(37 days)
No
The device description and performance studies focus on biological and chemical indicators for sterilization monitoring, with no mention of AI or ML technologies.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles in healthcare facilities, not to treat or diagnose a medical condition.
No
Explanation: This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to diagnose a medical condition in a patient. It indicates whether sterilization has occurred successfully.
No
The device description clearly outlines a physical biological indicator (SCBI) and a challenge pack, which are hardware components used in sterilization monitoring. The device relies on a chemical reaction and visual interpretation, not software processing.
Based on the provided information, the VERIFY® V24 Self-Contained Biological Indicator and the VERIFY® V24 Biological Indicator Challenge Pack are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is to monitor and qualify sterilization cycles for medical devices. This is a quality control function for the sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device description clearly states that the biological indicator is used to monitor the sterilization system and indicates the success or failure of the sterilization process based on the growth of spores. This is a test of the sterilizer's effectiveness, not a test on a patient sample.
- Lack of Biological Sample from a Patient: IVDs are designed to be used in vitro (outside the body) on biological specimens (like blood, urine, tissue) obtained from a patient to provide information about their health status. This device uses a standardized biological indicator (spores) to challenge the sterilization process, not a patient sample.
Therefore, the VERIFY® V24 Self-Contained Biological Indicator and Challenge Pack fall under the category of sterilization process indicators, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 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
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
VERIFY V24 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.
VERIFY V24 Biological Indicator 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.
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)
Self-Contained Biological Indicator (SCBI)
Table 5-3. Summary of Non-clinical Testing
- Test: 1/2 & 3/4 Cycle Performance
- Acceptance Criteria: All test SCBIs exposed in either the 1/2 or 3/4 cycle display passing results
- Conclusion: PASS
- Test: Simulated Use
- Acceptance Criteria: All processed SCBIs exhibit negative growth results All processed SCBI Label PIs exhibit a “pass” result All processed CIs exhibit a “pass” result
- Conclusion: PASS
- Test: Verification of Viable Spore Population after exposure to ALLClear
- Acceptance Criteria: The mean population of V24 SCBI exposed to the ALLClear pre-conditioning was -50% to +300% of the unexposed V24 SCBI population
- Conclusion: PASS
Table 5-4. Summary of Testing Previously Submitted for VERIFY V24 SCBI (K140499)
- Test: Reduced Incubation Time (RIT) Testing
- Acceptance Criteria: Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days
- Conclusion: PASS
- Test: Viable spore population
- Acceptance Criteria: 2.0 - 3.4 x 106 spore/SCBI
- Conclusion: PASS
- Test: D-value
- Acceptance Criteria: 4-8 sec
- Conclusion: PASS
- Test: Survival Time
- Acceptance Criteria: 4-30 sec
- Conclusion: PASS
- Test: Kill Time
- Acceptance Criteria: ≤ 16 min
- Conclusion: PASS
- Test: Hold Time
- Acceptance Criteria: Performance not affected if incubated within 72 hours of exposure to VHP sterilization
- Conclusion: PASS
Challenge Pack
Table 5-3. Summary of Non-clinical Testing
- Test: Comparitive Dose Response to Biological Model
- Acceptance Criteria: The challenge pack shall demonstrate equal or greater resistance as compared to the worst case biological model
- Conclusion: PASS
- Test: Simulated Use
- Acceptance Criteria: • All processed SCBIs exhibit negative growth results • All processed SCBI Label PIs exhibit a “pass” result • All processed CIs exhibit a “pass” result
- 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 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
2
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
5
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 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 ALLClear | |||
| Technology | |||
| • Express, Flex Scope and Standard Cycles of | |||
| the STERRAD® 100 | |||
| NX Sterilizer to | The VERIFY V24 Self-Contained Biological | ||
| Indicator is intended for routine monitoring of the | |||
| following 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 the | |||
| STERRAD 100S | |||
| Sterilizer | |||
| • Standard and Advanced | |||
| Cycles of the | |||
| STERRAD NX | |||
| Sterilizer | |||
| • Express, Flex Scope and Standard Cycles of the | |||
| STERRAD 100 NX | |||
| Sterilizer | The proposed and predicate | ||
| devices are identical. The | |||
| Fast Cycle is a new cycle in | |||
| the V-PRO s2 Low | |||
| Temperature Sterilizer, | |||
| which has been submitted in | |||
| this premarket notification. | |||
| The addition of use in | |||
| STERRAD cycles with All | |||
| Clear has been added | |||
| Feature | VERIFY V24 SCBI | ||
| (proposed) | VERIFY V24 SCBI | ||
| Predicate (K172748) | Comparison | ||
| include sterilizers with | |||
| or without All Clear | |||
| Technology | |||
| Indicator | |||
| organism | Geobacillus | ||
| stearothermophilus | Geobacillus | ||
| stearothermophilus | Same | ||
| Mechanism of | |||
| action | Visual detection of growth | ||
| based on media color | |||
| change in the presence of | |||
| surviving indicator | |||
| organisms. | Visual detection of growth | ||
| based on media color | |||
| change in the presence of | |||
| surviving indicator | |||
| organisms. | Same. simulated use testing | ||
| demonstrate appropriate | |||
| monitoring of indicated | |||
| sterilization cycles. | |||
| Accessories | VERIFY Incubator and | ||
| VERIFY SCBI HP | |||
| Activator (optional) | VERIFY Incubator and | ||
| VERIFY SCBI HP | |||
| Activator (optional) | Same | ||
| Viable spore | |||
| population | 2.0 - 3.4 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Same. Both contain greater |
| than 106 spores/BI. | |||
| Resistance | |||
| characteristics | Resistance @ 2.7 mg/L | ||
| H2O2: | |||
| • D-value 4.0 – 8.0 sec | |||
| • Survival Time 4 - 30 sec | |||
| • Kill Time ≤ 16 min | Resistance @ 2.7 mg/L | ||
| H2O2: | |||
| • D-value 4.0 – 8.0 sec | |||
| • Survival Time 4 - 30 sec | |||
| • Kill Time ≤ 16 min | Same. Simulated use testing | ||
| verifies suitability for use in | |||
| claimed cycles. | |||
| Culture | |||
| Conditions | 55-60°C, media included | ||
| in SCBI, 24 hour | |||
| incubation time. | 55-60°C, media included | ||
| in SCBI, 24 hour | |||
| incubation time. | Same | ||
| Primary | |||
| Packaging | Direct inoculum on plastic | ||
| vial, glass ampoule with | |||
| recovery media. | Direct inoculum on plastic | ||
| vial, glass ampoule with | |||
| recovery media. | Same | ||
| Process | |||
| indicator | VERIFY V24 Self- | ||
| Contained Biological | |||
| Indicator Vail Label | |||
| (subject of a separate | |||
| submission); magenta to | |||
| orange/yellow color | |||
| change. | VERIFY V-PRO | ||
| Chemical Indicator | |||
| magenta to yellow color | |||
| change. | Same | ||
| Shelf-life | 6 months: An 18-month | ||
| shelf life is established for | |||
| the SCBI however the | |||
| throughput process | |||
| indicator (subject to a | |||
| separate submission) has a | |||
| shelf life of 6 months so | |||
| the maximum labeled | |||
| shelf life for the SCBI is 6 | |||
| months | 9 months: An 18-month | ||
| shelf life is established for | |||
| the SCBI however the | |||
| throughput process | |||
| indicator (K140515) has a | |||
| shelf life of 9 months so | |||
| the maximum labeled | |||
| shelf life for the SCBI is 9 | |||
| months | Same |
Table 5-1. SCBI Physical Description and Technological Properties vs the Predicate Device
7
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
8
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| $\frac{1}{2}$ & $\frac{3}{4}$ Cycle | ||
| Performance | 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 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 |
| Table 5-4. Summary of Testing Previously Submitted for VERIFY V24 SCBI | |
|---|---|
| (K140499) |
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| 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 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 hours | |
| of exposure to VHP sterilization | PASS |
7. Device Name – Challenge Pack
| Trade Name: | VERIFY® V24 Self-Contained Biological Indicator
Challenge 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.
10
| Feature | VERIFY V24 Biological
Indicator Challenge
Pack
(proposed) | VERIFY V24 Biological
Indicator Challenge Pack
Predicate (K172748) | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY V24
Challenge Pack is
intended for qualification
testing of V-PRO® 1,
V-PRO 1 Plus, V-PRO
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
monitoring of V-PRO
Sterilizers. It has been
tested and validated solely
for use in Sterilizer
qualification testing. | The VERIFY V24
Challenge Pack is intended
for qualification testing of
V-PRO® 1, V PRO 1 Plus,
V-PRO maX, V-PRO maX
2 and V-PRO 60 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
monitoring of V-PRO
Sterilizers. It has been
tested and validated solely
for use in Sterilizer
qualification testing. | The proposed and predicate
devices are identical. The
V-PRO s 2 Low
Temperature Sterilizer, is a
new model Sterilizer which
has been submitted in a
separate premarket
notification (K182568). |
| Biological
Indicator | VERIFY V24 Self-
Contained Biological
Indicator (subject of this
submission) | VERIFY V24 Self-
Contained Biological
Indicator | Same |
| Class 1
Chemical
Indicator | The CELERITY HP
Chemical Indicator
(subject of a separate
Premarket Notification) is
placed inside the pouch.
A throughput process
indicator is also located on
the VERIFY V24 SCBI
label. | The VERIFY HPU
Chemical Indicator is
placed inside the pouch.
A throughput process
indicator is also located on
the VERIFY V24 SCBI
label. | Same |
| Means to
distinguish
processed
from
unprocessed | Chemical indicator of
proposed device visible
through the pack. | Chemical indicator of
proposed device visible
through 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 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 |
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.