VERIFY Spore Test Strip for S40 Sterilant

K180553 · STERIS Corporation · OVY · May 29, 2018 · General Hospital

Device Facts

• Record ID: K180553
• Device Name: VERIFY Spore Test Strip for S40 Sterilant
• Applicant: STERIS Corporation
• Product Code: OVY · General Hospital
• Decision Date: May 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6887
• Device Class: Class 2

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 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.

Device Story

Biological indicator for monitoring liquid chemical sterilization cycles; consists of filter paper strip inoculated with Geobacillus stearothermophilus spores in glassine envelope. User places strip in processor tray using transfer clip; initiates sterilization cycle. Post-cycle, user aseptically transfers strip into vial of modified tryptic soy broth with phenol red pH indicator. Incubated at 55-60°C for 24 hours. Result interpretation: red/non-turbid media indicates pass (spore kill achieved); yellow/turbid media indicates fail. Used in clinical settings to verify sterilization conditions; provides qualitative assessment of spore kill (5-log reduction). Does not confirm full cycle performance.

Clinical Evidence

Bench testing only. Performance validated via simulated use, media color stability, reduced incubation time, and 12-month shelf life testing. All tests met acceptance criteria.

Technological Characteristics

Filter paper carrier inoculated with Geobacillus stearothermophilus (≥1.0 x 10^5 CFU post-processing). Media: modified tryptic soy broth with phenol red. Incubation: 55-60°C. Shelf life: 12 months at 2-24°C, 30-80% RH. No electronic components or software.

Indications for Use

Indicated for users of STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo) to assess spore kill by S40 sterilant use dilution. Not intended to confirm full performance of the sterilization cycle.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the Steris Verify Spore Test Strip for S40 for use in the Steris System 1E Liquid Chemical Sterilant Processing System is subject to the following special controls to provide reasonable assurance of the safety and effectiveness of the device type of Spore Test Strip: - (1) Spore Strip Characterization - Population of viable spores on strip shall be a minimum of 5 log10 after 1. 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.

Predicate Devices

• VERIFY Spore Test Strip for S40 (DEN110002/K100049)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax No: [phone]

Contact:

Marcia L. Benedict Senior Director, Regulatory Affairs Telephone: [phone] Fax No: [phone]

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

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

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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 | K180553<br>VERIFY Spore Test Strip<br>for S40 Sterilant | Predicate DEN110002<br>VERIFY Spore Test Strip<br>for S40 | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY® Spore Test Strip<br>for S40 Sterilant is intended to<br>provide users with a means to<br>assess spore kill by S40 sterilant<br>use dilution in the STERIS<br>automated Liquid Chemical<br>Sterilant Processing Systems<br>(SYSTEM 1E Liquid Chemical<br>Sterilant Processing System and<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System).<br>A "no growth" result from the<br>VERIFY Spore Test Strip for S40<br>Sterilant after 24 hours of<br>incubation indicates that the | The Verify Spore Test Strip for<br>S40 is intended to provide users<br>with a means to assess spore kill<br>by S40 sterilant use dilution in<br>the SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System.<br>A "no growth" result from the<br>VERIFY Spore Test Strip for<br>S40 after 24 hours of incubation<br>indicates that the liquid chemical<br>sterilization process achieved the<br>conditions necessary to kill at<br>least 1 x 105 viable spores (5<br>logs) on the test strip. It does not<br>confirm the expected full<br>performance of the SYSTEM 1E | The proposed<br>rewording<br>describes the<br>sterilant and<br>the liquid<br>chemical<br>sterilization<br>cycle the<br>Spore Test<br>Strip assesses<br>rather than<br>citing one<br>processor by<br>name. |
| Feature | K180553<br>VERIFY Spore Test Strip<br>for S40 Sterilant | Predicate DEN110002<br>VERIFY Spore Test Strip<br>for S40 | Comparison |
| | liquid chemical sterilization<br>process achieved the conditions<br>necessary to kill at least 1 x 105<br>viable spores (5 logs) on the test<br>strip. It does not confirm the<br>expected full performance of the<br>liquid chemical sterilization<br>cycle. | Liquid Chemical Sterilization<br>Cycle. | |
| Organism | Geobacillus stearothermophilus<br>7953 spores | Geobacillus stearothermophilus<br>7953 spores | Identical |
| Viable Spore<br>Population | At manufacture: ≥1.5 x 105 CFU<br>Post-Builders: ≥ 1.0 x 105 CFU | At manufacture: ≥1.5 x 105 CFU<br>Post-Builders: ≥ 1.0 x 105 CFU | Identical |
| Resistance<br>characteristic<br>s | At 1635 ppm PAA:<br>• D-value 12 - 26 seconds<br>• Survival Time ≥ 38 seconds<br>• Kill Time ≥ 239 seconds | At 1635 ppm PAA:<br>• D-value 12 – 26 seconds<br>• Survival Time ≥ 38 seconds<br>• Kill Time ≥ 239 seconds | Identical |
| LCSPS cycle<br>parameters | • >1820 mg/L PAA<br>• 6 minutes<br>• 45.5 – 60°C | • >1820 mg/L PAA<br>• 6 minutes<br>• 45.5 – 60°C | Identical |
| Culture<br>Conditions | • Trypticase Soy Broth Based<br>Media<br>• Incubation Temp.: 55-60°C<br>• Incubation Time: 24 hours<br>minimum; up to 7 days | • Trypticase Soy Broth Based<br>Media<br>• Incubation Temp: 55-60°C<br>• Incubation Time: 24 hours<br>minimum; up to 7 days | Identical |
| Carrier<br>Material | Filter paper | Filter paper | Identical |
| Primary<br>Packaging | • 20 BIs in Glassine<br>• 20 Media Vials | • 20 BIs in Glassine<br>• 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.