(37 days)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers
· STERRAD® 100S Sterilizer (default cycle)
• STERRAD® 200 Sterilizer (default cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology
· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology
The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
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 of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
Here's a breakdown of the acceptance criteria and study information for the VERIFY V24 Self-Contained Biological Indicator and VERIFY V24 Biological Indicator Challenge Pack, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the document presents separate acceptance criteria and testing for the "Self-Contained Biological Indicator (SCBI)" and the "Challenge Pack."
For the VERIFY V24 Self-Contained Biological Indicator (SCBI):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ½ & ¾ Cycle Performance | All test SCBIs exposed in either the ½ or ¾ cycle display passing results | PASS |
| Simulated Use | All processed SCBIs exhibit negative growth results All processed SCBI Label PIs exhibit a “pass” result All processed CIs exhibit a “pass” result | PASS |
| Verification of Viable Spore Population after exposure to ALLClear | The mean population of V24 SCBI exposed to the ALLClear pre-conditioning was -50% to +300% of the unexposed V24 SCBI population | 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 | 2.0 - 3.4 x 10^6 spore/SCBI | PASS (stated to contain "greater than 10^6 spores/BI" and "Same" as predicate in Table 5-1) |
| D-value | 4-8 sec | PASS (stated "Same" as predicate in Table 5-1) |
| Survival Time | 4-30 sec | PASS (stated "Same" as predicate in Table 5-1) |
| Kill Time | ≤ 16 min | PASS (stated "Same" as predicate in Table 5-1) |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
For the VERIFY V24 Biological Indicator Challenge Pack:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Comparative Dose Response to Biological Model | The challenge pack shall demonstrate equal or greater resistance as compared to the worst case biological model | PASS |
| Simulated Use | All processed SCBIs exhibit negative growth results All processed SCBI Label PIs exhibit a “pass” result All processed CIs exhibit a “pass” result | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set in any of the studies. It refers to "All test SCBIs" and "All processed SCBIs" without providing a count.
The data provenance is not specified beyond being "nonclinical tests" and "performance testing to demonstrate substantial equivalence to the predicate." There is no mention of country of origin or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document describes tests related to the biological and chemical indicators themselves and their performance in sterilization cycles, not a diagnostic or interpretive task that would typically involve human expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the tests described are objective measures of biological indicator performance (e.g., growth/no growth, color change, spore population) rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device described (Biological Indicator and Challenge Pack) is a sterilization process indicator, not an AI or imaging device that would typically be involved in human-in-the-loop diagnostic tasks or benefit from a reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical biological indicator, not an algorithm. Its performance is evaluated through laboratory and simulated use testing.
7. The Type of Ground Truth Used
The ground truth for the performance tests appears to be based on:
- Biological viability: Growth or lack thereof of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by a color change in the growth medium.
- Established physical and chemical properties: D-value, survival time, kill time, and viable spore population are laboratory-measured physical characteristics against established standards.
- Chemical indicator color change: A visible, objective change in color on the indicator.
- Comparative resistance: The challenge pack's resistance compared to a "worst case biological model."
Essentially, the "ground truth" is defined by the expected biological or chemical response to a sterilization process.
8. The Sample Size for the Training Set
This is not applicable. There is no concept of a "training set" for a biological indicator. The tests described are performance and validation tests, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2019
STERIS Corporations Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K183300
Trade/Device Name: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 26, 2018 Received: November 27, 2018
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.
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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/CDRHLearn). 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,
Elizabeth F. Claverie -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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Indications for Use
510(k) Number (if known) K183300
Device Name
VERIFY V24 Biological Indicator Challenge Pack
Indications for Use (Describe)
The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
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 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K183300
Device Name
VERIFY V24 Self-Contained Biological Indicator
Indications for Use (Describe)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers
· STERRAD® 100S Sterilizer (default cycle)
• STERRAD® 200 Sterilizer (default cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology
· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology
| 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."
{4}------------------------------------------------
510(k) Summary For VERIFY® V24 Self-Contained Biological Indicator And VERIFY® V24 Self-Contained Biological Indicator Challenge Pack
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: Gregory Land Senior Regulatory Affairs Specialist
Telephone: (440) 392-7424 Fax No: (440) 357-9198 e-mail: greg_land@steris.com
Janary 2, 2019 Submission Date:
Premarket Notification Number: K183300
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name - Self-Contained Biological Indicator(SCBI) 1.
| Trade Name: | VERIFY® V24 Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC) |
2. Predicate Device - Self-Contained Biological Indicator(SCBI)
VERIFY® V24 Self-Contained Biological Indicator, K172748
3. Description of Device - Self-Contained Biological Indicator(SCBI)
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
{6}------------------------------------------------
Intended Use/ Indications for Use – Self-Contained Biological Indicator(SCBI) 4.
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:
- Non Lumen, Flexible, Lumen, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers
- Standard Cycle of the STERRAD® 100S Sterilizer ●
- . Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without All Clear Technology.
- Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX . Sterilizer to include sterilizers with or without All Clear Technology
5. Summary of Technical Characteristics - Self-Contained Biological Indicator(SCBI)
A comparison of technical characteristics versus the predicate is summarized in Table 5-1.
| Feature | VERIFY V24 SCBI (proposed) | VERIFY V24 SCBI Predicate (K172748) | Comparison |
|---|---|---|---|
| Intended Use | The VERIFY® V24 Self-Contained BiologicalIndicator is intended for routine monitoring of thefollowing sterilizers and cycles:• Non Lumen, Flexible,Lumen, Fast and Fast Non Lumen Cycles ofthe V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Sterilizers• Standard Cycle of theSTERRAD® 100SSterilizer• Standard and AdvancedCycles of theSTERRAD® NXSterilizer with or without ALLClearTechnology• Express, Flex Scope and Standard Cycles ofthe STERRAD® 100NX Sterilizer to | The VERIFY V24 Self-Contained BiologicalIndicator is intended for routine monitoring of thefollowing sterilizers and cycles:• Non Lumen, Flexible,Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers• Standard Cycle of theSTERRAD 100SSterilizer• Standard and AdvancedCycles of theSTERRAD NXSterilizer• Express, Flex Scope and Standard Cycles of theSTERRAD 100 NXSterilizer | The proposed and predicatedevices are identical. TheFast Cycle is a new cycle inthe V-PRO s2 LowTemperature Sterilizer,which has been submitted inthis premarket notification.The addition of use inSTERRAD cycles with AllClear has been added |
| Feature | VERIFY V24 SCBI(proposed) | VERIFY V24 SCBIPredicate (K172748) | Comparison |
| include sterilizers withor without All ClearTechnology | |||
| Indicatororganism | Geobacillusstearothermophilus | Geobacillusstearothermophilus | Same |
| Mechanism ofaction | Visual detection of growthbased on media colorchange in the presence ofsurviving indicatororganisms. | Visual detection of growthbased on media colorchange in the presence ofsurviving indicatororganisms. | Same. simulated use testingdemonstrate appropriatemonitoring of indicatedsterilization cycles. |
| Accessories | VERIFY Incubator andVERIFY SCBI HPActivator (optional) | VERIFY Incubator andVERIFY SCBI HPActivator (optional) | Same |
| Viable sporepopulation | 2.0 - 3.4 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Same. Both contain greaterthan 106 spores/BI. |
| Resistancecharacteristics | Resistance @ 2.7 mg/LH2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min | Resistance @ 2.7 mg/LH2O2:• D-value 4.0 – 8.0 sec• Survival Time 4 - 30 sec• Kill Time ≤ 16 min | Same. Simulated use testingverifies suitability for use inclaimed cycles. |
| CultureConditions | 55-60°C, media includedin SCBI, 24 hourincubation time. | 55-60°C, media includedin SCBI, 24 hourincubation time. | Same |
| PrimaryPackaging | Direct inoculum on plasticvial, glass ampoule withrecovery media. | Direct inoculum on plasticvial, glass ampoule withrecovery media. | Same |
| Processindicator | VERIFY V24 Self-Contained BiologicalIndicator Vail Label(subject of a separatesubmission); magenta toorange/yellow colorchange. | VERIFY V-PROChemical Indicatormagenta to yellow colorchange. | Same |
| Shelf-life | 6 months: An 18-monthshelf life is established forthe SCBI however thethroughput processindicator (subject to aseparate submission) has ashelf life of 6 months sothe maximum labeledshelf life for the SCBI is 6months | 9 months: An 18-monthshelf life is established forthe SCBI however thethroughput processindicator (K140515) has ashelf life of 9 months sothe maximum labeledshelf life for the SCBI is 9months | Same |
Table 5-1. SCBI Physical Description and Technological Properties vs the Predicate Device
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Summary of Nonclinical Tests – Self-Contained Biological Indicator(SCBI) 6.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
Table 5-3. Summary of Non-clinical Testing
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| $\frac{1}{2}$ & $\frac{3}{4}$ CyclePerformance | All test SCBIs exposed in either the $\frac{1}{2}$ or $\frac{3}{4}$ cycle display passing results | PASS |
| Simulated Use | All processed SCBIs exhibit negative growth results All processed SCBI Label PIs exhibit a “pass” result All processed CIs exhibit a “pass” result | PASS |
| Verification ofViable SporePopulation afterexposure toALLClear | The mean population of V24 SCBI exposed to the ALLClear pre-conditioning was -50% to +300% of the unexposed V24 SCBI population | PASS |
| Table 5-4. Summary of Testing Previously Submitted for VERIFY V24 SCBI | |
|---|---|
| (K140499) |
| 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 |
| Viable sporepopulation | 2.0 - 3.4 x 106 spore/SCBI | PASS |
| D-value | 4-8 sec | PASS |
| Survival Time | 4-30 sec | PASS |
| Kill Time | ≤ 16 min | PASS |
| Hold Time | Performance not affected if incubated within 72 hoursof exposure to VHP sterilization | PASS |
7. Device Name – Challenge Pack
| Trade Name: | VERIFY® V24 Self-Contained Biological IndicatorChallenge Pack |
|---|---|
| Common/usual Name: | Biological Indicator (BI) Process Challenge Device |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC) |
8. Predicate Device – Challenge Pack
VERIFY® V24 Self-Contained Biological Indicator, K172748
{9}------------------------------------------------
9. Description of Device - Challenge Pack
The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.
The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
10. Intended Use/ Indications for Use - Challenge Pack
The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V-PRO 1, V-PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined 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.
Summary of Technical Characteristics - Challenge Pack 11.
A comparison of technical characteristics versus the predicate is summarized in Table 5-1.
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| Feature | VERIFY V24 BiologicalIndicator ChallengePack(proposed) | VERIFY V24 BiologicalIndicator Challenge PackPredicate (K172748) | Comparison |
|---|---|---|---|
| Intended Use | The VERIFY V24Challenge Pack isintended for qualificationtesting of V-PRO® 1,V-PRO 1 Plus, V-PROmaX, V-PRO maX 2, V-PRO 60 and V-PRO s 2Low TemperatureSterilization Systemsfollowing installation,relocation, malfunctions ormajor repairs.The challenge pack isplaced in an otherwiseempty sterilizer chamber; ahospital-defined challengeload is not included.The challenge pack is notintended for routinemonitoring of V-PROSterilizers. It has beentested and validated solelyfor use in Sterilizerqualification testing. | The VERIFY V24Challenge Pack is intendedfor qualification testing ofV-PRO® 1, V PRO 1 Plus,V-PRO maX, V-PRO maX2 and V-PRO 60 LowTemperature SterilizationSystems followinginstallation, relocation,malfunctions or majorrepairs.The challenge pack isplaced in an otherwiseempty sterilizer chamber; ahospital-defined challengeload is not included.The challenge pack is notintended for routinemonitoring of V-PROSterilizers. It has beentested and validated solelyfor use in Sterilizerqualification testing. | The proposed and predicatedevices are identical. TheV-PRO s 2 LowTemperature Sterilizer, is anew model Sterilizer whichhas been submitted in aseparate premarketnotification (K182568). |
| BiologicalIndicator | VERIFY V24 Self-Contained BiologicalIndicator (subject of thissubmission) | VERIFY V24 Self-Contained BiologicalIndicator | Same |
| Class 1ChemicalIndicator | The CELERITY HPChemical Indicator(subject of a separatePremarket Notification) isplaced inside the pouch.A throughput processindicator is also located onthe VERIFY V24 SCBIlabel. | The VERIFY HPUChemical Indicator isplaced inside the pouch.A throughput processindicator is also located onthe VERIFY V24 SCBIlabel. | Same |
| Means todistinguishprocessedfromunprocessed | Chemical indicator ofproposed device visiblethrough the pack. | Chemical indicator ofproposed device visiblethrough the pack. | Same |
Table 5-1. Challenge Pack Physical Description and Technological Properties vs the Predicate Device
{11}------------------------------------------------
Summary of Nonclinical Tests – Challenge Pack 12.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Comparitive DoseResponse toBiological Model | The challenge pack shall demonstrate equal or greaterresistance as compared to the worst case biologicalmodel | PASS |
| Simulated Use | • All processed SCBIs exhibit negative growth results• All processed SCBI Label PIs exhibit a “pass” result• All processed CIs exhibit a “pass” result | PASS |
Table 5-3. Summary of Non-clinical Testing
13. Conclusion
Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, VERIFY V24 Self-Contained Biological Indicator (cleared in K172748), Class II (21 CFR 880.2800) product code FRC.
Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, VERIFY V24 Biological Indicator Challenge Pack (cleared in K172748), Class II (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).