CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack

K183294 · STERIS Corporation · FRC · Jan 3, 2019 · General Hospital

Device Facts

• Record ID: K183294
• Device Name: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jan 3, 2019
• 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 routine monitoring of the following sterilizer cycles: Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 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 Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes. The CELERITY 20 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 the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

Device Story

Biological indicator (BI) and challenge pack for monitoring vaporized hydrogen peroxide sterilization. BI contains Geobacillus stearothermophilus spores and nutrient media in a plastic vial; reporter enzyme reacts with fluorogenic substrate to produce fluorescent signal. Challenge pack contains BI and chemical indicator (CI) in a sealed pouch. Used by healthcare personnel in clinical settings. BI processed in sterilizer, then incubated in CELERITY HP Incubator. Incubator detects fluorescence within 20 minutes to confirm spore viability. Results indicate sterilization efficacy; negative result confirms successful cycle. Challenge pack used for system qualification after installation, relocation, or repair. Output informs healthcare providers of sterilization process success, ensuring patient safety by verifying instrument sterility.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via simulated use testing in V-PRO sterilizers, confirming negative growth for processed BIs and recoverable populations of 50-300% of label claim after exposure to STERRAD ALLClear. Challenge pack validated to provide equivalent or greater challenge than biological models under worst-case conditions.

Technological Characteristics

Plastic vial containing Geobacillus stearothermophilus spores and nutrient media. Sensing principle: enzymatic reaction with fluorogenic substrate. Incubated at 55-59°C. Challenge pack includes CI and barrier material in a sealed pouch. Connectivity: requires CELERITY HP Incubator for fluorescence detection.

Indications for Use

Indicated for routine monitoring of specific V-PRO and STERRAD low-temperature sterilization cycles and for qualification/requalification testing of V-PRO systems in healthcare facilities.

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 (K172752)
• CELERITY 20 HP Challenge Pack (K173488)

Reference Devices

• VERIFY Incubator for Assert VH2O2 SCBI (K171587)
• VERIFY V-PRO Chemical Indicator (K140515)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 3, 2019

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K183294

Trade/Device Name: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 26, 2018 Received: November 27, 2018

Dear Anthony Piotrkowski:

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

# Elizabeth F. Claverie -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)

K183294

Device Name

Celerity 20 HP Biological Indicator

Indications for Use (Describe)

The Celerity 20 HP Biological Indicator is intended 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, maX2 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 Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

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

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

51 0(k) Number (if known)

### K183294

### Device Name

CELERITY 20 HP Challenge Pack

### Indications for Use (Describe)

The CELERITY 20 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 the 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 21CFR801Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image contains the STERIS logo. The word "STERIS" is in a bold, serif typeface. Below the word is an image of several horizontal, curved lines that are stacked on top of each other. The lines are blue.

# 510(k) Summary For CELERITY 20 HP Biological Indicator And CELERITY 20 HP Challenge Pack

### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Tony Piotrkowski Contact: Director Regulatory Affairs

Telephone: [phone] Fax No: [phone] [e-mail] e-mail:

Submission Date: January 2, 2019

Premarket Notification Number: K183294

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

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# STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

#### Device Name 1.

| Trade Name: | CELERITY 20 HP Biological Indicator |
|------------------------|--------------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>[21 CFR 880.2800(a), FRC] |

#### 2. Predicate Device Biological Indicator

CELERITY 20 HP Biological Indicator, K172752 (modified under K181429)

#### 3. Description of Device - 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, 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.

#### 4. Intended Use/ Indications for Use - Biological Indicator

The Celerity 20 HP Biological Indicator is intended 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, maX2 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 Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

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

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# STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

#### Technical Characteristics Comparison Table – Biological Indicator 5.

| | CELERITY 20 HP BI | CELERITY 20 HP BI | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | K183294 (proposed) | Predicate (K172752) | Comparison |
| Intended Use | The Celerity 20 HP<br>Biological Indicator is<br>intended for routine<br>monitoring of the following<br>sterilizer cycles:<br>Lumen, Non Lumen,<br>Fast Non Lumen, Fast<br>and Flexible Cycles of<br>the V-PRO: 1, 1 Plus,<br>maX, maX2 and s2 Low<br>Temperature<br>Sterilization Systems. STERRAD® 100S<br>Sterilizer (Default Cycle) Standard and Advanced<br>Cycles of the<br>STERRAD® NX<br>Sterilizer with or without<br>ALLClear Standard, Flex Scope,<br>Express and DUO<br>Cycles of the<br>STERRAD® 100NX<br>Sterilizer with or without<br>ALLClear 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. | The CELERITY Biological<br>Indicator is used for routine<br>monitoring, and<br>qualification of the Non<br>Lumen, Flexible, Lumen<br>and Fast Non Lumen Cycles<br>of the V-PRO 1, 1 Plus,<br>maX, 60 and maX 2 Low<br>Temperature Sterilizers in<br>healthcare facilities.<br>When used in conjunction<br>with the VERIFY<br>CELERITY 20 HP<br>Incubator, the CELERITY<br>20 HP Biological Indicator<br>provides a fluorescent result<br>within 20 minutes. | The Fast Cycle is a new<br>cycle in the V-PRO s2<br>Low Temperature<br>Sterilizer, which has<br>been submitted in a<br>separate premarket<br>notification.<br>Testing to support<br>claims in sterilizers with<br>ALLClear is included in<br>this submission.<br>Indications for<br>STERRAD sterilizers<br>were cleared under<br>K172474. |
| Indicator<br>organism | Geobacillus<br>stearothermophilus | Geobacillus<br>stearothermophilus | Same |
| Mechanism<br>of action | 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. | 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 | CELERITY HP Incubator*<br>(K171587) | CELERITY HP Incubator*<br>(K171587) | Same |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/BI | 1.0 – 4.0 x 106 spore/BI | Same |
| Resistance<br>characteristics | Resistance @ 9.1 mg/L<br>H2O2:<br>D-value > 6 sec Survival Time ≥ 4 sec Kill Time ≤ 7 min | Resistance @ 9.1 mg/L<br>H2O2:<br>D-value > 3 sec Survival Time ≥ 4 sec Kill Time ≤ 6 min | Increased minimum D-<br>value specification,<br>within the range of the<br>predicate device. |
| Feature | CELERITY 20 HP BI<br>K183294 (proposed) | CELERITY 20 HP BI<br>Predicate (K172752) | Comparison |
| Culture Conditions | 55- 59°C, media included in<br>BI, 20-minute incubation<br>time. | 55- 59°C, media included in<br>BI, 20-minute incubation<br>time. | Same |
| Primary Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Same |
| Process indicator | VERIFY V-PRO Chemical<br>Indicator (K140515);<br>magenta to yellow color<br>change. | VERIFY V-PRO Chemical<br>Indicator (K140515);<br>magenta to yellow color<br>change. | Same |
| Shelf-life | Currently 10 months<br>Target of 13 months | Currently 10 months<br>Target of 13 months | Real-time testing<br>ongoing |

# Table 5-1. BI Physical Description and Technological Properties vs the Predicate Device

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# STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

#### Summary of Nonclinical Performance Tests – Biological Indicator 6.

Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-2 below.

| Test | Acceptance Criteria | Conclusion |
|------------------------------------------------------------------------|-----------------------------------------------------------------|------------|
| BI Simulated Use in the V-PRO maX<br>2 Sterilizer Fast Non Lumen Cycle | All BIs processed in full cycles will be<br>negative for growth | PASS |
| Recoverable Population after<br>exposure to STERRAD ALLClear | Recoverable Population of 50 – 300%<br>of the label claim | PASS |

### Table 5-2. Summary of Non-clinical Testing

#### Device Name – Challenge Pack 7.

| Trade Name: | CELERITY 20 HP Challenge Pack |
|------------------------|-----------------------------------------------------------|
| Common/usual Name: | Biological Indicator Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Sterilization Process Indicator<br>(21 CFR 880.2800, FRC) |

#### 8. Predicate Device - Challenge Pack

CELERITY 20 HP Challenge Pack K173488 (NOTE: The proposed and predicate devices are identical)

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#### 9. Description of Device - Challenge Pack

The CELERITY 20 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 20 HP Biological 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 72 hours (3 days) prior to activation.

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

The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.

#### 10. Intended Use/ Indications for Use - Challenge Pack

The CELERITY 20 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 hospitaldefined challenge load is not included.

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

#### 11. Technical Characteristics Comparison Table - Challenge Pack

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# STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

| Feature | CELERITY pack<br>K183294 (Proposed) | CELERITY pack<br>(K173488) Predicate | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended<br>Use /<br>Indication<br>for Use | The CELERITY 20 HP<br>Challenge 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>The Challenge Pack is placed<br>in an otherwise empty<br>sterilizer chamber; a hospital-<br>defined challenge load is<br>not included.<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>The Challenge Pack is placed<br>in an otherwise empty<br>sterilizer chamber; a hospital-<br>defined challenge load is<br>not included.<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<br>barrier material. | Sealed sterilization pouch<br>containing SCBI, CI and<br>barrier material. | Same |
| Biological<br>Indicator | Celerity 20 HP Biological<br>Indicator | Celerity 20 HP Biological<br>Indicator | Same |
| Chemical<br>Indicator | VERIFY HPU Chemical<br>Indicator | VERIFY HPU Chemical<br>Indicator | Same |
| 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 HP Incubator*<br>(K171587) | CELERITY HP Incubator*<br>(K171587) | Same |

Table 5-3. Summary of Pack Physical Description and Technological Properties

#### 12. Summary of Nonclinical Performance Tests – Challenge Pack

Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-4 below.

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# STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indictor and CELERITY 20 HP Challenge Pack

| Test | Acceptance Criteria | Conclusion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------|
| Simulated Use | Demonstrate the pack shows passing results in worst-<br>case load under worst-case sterilization conditions | PASS |
| Cycle-Specific Testing | The pack provides an equivalent or greater challenge<br>to the claimed cycle than the biological model under<br>worst-case conditions. | PASS |

Table 5-4. Summary of Non-Clinical Testing

#### 13. Conclusion

Based on the intended use, technological characteristics and the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator (cleared in K172752) Class II (21 CFR 880.2800, product code FRC).

The CELERITY 20 HP Challenge Pack has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, K173488, Class II (21 CFR 880.2800, Product code FRC).

* The Celerity HP Incubator was cleared in K171587 under the name "VERIFY Incubator for Assert VH2O2 SCBI"