(28 days)
No.
The document describes biological indicators and challenge packs used for monitoring sterilization cycles, and mentions the use of an incubator for detecting fluorescent results. There is no mention of AI models, machine learning, or deep neural networks in the description of the device's function or components.
No.
This device is designed to monitor and qualify sterilizers, ensuring they effectively sterilize other medical devices, rather than directly providing a therapeutic effect to a patient.
Yes
The device is a biological indicator and challenge pack used for monitoring and qualifying sterilization cycles. It provides a "fluorescent result" or "optical change (signal)" that indicates whether the sterilization process was successful, thus providing diagnostic information about the sterility of instruments rather than diagnosing a patient condition.
No
The devices are hardware-based biological and chemical indicators and a challenge pack for sterilizer monitoring. They consist of physical components like spores, nutrient media, plastic vials, foam, and Tyvek pouches. While they are used with an "Incubator" which likely contains software, the device itself is not software only, nor is it a software component. The submission explicitly details changes to physical packaging (pouches) and labeling, not software updates.
No.
The devices (Celerity 5 HP Biological Indicator, Celerity 5 HP Challenge Pack, Celerity 20 HP Biological Indicator, and Celerity 20 HP Challenge Pack) are intended for monitoring and qualifying sterilizer cycles, which is a process control function, not for obtaining information about a specimen derived from the human body.
N/A
Intended Use / Indications for 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® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.
Celerity 5 HP Challenge Pack:
The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
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® 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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.
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in the sterile processing department, usually by service technicians or biomedical technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test: Reduced Incubation Time Testing
Acceptance Criteria: 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 (for 5 HP BI) or 20 minutes (for 20 HP BI).
Result: PASS
Test: Simulated Use Testing
Acceptance Criteria: All processed Bis shall be sterile following full cycle exposure sterilizer cycles.
Result: PASS
Test: Cap Media Testing
Acceptance Criteria: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.
Result: PASS
Test: Stability Testing
Acceptance Criteria:
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 5 minutes (for 5 HP BI) or 20 minutes (for 20 HP BI).
Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.
Result: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduced Incubation Time Testing: 97% or greater positive growth results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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.
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-
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
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 (LCBO52); Celerity 5 HP Challenge Pack (LCBO59) Celerity 20 HP Biological Indicator (LCBO44); Celerity 20 HP Challenge Pack (LCBO45)
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® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.
Celerity 5 HP Challenge Pack:
The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
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® 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 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
Page 5
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."
FORM FDA 3881 (8/23) Page 2 of 2
Page 6
510(k) Summary For Celerity 5 HP Biological Indicator and Challenge Pack
Sponsor Facility
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060
Phone: (440) 354-2600
Fax: (440) 357-9198
Manufacturing Facility
STERIS Corporation
9325 Pinecone Drive
Mentor, OH 44060
Phone: (440) 392-7800
Fax: (440) 392-7896
Contact
Logan Persons
Regulatory Affairs Specialist
Phone: (440) 352-7325
Fax: (440) 357-9198
Email: Logan_Persons@steris.com
Submission Date:
May 9, 2025
Page 7
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.
Page 8
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 |
Page 9
| 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 10⁶ spore/BI | 1.0 – 4.0 x 10⁶ 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 |
Page 10
| 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 10⁶ spore/BI | 1.0 – 4.0 x 10⁶ 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 |
Page 11
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 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 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 the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers. | Same |
| 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.
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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 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 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.
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510(k) Summary For Celerity 20 HP Biological Indicator and Challenge Pack
Sponsor Facility
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060
Phone: (440) 354-2600
Fax: (440) 357-9198
Manufacturing Facility
STERIS Corporation
9325 Pinecone Drive
Mentor, OH 44060
Phone: (440) 392-7800
Fax: (440) 392-7896
Contact
Logan Persons
Regulatory Affairs Specialist
Phone: (440) 352-7325
Fax: (440) 357-9198
Email: Logan_Persons@steris.com
Submission Date:
May 9, 2025
Page 14
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.
Page 15
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 |
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| Feature | Celerity 20 HP BI (proposed) | Celerity 20 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 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 10⁶ spore/BI | 1.0 – 4.0 x 10⁶ 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, 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 |
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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 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 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. | Same |
| 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 Incubator (K250061) | Celerity HP Incubator (K171587)
Celerity Incubator (K250061) | Same |
13. Summary of Non-clinical Tests
Testing was performed to evaluate and demonstrate performance as summarized in Table 6.
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.