(185 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators and their detection via an incubator, with no mention of AI or ML for data analysis or interpretation.
No.
This device is designed to monitor sterilization cycles and qualify sterilization equipment, not to directly diagnose, treat, or prevent disease in a patient.
Yes
Explanation: The device, Celerity 5 HP Biological Indicator and Celerity 5 HP Challenge Pack, is used to monitor and test the effectiveness of sterilization cycles. It produces a result (fluorescent or color change) that indicates whether the sterilization process was successful, thus providing information about the proper functioning of the sterilizer, which is a form of diagnostic information.
No
The device description clearly indicates the product consists of physical components like spores, nutrient media, and a plastic vial. It also mentions a proprietary reader (Incubator) which is a hardware device.
Based on the provided information, the Celerity 5 HP Biological Indicator and the Celerity 5 HP Challenge Pack are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of both devices is to monitor and test the effectiveness of sterilization cycles for medical devices. They are used to confirm that the sterilization process has successfully killed microorganisms.
- Device Description: The devices contain biological spores and media to assess the sterilization process. The biological indicator produces a signal based on the viability of the spores after sterilization, which is then detected by an incubator. The challenge pack is a specific configuration for testing sterilizer performance.
- Lack of Diagnostic Purpose: Neither device is intended to diagnose a disease, condition, or state of health in a patient. They are used to evaluate the performance of a medical device sterilization process, which is a quality control measure for the medical devices themselves, not a diagnostic test for a patient.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. These devices do not fit that description.
N/A
Intended Use / Indications for Use
Celerity 5 HP Biological Indicator has the following Indications for Use:
The Celerity 5 HP Biological Indicator (BI) is used 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 2, 60 and s2 Low Temperature Sterilization Systems
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard. FLEX. 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 has the following Indications 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 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 Biological Indicator
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, 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 (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 5 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 2 hours prior to activation. The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60 ℃ in the CELERITY Incubator for a final determination of viability within 5 minutes of incubation.
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
Not Found
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)
Nonclinical Tests were performed for performance testing to demonstrate substantial equivalence to the predicate. The tests performed are:
Viable Spore Population:
- Description: Study to demonstrate that the product meets its specification for the spore population.
- Acceptance Criteria: Average population for each lot of 1.0 x 10^6 - 4.0 x 10^6 CFU/BI.
- Conclusion: Pass.
Resistance Characteristics Study:
- Description: Study to verify that the Celerity 5 Biological Indicator meets the acceptance criteria for resistance. Acceptance criteria are designed to demonstrate comparable or greater resistance values than the predicate device.
- Acceptance Criteria: D-Value: 2-20 seconds; All Survive: ≤ 4 seconds; All Kill: ≥ 6 minutes.
- Conclusion: Pass.
Carrier and Pack Material Growth Inhibition Evaluation:
- Description: Study to demonstrate that the primary packaging material used in the manufacture of the Biological Indicator (BI) does not hinder, or otherwise affect, the outgrowth of a low number of Geobacillus stearothermophilus spores.
- Acceptance Criteria: All BIs inoculated with Geobacillus stearothermophilus spores demonstrate growth.
- Conclusion: Pass.
Holding Time Assessment:
- Description: Study to demonstrate the labeled hold time of the BI.
- Acceptance Criteria: 120 minutes.
- Conclusion: Pass.
Signal Generation:
- Description: Study to demonstrate that the PBS media contained in the cap of the Celerity 5 HP Biological Indicator is able to generate a detectable fluorescent signal from viable G. stearothermophilus organisms.
- Acceptance Criteria: All BIs will demonstrate a positive fluorescent signal.
- Conclusion: Pass.
Simulated Use Testing – V-PRO:
- Description: Study to demonstrate that the Project Blayze Biological Indicator (BI) for Gaseous Hydrogen Peroxide Sterilization Processes functions appropriately when processed in the claimed sterilizer cycles with a validated load.
- Acceptance Criteria: All BIs processed in a full cycle will demonstrate a negative signal corresponding to a no-growth result upon seven day incubation.
- Conclusion: Pass.
Simulated Use Testing – STERRAD:
- Description: Study to demonstrate the Project Blayze Biological Indicator (BI) for Gaseous Hydrogen Peroxide Sterilization Processes functions appropriately when processed in STERRAD® Sterilizers with a validated load.
- Acceptance Criteria: All BIs processed in a full cycle will demonstrate a negative signal corresponding to a no-growth result upon seven day incubation.
- Conclusion: Pass.
Population after ALLClear Exposure:
- Description: Study to demonstrate ALLClear preconditioning does not impact BI performance.
- Acceptance Criteria: Each BI signal evaluation was positive following exposure to the All-Clear precondition treatment; The mean population of each BI exposed to the All-Clear precondition treatment was within 50-300% of the unexposed control mean population.
- Conclusion: Pass.
Reduced Incubation Time:
- Description: Study to verify Reduced Incubation Time of the BI.
- Acceptance Criteria: Study will demonstrate that 97% or greater of the positive samples at seven days also gave a positive signal at the claimed RIT time.
- Conclusion: Pass.
Reduced Incubation Time – Engineering Mode:
- Description: Study to verify the Reduced Incubation Time of 5-minute correlates to a 20-minute result like the predicate device and 7 day growth.
- Acceptance Criteria: Study will demonstrate that 97% or greater of the positive samples at seven days also Pass.
- Conclusion: Pass.
Celerity 5 HP Challenge Pack Simulated Use Testing:
- Description: Study to demonstrate performance of challenge pack under worst-case conditions.
- Acceptance Criteria: Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions.
- Conclusion: Pass.
Dose Response Testing:
- Description: Study to demonstrate the challenge pack provides adequate challenge to perform intended use.
- Acceptance Criteria: The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.
- Conclusion: Pass.
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 shows 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K223717
Trade/Device Name: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2023 Received: May 19, 2023
Dear Gregory Land:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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-regulatoryassistance/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).
Sincerelv.
Christopher K. Dugard -2
Clarence W. Murray, III, PhD Deputy Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Celerity 5 HP Biological Indicator;
Celerity 5 HP Challenge Pack
Indications for Use (Describe)
Celerity 5 HP Biological Indicator
The Celerity 5 HP Biological Indicator (BI) is used 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
2, 60 and s2 Low Temperature Sterilization Systems
- · STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
· Standard. FLEX. 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.
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.
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."
3
510(K) Summary For Celerity 5 HP Biological Indicator And Celerity 5 HP 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:
Contact
Gregory Land Lead Regulatory Affairs Specialist Phone: (440) 392-7424 Email: greg land@steris.com
Submission Date: June 13, 2023
K Number: K223717
4
1 Device Name
Celerity 5 HP Biological Indicator
| Trade Name: | Celerity 5 HP Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |
Celerity 5 HP Challenge Pack
| Trade Name: | Celerity 5 HP Challenge Pack |
|---|---|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |
Predicate Device 2
Celerity 5 HP Biological Indicator
| 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 |
Celerity 5 HP Challenge Pack
| 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 |
Description of Device 3
Celerity 5 HP Biological Indicator
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, 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 (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 5 HP Biological
5
Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 2 hours prior to activation.
The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.
The activated BI is incubated at 55-60 ℃ in the CELERITY Incubator for a final determination of viability within 5 minutes of incubation.
4 Intended Use/Indications for Use
Celerity 5 HP Biological Indicator
The Celerity 5 HP Biological Indicator (BI) is used 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, maX 2, 60 and s2 Low Temperature Sterilization Systems
- . STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® 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.
റ Summary of Technical Characteristics
Table 1. Biological Indicator Subject Device Comparison to the Predicate Device
| Feature | CELRITY 5 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The Celerity 5 HP Biological
Indicator (BI) is used for
routine monitoring of the
following sterilizer cycles:
• Lumen, Non Lumen, Fast
Non Lumen, Fast and | The Celerity 20 HP
Biological Indicator is
intended for routine
monitoring of the following
sterilizer cycles: | Proposed device has a
5-minute read time |
| Feature | CELRITY 5 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
| | Flexible Cycles of the V-
PRO 1, 1 Plus, maX, maX
2, 60 and s2 Low
Temperature Sterilization
Systems
• STERRAD® 100S
Sterilizer (Default Cycle)
• Standard and Advanced
Cycles of the STERRAD®
NX® Sterilizer with or
without ALLClear®
• Standard, FLEX, 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 and
Flexible Cycles of the V-
PRO® Low Temperature
Sterilization Systems
• STERRAD® 100S
Sterilizer (Default Cycle)
• Standard and Advanced
Cycles of the STERRAD®
NX Sterilizer with or
without ALLClear
• Standard, Flex Scope,
Express and DUO Cycles
of the STERRAD® 100NX
Sterilizer with or without
ALLClear
When used in conjunction
with the Celerity HP
Incubator, the Celerity 20 HP
BI provides a fluorescent
result within 20 minutes. | |
| 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 | Automated incubator / reader | Automated incubator /
reader | Same |
| Viable spore
population | 1.0 – 4.0 x 106 spore/BI | 1.0 – 4.0 x 106 spore/BI | Same |
| Resistance | Resistance @ 9.1 mg/L H2O2:
• D-value ≥ 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 7 min | Resistance @ 9.1 mg/L H2O2:
• D-value ≥ 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 7 min | Same |
| Culture
Conditions | 55-59°C, media included in BI,
5-minute incubation time. | 55-59°C, media included in
BI, 20-minute incubation
time. | Similar |
| Feature | CELRITY 5 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
| Primary Packaging | Direct inoculum on plastic
vial, cap with recovery media. | Direct inoculum on plastic
vial, cap with recovery
media. | Same |
| Process indicator | VERIFY V-PRO Chemical
Indicator (K140515); magenta
to yellow color change. | VERIFY V-PRO Chemical
Indicator (K140515);
magenta to yellow color
change. | Same |
| Shelf-life | 8 months | 10 months | Similar |
6
7
Table 2: Challenge Pack Comparison to Predicate Device
| Feature | CELERITY 5 HP Challenge pack
Proposed | CELERITY 20 HP Challenge pack
(K173488) 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 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 SCBI, CI and barrier
material. | Sealed sterilization pouch
containing SCBI, CI and
barrier material. | Same |
| Biological
Indicator | Celerity 5 HP Biological
Indicator | Celerity 20 HP Biological
Indicator | Similar |
8
| Feature | CELERITY 5 HP Challenge pack
Proposed | CELERITY 20 HP Challenge pack
(K173488) Predicate | Comparison |
|------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|
| Chemical
Indicator | Celerity HP Chemical Indicator | VERIFY HPU Chemical
Indicator | Same - brand
name has
changed |
| 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 (K223715) | CELERITY HP Incubator*
(K171587)
Celerity Incubator (K213881) | Similar |
6 Summary of nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3 below.
| Test | Description | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Viable Spore Population | Study to demonstrate that | ||
| the product meets its | |||
| specification for the spore | |||
| population. | Average population for each | ||
| lot of 1.0 x 106 - 4.0 x 106 | |||
| CFU/BI | Pass | ||
| Resistance Characteristics | |||
| Study | Study to verify that the | ||
| Celerity 5 Biological | |||
| Indicator meets the | |||
| acceptance criteria for | |||
| resistance. Acceptance | |||
| criteria are designed to | |||
| demonstrate comparable or | |||
| greater resistance values | |||
| than the predicate device | D-Value: 2-20 secondsAll Survive: ≤ 4 secondsAll Kill: ≥ 6 minutes | Pass | |
| Carrier and Pack Material | |||
| Growth Inhibition | |||
| Evaluation | Study to demonstrate that | ||
| the primary packaging | |||
| material used in the | |||
| manufacture of the | |||
| Biological Indicator (BI) | |||
| does not hinder, or | |||
| otherwise affect, the | |||
| outgrowth of a low | |||
| number of Geobacillus | |||
| stearothermophilus spores | All BIs inoculated with | ||
| Geobacillus | |||
| stearothermophilus spores | |||
| demonstrate growth | Pass | ||
| Holding Time Assessment | Study to demonstrate the | ||
| labeled hold time of the BI | 120 minutes | Pass | |
| Signal Generation | Study to demonstrate | ||
| the PBS media | All BIs will demonstrate a | ||
| positive fluorescent signal | Pass | ||
| contained in the cap of | |||
| the Celerity 5 HP | |||
| Biological Indicator is | |||
| able to generate a | |||
| detectable fluorescent | |||
| signal from viable G. | |||
| stearothermophilus | |||
| organisms. | |||
| Simulated Use Testing – V- | |||
| PRO | Study to demonstrate | ||
| that the Project Blayze | |||
| Biological Indicator | |||
| (BI) for Gaseous | |||
| Hydrogen Peroxide | |||
| Sterilization Processes | |||
| functions | |||
| appropriately when | |||
| processed in the | |||
| claimed sterilizer | |||
| cycles with a validated | |||
| load. | All BIs processed in a full | ||
| cycle will demonstrate a | |||
| negative signal | |||
| corresponding to a no- | |||
| growth result upon seven | |||
| day incubation. | Pass | ||
| Simulated Use Testing – | |||
| STERRAD | Study to demonstrate | ||
| the Project Blayze | |||
| Biological Indicator | |||
| (BI) for Gaseous | |||
| Hydrogen Peroxide | |||
| Sterilization Processes | |||
| functions | |||
| appropriately when | |||
| processed in | |||
| STERRAD® | |||
| Sterilizers with a | |||
| validated load. | All BIs processed in a | ||
| full cycle will | |||
| demonstrate a negative | |||
| signal corresponding to a | |||
| no-growth result upon | |||
| seven day incubation. | Pass | ||
| Population after ALLClear | |||
| Exposure | Study to demonstrate | ||
| ALLClear | |||
| preconditioning does | |||
| not impact BI | |||
| performance. | Each BI signal evaluation was | ||
| positive following exposure | |||
| to the All-Clear precondition | |||
| treatment | |||
| The mean population of each | |||
| BI exposed to the All-Clear | |||
| precondition treatment was | |||
| within 50-300% of the | |||
| unexposed control mean | |||
| population. | Pass | ||
| Reduced Incubation Time - | Study to verify Reduced | ||
| Incubation Time of the BI | Study will demonstrate that | ||
| 97% or greater of the positive | Pass | ||
| samples at seven days also gave a positive signal at the claimed RIT time | |||
| Reduced Incubation Time – | |||
| Engineering Mode | Study to verify the | ||
| Reduced Incubation Time | |||
| of 5-minute correlates to a | |||
| 20-minute result like the | |||
| predicate device and 7 day | |||
| growth. | study will demonstrate that | ||
| 97% or greater of the positive | |||
| samples at seven days also Pass | |||
| Celerity 5 HP Challenge Pack | |||
| Simulated Use Testing | Study to demonstrate | ||
| performance of challenge | |||
| pack under worst-case | |||
| conditions. | Demonstrate the pack shows | ||
| passing results in worst-case | |||
| load under worst-case | |||
| sterilization conditions | Pass | ||
| Dose Response Testing | Study to demonstrate the | ||
| challenge pack provides | |||
| adequate challenge to | |||
| perform intended use. | The pack provides an | ||
| equivalent or greater | |||
| challenge to the claimed cycle | |||
| than the biological model | |||
| under worst-case conditions. | Pass |
Table 3. Summary of Non-clinical Testing
9
10
7 Conclusion
Based on the intended use, technological characteristics and the nonclinical tests performed, the subject Celerity 5 HP Biological Indicator device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator, K183294 Class II [21 CFR 880.2800(a)], product code FRC.
Based on the intended use, technological characteristics and the nonclinical tests performed, the subject Celerity 5 HP Challenge Pack device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the CELERITY 20 HP Challenge Pack, K183294 Class II [21 CFR 880.2800(a)], product code FRC.