Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

K251452 · Steris · FRC · Jun 6, 2025 · General Hospital

Device Facts

• Record ID: K251452
• Device Name: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
• Applicant: Steris
• Product Code: FRC · General Hospital
• Decision Date: Jun 6, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Celerity 5 HP Biological Indicator: The Celerity 5 HP Biological Indicator (BI) is intended for 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 - Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear® - Standard, FLEX, Express and DUO Cycles of the STERRAD® 1 OONX® 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. Celerity 20 HP Biological Indicator: The Celerity 20 HP Biological Indicator (BI) is intended for 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. - Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear - Standard, FLEX, Express and DUO Cycles of the STERRAD® 1 OONX® Sterilizer with or without ALLClear®. When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 5 minutes. Celerity 20 HP 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 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

Biological indicators (BI) and challenge packs monitor vapor phased hydrogen peroxide sterilization efficacy. BIs contain Geobacillus stearothermophilus spores and nutrient media in a plastic vial. During sterilization, spores are exposed to the process; if viable, a reporter enzyme reacts with a fluorogenic substrate to produce a fluorescent signal. The STERIS Celerity Incubator detects this fluorescence within 5 or 20 minutes to confirm sterilization success. Challenge packs, containing a BI, chemical indicator, and absorptive foam in a Tyvek pouch, are used by technicians for system qualification. The device update involves replacing cellophane wrappers with laminated pouches and establishing a 3-month in-use shelf-life. Healthcare providers use the fluorescent output to verify sterilization cycle effectiveness, ensuring patient safety by confirming the destruction of resistant microorganisms on instruments.

Clinical Evidence

Bench testing only. Performance validated via reduced incubation time testing (97% correlation with 7-day growth), simulated use testing (sterility confirmation), cap media testing (fluorescent signal verification), and stability testing (population counts, D-values, and survival/kill times).

Technological Characteristics

Biological indicator consisting of Geobacillus stearothermophilus spores and fluorogenic nutrient media in a plastic vial. Challenge pack includes BI, chemical indicator, and absorptive foam in a Tyvek pouch. Operates via enzymatic fluorescence detection. Requires Celerity Incubator for readout. Shelf-life requires storage in original laminated pouch.

Indications for Use

Indicated for routine monitoring of vapor phased hydrogen peroxide sterilization cycles in V-PRO and STERRAD systems, and for qualification/requalification testing of V-PRO systems following installation, relocation, or repair. Used by sterile processing staff, service technicians, or biomedical technicians.

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 5 HP Biological Indicator (K250044)
• Celerity 5 HP Challenge Pack (K250044)
• Celerity 20 HP Biological Indicator (K250044)
• Celerity 20 HP Challenge Pack (K250044)

Reference Devices

• Celerity HP Indicator (K231488)
• Celerity HP Incubator (K171587)
• Celerity Incubator (K250061)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 6, 2025

Steris
Logan Persons
Regulatory Affairs Specialist
5960 Heisley Rd
Mentor, Ohio 44060

Re: K251452
Trade/Device Name: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
Regulation Number: 21 CFR 880.2800
Regulation Name: Sterilization Process Indicator
Regulatory Class: Class II
Product Code: FRC
Dated: May 9, 2025
Received: May 9, 2025

Dear Logan Persons:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251452 - Logan Persons
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251452 - Logan Persons
Page 3

assistance/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,

Stephen A. Anisko -S

Digitally signed by
Stephen A. Anisko -S
Date: 2025.06.06 14:42:06
-04'00'

for: Christopher K. Dugard
Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251452

Device Name
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)
Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

Indications for Use (Describe)
Celerity 5 HP Biological Indicator:
The Celerity 5 HP Biological Indicator (BI) is intended for 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
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 1 OONX® 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.

Celerity 20 HP Biological Indicator
The Celerity 20 HP Biological Indicator (BI) is intended for 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.
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 1 OONX® 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.

Celerity 20 HP 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 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)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services [phone]

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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:

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"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."

FORM FDA 3881 (8/23)
Page 2 of 2

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K251452

STERIS

510(k) Summary
For
Celerity 5 HP Biological Indicator and Challenge Pack

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
Logan Persons
Regulatory Affairs Specialist
Phone: [phone]
Fax: [phone]
Email: [e-mail]

Submission Date:
May 9, 2025

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
Page 1 of 12

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K251452

STERIS

# 1. Device Name

Trade Name: Celerity 5 HP Biological Indicator (LCB052)
Common/usual Name: Biological Indicator
Device Classification: Class II
Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

Trade Name: Celerity 5 HP Challenge Pack (LCB059)
Common/usual Name: Biological Indicator Challenge Pack
Device Classification: Class II
Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

# 2. Predicate Device

Proprietary Name: Celerity 5 HP Biological Indicator (LCB052)
Common/usual Name: Biological indicator
Classification Name: Indicator, Biological Sterilization Process
510(k) Submitter/Holder: STERIS Corporation
510(k) Number: K250044

Proprietary Name: Celerity 5 HP Challenge Pack (LCB059)
Common/usual Name: Biological indicator Challenge Pack
Classification Name: Indicator, Biological Sterilization Process
510(k) Submitter/Holder: STERIS Corporation
510(k) Number: K250044

# 3. Description of Device

## Celerity 5 HP BI

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 is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

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

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K251452

STERIS

The intended change to the devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

## 4. Intended Use/Indications for Use

### Celerity 5 HP BI

The Celerity 5 HP Biological Indicator (BI) is intended for 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
- 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 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.

## 5. Summary of Technical Characteristics

Table 1. BI Subject Device Comparison to the Predicate Device (Celerity 5 HP)

| Feature | Celerity 5 HP BI (proposed) | Celerity 5 HP BI Predicate (K250044) | Comparison |
| --- | --- | --- | --- |
| Intended Use | The Celerity 5 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles: | The Celerity 5 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles: | Same |

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

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K251452

STERIS

#

| Feature | Celerity 5 HP BI (proposed) | Celerity 5 HP BI Predicate (K250044) | Comparison |
| --- | --- | --- | --- |
| | • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems.
• 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® Incubator, the Incubator provides a fluorescent result within 5 minutes. | • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems.
• 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® Incubator, the Incubator provides a fluorescent result within 5 minutes. | |
| Indicator organism | Geobacillus stearothermophilus | Geobacillus stearothermophilus | Same |
| Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | Same |
| Accessories | Celerity Incubator | Celerity Incubator | Same |
| Viable spore population | 1.0 – 4.0 x 10^6 spore/BI | 1.0 – 4.0 x 10^6 spore/BI | Same |
| Resistance characteristics | Resistance @ 9.1 mg/L H2O2:
• D-value ≥ 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L H2O2:
• D-value > 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Same |
| Culture Conditions | 55-60°C, media included in BI, 5-minute incubation time. | 55-60°C, media included in BI, 5-minute incubation time. | Same |
| Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Direct inoculum on plastic vial, cap with recovery media. | Same |
| Process indicator | Celerity HP Indicator (K231488); magenta to yellow color change. | Celerity HP Indicator (K231488); magenta to yellow color change. | Same |
| Shelf-life | 7 months when stored inside of its original laminated pouch (10 month stability planned). 3 months once pouch is opened. | 3 Months | Shelf-life will require storage in original packaging |

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

{9}

K251452

STERIS

Table 2. Challenge Pack Comparison to Predicate Device (Celerity 5 HP)

| Feature | Celerity 5 HP Challenge pack Proposed | Celerity 5 HP Challenge pack (K250044) Predicate | Comparison |
| --- | --- | --- | --- |
| Intended Use / Indication for Use | 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 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. | Same |
| | The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. | 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. | 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. | |
| General Design | Sealed sterilization pouch containing BI, CI and barrier material. | Sealed sterilization pouch containing BI, CI and barrier material. | Same |
| Biological Indicator | Celerity 5 HP Biological Indicator | Celerity 5 HP Biological Indicator | Same |
| Chemical Indicator | Celerity HP Chemical Indicator | Celerity HP Chemical Indicator | Same |
| Means to distinguish processed pack from unprocessed | Proposed device’s internal indicator is visible through the pack. | Proposed device’s internal indicator is visible through the pack. | Same |
| Required accessories | Celerity Incubator (K250061) | Celerity Incubator (K250061) | Same |

6. Summary of Non-clinical Tests

Testing was performed to evaluate and demonstrate performance as summarized in Table 3.

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

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K251452

STERIS

Table 3. Performance Testing

| Test | Acceptance Criteria | Result |
| --- | --- | --- |
| Reduced Incubation Time Testing | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5-minutes | PASS |
| Simulated Use Testing | All processed Bis shall be sterile following full cycle exposure sterilizer cycles. | PASS |
| Cap Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
| Stability Testing | Population
The mean initial population at the start of the stability study must be 1.0-4.0 x 10^{6} CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.

D-value
D-value between 6 and 20 seconds.

Survival/Kill
Demonstration of one all survive time and one all kill time point.

RIT
All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5 minutes.

Media Testing
All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |

7. Conclusion

The Celerity 5 HP Biological Indicator and Challenge Pack have 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 (K250044), Class II (21 CFR 880.2800), product code FRC.

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

{11}

K251452

STERIS

510(k) Summary
For
Celerity 20 HP Biological Indicator and Challenge Pack

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
Logan Persons
Regulatory Affairs Specialist
Phone: [phone]
Fax: [phone]
Email: [e-mail]

Submission Date:
May 9, 2025

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
Page 7 of 12

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K251452

STERIS

#

# 8. Device Name

Trade Name: Celerity 20 HP Biological Indicator (LCB044)

Common/usual Name: Biological Indicator

Device Classification: Class II

Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

Trade Name: Celerity 20 HP Challenge Pack (LCB045)

Common/usual Name: Biological Indicator Challenge Pack

Device Classification: Class II

Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]

# 9. Predicate Device

Proprietary Name: Celerity 20 HP Biological Indicator (LCB044)

Common/usual Name: Biological indicator

Classification Name: Indicator, Biological Sterilization Process

510(k) Submitter/Holder: STERIS Corporation

510(k) Number: K250044

Proprietary Name: Celerity 20 HP Challenge Pack (LCB045)

Common/usual Name: Biological indicator Challenge Pack

Classification Name: Indicator, Biological Sterilization Process

510(k) Submitter/Holder: STERIS Corporation

510(k) Number: K250044

# 10. Description of Device

## Celerity 20 HP BI

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 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.

## Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

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

{13}

K251452

STERIS

The intended change to these devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

## 11. Intended Use/Indications for Use

### Celerity 20 HP BI

The Celerity 20 HP Biological Indicator (BI) is intended for 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
- 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 20 minutes.

### Celerity 20 HP Challenge Pack

The Celerity 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.

## 12. Summary of Technical Characteristics

Table 4. BI Subject Device Comparison to the Predicate Device (Celerity 20 HP)

| Feature | Celerity 20 HP BI (proposed) | Celerity 20 HP BI Predicate (K250044) | Comparison |
| --- | --- | --- | --- |
| Intended Use | The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles: | The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles: | Same |

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

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STERIS

| | • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems.
• 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. | • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems.
• 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. | |
| --- | --- | --- | --- |
| Indicator organism | Geobacillus stearothermophilus | Geobacillus stearothermophilus | Same |
| Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | Same |
| Accessories | Celerity HP Incubator
Celerity Incubator | Celerity HP Incubator
Celerity Incubator | Same |
| Viable spore population | 1.0 – 4.0 x 10^{6} spore/BI | 1.0 – 4.0 x 10^{6} spore/BI | Same |
| Resistance characteristics | Resistance @ 9.1 mg/L H_{2}O_{2}:
• D-value ≥ 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L H_{2}O_{2}:
• D-value > 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Same |
| Culture Conditions | 55-60°C, media included in BI, 20-minute incubation time. | 55-60°C, media included in BI, 20-minute incubation time. | Same |
| Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Direct inoculum on plastic vial, cap with recovery media. | Same |
| Process indicator | Celerity HP Indicator (K231488); magenta to yellow color change. | Celerity HP Indicator (K231488); magenta to yellow color change. | Same |
| Shelf-life | 7 months when stored inside of its original laminated pouch (10 month stability planned). 3 months once pouch is opened. | 3 months | Shelf-life will require storage in original packaging |

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
Page 10 of 12

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Table 5. Challenge Pack Comparison to Predicate Device (Celerity 20 HP)

| Feature | Celerity 20 HP Challenge pack Proposed | Celerity 20 HP Challenge pack (K250044) Predicate | Comparison |
| --- | --- | --- | --- |
| Intended Use / Indication for Use | 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 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. | Same |
| | The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. | 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. | 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. | |
| General Design | Sealed sterilization pouch containing BI, CI and barrier material. | Sealed sterilization pouch containing BI, CI and barrier material. | Same |
| Biological Indicator | Celerity 20 HP Biological Indicator | Celerity 20 HP Biological Indicator | Same |
| Chemical Indicator | Celerity HP Chemical Indicator | Celerity HP Chemical Indicator | Same |
| Means to distinguish processed pack from unprocessed | Proposed device’s internal indicator is visible through the pack. | Proposed device’s internal indicator is visible through the pack. | Same |
| Required accessories | Celerity HP Incubator (K171587) | Celerity HP Incubator (K171587) | Same |
| | Celerity Incubator (K250061) | Celerity Incubator (K250061) | |

13. Summary of Non-clinical Tests

Testing was performed to evaluate and demonstrate performance as summarized in Table 6.

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

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K251452

STERIS®

Table 6. Performance Testing

| Test | Acceptance Criteria | Result |
| --- | --- | --- |
| Reduced Incubation Time Testing | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes | PASS |
| Simulated Use Testing | All processed Bis shall be sterile following full cycle exposure sterilizer cycles. | PASS |
| Cap Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
| Stability Testing | Population
The mean initial population at the start of the stability study must be 1.0-4.0 x 106 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.

D-value
D-value between 6 and 20 seconds.

Survival/Kill
Demonstration of one all survive time and one all kill time point.

RIT
All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.

Media Testing
All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |

14. Conclusion

The Celerity 20 HP Biological Indicator and Challenge Pack have 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 (K250044), Class II (21 CFR 880.2800), product code FRC.

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