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

K250044 · STERIS Corporation · FRC · Feb 6, 2025 · General Hospital

Device Facts

• Record ID: K250044
• 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 Corporation
• Product Code: FRC · General Hospital
• Decision Date: Feb 6, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, 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® Sterlizer with or without ALLClear®. When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes. 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 chad 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. The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: Lumen, 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 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 chaded. 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 for monitoring vaporized hydrogen peroxide sterilization. BIs contain Geobacillus stearothermophilus spores and nutrient media in a plastic vial. During sterilization, spores are exposed to the process; if sterilization fails, spores remain viable. Post-process, the Celerity Incubator detects a fluorescent signal generated by a reporter enzyme reacting with a fluorogenic substrate within the media. 5 HP BI provides results in 5 minutes; 20 HP BI in 20 minutes. Challenge packs include a BI, chemical indicator, and absorptive foam in a Tyvek pouch; used by service/biomedical technicians for system qualification after installation or repair. Healthcare providers use the fluorescent output to confirm sterilization efficacy. Benefits include rapid verification of sterilization cycles, ensuring patient safety by preventing the use of non-sterile instruments.

Clinical Evidence

Bench testing only. Performance validated via reduced incubation time testing, simulated use testing, bacteriostasis, cap media testing, stability testing, and specialty cycle validation. All tests met acceptance criteria, confirming performance equivalent to predicates.

Technological Characteristics

Biological indicator containing Geobacillus stearothermophilus spores and fluorogenic nutrient media in a plastic vial. Mechanism: enzymatic fluorescence detection. Resistance: D-value > 6 sec at 9.1 mg/L H2O2. Accessories: Celerity Incubator. Challenge pack: Tyvek pouch with BI, chemical indicator, and absorptive foam.

Indications for Use

Indicated for routine monitoring of specific low-temperature hydrogen peroxide sterilization cycles (V-PRO and STERRAD systems) and for qualification/requalification testing of V-PRO systems by sterile processing personnel.

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 (K223717)
• Celerity 5 HP Challenge Pack (K223717)
• Celerity 20 HP Biological Indicator (K183294)
• Celerity 20 HP Challenge Pack (K183294)

Reference Devices

• Celerity HP Indicator (K231488)

Submission Summary (Full Text)

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February 6, 2025

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

Re: K250044

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: January 8, 2025 Received: January 10, 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.

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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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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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: 2025.02.06 17:36:11 -05'00'

for: Christopher K. Dugard Division 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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### Indications for Use

510(k) Number (if known) K250044

#### 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, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, 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® Sterlizer 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 chad 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, 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 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 chaded. 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)

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Image /page/5/Picture/1 description: The image shows the logo for STERIS corporation. The logo consists of the word "STERIS" in a large, bold, sans-serif font, with the registered trademark symbol to the right of the "S". Below the word "STERIS" is a graphic of several horizontal, wavy lines in a light blue color. The lines are stacked on top of each other, creating a visual effect of water waves.

## 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:

#### 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: Logan Persons(@steris.com

#### Submission Date:

January 10, 2025

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Image /page/6/Picture/2 description: The image shows a blue logo with a series of horizontal, wavy lines stacked on top of each other. There are five lines in total, and they are all the same color. The lines are arranged in a way that creates a sense of depth and movement. The logo is simple and modern, and the blue color gives it a clean and professional look.

#### 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 |
|-------------------------|---------------------------------------------|
| Common/usual Name | Biological indicator |
| Classification Name: | Indicator, Biological Sterilization Process |
| 510(k) Submitter/Holder | STERIS Corporation |
| 510(k) Number: | K223717 |
| Proprietary Name | Celerity 5 HP Challenge Pack |
| Common/usual Name | Biological indicator Challenge Pack |
| Classification Name: | Indicator, Biological Sterilization Process |
| 510(k) Submitter/Holder | STERIS Corporation |
| 510(k) Number: | K223717 |

#### 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 and a layer of absorptive foam within a Tyvek pouch.

#### 4. Intended Use/Indications for Use Celerity 5 HP BI

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Image /page/7/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same light blue color. The lines are not perfectly straight, but rather have a gentle, undulating curve, resembling waves or contours. The logo is simple and abstract, with a clean and modern aesthetic.

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<br>(proposed) | Celerity 5 HP BI<br>Predicate (K223717) | Comparison | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | The Celerity 5 HP<br>Biological Indicator (BI) is<br>intended for routine<br>monitoring of the<br>following sterilizer cycles:<br><br>Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and<br>Specialty Cycles of<br>the V-PRO: 1, 1 Plus,<br>maX, maX2, 60 and<br>s2 Low Temperature<br>Sterilization Systems. Standard and<br>Advanced Cycles of<br>the STERRAD® NX | The Celerity 5 HP<br>Biological Indicator (BI) is<br>intended for routine<br>monitoring of the<br>following sterilizer cycles:<br><br>Lumen, Non Lumen, Fast Non Lumen, Fast, and Flexible<br>Cycles of the V-PRO:<br>1, 1 Plus, maX, maX2<br>60 and s2 Low<br>Temperature<br>Sterilization Systems. Standard Cycle of the<br>STERRAD® 100S Standard and<br>Advanced Cycles of | Similar. Proposed device<br>will add the Specialty Cycle<br>and remove the STERRAD<br>100S Standard Cycle | |
| Feature | Celerity 5 HP BI (proposed) | Celerity 5 HP BI Predicate (K223717) | Comparison | |
| | Sterilizer with or<br>without ALLClear<br>Standard, FLEX,<br>Express and DUO<br>Cycles of the<br>STERRAD® 100NX<br>Sterilizer with or<br>without ALLClear<br><br>When used in conjunction<br>with the Celerity®<br>Incubator, the Incubator<br>provides a fluorescent<br>result within 5 minutes. | the STERRAD® NX<br>Sterilizer with or<br>without ALLClear<br>Standard, FLEX,<br>Express and DUO<br>Cycles of the<br>STERRAD® 100NX<br>Sterilizer with or<br>without ALLClear<br><br>When used in conjunction<br>with the Celerity®<br>Incubator, the Incubator<br>provides a fluorescent<br>result within 5 minutes. | | |
| Indicator<br>organism | <i>Geobacillus<br/>stearothermophilus</i> | <i>Geobacillus<br/>stearothermophilus</i> | Same | |
| Mechanism of<br>action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety | Same | |
| Accessories | Celerity Incubator | Celerity Incubator | 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<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 6 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Same | |
| | Culture<br>Conditions | 55- 59°C, media included<br>in BI, 20-minute<br>incubation time. | 55- 59°C, media included<br>in BI, 20-minute<br>incubation time. | Same |
| | | Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Direct inoculum on plastic<br>vial, cap with recovery<br>media. |
| Process<br>indicator | Celerity HP Indicator<br>(K231488); magenta to<br>yellow color change. | | Celerity HP Indicator<br>(K231488); magenta to<br>yellow color change. | Same |
| Shelf-life | 3 months (with target of<br>24 months) | | 10 Months | Similar |
| Feature | Celerity 5 HP Challenge pack<br>Proposed | Celerity 5 HP Challenge pack<br>(K223717) Predicate | Comparison | |
| Intended Use /<br>Indication for<br>Use | The Celerity 5 HP Challenge<br>Pack is intended for qualification<br>testing of the V-PRO Low<br>Temperature Sterilization System<br>following installation, relocation,<br>malfunctions or major repairs and<br>for routine requalification testing. | The Celerity 5 HP Challenge<br>Pack is intended for qualification<br>testing of the V-PRO Low<br>Temperature Sterilization<br>System following installation,<br>relocation, malfunctions or<br>major repairs and for routine<br>requalification testing. | Same | |
| | The Challenge Pack is placed in<br>an otherwise empty sterilizer<br>chamber; a hospital-defined<br>challenge load is<br>not included. | The Challenge Pack is placed in<br>an otherwise empty sterilizer<br>chamber; a hospital-defined<br>challenge load is<br>not included. | Same | |
| | The challenge pack is not<br>intended for routine monitoring of<br>the V-PRO Sterilizers. It has been<br>tested and validated solely for use<br>in periodic testing of the<br>sterilizers. | The challenge pack is not<br>intended for routine monitoring<br>of the V-PRO Sterilizers. It has<br>been tested and validated solely<br>for use in periodic testing of the<br>sterilizers. | Same | |
| General<br>Design | Sealed sterilization pouch<br>containing BI, CI and barrier<br>material. | Sealed sterilization pouch<br>containing BI, CI and barrier<br>material. | Same | |
| Biological<br>Indicator | Celerity 5 HP Biological<br>Indicator | Celerity 5 HP Biological<br>Indicator | Same | |
| Chemical<br>Indicator | Celerity HP Chemical Indicator | Celerity HP Chemical Indicator | Same | |
| Means to<br>distinguish<br>processed pack<br>from<br>unprocessed | Proposed device's internal<br>indicator is visible through the<br>pack. | Proposed device's internal<br>indicator is visible through the<br>pack. | Same | |
| Required<br>accessories | Celerity Incubator (Subject of a<br>concurrent submission) | Celerity Incubator (Subject of a<br>concurrent submission) | Same | |

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## S STE

Image /page/8/Picture/2 description: The image shows a blue icon with a series of horizontal lines that curve up and down, resembling waves. There are six lines in total, stacked vertically on top of each other. The lines are evenly spaced and have a consistent thickness. The icon is simple and abstract, likely representing water or a similar concept.

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

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# STEI

Image /page/9/Picture/2 description: The image shows a blue logo with a series of horizontal, wavy lines stacked on top of each other. There are five lines in total, each slightly curved to create a wave-like pattern. The lines are evenly spaced and appear to be of uniform thickness. The logo is simple and abstract, suggesting movement or fluidity.

#### 6. Summary of Non-clinical Tests

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 3.

| Table 3. Performance Testing | |
|------------------------------|--|
| | |

| Test | Acceptance Criteria | Result | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Reduced<br>Incubation Time<br>Testing | All BI lots will demonstrate 97% or greater positive growth<br>results at 7 days as compared to the fluorescent result at<br>less than or equal to 5-minutes | PASS | | |
| Simulated Use<br>Testing | All processed Bis shall be sterile following full cycle<br>exposure sterilizer cycles. | PASS | | |
| Bacteriostasis<br>Testing | All BIs inoculated with 10-100 Geobacillus<br>stearothermophilus spores will demonstrate growth | PASS | | |
| Cap Media<br>Testing | All BIs will demonstrate a positive fluorescent signal in the<br>fluorescent incubators. | PASS | | |
| Stability Testing | Population<br><br>The mean initial population at the start of the stability<br>study must be 1.0-4.0 x 106 CFU/BI. At each subsequent<br>time point, the mean population shall be 50-300% of the<br>initial mean population.<br><br>D-value<br><br>D-value between 6 and 20 seconds.<br><br>Survival/Kill<br><br>Demonstration of one all survive time and one all kill time<br>point.<br><br>RIT<br><br>All BI lots will demonstrate 97% or greater positive growth<br>results at 7 days as compared to the fluorescent result at<br>less than or equal to 5 minutes.<br><br>Media Testing<br><br>All BIs will demonstrate a positive fluorescent signal in the<br>fluorescent incubators. | PASS | | |
| | Specialty Cycle | | All Bis will demonstrate a positive signal and growth after<br>exposure to a sublethal cycle and a 20 hour aeration phase. | PASS |
| | Hold Time<br>Testing | | The hold time will be established using the longest hold<br>time where there is no statistical or practical difference<br>from the initial hold time (time 0). | 72 Hour<br>Hold Time<br>Established |

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# STERIS®

Image /page/10/Picture/2 description: The image shows a blue icon with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same color. The lines are arranged in a way that creates a sense of depth and movement. The icon is simple and clean, and it could be used to represent a variety of things, such as water, waves, or sound.

#### 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 nonclinical performance data, the subject device is as safe, as effective, and performs as well as

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# STERIS®

the legally marketed predicate device (K223717), Class II (21 CFR 880.2800), product code FRC.

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Image /page/12/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is written in large, bold, black letters at the top of the logo, with a small "®" symbol in the upper right corner. Below the word "STERIS" is a graphic of several horizontal, wavy blue lines, resembling water.

## 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:

#### Manufacturing Facility

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

#### Contact

Logan Persons Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Logan Persons(@steris.com

#### Submission Date:

January 10, 2025

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Image /page/13/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a pattern that resembles waves or ripples. The logo is simple and abstract, with no text or other elements included.

#### 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),<br>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),<br>FRC] |

#### 9. Predicate Device

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

#### 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 and a layer of absorptive foam within a Tyvek pouch.

#### 11. Intended Use/Indications for Use Celerity 20 HP BI

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Image /page/14/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. There are six lines in total, and they are all the same light blue color. The lines are arranged in a way that creates a sense of depth and movement. The logo is simple and modern, and the blue color gives it a calming and refreshing feel.

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<br>(proposed) | Celerity 20 HP BI<br>Predicate (K183294) | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | The Celerity 20 HP<br>Biological Indicator<br>(BI) is intended for<br>routine monitoring of<br>the following sterilizer<br>cycles:<br><br>• Lumen, Non<br>• Lumen, Fast Non<br>• Lumen, Fast,<br>Flexible, and<br>Specialty Cycles of<br>the V-PRO: 1, 1<br>Plus, maX, maX2,<br>60 and s2 Low<br>Temperature | The Celerity 20 HP<br>Biological Indicator<br>(BI) is intended for<br>routine monitoring of<br>the following sterilizer<br>cycles:<br><br>• Lumen, Non<br>• Lumen, Fast Non<br>• Lumen, Fast,<br>Flexible, and<br>Specialty Cycles of<br>the V-PRO: 1, 1<br>Plus, maX, maX2,<br>60 and s2 Low<br>Temperature | Similar. Proposed device<br>will remove STERRAD<br>100S Standard Cycle |
| Feature | Celerity 20 HP BI<br>(proposed) | Celerity 20 HP BI<br>Predicate (K183294) | Comparison |
| | Sterilization<br>Systems.<br>• Standard and<br>Advanced Cycles of<br>the STERRAD®<br>NX Sterilizer with<br>or without<br>ALLClear<br>• Standard, FLEX,<br>Express and DUO<br>Cycles of the<br>STERRAD®<br>100NX Sterilizer<br>with or without<br>ALLClear<br>When used in<br>conjunction with the<br>Celerity® Incubator, the<br>Incubator provides a<br>fluorescent result within<br>20 minutes. | Sterilization<br>Systems.<br>• Standard Cycle of<br>the STERRAD®<br>100S<br>• Standard and<br>Advanced Cycles of<br>the STERRAD®<br>NX Sterilizer with<br>or without<br>ALLClear<br>• Standard, FLEX,<br>Express and DUO<br>Cycles of the<br>STERRAD®<br>100NX Sterilizer<br>with or without<br>ALLClear<br>When used in<br>conjunction with the<br>Celerity HP Incubator,<br>the Celerity 20 HP BI<br>provides a fluorescent<br>result within 20 minutes. | |
| Indicator<br>organism | <i>Geobacillus<br/>stearothermophilus</i> | <i>Geobacillus<br/>stearothermophilus</i> | Same |
| Mechanism<br>of action | An enzyme, which is<br>produced by the<br>organism, reacts with a<br>fluorogenic substrate<br>within the defined<br>nutrient media to<br>produce a fluorescent<br>moiety | An enzyme, which is<br>produced by the<br>organism, reacts with a<br>fluorogenic substrate<br>within the defined<br>nutrient media to<br>produce a fluorescent<br>moiety | Same |
| Accessories | Celerity Incubator | Celerity Incubator | 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<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 6 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Same |
| Feature | Celerity 20 HP BI<br>(proposed) | Celerity 20 HP BI<br>Predicate (K183294) | Comparison |
| Culture<br>Conditions | 55- 59°C, media<br>included in BI, 20-<br>minute incubation time. | 55- 59°C, media<br>included in BI, 20-<br>minute incubation time. | Same |
| Primary<br>Packaging | Direct inoculum on<br>plastic vial, cap with<br>recovery media. | Direct inoculum on<br>plastic vial, cap with<br>recovery media. | Same |
| Process<br>indicator | Celerity HP Indicator<br>(K231488); magenta to<br>yellow color change. | Celerity HP Indicator<br>(K231488); magenta to<br>yellow color change. | Same |
| Shelf-life | 3 months (with target of<br>24 months) | 10 Months | Similar |

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# STERIS®

Image /page/15/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue. The lines are arranged in a way that creates a sense of movement or flow. The logo is simple and abstract, with no other elements or text present.

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## S STE

Image /page/16/Picture/2 description: The image shows a logo with a series of horizontal, curved lines stacked on top of each other. The lines are all the same color, a light blue, and they create a wave-like pattern. The overall effect is reminiscent of water or sound waves, giving the logo a sense of movement and fluidity.

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

| Feature | Celerity 20 HP Challenge pack<br>Proposed | Celerity 20 HP Challenge pack<br>(K183294) Predicate | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| The Celerity 20 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. | 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. | | |
| Intended Use<br>/ Indication<br>for Use | 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 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 |

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## STI

Image /page/17/Picture/2 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a pattern that resembles waves or contours. The logo is simple and abstract, with no text or other elements present.

| Feature | Celerity 20 HP Challenge<br>pack<br>Proposed | Celerity 20 HP Challenge<br>pack<br>(K183294) Predicate | Comparison |
|------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|------------|
| General<br>Design | Sealed sterilization pouch<br>containing BI, CI and barrier<br>material. | Sealed sterilization pouch<br>containing BI, CI and barrier<br>material. | Same |
| Biological<br>Indicator | Celerity 20 HP Biological<br>Indicator | Celerity 20 HP Biological<br>Indicator | Same |
| Chemical<br>Indicator | Celerity HP Chemical<br>Indicator | Celerity HP 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 Incubator (Subject of<br>a concurrent submission) | Celerity Incubator (Subject of<br>a concurrent submission) | Same |

#### 13. Summary of Non-clinical Tests

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 6.

| Test | Acceptance Criteria | Result |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Reduced<br>Incubation Time<br>Testing | All BI lots will demonstrate 97% or greater positive growth<br>results at 7 days as compared to the fluorescent result at<br>less than or equal to 20 minutes | PASS |
| Simulated Use<br>Testing | All processed Bis shall be sterile following full cycle<br>exposure sterilizer cycles. | PASS |
| Bacteriostasis<br>Testing | All BIs inoculated with 10-100 Geobacillus<br>stearothermophilus spores will demonstrate growth | PASS |
| Cap Media<br>Testing | All BIs will demonstrate a positive fluorescent signal in the<br>fluorescent incubators. | PASS |
| Stability Testing | Population<br>The mean initial population at the start of the stability<br>study must be 1.0-4.0 x $10^6$ CFU/BI. At each subsequent | PASS |

#### Table 6. Performance Testing

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| | 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. |…