(177 days)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert Self-Contained Biolgoical Indicator in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. 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 document describes the VERIFY Assert Self-Contained Biological Indicator (SCBI) for monitoring steam sterilization processes. The acceptance criteria and testing are detailed for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | 1.6 - 1.9 x 10^6 spore/SCBI |
| Resistance | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | D121 ≥ 2.29 minD132 ≥ 49 sD135 ≥ 40 s |
| Survival Time | Meets the longer of FDA and ISO 11138-3 requirements | 121 C ≥ 9.81 min132 C ≥ 3.51 min135 C ≥ 2.83 min |
| Kill Time | Meets the shorter of FDA and ISO 11138-3 requirements | 121 C ≤ 25.57 min132 C ≤ 9.21 min135 C ≤ 7.73 min |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case steam exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growthFull cycle - no growth |
| Process indicator | Meets requirements for a “Class 1” process indicator of ISO 11140-1:2005 | PASS (Testing provided in K112256) |
The provided document is a 510(k) summary for a medical device (Biological Indicator) and lacks specific information regarding studies involving AI, human readers, or image analysis. Therefore, the following sections will indicate that the information is not applicable based on the content.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes performance testing for biological indicators used in sterilization. It does not refer to "test sets" in the context of AI/machine learning or human reader studies. The data provenance is laboratory testing related to the performance of biological indicators under specific conditions rather than patient data. Specific sample sizes for each test are not explicitly detailed in the summary, but the resistance and population values are quantitative measurements of the device itself rather than data collected from a large number of 'samples' in the sense of a clinical trial. The testing is likely prospective and conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a biological indicator, and its performance is determined through standardized laboratory tests (e.g., spore count, D-value determination, growth/no growth observation) rather than interpretation by human experts.
4. Adjudication Method for the Test Set:
Not applicable. The determination of device performance (e.g., whether spores are killed, whether a fluorescent signal is produced) is based on objective laboratory measurements and biological principles, not expert 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:
Not applicable. This document pertains to a biological indicator for sterilization monitoring, not an AI-powered diagnostic or interpretive device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is a biological indicator. Its "performance" involves a chemical/biological reaction monitored by a specific reader, but this is not an "algorithm" in the context of standalone AI performance. The reader provides a fluorescent result.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by:
- Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Fluorescent Signal: The detection of a fluorescent moiety produced by the organism's enzyme reacting with a substrate, indicating viability.
- Standardized Test Methods: Adherence to established standards like ISO 11138 and FDA guidance for biological indicators.
- Quantitative Measurements: D-values (decimal reduction time), survival time, kill time, and spore population counts based on microbiological assays.
8. The Sample Size for the Training Set:
Not applicable. This document does not describe an AI/machine learning model that requires a training set. The device is a physical biological indicator.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set for an AI model is described.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
STERIS Corporation Mr. Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K162701
Trade/Device Name: VERIFY Assert Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2805 Regulation Name: Recombinant Biological Indicator Regulatory Class: Class II Product Code: OWP Dated: February 17, 2017 Received: February 21, 2017
Dear Mr. Anthony Piotrkowski:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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Indications for Use
510(k) Number (if known) K162701
Device Name
VERIFY Assert Self-Contained Biological Indicator
Indications for Use (Describe)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, serif font at the top of the image. Below the word, there is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water waves.
510(k) Summary For K162701 VERIFY Assert Self-Contained 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
Tony Piotrkowski Contact: Senior Manager, Regulatory Affairs
Telephone:(440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Submission Date: March 15, 2017
Premarket Notification Number: K162701
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | VERIFY Assert Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Recombinant Biological Indicator (21 CFR 880.2805, OWP) |
2. Predicate Device
VERIFY CRONOS Self-Contained Biological Indicator K102469/DEN110006
Reference Devices
3M Attest Super Rapid Readout Biological Indicator, Model 1492 K121484 Attest Rapid Readout Biological Indicator, Model 1292 K090569 Attest Rapid Readout Biological Indicator, Model 1291 K926364
3. Description_of Device
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert Self-Contained Biolgoical Indicator in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
4. Intended Use/ Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
| Feature | Assert SCBI | VERIFY Cronos SCBI | |
|---|---|---|---|
| (proposed -K162701) | (predicate-K102469) | Comparison | |
| IntendedUse | The VERIFY Assert Self-Contained BiologicalIndicator (SCBI) is forroutine monitoring,qualification testing andproduct testing of thefollowing steamsterilization processes:270F, 4-minute dynamicair removal; 275F, 3-minute dynamic airremoval; 250 F, 30 minutegravity; 270, 15-minutesgravity.When used in conjunctionwith the Reader for theVERIFY Assert Self-Contained Incubator, theVERIFY Assert Self-Contained Indicatorprovides a fluorescentresult within 40 minutes. | For use by health careproviders for qualificationand routine monitoring ofsteam sterilizationprocesses. The VERIFYCronos SCBI is onlyvalidated to be used in thefollowing steamsterilization cycles:132 C vacuum-assistedsteam with 4-minutesterilization time; 135 Cvacuum-assisted steam with3-minute sterilization time;121 C gravity steam with30-minute sterilizationtime; 132 C gravity steamwith 15-minutesterilization time; 135 Cgravity steam with 10-minute sterilization time;132 C Steam Flush Pressure Pulse with 4- minutesterilization time. | Both are intended formonitoring steamsterilization cycles.Use statement for theproposed device has beenaligned with AAMI ST79,Table 6 recommendationsfor use of BI.The Assert SCBI is claimingdifferent cycles compared tothe predicate (no 10-minute135 gravity adding 135SFPP). Simulated usetesting in sterilizers with aload under pass and failconditions demonstrateperformance of the AssertSCBI in these additionalcycles. |
| Indicatororganism | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | Same |
| Mechanismof action | An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substratewithin the defined nutrientmedia to produce afluorescent moiety | An enzyme, which isproduced by the plasmid,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety | Same mechanism of action,testing provideddemonstrates conformancewith ISO 11138 and theFDA guidance on BIsubmissions |
| Accessories | Automated incubator /reader | Automated incubator /reader | RIT testing performed withthe proposedincubator/reader. |
| Viable sporepopulation | 1.0 - 4.0 x 106 spore/SCBI | 1.0 - 5.0 x 106 spore/SCBI | Proposed population rangewithin that of the predicateand both meet FDAguidance and ISO 11138requirements |
| Feature | Assert SCBI(proposed -K162701) | VERIFY Cronos SCBI(predicate-K102469) | Comparis on |
| Resistance | $D_{121} ≥ 1.5$ min$D_{132} ≥ 10$ s$D_{135} ≥ 8$ s | 121°C - 1.5 to 3.0 min132°C - 10 to 30 sec134°C - 8 sec to 20 sec135°C - 8 sec to 20 sec | Both proposed and predicatemeet criteria of ISO 11138-3and FDA guidance |
| CultureConditions | 55- 59 °C, media includedin SCBI, 40 minuteincubation time. | 55- 59 °C, media includedin SCBI, 120 minuteincubation time. | RIT Testing and ISO 11138media testing verifiesperformance |
| PrimaryPackaging | Direct inoculum on plasticvial, cap with recoverymedia. | Inoculated paper in plasticvial with cap and glassampoule with recoverymedia in capped vial. | Similar configuration.Component testing per ISO11138-1 Annex Bdemons trates packaging iscompatible with indicatorand sterilization process. |
| Processindicator | STERIS STEAM Π(K112256) | STERIS STEAM Π(K112256) | Same indicator on bothproducts |
Table 5-1 Summary of SCBI Physical Description and Technological Properties
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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator
6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| ReducedIncubation Time(RIT) Testing | Meets FDA's requirement of > 97%alignment of the 40-minute results with theconventional incubation time of 7 days | PASS |
| Viable sporepopulation | 1.0 - 4.0 x 10 spore/SCBI | 1.6 - 1.9 x 106 spore/SCBI |
| Resistance | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | D121 ≥ 2.29 minD132 ≥ 49 sD135 ≥ 40 s |
| Survival Time | Meets the longer of FDA and ISO 11138-3requirements | 121 C ≥ 9.81 min132 C ≥ 3.51 min135 C ≥ 2.83 min |
| Kill Time | Meets the shorter of FDA and ISO 11138-3requirements | 121 C ≤ 25.57 min132 C ≤ 9.21 min135 C ≤ 7.73 min |
| Carrier growthinhibition / mediagrowth promotion | Positive growth of less than 100 spores afterprimary packaging and media are subject toworst case steam exposure | PASS |
| Hold Time | Performance not affected if incubatedwithin 72 hours of exposure to steamsterilization | PASS |
| Simulated Use | Demonstrate growth when exposed toabbreviated cycle and all kill in a full cycle | Abbreviated cycle -growthFull cycle - no growth |
Table 5-2. Summary of Non-clinical Testing
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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Process indicator | Meets requirements for a “Class 1” processindicator of ISO 11140-1:2005 | PASSTesting provided inK112256 |
7. Conclusion
The VERIFY Assert Self-Contained 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 substantially equivalent and is as safe and as effective as the legally marketed predicate device Class II (21 CFR 880.2805, Product code OWP).
N/A