Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

K223717 · STERIS Corporation · FRC · Jun 15, 2023 · General Hospital

Device Facts

• Record ID: K223717
• Device Name: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jun 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Celerity 5 HP Biological Indicator The Celerity 5 HP Biological Indicator (BI) is used for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible 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® • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®. When used in conjunction with the Celerity® Incubator provides a fluorescent result within 5 minutes. Celerity 5 HP Challenge Pack The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Device Story

Device consists of Geobacillus stearothermophilus spores and nutrient media in a plastic vial; used to monitor vapor-phased hydrogen peroxide sterilization cycles. After sterilization, user activates BI by puncturing cap to release media; incubated in Celerity Incubator at 55-60°C. Reporter enzyme produced by surviving spores reacts with fluorogenic substrate to produce fluorescent signal. Reader detects fluorescence within 5 minutes to confirm viability. Challenge pack version includes BI and chemical indicator in a pouch for system qualification testing. Used in hospitals to verify sterilization efficacy; provides rapid feedback to clinicians to ensure instruments are safe for patient use.

Clinical Evidence

No clinical data. Bench testing only. Studies included viable spore population verification, resistance characteristics (D-value, survival/kill times), growth inhibition, holding time assessment, signal generation, and simulated use testing in V-PRO and STERRAD sterilizers. Reduced incubation time (5-minute) was validated against 7-day growth results, demonstrating ≥97% correlation.

Technological Characteristics

Biological indicator containing G. stearothermophilus spores and nutrient media in a plastic vial. Sensing principle: enzymatic fluorescence detection. Energy source: Celerity Incubator (55-59°C). Connectivity: Standalone reader. Sterilization: Vapor-phased hydrogen peroxide. Spore population: 1.0–4.0 x 10^6 CFU/BI. Resistance: D-value ≥ 6 sec at 9.1 mg/L H2O2.

Indications for Use

Indicated for routine monitoring of specific V-PRO and STERRAD low-temperature hydrogen peroxide sterilization cycles and for qualification/requalification testing of V-PRO systems. Used by healthcare providers in clinical settings.

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)
• Celerity 20 HP Challenge Pack (K183294)

Reference Devices

• VERIFY V-PRO Chemical Indicator (K140515)
• CELERITY 20 HP Challenge pack (K173488)
• CELERITY Incubator (K223715)
• CELERITY HP Incubator (K171587)
• Celerity Incubator (K213881)

Submission Summary (Full Text)

{0}------------------------------------------------

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 15, 2023

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

Re: K223717

Trade/Device Name: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2023 Received: May 19, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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).

Sincerelv.

# Christopher K. Dugard -2

Clarence W. Murray, III, PhD Deputy Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

Submission Number (if known)

K223717

Device Name

Celerity 5 HP Biological Indicator;

Celerity 5 HP Challenge Pack

Indications for Use (Describe)

Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is used for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO 1, 1 Plus, 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®

· Standard. FLEX. Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low

Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

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 [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."

{3}------------------------------------------------

# 510(K) Summary For Celerity 5 HP Biological Indicator And Celerity 5 HP Challenge Pack

# Sponsor Facility

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

# Manufacturing Facility

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

# Contact

Gregory Land Lead Regulatory Affairs Specialist Phone: [phone] Email: greg [e-mail]

Submission Date: June 13, 2023

K Number: K223717

{4}------------------------------------------------

#### 1 Device Name

### Celerity 5 HP Biological Indicator

| Trade Name: | Celerity 5 HP Biological Indicator |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |

#### Celerity 5 HP Challenge Pack

| Trade Name: | Celerity 5 HP Challenge Pack |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |

#### Predicate Device 2

### Celerity 5 HP Biological Indicator

| Proprietary Name | Celerity 20 HP Biological Indicator |
|-------------------------|---------------------------------------------|
| Common/usual Name | Biological indicator |
| Classification Name: | Indicator, Biological Sterilization Process |
| 510(k) Submitter/Holder | STERIS Corporation |
| 510(k) Number: | K183294 |

### Celerity 5 HP Challenge Pack

| Proprietary Name | Celerity 20 HP Biological Indicator |
|-------------------------|---------------------------------------------|
| Common/usual Name | Biological indicator |
| Classification Name: | Indicator, Biological Sterilization Process |
| 510(k) Submitter/Holder | STERIS Corporation |
| 510(k) Number: | K183294 |

#### Description of Device 3

### Celerity 5 HP Biological Indicator

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 5 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.

#### Celerity 5 HP Challenge Pack

The CELERITY 5 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 5 HP Biological

{5}------------------------------------------------

Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 2 hours prior to activation.

The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.

The activated BI is incubated at 55-60 ℃ in the CELERITY Incubator for a final determination of viability within 5 minutes of incubation.

#### 4 Intended Use/Indications for Use

### Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is used for routine monitoring of the following sterilizer cycles:

- Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible 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®
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator provides a fluorescent result within 5 minutes.

### Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

#### റ Summary of Technical Characteristics

#### Table 1. Biological Indicator Subject Device Comparison to the Predicate Device

| Feature | CELRITY 5 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The Celerity 5 HP Biological<br>Indicator (BI) is used for<br>routine monitoring of the<br>following sterilizer cycles:<br>• Lumen, Non Lumen, Fast<br>Non Lumen, Fast and | The Celerity 20 HP<br>Biological Indicator is<br>intended for routine<br>monitoring of the following<br>sterilizer cycles: | Proposed device has a<br>5-minute read time |
| Feature | CELRITY 5 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
| | Flexible Cycles of the V-<br>PRO 1, 1 Plus, maX, maX<br>2, 60 and s2 Low<br>Temperature Sterilization<br>Systems<br>• STERRAD® 100S<br>Sterilizer (Default Cycle)<br>• Standard and Advanced<br>Cycles of the STERRAD®<br>NX® Sterilizer with or<br>without ALLClear®<br>• Standard, FLEX, Express<br>and DUO Cycles of the<br>STERRAD® 100NX®<br>Sterilizer with or without<br>ALLClear®.<br>When used in conjunction<br>with the Celerity® Incubator,<br>the Incubator provides a<br>fluorescent result within 5<br>minutes. | • Lumen, Non Lumen, Fast<br>Non Lumen, Fast and<br>Flexible Cycles of the V-<br>PRO® Low Temperature<br>Sterilization Systems<br>• STERRAD® 100S<br>Sterilizer (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<br>of 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. | |
| 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 /<br>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 |
| Culture<br>Conditions | 55-59°C, media included in BI,<br>5-minute incubation time. | 55-59°C, media included in<br>BI, 20-minute incubation<br>time. | Similar |
| Feature | CELRITY 5 HP Biological<br>Indicator<br>(proposed) | Celerity 20 HP Biological<br>Indicator (K183294) | Comparison |
| Primary Packaging | Direct inoculum on plastic<br>vial, cap with recovery media. | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Same |
| Process indicator | VERIFY V-PRO Chemical<br>Indicator (K140515); magenta<br>to yellow color change. | VERIFY V-PRO Chemical<br>Indicator (K140515);<br>magenta to yellow color<br>change. | Same |
| Shelf-life | 8 months | 10 months | Similar |

{6}------------------------------------------------

{7}------------------------------------------------

# Table 2: Challenge Pack Comparison to Predicate Device

| Feature | CELERITY 5 HP Challenge pack<br>Proposed | CELERITY 20 HP Challenge pack<br>(K173488) Predicate | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use<br>/ Indication<br>for Use | The CELERITY 5 HP Challenge<br>Pack is intended for<br>qualification testing of the V-<br>PRO Low<br>Temperature Sterilization<br>System following installation,<br>relocation, malfunctions or<br>major repairs and for routine<br>requalification testing.<br><br>The Challenge Pack is placed<br>in an otherwise empty<br>sterilizer chamber; a hospital-<br>defined challenge load is<br>not included.<br><br>The challenge pack is not<br>intended for routine<br>monitoring of the V-PRO<br>Sterilizers. It has been tested<br>and validated solely for use in<br>periodic testing of the<br>sterilizers. | The CELERITY 20 HP<br>Challenge Pack is intended<br>for qualification testing of the<br>V-PRO Low<br>Temperature Sterilization<br>System following installation,<br>relocation, malfunctions or<br>major repairs and for routine<br>requalification testing.<br><br>The Challenge Pack is placed<br>in an otherwise empty<br>sterilizer chamber; a hospital-<br>defined challenge load is<br>not included.<br><br>The challenge pack is not<br>intended for routine<br>monitoring of the V-PRO<br>Sterilizers. It has been tested<br>and validated solely for use in<br>periodic testing of the<br>sterilizers. | Same |
| General<br>Design | Sealed sterilization pouch<br>containing SCBI, CI and barrier<br>material. | Sealed sterilization pouch<br>containing SCBI, CI and<br>barrier material. | Same |
| Biological<br>Indicator | Celerity 5 HP Biological<br>Indicator | Celerity 20 HP Biological<br>Indicator | Similar |

{8}------------------------------------------------

| Feature | CELERITY 5 HP Challenge pack<br>Proposed | CELERITY 20 HP Challenge pack<br>(K173488) Predicate | Comparison |
|------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|
| Chemical<br>Indicator | Celerity HP Chemical Indicator | VERIFY HPU Chemical<br>Indicator | Same - brand<br>name has<br>changed |
| Means to<br>distinguish<br>processed<br>pack from<br>unprocessed | Proposed device's internal<br>indicator is visible through the<br>pack. | Proposed device's internal<br>indicator is visible through<br>the pack. | Same |
| Required<br>accessories | CELERITY Incubator (K223715) | CELERITY HP Incubator*<br>(K171587)<br>Celerity Incubator (K213881) | Similar |

#### 6 Summary of nonclinical Tests

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

| Test | Description | Acceptance Criteria | Conclusion |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Viable Spore Population | Study to demonstrate that<br>the product meets its<br>specification for the spore<br>population. | Average population for each<br>lot of 1.0 x 106 - 4.0 x 106<br>CFU/BI | Pass |
| Resistance Characteristics<br>Study | Study to verify that the<br>Celerity 5 Biological<br>Indicator meets the<br>acceptance criteria for<br>resistance. Acceptance<br>criteria are designed to<br>demonstrate comparable or<br>greater resistance values<br>than the predicate device | D-Value: 2-20 secondsAll Survive: ≤ 4 secondsAll Kill: ≥ 6 minutes | Pass |
| Carrier and Pack Material<br>Growth Inhibition<br>Evaluation | Study to demonstrate that<br>the primary packaging<br>material used in the<br>manufacture of the<br>Biological Indicator (BI)<br>does not hinder, or<br>otherwise affect, the<br>outgrowth of a low<br>number of Geobacillus<br>stearothermophilus spores | All BIs inoculated with<br>Geobacillus<br>stearothermophilus spores<br>demonstrate growth | Pass |
| Holding Time Assessment | Study to demonstrate the<br>labeled hold time of the BI | 120 minutes | Pass |
| Signal Generation | Study to demonstrate<br>the PBS media | All BIs will demonstrate a<br>positive fluorescent signal | Pass |
| | contained in the cap of<br>the Celerity 5 HP<br>Biological Indicator is<br>able to generate a<br>detectable fluorescent<br>signal from viable G.<br>stearothermophilus<br>organisms. | | |
| Simulated Use Testing – V-<br>PRO | Study to demonstrate<br>that the Project Blayze<br>Biological Indicator<br>(BI) for Gaseous<br>Hydrogen Peroxide<br>Sterilization Processes<br>functions<br>appropriately when<br>processed in the<br>claimed sterilizer<br>cycles with a validated<br>load. | All BIs processed in a full<br>cycle will demonstrate a<br>negative signal<br>corresponding to a no-<br>growth result upon seven<br>day incubation. | Pass |
| Simulated Use Testing –<br>STERRAD | Study to demonstrate<br>the Project Blayze<br>Biological Indicator<br>(BI) for Gaseous<br>Hydrogen Peroxide<br>Sterilization Processes<br>functions<br>appropriately when<br>processed in<br>STERRAD®<br>Sterilizers with a<br>validated load. | All BIs processed in a<br>full cycle will<br>demonstrate a negative<br>signal corresponding to a<br>no-growth result upon<br>seven day incubation. | Pass |
| Population after ALLClear<br>Exposure | Study to demonstrate<br>ALLClear<br>preconditioning does<br>not impact BI<br>performance. | Each BI signal evaluation was<br>positive following exposure<br>to the All-Clear precondition<br>treatment<br>The mean population of each<br>BI exposed to the All-Clear<br>precondition treatment was<br>within 50-300% of the<br>unexposed control mean<br>population. | Pass |
| Reduced Incubation Time - | Study to verify Reduced<br>Incubation Time of the BI | Study will demonstrate that<br>97% or greater of the positive | Pass |
| | | samples at seven days also gave a positive signal at the claimed RIT time | |
| Reduced Incubation Time –<br>Engineering Mode | Study to verify the<br>Reduced Incubation Time<br>of 5-minute correlates to a<br>20-minute result like the<br>predicate device and 7 day<br>growth. | study will demonstrate that<br>97% or greater of the positive<br>samples at seven days also Pass | |
| Celerity 5 HP Challenge Pack | | | |
| Simulated Use Testing | Study to demonstrate<br>performance of challenge<br>pack under worst-case<br>conditions. | Demonstrate the pack shows<br>passing results in worst-case<br>load under worst-case<br>sterilization conditions | Pass |
| Dose Response Testing | Study to demonstrate the<br>challenge pack provides<br>adequate challenge to<br>perform intended use. | The pack provides an<br>equivalent or greater<br>challenge to the claimed cycle<br>than the biological model<br>under worst-case conditions. | Pass |

Table 3. Summary of Non-clinical Testing

{9}------------------------------------------------

{10}------------------------------------------------

#### 7 Conclusion

Based on the intended use, technological characteristics and the nonclinical tests performed, the subject Celerity 5 HP Biological Indicator 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.

Based on the intended use, technological characteristics and the nonclinical tests performed, the subject Celerity 5 HP Challenge Pack device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the CELERITY 20 HP Challenge Pack, K183294 Class II [21 CFR 880.2800(a)], product code FRC.