(185 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Celerity 5 HP Biological Indicator and Celerity 5 HP Challenge Pack
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|
| Viable Spore Population | Average population for each lot of 1.0 x 10^6 - 4.0 x 10^6 CFU/BI | Pass |
| Resistance Characteristics Study (D-Value) | 2-20 seconds | Pass |
| Resistance Characteristics Study (All Survive) | ≤ 4 seconds | Pass |
| Resistance Characteristics Study (All Kill) | ≥ 6 minutes | Pass |
| Carrier and Pack Material Growth Inhibition | All BIs inoculated with Geobacillus stearothermophilus spores demonstrate growth | Pass |
| Holding Time Assessment | 120 minutes | Pass |
| Signal Generation | All BIs will demonstrate a positive fluorescent signal | Pass |
| Simulated Use Testing – V-PRO | 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 | 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 | 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 will demonstrate that 97% or greater of the positive samples at seven days also gave a positive signal at the claimed RIT time. | Pass |
| Reduced Incubation Time – Engineering Mode | Study will demonstrate that 97% or greater of the positive samples at seven days also gave a positive signal. (Note: The table entry for "Engineering Mode" in the "Reported Performance" column only states "Pass", and the detailed criteria are repeated from the "Reduced Incubation Time", implying it aims to meet similar performance for the 5-minute read time correlation to the 20-minute result and 7-day growth.) | Pass |
| Simulated Use Testing (Challenge Pack) | Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions. | Pass |
| Dose Response Testing (Challenge Pack) | The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes non-clinical tests performed to demonstrate substantial equivalence. It does not provide specific sample sizes for "test sets" in the context of human-involved studies (e.g., retrospective or prospective patient data). The evaluation appears to be based on laboratory testing of the biological indicators themselves.
- Sample Size: Not specified in terms of number of "cases" or patient data points. The tests likely involved multiple units of the biological indicator and challenge pack.
- Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (STERIS Corporation). Therefore, there is no country of origin of patient data, nor is it retrospective or prospective in the medical imaging sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The "ground truth" for a biological indicator is based on microbiological assays (e.g., spore viability, D-value, kill time) and engineered test conditions, rather than expert interpretation of medical images or pathologies.
4. Adjudication Method for the Test Set:
Not applicable. As the tests are non-clinical and objective (e.g., measuring spore population, observing growth/no growth), there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a biological indicator for monitoring sterilization processes, not a medical imaging or diagnostic device that involves human readers.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
The device is a standalone biological indicator that produces a result (fluorescent signal) which is then read by the Celerity® Incubator. While humans initiate the process and interpret the incubator's output, the "performance" described in the tests (e.g., D-value, kill time, signal generation) refers to the intrinsic behavior of the biological indicator. In this sense, the tests demonstrate the standalone performance of the BI.
7. Type of Ground Truth Used:
The ground truth used is primarily microbiological and physical measurements based on established standards for biological indicators. This includes:
- Spore population counts: Direct enumeration of viable spores.
- D-value determination: A measure of the resistance of microorganisms to a sterilizing agent.
- Survival and kill times: Time points at which a specified percentage of organisms survive or are killed.
- Growth/no growth observations: The fundamental output of a biological indicator.
- Fluorescent signal detection: Objective detection by the incubator.
- Worst-case sterilization conditions: Established laboratory parameters to rigorously challenge the device's performance.
8. Sample Size for the Training Set:
Not applicable. This device is a physical biological indicator, not an AI/machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as it's not an AI/ML device).
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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
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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
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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)
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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
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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
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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 BiologicalIndicator(proposed) | Celerity 20 HP BiologicalIndicator (K183294) | Comparison |
|---|---|---|---|
| Intended Use | The Celerity 5 HP BiologicalIndicator (BI) is used forroutine monitoring of thefollowing sterilizer cycles:• Lumen, Non Lumen, FastNon Lumen, Fast and | The Celerity 20 HPBiological Indicator isintended for routinemonitoring of the followingsterilizer cycles: | Proposed device has a5-minute read time |
| Feature | CELRITY 5 HP BiologicalIndicator(proposed) | Celerity 20 HP BiologicalIndicator (K183294) | Comparison |
| Flexible Cycles of the V-PRO 1, 1 Plus, maX, maX2, 60 and s2 LowTemperature SterilizationSystems• STERRAD® 100SSterilizer (Default Cycle)• Standard and AdvancedCycles of the STERRAD®NX® Sterilizer with orwithout ALLClear®• Standard, FLEX, Expressand DUO Cycles of theSTERRAD® 100NX®Sterilizer with or withoutALLClear®.When used in conjunctionwith the Celerity® Incubator,the Incubator provides afluorescent result within 5minutes. | • Lumen, Non Lumen, FastNon Lumen, Fast andFlexible Cycles of the V-PRO® Low TemperatureSterilization Systems• STERRAD® 100SSterilizer (Default Cycle)• Standard and AdvancedCycles of the STERRAD®NX Sterilizer with orwithout ALLClear• Standard, Flex Scope,Express and DUO Cyclesof the STERRAD® 100NXSterilizer with or withoutALLClearWhen used in conjunctionwith the Celerity HPIncubator, the Celerity 20 HPBI provides a fluorescentresult within 20 minutes. | ||
| Indicatororganism | Geobacillusstearothermophilus | Geobacillusstearothermophilus | Same |
| Mechanism ofaction | An enzyme, which is producedby the organism, reacts with afluorogenic substrate withinthe defined nutrient media toproduce a fluorescent moiety. | An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety. | Same |
| Accessories | Automated incubator / reader | Automated incubator /reader | Same |
| Viable sporepopulation | 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 |
| CultureConditions | 55-59°C, media included in BI,5-minute incubation time. | 55-59°C, media included inBI, 20-minute incubationtime. | Similar |
| Feature | CELRITY 5 HP BiologicalIndicator(proposed) | Celerity 20 HP BiologicalIndicator (K183294) | Comparison |
| Primary Packaging | Direct inoculum on plasticvial, cap with recovery media. | Direct inoculum on plasticvial, cap with recoverymedia. | Same |
| Process indicator | VERIFY V-PRO ChemicalIndicator (K140515); magentato yellow color change. | VERIFY V-PRO ChemicalIndicator (K140515);magenta to yellow colorchange. | Same |
| Shelf-life | 8 months | 10 months | Similar |
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Table 2: Challenge Pack Comparison to Predicate Device
| Feature | CELERITY 5 HP Challenge packProposed | CELERITY 20 HP Challenge pack(K173488) Predicate | Comparison |
|---|---|---|---|
| Intended Use/ Indicationfor Use | The CELERITY 5 HP ChallengePack is intended forqualification testing of the V-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers. | The CELERITY 20 HPChallenge Pack is intendedfor qualification testing of theV-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers. | Same |
| GeneralDesign | Sealed sterilization pouchcontaining SCBI, CI and barriermaterial. | Sealed sterilization pouchcontaining SCBI, CI andbarrier material. | Same |
| BiologicalIndicator | Celerity 5 HP BiologicalIndicator | Celerity 20 HP BiologicalIndicator | Similar |
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| Feature | CELERITY 5 HP Challenge packProposed | CELERITY 20 HP Challenge pack(K173488) Predicate | Comparison |
|---|---|---|---|
| ChemicalIndicator | Celerity HP Chemical Indicator | VERIFY HPU ChemicalIndicator | Same - brandname haschanged |
| Means todistinguishprocessedpack fromunprocessed | Proposed device's internalindicator is visible through thepack. | Proposed device's internalindicator is visible throughthe pack. | Same |
| Requiredaccessories | 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 thatthe product meets itsspecification for the sporepopulation. | Average population for eachlot of 1.0 x 106 - 4.0 x 106CFU/BI | Pass |
| Resistance CharacteristicsStudy | Study to verify that theCelerity 5 BiologicalIndicator meets theacceptance criteria forresistance. Acceptancecriteria are designed todemonstrate comparable orgreater resistance valuesthan the predicate device | D-Value: 2-20 secondsAll Survive: ≤ 4 secondsAll Kill: ≥ 6 minutes | Pass |
| Carrier and Pack MaterialGrowth InhibitionEvaluation | Study to demonstrate thatthe primary packagingmaterial used in themanufacture of theBiological Indicator (BI)does not hinder, orotherwise affect, theoutgrowth of a lownumber of Geobacillusstearothermophilus spores | All BIs inoculated withGeobacillusstearothermophilus sporesdemonstrate growth | Pass |
| Holding Time Assessment | Study to demonstrate thelabeled hold time of the BI | 120 minutes | Pass |
| Signal Generation | Study to demonstratethe PBS media | All BIs will demonstrate apositive fluorescent signal | Pass |
| contained in the cap ofthe Celerity 5 HPBiological Indicator isable to generate adetectable fluorescentsignal from viable G.stearothermophilusorganisms. | |||
| Simulated Use Testing – V-PRO | Study to demonstratethat the Project BlayzeBiological Indicator(BI) for GaseousHydrogen PeroxideSterilization Processesfunctionsappropriately whenprocessed in theclaimed sterilizercycles with a validatedload. | All BIs processed in a fullcycle will demonstrate anegative signalcorresponding to a no-growth result upon sevenday incubation. | Pass |
| Simulated Use Testing –STERRAD | Study to demonstratethe Project BlayzeBiological Indicator(BI) for GaseousHydrogen PeroxideSterilization Processesfunctionsappropriately whenprocessed inSTERRAD®Sterilizers with avalidated load. | All BIs processed in afull cycle willdemonstrate a negativesignal corresponding to ano-growth result uponseven day incubation. | Pass |
| Population after ALLClearExposure | Study to demonstrateALLClearpreconditioning doesnot impact BIperformance. | Each BI signal evaluation waspositive following exposureto the All-Clear preconditiontreatmentThe mean population of eachBI exposed to the All-Clearprecondition treatment waswithin 50-300% of theunexposed control meanpopulation. | Pass |
| Reduced Incubation Time - | Study to verify ReducedIncubation Time of the BI | Study will demonstrate that97% 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 theReduced Incubation Timeof 5-minute correlates to a20-minute result like thepredicate device and 7 daygrowth. | study will demonstrate that97% or greater of the positivesamples at seven days also Pass | |
| Celerity 5 HP Challenge Pack | |||
| Simulated Use Testing | Study to demonstrateperformance of challengepack under worst-caseconditions. | Demonstrate the pack showspassing results in worst-caseload under worst-casesterilization conditions | Pass |
| Dose Response Testing | Study to demonstrate thechallenge pack providesadequate challenge toperform intended use. | The pack provides anequivalent or greaterchallenge to the claimed cyclethan the biological modelunder worst-case conditions. | Pass |
Table 3. Summary of Non-clinical Testing
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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.
§ 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).