(136 days)
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, 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
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
The subject device 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. CELERITY Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the CELERITY 20 HP Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| BI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles | All BIs processed in half cycle will be negative for growth. | PASS |
| BI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles | All BIs inoculated with low numbers of Geobacillus stearothermophilus spores will demonstrate growth. | PASS |
| BI Simulated Use in the STERRAD Sterilizer Cycles | All BIs processed in full cycles will be negative for growth. | PASS |
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | PASS |
| Resistance (D-value) | D-value > 3 sec (at 9.1 mg/L H₂O₂) | PASS |
| Survival Time | Survival Time ≥ 4 sec (at 9.1 mg/L H₂O₂) | PASS |
| Kill Time | Kill Time ≤ 6 min (at 9.1 mg/L H₂O₂) | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use (V-PRO Sterilizers) | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of BIs per sterilization cycle for half-cycle, growth inhibition, or simulated use tests). It mentions "All BIs" in the acceptance criteria, suggesting a comprehensive evaluation.
The data provenance is from non-clinical testing performed by STERIS Corporation, a manufacturer in the United States (Mentor, Ohio). The studies are prospective as they are conducted to demonstrate the performance of the device for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. Biological Indicators (BIs) rely on the growth or non-growth of a reference microorganism (Geobacillus stearothermophilus) under controlled conditions to determine sterilization effectiveness. The "ground truth" is established through microbiological principles (presence/absence of live spores and enzyme activity) rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
This is not applicable as the results are based on objective biological and chemical reactions (fluorescence, growth/no growth), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices where human readers interpret outputs, often with and without AI assistance. This device is a biological indicator for sterilization monitoring, and its performance is evaluated directly through biological and chemical tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance evaluation is standalone (algorithm only) in the sense that the device's mechanism (fluorescence detection by the Celerity HP Incubator) operates automatically without human intervention once the BI is placed in the incubator. The results (fluorescent within 20 minutes for growth, or lack thereof) are objective outputs of the system. Human involvement is limited to placing the BI in the incubator and observing the incubator's output indicator.
7. The Type of Ground Truth Used
The ground truth is based on microbiological principles and direct observation of microbial growth or enzyme activity. Specifically:
- For sterilization efficacy, the ground truth is the absence of viable Geobacillus stearothermophilus spores after processing.
- For growth promotion/inhibition, the ground truth is the presence of viable Geobacillus stearothermophilus spores and their ability to grow, or the enzyme reaction leading to fluorescence.
- Reduced Incubation Time (RIT) Testing compared the 20-minute fluorescent results to the conventional 7-day incubation time results (which would involve visual inspection for growth over a longer period).
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this biological indicator. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its performance is based on established biological and chemical reactions and engineering controls.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this device, this question is not applicable.
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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 and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a black square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in bold black letters. The word "ADMINISTRATION" is on the second line.
January 26, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K172474
Trade/Device Name: CELERITY 20 HP Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 16, 2017 Received: November 17, 2017
Dear Mr. Piotrkowski:
This letter corrects our substantially equivalent letter of December 29, 2017.
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLeam). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172474
Device Name
CELERITY 20 HP Biological Indicator
Indications for Use (Describe)
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, 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
· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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STERIS®
510(k) Summary For CELERITY 20 HP Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Contact: Anthony Piotrkowski Senior Manager Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com
Submission Date: December 5, 2017
Premarket Notification Number: K172474
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | CELERITY 20 HP Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC) |
2. Predicate Device
VERIFY® V24 Self-Contained Biological Indicator, K140708
Reference Devices
3M Attest™ Rapid Readout Biological Indicator 1295, K160546
3. Description of Device
The subject device 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. CELERITY Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
Intended Use/ Indications for Use 4.
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, 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 ●
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX ● Sterilizer
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When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
ડાં Summary of Technical Characteristics
A comparison of technical characteristics versus the predicate is summarized in Table 5-1 and versus the reference device in Table 5-2.
Table 5-1 BI Physical Description and Technological Properties vs the Predicate Device
| Feature | Celerity VH2O2 BI(proposed) K172474 | VERIFY V24 SCBIPredicate (K140708) | Comparison | |
|---|---|---|---|---|
| Intended Use | The Celerity 20 HPBiological Indicator (BI)is intended for routinemonitoring of thefollowing sterilizercycles:• Lumen, Non Lumen,and Flexible Cycles ofthe V-PRO® LowTemperatureSterilization Systems.• STERRAD® 100SSterilizer (DefaultCycle)• Standard andAdvanced Cycles ofthe STERRAD® NXSterilizer• Standard, FLEX,Express and DUOCycles of theSTERRAD® 100NXSterilizerWhen used in conjunctionwith the Celerity HPIncubator, the Incubatorfor the Celerity 20 HP BIprovides a fluorescentresult within 20 minutes. | The VERIFY® V24 SelfContained BiologicalIndicator is intended forroutine monitoring of thefollowing sterilizationcycles in healthcarefacilities:• Lumen, Non Lumenand Flexible cycles ofV-PRO® LowTemperatureSterilization Systems• Default Cycle of theSTERRAD 100SSterilizer• Default Cycle of theSTERRAD 200Sterilizer• Standard andAdvanced Cycles ofthe STERRAD NXSterilizer• Express, Standard andFlex Scope Cycles ofthe STERRAD 100NX Sterilizer | The intended cycles for theproposed and predicate arethe same with the followingexceptions:• Use of the proposeddevice in the DefaultCycle of the STERRAD200 Sterilizer - theSTERRAD 200 Sterilizeris no longer on themarket.• Use of the predicatedevice in the Duo Cycleof the STERRAD 100NX- the Duo Cycle had notyet been cleared for usewhen the predicate wassubmitted for clearance.• V-PRO sterilizer claimswere cleared in K171504The proposed indications foruse include informationabout the incubator/readerand read time that aresupported through testing inaccordance with FDAguidance for BI 510(k). | |
| Indicatororganism | Geobacillusstearothermophilus | Geobacillusstearothermophilus | Same | |
| Celerity VH2O2 BI | VERIFY V24 SCBI | |||
| Feature | (proposed) K172474 | Predicate (K140708) | Comparison | |
| Mechanism ofaction | An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety. | Visual detection of growthbased on media colorchange in the presence ofsurviving indicatororganisms. | Both devices indicatesurvival of indicatororganisms after sterilization.The mechanism of theproposed device is moresimilar to the referencedevice (see table 5-2).Resistance testing andsimulated use testingdemonstrate appropriatemonitoring of indicatedsterilization cycles. | |
| Accessories | Automated incubator /reader | None | This accessory is moresimilar to the referencedevice (see table 5-2) than tothe predicate device.RIT testing and simulateduse testing demonstrateappropriate monitoring ofindicated sterilizationcycles. | |
| Viable sporepopulation | 1.0 - 4.0 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Both contain greater than106 spores/BI. | |
| Resistancecharacteristics | Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min | Resistance @ 2.7 mg/LH2O2:• D-value 4.0 - 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min | Resistance testing forproposed device at a higherH2O2 concentration.Simulated use testingverifies suitability for use inclaimed cycles. | |
| CultureConditions | 55- 59°C, media includedin BI, 20-minuteincubation time. | 55- 59°C, media includedin SCBI, 24h incubationtime. | RIT Testing and ISO 11138-1media testing verifiesperformance | |
| PrimaryPackaging | Direct inoculum on plasticvial, cap with recoverymedia. | Direct inoculum on plasticvial, glass ampule withrecovery media. | Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatorand sterilization process. | |
| Processindicator | VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change. | VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change. | Same chemical indicator onboth BI. | |
| Shelf-life | Currently 3 monthsTarget of 13 months | 18 months | Real-time testing ongoing | |
| Feature | Celerity VH2O2 BI(proposed) K172474 | Attest 1295Reference (K160546) | Comparison | |
| Intended Use | The Celerity 20 HPBiological Indicator (BI)is intended for routinemonitoring of thefollowing sterilizercycles:• Lumen, Non Lumen,and Flexible Cycles ofthe V-PRO® LowTemperatureSterilization Systems.• STERRAD® 100SSterilizer (DefaultCycle)• Standard andAdvanced Cycles ofthe STERRAD® NXSterilizer• Standard, FLEX,Express and DUOCycles of theSTERRAD® 100NXSterilizerWhen used in conjunctionwith the Celerity HPIncubator, the Incubatorfor the Celerity 20 HP BIprovides a fluorescentresult within 20 minutes. | Use the 3M™ Attest™Rapid Readout BiologicalIndicator 1295 inconjunction with the 3MAttest™ Auto reader 490Has a standard method ofroutine monitoring ofvaporized hydrogenperoxide sterilizationprocesses in the Amsco®V-PRO® maX LowTemperature SterilizationSystem (Lumen, NonLumen, and Flexiblecycles), and inSTERRAD® 100S,STERRAD® NX(Standard and Advancedcycles) and 100NX(Standard, Flex, Expressand Duo cycles) systems. | Intended cycles for bothreference and proposeddevices include the sameSTERRAD cycles.Both require an automatedincubator/reader for results.V-PRO sterilizer claims forthe proposed device werecleared under K171504. | |
| Indicatororganism | Geobacillusstearothermophilus | Geobacillusstearothermophilus | Same | |
| Mechanism ofaction | An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety. | An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within thedefined nutrient media toproduce a fluorescentmoiety. | Same mechanism of action | |
| Accessories | Automated incubator /reader | Automated incubator /reader | This accessory is similar tothe reference. RIT testingand simulated use testingdemonstrate appropriatemonitoring of indicatedsterilization cycles. | |
| Viable sporepopulation | $1.0 - 4.0 \times 10^6$ spore/BI | $\ge 1.0 \times 10^6$ spore/BI | Both contain greater than$10^6$ spore/BI | |
| Feature | Celerity VH2O2 BI(proposed) K172474 | Attest 1295Reference (K160546) | Comparison | |
| Resistancecharacteristics | Resistance @ 9.1 mg/LH2O2:• D-value > 3 sec• Survival Time ≥ 4 sec• Kill Time ≤ 6 min | Resistance @ 10 mg/LH2O2:• D-value > 1 sec• Survival Time ≥ 5 sec• Kill Time = 7 min | Resistance values are similarfor both devices. Simulateduse testing verifiessuitability for use in claimedcycles. | |
| CultureConditions | 55- 59°C, media includedin BI, 20-minuteincubation time. | 60 +/- 2°C; mediaincluded in SCBI, 4-hourincubation time. | RIT Testing and ISO 11138-1media testing verifiesperformance. | |
| PrimaryPackaging | Direct inoculum on plasticvial, cap with recoverymedia. | Inoculation on plastic discwithin vial, ampoule ofrecovery medium. | Similar configuration.Component testing per ISO11138-1 Annex Bdemonstrates packaging iscompatible with indicatororganism and sterilizationprocess. | |
| Processindicator | VERIFY V-PROChemical Indicator(K140515); magenta toyellow color change. | H2O2 sensitive ink:appears blue untilprocessed, then appearspink | Both contain a VH2O2 CI todistinguish processed BIfrom unprocessed BI. | |
| Shelf-life | Currently 3 monthsTarget of 13 months | 18 months | Real-time testing ongoing |
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Note: The BI is identical to that provided in K171504 only the name and indications have been changed.
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Table 5-2 BI Physical Description and Technological Properties vs the Reference Device
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6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate in STERRAD Sterilizers has been completed and is summarized in Table 5-3 below.
| Table 5-3. Summary of Non-clinical Testing | ||
|---|---|---|
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| BI Half Cycle PerformanceEvaluation in the STERRADSterilizer Cycles | All BIs processed in half cycle will benegative for growth. | PASS |
| BI Growth Inhibition FollowingExposure to STERRAD SterilizerCycles | All BIs inoculated with low numbers ofGeobacillus stearothermophilus sporeswill demonstrate growth. | PASS |
| BI Simulated Use in the STERRADSterilizer Cycles | All BIs processed in full cycles will benegative for growth. | PASS |
Performance testing to demonstrate substantial equivalence to the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-4.
| Table 5-4. Summary of Non-clinical Testing Previously Submitted in K171504 | |
|---|---|
| ---------------------------------------------------------------------------- | -- |
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Reduced IncubationTime (RIT) Testing | Meets FDA's requirement of > 97% alignment of the20-minute results with the conventional incubationtime of 7 days | PASS |
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Viable sporepopulation | 1.0 - 4.0 x 106 spore/SCBI | PASS |
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time ≥ 4 sec | PASS |
| Kill Time | Kill Time ≤ 6 min | PASS |
| Carrier growthinhibition / mediagrowth promotion | Positive growth of less than 100 spores afterprimary packaging and media are subject to worstcase VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72hours of exposure to VHP sterilization | PASS |
| Simulated Use | Demonstrate no growth when exposed to worst-case cycles | PASS |
7. Conclusion
The Celerity 20 HP Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed pril book device, VERIFY V24 Self-Contained Biological Indicator cleared in K140708, (21 CFR 880.2800, 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).