. Device Description

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Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.

4. Intended Use:

The VERIFY® Spore Test Strip for S40 Sterilant 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 Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10° viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.

5. Technological Characteristic Comparison Table

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

The revised indication for use statement will enable use of the VERIFY Spore Test Strip for S40 Sterilant in a STERIS automated liquid chemical sterilant processor that uses S40 Sterilant Concentrate in an identical controlled cycle. This will facilitate the indicator's intended use in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.

Feature	K180553VERIFY Spore Test Stripfor S40 Sterilant	Predicate DEN110002VERIFY Spore Test Stripfor S40	Comparison
Intended use	The VERIFY® Spore Test Stripfor S40 Sterilant is intended toprovide users with a means toassess spore kill by S40 sterilantuse dilution in the STERISautomated Liquid ChemicalSterilant Processing Systems(SYSTEM 1E Liquid ChemicalSterilant Processing System andSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem).A "no growth" result from theVERIFY Spore Test Strip for S40Sterilant after 24 hours ofincubation indicates that the	The Verify Spore Test Strip forS40 is intended to provide userswith a means to assess spore killby S40 sterilant use dilution inthe SYSTEM 1E LiquidChemical Sterilant ProcessingSystem.A "no growth" result from theVERIFY Spore Test Strip forS40 after 24 hours of incubationindicates that the liquid chemicalsterilization process achieved theconditions necessary to kill atleast 1 x 105 viable spores (5logs) on the test strip. It does notconfirm the expected fullperformance of the SYSTEM 1E	The proposedrewordingdescribes thesterilant andthe liquidchemicalsterilizationcycle theSpore TestStrip assessesrather thanciting oneprocessor byname.
Feature	K180553VERIFY Spore Test Stripfor S40 Sterilant	Predicate DEN110002VERIFY Spore Test Stripfor S40	Comparison
	liquid chemical sterilizationprocess achieved the conditionsnecessary to kill at least 1 x 105viable spores (5 logs) on the teststrip. It does not confirm theexpected full performance of theliquid chemical sterilizationcycle.	Liquid Chemical SterilizationCycle.
Organism	Geobacillus stearothermophilus7953 spores	Geobacillus stearothermophilus7953 spores	Identical
Viable SporePopulation	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
LCSPS cycleparameters	• >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 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

Table 1. Device Comparison Table

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

6. Description of Spore Strip Specifications:

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

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

Table 1 demonstrates the validated populations, resistance characteristics, and reduced incubation time the predicate Spore Test Strips maintain over the product's labeled use life of 12 months when stored at 2-24°C and 30-80% relative humidity.

Value	Spore Test Strip for S40
Population
• At manufacture	$\geq$ 1.5 x 105 cfu/strip
• After wash-off (end of cycle)	$\geq$ 1.0 x 105 cfu/strip
Resistance
• D-value	12-26 sec at 1635 ppm PAA
• Survival Time	$\geq$ 38 seconds
• Kill Time	$\leq$ 239 seconds
Reduced Incubation Time	24 hours

Table 1. Spore Test Strip Specifications *

*cfu = colony forming units, ppm = parts per million, PAA = peracetic acid

7. Summary of Non-Clinical Testing

Table 2 summarizes non-clinical testing performed on the device. Based on the testing results from the simulated use, stability of media color, reduced Incubation Time, and the shelf life testing the device demonstrated it met the acceptance criteria for each test.

Table 2. Performance Testing on Predicate

Testing	Results
Simulated Use	PASS
Stability of Media Color	PASS
Reduced Incubation Time	PASS
Shelf Life for 12 months	PASS

8. 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 well as the legally marketed predicate device (DEN110002), 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.