(94 days)
Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.
The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
The document provided describes the "VERIFY® Incubator for Assert™ Self Contained Biological Indicators" and its nonclinical testing to demonstrate substantial equivalence to a predicate device. This device is an incubator/reader used to incubate and automatically read self-contained biological indicators for sterilization processes.
Here's a breakdown of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Maintenance of Incubation Temperature | Maintain 55-60 °C for a minimum of 40 minutes (incubation time of Verify Assert SCBI as stated in K162701) | PASS |
| Qualification testing with Verify Assert SCBI | 40-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time. | PASS |
| Qualification testing with Verify Assert SCBI | Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator. | PASS |
| Qualification testing with Verify Assert SCBI | Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator. | PASS |
| Alarm, LED and Print function Test | Demonstrate proper function of alarms, LED and print outputs. | PASS |
Study Proving the Device Meets Acceptance Criteria:
The document describes nonclinical performance testing.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of biological indicators (sample size) used for the qualification testing. It refers to "testing with SCBI exposed to full cycle exposure" and "testing with SCBI exposed in abbreviated cycle exposure," implying multiple indicators were tested.
- Data Provenance: The document doesn't specify the country of origin for the data. Given it's a submission to the FDA (United States), it is highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing is described as "performance testing," which typically refers to prospectively collected data for validation purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an incubator/reader for biological indicators. The "ground truth" for this type of device is the actual growth or non-growth of microorganisms in the biological indicator, determined through traditional microbiological culturing methods (e.g., 7-day growth results for biological indicators). There is no mention of human experts (like radiologists) being involved in establishing the ground truth for this specific device, as its function is to automate the reading of a biological indicator. The "7-day growth results" serve as the objective ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The ground truth is based on the biological end-point (microbial growth/no growth), not subjective human interpretation 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:
Not applicable. This device is an automated incubator/reader for biological indicators, not an AI-assisted diagnostic imaging device that involves human reader interpretation. No human readers are involved in the "reading" process of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is effectively a standalone performance study. The device itself (the incubator/reader) provides the fluorescent read, which is then compared against the established biological "truth" (7-day growth results). Its primary function is automated reading without human interpretation of its output beyond acknowledging the alarm or visual indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used is the microbiological growth status of the biological indicators, specifically the "7-day growth results." This is an objective measurement of whether the microorganisms in the biological indicator proliferated or not, which is the definitive indicator of sterilization effectiveness.
8. The sample size for the training set:
Not applicable. This document describes a traditional medical device (an incubator/reader) validated through performance testing, not a machine learning or AI-based device that typically requires a separate training set. The device's "knowledge" is built into its design (temperature control, fluorescence detection) rather than learned from a data set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Steris Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5976 Heisley Rd Mentor, Ohio 44060
Re: K163587
Trade/Device Name: Verify Incubator For Assert Self Contained Biological Indicators 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 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 devicerelated adverse events) (21 CFR 803); good 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.
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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/ResourcesforYou/Industry/default.htm. 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.
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) K163587
Device Name
VERIFY® Incubator for Assert™ Self Contained Biological Indicators
Indications for Use (Describe)
Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for 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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510(k) Summary For K163587 VERIFY® Incubator for Assert™ Self-Contained Biological Indicators
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
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com
Submission Date: March 22, 2017
510(k) Number: K163587
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | VERIFY® Incubator for Assert™ Self ContainedBiological Indicators |
|---|---|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Recombinant Biological Indicator(21 CFR 880.2805, OWP) |
2. Predicate Device
VERIFY CRONOS SCBI K102469/DEN110006
Reference Device: 3M Attest 390 Auto-reader K123546
3. Description of Device
The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
4. Intended Use/ Indications for Use
Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Tables 1 and 2.
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| Feature | VERIFY Incubator forAssert SCBI(proposed) | VERIFY CRONOSSCBI(K102469/DEN110006)Predicate | Comparison |
|---|---|---|---|
| Intended Use | Use the VERIFY®Incubator for Assert™ SelfContained BiologicalIndicators SCBI(Incubator) to incubate andautomatically readVERIFY Assert Self-Contained BiologicalIndicators at 57 °C for afluorescent result within40 minutes. | The Verify Cronos Self-Contained BiologicalIndicator for SteamSterilization Processes isintended for use by healthcare providers as astandard method tomonitor steam sterilizationprocesses. The VerifyCronos is validated to beused in the followingsteam sterilization cycles:1.) Standard Prevac270°F/132°C for 4 minutes2.) Standard Prevac275°F/135°C for 3 minutes3.) Standard Gravity250°F/121°C for 30 minutes4.) Standard Gravity270°F/132°C for 15 minutes5.) Standard Gravity275°F/135°C for 10 minutes6.) Standard SFPP270°F/132°C for 4minutes | The predicate incubator wasan accessory to theBiological Indicator and didnot have its own intendeduse or indications for use.The proposed device is anaccessory to the VERIFYAttest SCBI. |
| Basis ofReadout | Photodiode detectsfluorescence produced byenzymatic activity thatresults from growingbiological indicatororganisms | Photodiode detectsfluorescence produced byenzymatic activity thatresults from growingbiological indicatororganisms | Same |
| IncubationTemperatureRange | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage Range | 90 to 264 VAC with 12VDC conversion. | 90 to 264 VAC with 12VDC conversion. | Same |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - nocalibration by customer | Factory calibration - nocalibration by customer | Same |
| IncubationTime | 40 minutes | 40 minutes | Same |
| Feature | VERIFY Incubator forAssert SCBI(proposed) | VERIFY CRONOSSCBI(K102469/DEN110006)Predicate | Comparison |
| FluorescenceDetection | Active enzyme from thespores cleaves thefluorogenic substratecontained within theSCBI's media to produce afluorescent molecule. | Active enzyme from thespores cleaves thefluorogenic substratecontained within theSCBI's media to produce afluorescent molecule. | Same |
| Indication ofResults | Positive - audible alarm,visual LED lights andscreenNegative - no alarm,visual indication withLED lights and LCDscreenUser must acknowledgeresults | Positive - audible alarm,visual LED lights andscreenNegative - no alarm,visual indication withLED lights and LCDscreenUser must acknowledgeresults | Same |
| Compliance | Electrical Safety and EMCTesting• IEC 61010-1 (2010)Third Ed• IEC 61010-2-010(2013) Third EdElectromagneticcompatibility• USA Title 47, Codeof FederalRegulations (2007)for:• Radiated Emissions(FCC Part 15,Subpart B, Class A)• ConductedEmissions (FCCPart 15, Subpart B,Class A)• IEC 61326:2013 -• EN 55011:2009, Inc.A1:2010• EN 61000-3-2:2006,Inc. A1:2009 andA2:2009EN 61000-3-3-2013 | Electrical Safety and EMCTesting• IEC 61010-1 secondEd• IEC 61010-2-010Second EdElectromagneticcompatibility• USA Title 47, Codeof FederalRegulations (2007)for:• Radiated Emissions(FCC Part 15,Subpart B, Class A)• ConductedEmissions (FCCPart 15, Subpart B,Class A)• IEC 61326:• EN 55011:• EN 61000-3-2:2006,Inc. A1:2009 andA2:2009EN 61000-3-3 | Both meet applicableelectrical safety standards |
| Feature | VERIFY Incubator forAssert SCBI(proposed) | VERIFY CRONOSSCBI(K102469/DEN110006)Predicate | Comparison |
| SystemOperation | The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 57°C.The measurement offluorescence is initiated byplacement of a VERIFYAssert SCBI into any ofthe incubation wells andpressing the adjacent"ACTION" button.When an SCBI is placedinto a well, the auto-readerdetects its presence. Uponpressing the buttonassociated with that well, ablinking yellowish lightindicates that incubation isin process and the readinitiated.A "positive" reading isinterpreted as anindication of a potentialsterilization cycle failure.A "positive" finding isindicated to the user byred light on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCDscreen. The alarm must bemuted by the operatorwhen a positive result isobtained. The LCD screenprovides instructions forthe user to turn off thealarm for that specificSCBI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positiveat the end of theincubation time, the resultis negative. Negativeresults are identified by agreen light on the frontpanel adjacent to the wellwith the "negative" BI andby text on the LCD. | The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 57°C.The measurement offluorescence is initiated byplacement of a VERIFYAssert SCBI into any ofthe incubation wells andpressing the adjacent"ACTION" button.When an SCBI is placedinto a well, the auto-readerdetects its presence. Uponpressing the buttonassociated with that well, ablinking yellowish lightindicates that incubation isin process and the readinitiated.A "positive" reading isinterpreted as anindication of a potentialsterilization cycle failure.A "positive" finding isindicated to the user byred light on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCDscreen. The alarm must bemuted by the operatorwhen a positive result isobtained. The LCD screenprovides instructions forthe user to turn off thealarm for that specificSCBI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positiveat the end of theincubation time, the resultis negative. Negativeresults are identified by agreen light on the frontpanel adjacent to the wellwith the "negative" BI andby text on the LCD. | Same |
Table 1 Summary of Incubator Physical Description and Technological Properties vs Predicate
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Table 2 Summary of Incubator Physical Description and Technological Properties vs Reference Device
| Feature | VERIFY Incubator forAssert SCBI(proposed) | Attest 390(K123546) Reference | Comparison |
|---|---|---|---|
| Intended Use | Use the VERIFY®Incubator for Assert™ SelfContained BiologicalIndicators SCBI(Incubator) to incubate andautomatically readVERIFY Assert Self-Contained BiologicalIndicators at 57 °C for afluorescent result within40 minutes. | The 3M Attest 390 Auto-reader is designed toincubate and automaticallyread the 3M Attest Rapidreadout Biologicalindicators for Steam 1291,1292, at 60 °C for a finalfluorescent result at 1 hourfor 1291 and 3 hours for1292. | Both are intended forincubation and automaticreading of specific self-contained biologicalindicators. |
| Basis ofReadout | Photodiode detectsfluorescence produced byenzymatic activity thatresults from growingbiological indicatororganisms | Photodiode detectsfluorescence produced byenzymatic activity thatresults from growingbiological indicatororganisms | Same |
| IncubationTemperatureRange | 55 - 60 °C | 60 ± 2 °C | Both operate within thegrowth temperature range ofGeobacillusstearothermophilus |
| Voltage Range | 90 to 264 VAC with 12VDC conversion. | 100-240 VAC with 12VDC conversion. | Similar range and sameoperating voltage. Electricalsafety testing demonstratessuitability. |
| Test capacity | 8 wells | 10 wells | Both can accommodatemultiple samples |
| Calibration | Factory calibration - nocalibration by customer | Factory calibration - nocalibration by customer | Same |
| IncubationTime | 40 minutes | 1 hour (1291), 3 hours(1292) | Reduced incubation timetesting in accordance withFDA guidance is provided inthis submission |
| FluorescenceDetection | Active enzyme from thespores cleaves thefluorogenic substratecontained within theSCBI's media to produce afluorescent molecule. | UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the SCBI'smedia. The emitted lightis detected by aphotodiode. | Similar Detection Method -photodiode sensors |
| Feature | VERIFY Incubator forAssert SCBI(proposed) | Attest 390(K123546) Reference | Comparison |
| SystemOperation | The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 57°C.The measurement offluorescence is initiated byplacement of a VERIFYAssert SCBI into any ofthe incubation wells andpressing the adjacent"ACTION" button.When an SCBI is placedinto a well, the auto-readerdetects its presence. Uponpressing the buttonassociated with that well, ablinking yellowish lightindicates that incubation isin process and the readinitiated.A "positive" reading isinterpreted as anindication of a potentialsterilization cycle failure.A "positive" finding isindicated to the user byred light on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCDscreen. The alarm must bemuted by the operatorwhen a positive result isobtained. The LCD screenprovides instructions forthe user to turn off thealarm for that specificSCBI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positiveat the end of theincubation time, the resultis negative. Negativeresults are identified by agreen light on the frontpanel adjacent to the wellwith the "negative" BI andby text on the LCD. | The measurement offluorescence is initiated byplacement of an AttestSCBI into any of theincubation wells. Thereader/incubator wells arecolor-coded to match thecolor of the top of theSCBIs. The incubatorblock may be color coded.When a BI is placed into awell, its presence isdetected. The LCD screenbelow the SCBI shows thetime remaining tocomplete the incubationperiod.Detection of a positiveresult is indicated by a '+'sign on the LCD screen,accompanied by anaudible alarm. A positiveresult is indicative of asterilization cycle failure.The alarm must be mutedby the operator when apositive result is obtained.Pressing the mute buttondisables the alarm only forthe specific SCBI whichwas just identified aspositive. Should anotherBI become "positive", thealarm will again sound.If the result is not positiveat the end of theincubation time, the resultis negative. Negativeresults are identified by a'- 'sign on the LCDscreen. | Both have similar modes ofoperation only type ofbiological indicator isintended for use with theproposed device so no colorcoding is required and bothalarm for a positive BI. |
| Feature | VERIFY Incubator forAssert SCBI(proposed) | Attest 390(K123546) Reference | Comparison |
| Indication ofResults | Positive - audible alarm,visual LED lights andscreenNegative - no alarm,visual indication withLED lights and LCDscreenUser must acknowledgeresults | Positive - audible alarm(if enabled), "+" indicationon LCD panel, andflashing of LCD panelbacklightingNegative - no alarm, "-"indication on LCD panel | Similar Indication of Results |
| Compliance | Electrical Safety and EMCTestingIEC 61010-1 (2010)Third Ed IEC 61010-2-010(2013) Third Ed Electromagneticcompatibility USA Title 47, Codeof FederalRegulations (2007)for: Radiated Emissions(FCC Part 15,Subpart B, Class A) ConductedEmissions (FCCPart 15, Subpart B,Class A) IEC 61326:2013 - EN 55011:2009, Inc.A1:2010 EN 61000-3-2:2006,Inc. A1:2009 andA2:2009 EN 61000-3-3:2013 | Electrical Safety and EMCTesting IEC 61010-1 (2001)Second Ed IEC 61010-2-010(2003) Second Ed Electromagneticcompatibility USA Title 47, Codeof FederalRegulations (2009)for: Radiated Emissions(FCC Part 15,Subpart B, ClassA) ConductedEmissions (FCCPart 15, Subpart B,Class A) IEC 61326: | Both meet relevant electricalstandards for safety,emissions and compatibilitythat were active at time ofsubmission. |
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6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Maintenance ofIncubationTemperature | Maintain 55-60 °C for a minimum of 40 minutes(incubation time of Verify Assert SCBI as statedin K162701) | PASS |
| Qualification testingwith Verify AssertSCBI | 40-minute fluorescent read meets >97%alignment with 7-day growth results per FDAguidance on reduced incubation time. | PASS |
Table 3. Summary of Non-clinical Testing
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Qualification testingwith Verify AssertSCBI | Pass testing with SCBI exposed to full cycleexposure and negative growth result in incubator | PASS |
| Fail testing with SCBI exposed in abbreviatedcycle exposure and positive result in incubator | PASS | |
| Alarm, LED andPrint function Test | Demonstrate proper function of alarms, LED andprint outputs | PASS |
7. Conclusion
The VERIFY® Incubator for Assert™ Self-Contained BI's 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