(27 days)
No
The description focuses on a biological indicator and an incubator that detects a fluorescent signal. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a biological indicator used to monitor and qualify low-temperature sterilization systems, not to directly treat or diagnose a medical condition in a patient.
No
The devices described (Biological Indicators and Challenge Packs) are used for monitoring and qualification testing of sterilization systems in a sterile processing department. They assess the efficacy of sterilization processes, not to diagnose a patient's medical condition or disease.
No
The device description clearly outlines physical components such as biological indicators containing spores and nutrient media in plastic vials, as well as challenge packs containing foam and Tyvek pouches. It also mentions the use of a "STERIS proprietary reader, STERIS Celerity Incubator," which is a hardware component.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use of these devices is to monitor and qualify sterilization cycles for medical devices. They are used to assess the effectiveness of the sterilization process itself, not to diagnose a condition or disease in a patient using a sample from the patient's body.
- Device Description: The device description details the components (spores, media, vial, pouch) and how they function to indicate whether sterilization was successful. This process involves a biological indicator reacting to the sterilization process, not analyzing a patient sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
These devices fall under the category of sterilization process indicators, which are used to verify the effectiveness of sterilization equipment and procedures. They are a type of quality control tool for medical device reprocessing, not diagnostic tools for patient care.
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, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, 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.
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 and a layer of absorptive foam within a Tyvek pouch.
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.
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
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)
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: 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
Result: PASS
Test: Simulated Use Testing
Acceptance Criteria: All processed Bis shall be sterile following full cycle exposure sterilizer cycles.
Result: PASS
Test: Bacteriostasis Testing
Acceptance Criteria: All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth
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 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.
D-value: D-value between 6 and 20 seconds.
Survival/Kill: Demonstration of one all survive time and one all kill time point.
RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5 minutes.
Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.
Result: PASS
Test: Specialty Cycle
Acceptance Criteria: All Bis will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.
Result: PASS
Test: Hold Time Testing
Acceptance Criteria: The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).
Result: 72 Hour Hold Time Established
Summary of Non-clinical Tests (Celerity 20 HP Biological Indicator and Challenge Pack)
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 6.
Table 6. Performance Testing
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 20 minutes
Result: PASS
Test: Simulated Use Testing
Acceptance Criteria: All processed Bis shall be sterile following full cycle exposure sterilizer cycles.
Result: PASS
Test: Bacteriostasis Testing
Acceptance Criteria: All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth
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 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.
D-value: D-value between 6 and 20 seconds.
Survival/Kill: Demonstration of one all survive time and one all kill time point.
RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.
Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.
Result: PASS
Test: Specialty Cycle
Acceptance Criteria: All Bis will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.
Result: Pass
Test: Hold Time Testing
Acceptance Criteria: The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).
Result: 72 Hour Hold Time Established
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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: 2025.02.06 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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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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: (440) 354-2600 Fax:
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:
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
(proposed) | Celerity 5 HP BI
Predicate (K223717) | Comparison | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | 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, maX2, 60 and
s2 Low Temperature
Sterilization Systems. Standard and
Advanced Cycles of
the STERRAD® NX | The Celerity 5 HP
Biological Indicator (BI) is
intended for routine
monitoring of the
following sterilizer cycles:
Lumen, Non Lumen, Fast Non Lumen, Fast, and Flexible
Cycles of the V-PRO:
1, 1 Plus, maX, maX2
60 and s2 Low
Temperature
Sterilization Systems. Standard Cycle of the
STERRAD® 100S Standard and
Advanced Cycles of | Similar. Proposed device
will add the Specialty Cycle
and remove the STERRAD
100S Standard Cycle | |
| Feature | Celerity 5 HP BI (proposed) | Celerity 5 HP BI Predicate (K223717) | Comparison | |
| | 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. | 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. | | |
| 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- 59°C, media included
in BI, 20-minute
incubation time. | 55- 59°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. |
| Process
indicator | Celerity HP Indicator
(K231488); magenta to
yellow color change. | | Celerity HP Indicator
(K231488); magenta to
yellow color change. | Same |
| Shelf-life | 3 months (with target of
24 months) | | 10 Months | Similar |
| Feature | Celerity 5 HP Challenge pack
Proposed | Celerity 5 HP Challenge pack
(K223717) Predicate | Comparison | |
| Intended Use /
Indication for
Use | The Celerity 5 HP Challenge
Pack is intended for qualification
testing of the V-PRO Low
Temperature Sterilization System
following installation, relocation,
malfunctions or major repairs and
for routine requalification testing. | The Celerity 5 HP Challenge
Pack is intended for qualification
testing of the V-PRO Low
Temperature Sterilization
System following installation,
relocation, malfunctions or
major repairs and for routine
requalification testing. | Same | |
| | The Challenge Pack is placed in
an otherwise empty sterilizer
chamber; a hospital-defined
challenge load is
not included. | The Challenge Pack is placed in
an otherwise empty sterilizer
chamber; a hospital-defined
challenge load is
not included. | Same | |
| | The challenge pack is not
intended for routine monitoring of
the V-PRO Sterilizers. It has been
tested and validated solely for use
in periodic testing of the
sterilizers. | The challenge pack is not
intended for routine monitoring
of the V-PRO Sterilizers. It has
been tested and validated solely
for use in periodic testing of the
sterilizers. | 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 (Subject of a
concurrent submission) | Celerity Incubator (Subject of a
concurrent submission) | Same | |
8
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)
9
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 | ||||
| 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 | |||
| Bacteriostasis | ||||
| Testing | All BIs inoculated with 10-100 Geobacillus | |||
| stearothermophilus spores will demonstrate growth | 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 | | |
| | Specialty Cycle | | All Bis will demonstrate a positive signal and growth after
exposure to a sublethal cycle and a 20 hour aeration phase. | PASS |
| | Hold Time
Testing | | The hold time will be established using the longest hold
time where there is no statistical or practical difference
from the initial hold time (time 0). | 72 Hour
Hold Time
Established |
10
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
11
STERIS®
the legally marketed predicate device (K223717), Class II (21 CFR 880.2800), product code FRC.
12
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: (440) 354-2600 Fax:
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 (440) 392-7896 Fax:
Contact
Logan Persons Regulatory Affairs Specialist Phone: (440) 352-7325 Fax: (440) 357-9198 Email: Logan Persons(@steris.com
Submission Date:
January 10, 2025
13
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), |
| 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 |
|---|---|
| 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
14
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
(proposed) | Celerity 20 HP BI
Predicate (K183294) | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | 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, maX2,
60 and s2 Low
Temperature | 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, maX2,
60 and s2 Low
Temperature | Similar. Proposed device
will remove STERRAD
100S Standard Cycle |
| Feature | Celerity 20 HP BI
(proposed) | Celerity 20 HP BI
Predicate (K183294) | Comparison |
| | 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. | Sterilization
Systems.
• Standard Cycle of
the STERRAD®
100S
• 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. | |
| 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 |
| Feature | Celerity 20 HP BI
(proposed) | Celerity 20 HP BI
Predicate (K183294) | Comparison |
| Culture
Conditions | 55- 59°C, media
included in BI, 20-
minute incubation time. | 55- 59°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 | 3 months (with target of
24 months) | 10 Months | Similar |
15
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.
16
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
Proposed | Celerity 20 HP Challenge pack
(K183294) Predicate | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| The Celerity 20 HP Challenge
Pack is intended for
qualification testing of the V-
PRO Low
Temperature Sterilization
System following installation,
relocation, malfunctions or
major repairs and for routine
requalification testing. | The Celerity 20 HP
Challenge Pack is intended
for qualification testing of the
V-PRO Low
Temperature Sterilization
System following installation,
relocation, malfunctions or
major repairs and for routine
requalification testing. | | |
| Intended Use
/ Indication
for Use | The Challenge Pack is placed
in an otherwise empty
sterilizer chamber; a hospital-
defined challenge load is
not included.
The challenge pack is not
intended for routine
monitoring of the V-PRO
Sterilizers. It has been tested
and validated solely for use in
periodic testing of the
sterilizers. | The Challenge Pack is 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 |
17
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
pack
Proposed | Celerity 20 HP Challenge
pack
(K183294) Predicate | Comparison |
|------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|------------|
| 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 Incubator (Subject of
a concurrent submission) | Celerity Incubator (Subject of
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 | ||
| 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 | |
| Bacteriostasis | ||
| Testing | All BIs inoculated with 10-100 Geobacillus | |
| stearothermophilus spores will demonstrate growth | PASS | |
| Cap Media | ||
| Testing | All BIs will demonstrate a positive fluorescent signal in the | |
| fluorescent incubators. | PASS | |
| Stability Testing | Population | |
| The mean initial population at the start of the stability | ||
| study must be 1.0-4.0 x $10^6$ CFU/BI. At each subsequent | PASS |
Table 6. Performance Testing
18
Image /page/18/Picture/2 description: The image shows a stylized graphic of several horizontal lines that are stacked vertically. The lines are blue and have a wavy or undulating pattern, creating a sense of movement or flow. The overall shape of the graphic is rectangular, with the lines filling the space from top to bottom. The lines are evenly spaced and have a consistent thickness.
| 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. | ||
| Specialty Cycle | All Bis will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase. | Pass |
| Hold Time | ||
| Testing | The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0). | 72 Hour |
| Hold Time | ||
| Established |
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 nonclinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K183294), Class II (21 CFR 880.2800), product code FRC.