Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Device Description

VERIFY® Incubator for Assert™ | VH2O2 Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert |VH2O2| Self-Contained Biological Indicator (SCBI), subject of a concurrent submission, K171504, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of an endogenous 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

AI/ML Overview

The information provided describes the acceptance criteria and a summary of non-clinical tests performed for the VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator.

Here's the breakdown as requested:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Maintain 55-60 °C for a minimum of 20 minutes (incubation time of Verify Assert SCBI as stated in K162701)	PASS
20-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time.	PASS
Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator	PASS
Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator	PASS
Demonstrate proper function of alarms, LED and print outputs	PASS

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample size used for the qualification testing with the Verify Assert SCBI, nor does it explicitly state the data provenance (country of origin or retrospective/prospective nature). It only mentions "Qualification testing with Verify Assert SCBI."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The device in question is an incubator/reader for biological indicators, and the ground truth appears to be based on "7-day growth results," which is a standard biological outcome, not expert interpretation in the same way a medical imaging device would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations, such as in medical imaging. For a device that incubates and reads biological indicators, the outcome (fluorescent result vs. 7-day growth) is objective.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, especially in conjunction with AI. The VERIFY Incubator is an automated reader for biological indicators and does not involve human readers in its primary function, nor does it incorporate AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance assessment was conducted for the device. The "Qualification testing with Verify Assert SCBI" assesses the incubator's ability to accurately read the biological indicators (fluorescent result) against a definitive biological outcome (7-day growth results). This is intrinsically a standalone performance evaluation of the device's automated reading capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for the qualification testing is outcomes data, specifically "7-day growth results." This refers to the definitive determination of bacterial growth after a standard incubation period, which is the established method for verifying sterilization effectiveness for biological indicators when a rapid read is not available.

8. The sample size for the training set

The document does not provide information about a training set since this product is an incubator/reader and not an AI/ML device that requires training.

9. How the ground truth for the training set was established

Not applicable, as no training set (for an AI/ML model) is mentioned or implied for this device.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2017

STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5976 Heislev Rd Mentor, Ohio 44060

Re: K171587

Trade/Device Name: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: July 31, 2017 Received: August 1, 2017

Dear Mr. 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

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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.

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.

Tara A. Ryan -S

for

Lori Wiggins 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) K171587

Device Name

VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators

Indications for Use (Describe)

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 VERIFY® Incubator for Assert™ VH2O2 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: e-mail: tony_piotrkowski@steris.com

Submission Date: August 21, 2017

Premarket Notification Number: K171587

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™ VH2O2 SelfContained Biological Indicators
Common/usual Name:	Incubator/Reader (accessory to Biological Indicator)
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC)

2. Predicate Device

3M Attest 390 Auto-reader, K123546

Reference Device: VERIFY® Incubator for Assert™ Self Contained Biological Indicators, K163587

3. Description of Device

4. Intended Use/ Indications for Use

5. Summary of Technical Characteristics

Comparisons of technical characteristics versus the predicate and reference devices are summarized in Tables 5-1 and 5-2 respectively.

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Table 5-1 Summary of Incubator Physical Description and Technological Properties vs Predicate

Feature	VERIFY Incubator forAssert VH2O2 SCBI(proposed)	Attest 390(K123546) Predicate	Comparison
Intended Use	Use the VERIFYIncubator for AssertVH2O2 Self ContainedBiological Indicators toincubate and automaticallyread VERIFY AssertVH2O2 Self-ContainedBiological Indicators at 57°C for a fluorescent resultwithin 20 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	100-240 VAC with 12VDC conversion.	100-240 VAC with 12VDC conversion.	Same
Test capacity	8 wells	10 wells	Both can accommodatemultiple samples
Calibration	Factory calibration - nocalibration by customer	Factory calibration - nocalibration by customer	Same
IncubationTime	20 minutes	1 hour (1291), 3 hours(1292)	Reduced incubation timetesting, in accordance withFDA guidance, confirmsread time
FluorescenceDetection	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the SCBI'smedia. The emitted lightis detected by aphotodiode.	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the SCBI'smedia. The emitted lightis detected by aphotodiode.	Same
Feature	VERIFY Incubator forAssert VH2O2 SCBI(proposed)	Attest 390(K123546) Predicate	Comparison
SystemOperation	The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 57℃.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 yellow 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 one type ofbiological indicator isintended for use with theproposed device so no colorcoding is required and bothalarm for a positive BI.
Feature	VERIFY Incubator forAssert VH2O2 SCBI(proposed)	Attest 390(K123546) Predicate	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 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 andA2:2009• EN 61000-3-3:2013	Electrical Safety and EMCTesting• IEC 61010-1 (2001)Second Ed• IEC 61010-2-010(2003) Second EdElectromagneticcompatibility• 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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Table 5-2 Summary of Incubator Physical Description and Technological Properties
vs Reference Device

Feature	VERIFY Incubator forAssert SCBI(proposed)	VERIFY Incubator forAssert SCBI K163587(Reference)	Comparison
Intended Use	Use the VERIFYIncubator for AssertVH2O2 Self ContainedBiological Indicators toincubate and automaticallyread VERIFY AssertVH2O2 Self-ContainedBiological Indicators at 57 °C for a fluorescent resultwithin 20 minutes.	Use the VERIFY®Incubator for Assert™Self Contained BiologicalIndicators SCBI toincubate and automaticallyread VERIFY Assert Self-Contained BiologicalIndicators at 57 °C for afluorescent result within40 minutes.	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	55 - 60 °C	Same
Voltage Range	100-240 VAC with 12VDC conversion.	100-240 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	20 minutes	40 minutes	Reduced incubation timetesting, in accordance withFDA guidance, is confirmsread time.
FluorescenceDetection	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the SCBI'smedia. The emitted lightis detected by aphotodiode.	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the SCBI'smedia. The emitted lightis detected by aphotodiode.	Same

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K171587/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATIONVERIFY® Incubator for Assert™ VH2O2 Self-Contained Biological Indicators
	VERIFY Incubator for	VERIFY Incubator for
Feature	Assert SCBI	Assert SCBI K163587	Comparison
	(proposed)	(Reference)
C ----------	The vas device substances 11- The needer immer haten mis 11

Feature	Assert SCBI(proposed)	Assert SCBI K163587(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 yellow 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 yellow 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

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Feature	VERIFY Incubator forAssert SCBI(proposed)	VERIFY Incubator forAssert SCBI K163587(Reference)	Comparison
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 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	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	Same

Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

Test	Acceptance Criteria	Conclusion
Maintenance ofIncubationTemperature	Maintain 55-60 °C for a minimum of 20 minutes(incubation time of Verify Assert SCBI as statedin K162701)	PASS

Table 5-3. Summary of Non-clinical Testing

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Test	Acceptance Criteria	Conclusion
Qualification testingwith Verify AssertSCBI	20-minute fluorescent read meets >97%alignment with 7-day growth results per FDAguidance on reduced incubation time.	PASS
Qualification testingwith Verify AssertSCBI	Pass testing with SCBI exposed to full cycleexposure and negative growth result in incubatorFail 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 VH2O2 Assert Self-Contained Biological Indicator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as the legally marketed predicate device, K123546, Class II (21 CFR 880.2800, Product code FRC).

Regulation Number and Section

§ 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).