Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator

K231490 · STERIS Corporation · FRC · Aug 7, 2023 · General Hospital

Device Facts

• Record ID: K231490
• Device Name: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Aug 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles: Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems STERRAD® 100S Sterilizer (Default Cycle) Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes. The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles: Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems STERRAD® 100S Sterilizer (Default Cycle) STERRAD® 200 Sterilizer (Default Cycle) Standard and Advanced Cycles of the STERRAD® NX Sterilizers with ALLClear® Technology Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.

Device Story

Biological indicators (BIs) monitor low-temperature hydrogen peroxide sterilization cycles. Celerity 20 HP BI uses Geobacillus stearothermophilus spores and nutrient media in a plastic vial; reporter enzyme reacts with fluorogenic substrate to produce fluorescent signal. Celerity HP Incubator detects fluorescence within 20 minutes. VERIFY V24 SCBI uses visual color change (orange to yellow/turbid) after 24-hour incubation to indicate sterilization failure. Used in healthcare facilities to accompany medical devices during sterilization. Provides objective confirmation of sterilization process efficacy; helps ensure patient safety by verifying instrument sterility before reuse.

Clinical Evidence

Bench testing only. Performance verified through resistance testing (D-value, survival/kill times) and process qualification of the V-PRO maX 2 Specialty Cycle. Results demonstrate equivalent resistance to predicate devices.

Technological Characteristics

Plastic vial containing Geobacillus stearothermophilus spores and nutrient media. Celerity 20 HP: fluorogenic enzyme-substrate reaction; 20-minute incubation. VERIFY V24: visual colorimetric (magenta to orange/yellow) growth detection; 24-hour incubation. Both are standalone indicators used with proprietary incubators.

Indications for Use

Indicated for routine monitoring of specific low-temperature hydrogen peroxide sterilization cycles (V-PRO and STERRAD systems) in healthcare facilities. Used to confirm sterilization efficacy by monitoring Geobacillus stearothermophilus spore viability.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Celerity 20 HP Biological Indicator (K183294)
• VERIFY V24 Self-Contained Biological Indicator (K183300)

Reference Devices

• VERIFY V-PRO Chemical Indicator (K140515)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

August 7, 2023

STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

### Re: K231490

Trade/Device Name: Celerity 20 HP Biological Indicator; V24 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: Mav 22, 2023 Received: May 23, 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.

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Christopher K. Dugard -S

for Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231490

#### Device Name

VERIFY V24 Self-Contained Biological Indicator

Indications for Use (Describe)

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

· STERRAD® 200 Sterilizer (Default Cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with ALLClear® Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.

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.

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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:

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## Indications for Use

510(k) Number (if known) K231490

Device Name Celerity 20 HP Biological Indicator

#### Indications for Use (Describe)

The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

- Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology

When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.

| 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)

#### 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 [e-mail]

"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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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, sans-serif font at the top of the image. Below the word is a graphic of several horizontal, curved lines that resemble waves. The lines are blue, and the background is white.

# 510(K) Summary For K231490 Celerity 20 HP Biological Indicator

### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax: [phone]

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax:

### Contact

Gregory Land Lead Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: greg land(@steris.com

### Submission Date:

May 22, 2023

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#### Device Name 1

Trade Name: CELERITY 20 HP Biological Indicator Common/usual Name: Biological Indicator Device Classification: Class II Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

#### 2 Predicate Device

Proprietary Name Common/usual Name Classification Name: 510(k) Submitter/Holder 510(k) Number:

Celerity 20 HP Biological Indicator Biological indicator Indicator, Biological Sterilization Process STERIS Corporation K183294

#### 3 Description of Device

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

#### ব Intended Use/Indications for Use

The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:

- Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 ● Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
- STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® . Technology
- Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or ● without ALLClear® Technology

When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.

#### 5 Summary of Technical Characteristics

- 5.1

| Feature | CELRITY 20 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Celerity 20 HP Biological<br>Indicator is intended for | The Celerity 20 HP Biological<br>Indicator is intended for | The proposed and<br>predicate devices are<br>identical. The |
| Feature | CELRITY 20 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
| | routine monitoring of the<br>following sterilizer cycles:<br>• Lumen, Non Lumen, Fast<br>Non Lumen, Fast, Flexible<br>and Specialty Cycles of the<br>V-PRO 1, 1 Plus, maX, maX<br>2, 60 and s2 Low<br>Temperature Sterilization<br>Systems.<br>• STERRAD® 100S Sterilizer<br>(Default Cycle)<br>• Standard and Advanced<br>Cycles of the STERRAD®<br> | routine monitoring of the<br>following sterilizer cycles:<br>• Lumen, Non Lumen, Fast<br>Non Lumen, Fast and<br>Flexible Cycles of the V-<br>PRO: 1, 1 Plus, maX, maX2<br>and s2 Low Temperature<br>Sterilization Systems.<br>• STERRAD® 100S Sterilizer<br>(Default Cycle)<br>• Standard and Advanced<br>Cycles of the STERRAD®<br>NX Sterilizer with or<br>without ALLClear<br>• Standard, Flex Scope,<br>Express and DUO Cycles of<br>the STERRAD® 100NX<br>Sterilizer with or without<br>ALLClear<br>When used in conjunction<br>with the Celerity HP<br>Incubator, the Celerity 20 HP<br>BI provides a fluorescent<br>result within 20 minutes. | Specialty Cycle is a<br>new cycle in the V-<br>PRO maX 2 Low<br>Temperature<br>Sterilizer, which has<br>been submitted in this<br>premarket notification. |
| Indicator<br>organism | Geobacillus<br>stearothermophilus | Geobacillus<br>stearothermophilus | Same |
| Mechanism of<br>action | An enzyme, which is produced<br>by the organism, reacts with a<br>fluorogenic substrate within<br>the defined nutrient media to<br>produce a fluorescent moiety. | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety. | Same |
| Accessories | Automated incubator / reader | Automated incubator / reader | Same |
| Viable spore<br>population | 1.0 – 4.0 x 106 spore/BI | 1.0 - 4.0 x 106 spore/BI | Same |
| Resistance | Resistance @ 9.1 mg/L H2O2:<br>• D-value > 6 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 7 min | Resistance @ 9.1 mg/L H2O2:<br>• D-value > 6 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 7 min | Same |
| Feature | CELRITY 20 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
| Culture<br>Conditions | 55-59°C, media included in<br>BI, 20-minute incubation time. | 55-59°C, media included in<br>BI, 20-minute incubation time. | Same |
| Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery media. | Direct inoculum on plastic<br>vial, cap with recovery media. | Same |
| Process indicator | VERIFY V-PRO Chemical<br>Indicator (K140515); magenta<br>to yellow color change. | VERIFY V-PRO Chemical<br>Indicator (K140515); magenta<br>to yellow color change. | Same |
| Shelf-life | 10 months | 10 months | Same |

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### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

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### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator

#### 6 Summary of Non-clinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

| Test | Acceptance Criteria | Conclusion |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Verification of Celerity HP BI<br>Performance after V-PRO Specialty<br>Cycle Extended Aeration | Celerity BIs exposed to the Specialty<br>Cycle demonstrate essentially<br>equivalent or not significantly<br>different resistance as compared to<br>SCBIs exposed to the 136L V-PRO<br>Sterilizer Fast Non Lumen Cycle | Pass |
| Final Process Qualification of the<br>VPRO maX2 Sterilizer Specialty<br>Cycle | The V-PRO maX 2 Sterilizer<br>Specialty Cycle final process<br>qualification was successful. | Pass |

Table 5-3. Summary of Non-clinical Testing

#### 7 Conclusion

Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the Celerity 20 HP Biological Indicator, K183294 Class II [21 CFR 880.2800(a)], product code FRC.

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Image /page/8/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.

# 510(K) Summary For K231490 VERIFY V24 Self-Contained Biological Indicator

### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax: [phone]

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax: [phone]

### Contact

Gregory Land Lead Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: greg land(@steris.com

### Submission Date:

May 22, 2023

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#### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY V24 Self-Contained Biological Indicator

#### Device Name 8

| Trade Name: | VERIFY V24 Self-Contained Biological Indicator |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |

#### の Predicate Device

Proprietary Name: VERIFY V24 Self-Contained Biological Indicator Common/usual Name Biological indicator Classification Name: Indicator, Biological Sterilization Process 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K183300

# 10 Description of Device

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 SCBI into the V-PRO® Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

## 11 Intended Use/Indications for Use

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

- Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, ● 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
- STERRAD® 100S Sterilizer (Default Cycle)
- STERRAD® 200 Sterilizer (Default Cycle) ●
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with . ALLClear® Technology
- . Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology

# 12 Summary of Technical Characteristics

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| Feature | VERIFY V24 SCBI<br>(proposed) | VERIFY V24 SCBI Predicate<br>(K183300) | Comparison |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY® V24 Self-<br>Contained Biological<br>Indicator is intended for<br>routine monitoring of the<br>following sterilizer cycles:<br>• Lumen, Non Lumen,<br>• Flexible, Fast, Fast Non<br>Lumen and Specialty<br>Cycles of the V-PRO® 1,<br>• 1 Plus, maX, maX 2, 60<br>and s2 Sterilizers<br>• STERRAD® 100S<br>Sterilizer (Default Cycle)<br>• STERRAD® 200<br>Sterilizer (Default Cycle)<br>• Standard and Advanced<br>Cycles of the<br>STERRAD® NX<br>Sterilizer to include<br>sterilizers with<br>ALLClear® Technology<br>• Express, Flex Scope and<br>Standard Cycles of the<br>STERRAD® 100NX<br>Sterilizer to include<br>sterilizers with<br>ALLClear® technology. | The VERIFY® V24 Self-<br>Contained Biological Indicator<br>is intended for routine<br>monitoring of the following<br>sterilizer cycles:<br>• Lumen, Non Lumen,<br>• Flexible, Fast and Fast Non<br>Lumen Cycles of the V-<br>PRO® 1, 1 Plus, maX, maX<br>2, 60 and s2 Sterilizers<br>• STERRAD® 100S<br>Sterilizer (Default Cycle)<br>• STERRAD® 200 Sterilizer<br>(Default Cycle)<br>• Standard and Advanced<br>Cycles of the STERRAD®<br>NX Sterilizer to include<br>sterilizers with ALLClear®<br>Technology<br>• Express, Flex Scope and<br>Standard Cycles of the<br>STERRAD® 100NX<br>Sterilizer to include<br>sterilizers with ALLClear®<br>technology. | The proposed and<br>predicate devices are<br>identical. The Specialty<br>Cycle is a new cycle in<br>the V-PRO maX 2 Low<br>Temperature Sterilizer,<br>which has been<br>submitted in this<br>premarket notification. |
| Indicator<br>organism | Geobacillus<br>stearothermophilus | Geobacillus<br>stearothermophilus | Same |
| Mechanism of<br>action | Visual detection of growth<br>based on media color change<br>in the presence of surviving<br>indicator organisms. | Visual detection of growth<br>based on media color change<br>in the presence of surviving<br>indicator organisms. | Same |
| Accessories | VERIFY Incubator and<br>VERIFY SCBI HP Activator<br>(optional) | VERIFY Incubator and<br>VERIFY SCBI HP Activator<br>(optional) | Same |
| Viable spore<br>population | 2.0 - 3.4 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Same |
| Resistance<br>characteristics | Resistance @ 2.7 mg/L H2O2:<br>• D-value 4.0 – 8.0 sec<br>• Survival Time 4 - 30 sec<br>• Kill Time ≤ 16 min | Resistance @ 2.7 mg/L H2O2:<br>• D-value 4.0 – 8.0 sec<br>• Survival Time 4 - 30 sec<br>• Kill Time ≤ 16 min | Same |
| Culture<br>Conditions | 55- 60°C, media included in<br>SCBI, 24 hour incubation<br>time. | 55- 60°C, media included in<br>SCBI, 24 hour incubation<br>time. | Same |
| Primary<br>Packaging | Direct inoculum on plastic<br>vial, glass ampoule with<br>recovery media. | Direct inoculum on plastic<br>vial, glass ampoule with<br>recovery media. | Same |
| Process indicator | VERIFY V24 Self-Contained<br>Biological Indicator Vial | VERIFY V24 Self-Contained<br>Biological Indicator Vial | Same |
| Feature | VERIFY V24 SCBI<br>(proposed) | VERIFY V24 SCBI Predicate<br>(K183300) | Comparison |
| | Label; magenta to<br>orange/yellow color change. | Label; magenta to<br>orange/yellow color change. | |
| Shelf-life | 15 Months | 15 Months | Same |

### 12.1 YERIFY V24 Self-Contained Biological Indicator

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# 13 Summary of Non-clinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

| Test | Acceptance Criteria | Conclusion | | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------|------|
| Verification of V24 SCBI<br>Performance after V-PRO Specialty<br>Cycle Extended Aeration | SCBIs exposed to the Specialty Cycle<br>demonstrate essentially equivalent or<br>not significantly different resistance<br>as compared to SCBIs exposed to the<br>136L V-PRO Sterilizer Fast Non<br>Lumen Cycle | Pass | | |
| | Final Process Qualification of the<br>VPRO maX2 Sterilizer Specialty<br>Cycle | | The V-PRO maX 2 Sterilizer<br>Specialty Cycle final process<br>qualification was successful. | Pass |

Table 5-3. Summary of Non-clinical Testing

# 14 Conclusion

Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the VERIFY V24 Self-Contained Biological Indicator, K183300 Class II [21 CFR 880.2800(a)], product code FRC.