VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

K171587 · STERIS Corporation · FRC · Aug 22, 2017 · General Hospital

Device Facts

• Record ID: K171587
• Device Name: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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 Story

The VERIFY Incubator is a benchtop reader/incubator used to monitor sterilization cycles. It accepts VERIFY Assert VH2O2 Self-Contained Biological Indicators (SCBI) containing Geobacillus stearothermophilus. The device maintains a constant temperature (55-60°C) to facilitate the outgrowth of the biological indicator. It uses UV LEDs to excite a fluorescent moiety produced by enzymatic activity within the SCBI; a photodiode detects the resulting fluorescence. If fluorescence increases, the device identifies the SCBI as 'positive,' indicating a potential sterilization failure. Results are communicated to the user via an LCD screen, audible alarms, and front-panel LED indicators. The device is operated by healthcare personnel in clinical environments. It provides rapid (20-minute) results, allowing for timely assessment of sterilization cycle success or failure, thereby helping to ensure the sterility of processed medical instruments.

Clinical Evidence

Bench testing only. Performance testing demonstrated >97% alignment between the 20-minute fluorescent read and 7-day growth results, consistent with FDA guidance for reduced incubation time. Testing confirmed the device correctly identifies positive results for abbreviated cycle exposures and negative results for full cycle exposures. Alarm, LED, and print functions were verified as operational.

Technological Characteristics

Benchtop incubator/reader with 8 wells. Operates at 55-60°C. Uses UV LED excitation and photodiode detection for fluorescence. Powered by 100-240 VAC with 12 VDC conversion. Factory calibrated. Complies with IEC 61010-1, IEC 61010-2-010, and EMC standards (FCC Part 15, IEC 61326, EN 55011).

Indications for Use

Indicated for use in clinical settings to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators (SCBI) to monitor sterilization cycle efficacy.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• 3M Attest 390 Auto-reader (K123546)

Reference Devices

• VERIFY Incubator for Assert Self Contained Biological Indicators (K163587)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| 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: [phone] Fax No: [phone]

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Anthony Piotrkowski

Telephone: [phone] Fax No: e-mail: [e-mail]

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 Self<br>Contained Biological Indicators |
|------------------------|-----------------------------------------------------------------------------|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>(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

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

#### 4. Intended Use/ Indications for Use

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 ℃ for a fluorescent result within 20 minutes.

#### 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 for<br>Assert VH2O2 SCBI<br>(proposed) | Attest 390<br>(K123546) Predicate | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY<br>Incubator for Assert<br>VH2O2 Self Contained<br>Biological Indicators to<br>incubate and automatically<br>read VERIFY Assert<br>VH2O2 Self-Contained<br>Biological Indicators at 57<br>°C for a fluorescent result<br>within 20 minutes. | The 3M Attest 390 Auto-<br>reader is designed to<br>incubate and automatically<br>read the 3M Attest Rapid<br>readout Biological<br>indicators for Steam 1291,<br>1292, at 60 °C for a final<br>fluorescent result at 1 hour<br>for 1291 and 3 hours for<br>1292. | Both are intended for<br>incubation and automatic<br>reading of specific self-<br>contained biological<br>indicators. |
| Basis of<br>Readout | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that<br>results from growing<br>biological indicator<br>organisms | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that<br>results from growing<br>biological indicator<br>organisms | Same |
| Incubation<br>Temperature<br>Range | 55 - 60 °C | 60 ± 2 °C | Both operate within the<br>growth temperature range of<br>Geobacillus<br>stearothermophilus |
| Voltage Range | 100-240 VAC with 12<br>VDC conversion. | 100-240 VAC with 12<br>VDC conversion. | Same |
| Test capacity | 8 wells | 10 wells | Both can accommodate<br>multiple samples |
| Calibration | Factory calibration - no<br>calibration by customer | Factory calibration - no<br>calibration by customer | Same |
| Incubation<br>Time | 20 minutes | 1 hour (1291), 3 hours<br>(1292) | Reduced incubation time<br>testing, in accordance with<br>FDA guidance, confirms<br>read time |
| Fluorescence<br>Detection | UV LEDs are used to<br>excite the fluorescent<br>molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate<br>contained in the SCBI's<br>media. The emitted light<br>is detected by a<br>photodiode. | UV LEDs are used to<br>excite the fluorescent<br>molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate<br>contained in the SCBI's<br>media. The emitted light<br>is detected by a<br>photodiode. | Same |
| Feature | VERIFY Incubator for<br>Assert VH2O2 SCBI<br>(proposed) | Attest 390<br>(K123546) Predicate | Comparison |
| System<br>Operation | The reader/incubator wells<br>are arranged in 2 banks of<br>4 wells and preset to 57℃.<br>The measurement of<br>fluorescence is initiated by<br>placement of a VERIFY<br>Assert SCBI into any of<br>the incubation wells and<br>pressing the adjacent<br>"ACTION" button.<br>When an SCBI is placed<br>into a well, the auto-reader<br>detects its presence. Upon<br>pressing the button<br>associated with that well, a<br>blinking yellow light<br>indicates that incubation is<br>in process and the read<br>initiated.<br>A "positive" reading is<br>interpreted as an<br>indication of a potential<br>sterilization cycle failure.<br>A "positive" finding is<br>indicated to the user by<br>red light on the front panel<br>adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD<br>screen. The alarm must be<br>muted by the operator<br>when a positive result is<br>obtained. The LCD screen<br>provides instructions for<br>the user to turn off the<br>alarm for that specific<br>SCBI.<br>Should another BI become<br>"positive", the alarm will<br>sound again and the above<br>actions are repeated.<br>If the result is not positive<br>at the end of the<br>incubation time, the result<br>is negative. Negative<br>results are identified by a<br>green light on the front<br>panel adjacent to the well<br>with the "negative" BI and<br>by text on the LCD. | The measurement of<br>fluorescence is initiated by<br>placement of an Attest<br>SCBI into any of the<br>incubation wells. The<br>reader/incubator wells are<br>color-coded to match the<br>color of the top of the<br>SCBIs. The incubator<br>block may be color coded.<br>When a BI is placed into a<br>well, its presence is<br>detected. The LCD screen<br>below the SCBI shows the<br>time remaining to<br>complete the incubation<br>period.<br>Detection of a positive<br>result is indicated by a '+'<br>sign on the LCD screen,<br>accompanied by an<br>audible alarm. A positive<br>result is indicative of a<br>sterilization cycle failure.<br>The alarm must be muted<br>by the operator when a<br>positive result is obtained.<br>Pressing the mute button<br>disables the alarm only for<br>the specific SCBI which<br>was just identified as<br>positive. Should another<br>BI become "positive", the<br>alarm will again sound.<br>If the result is not positive<br>at the end of the<br>incubation time, the result<br>is negative. Negative<br>results are identified by a<br>'- 'sign on the LCD<br>screen. | Both have similar modes of<br>operation only one type of<br>biological indicator is<br>intended for use with the<br>proposed device so no color<br>coding is required and both<br>alarm for a positive BI. |
| Feature | VERIFY Incubator for<br>Assert VH2O2 SCBI<br>(proposed) | Attest 390<br>(K123546) Predicate | Comparison |
| Indication of<br>Results | Positive - audible alarm,<br>visual LED lights and<br>screen<br>Negative - no alarm,<br>visual indication with<br>LED lights and LCD<br>screen<br>User must acknowledge<br>results | Positive – audible alarm<br>(if enabled), “+” indication<br>on LCD panel, and<br>flashing of LCD panel<br>backlighting<br>Negative - no alarm, “-<br>”indication on LCD panel | Similar Indication of Results |
| Compliance | Electrical Safety and EMC<br>Testing<br>• IEC 61010-1 (2010)<br>Third Ed<br>• IEC 61010-2-010<br>(2013) Third Ed<br>Electromagnetic<br>compatibility<br>• USA Title 47, Code<br>of Federal<br>Regulations (2007)<br>for:<br>• Radiated Emissions<br>(FCC Part 15,<br>Subpart B, Class A)<br>• Conducted<br>Emissions (FCC<br>Part 15, Subpart B,<br>Class A)<br>• IEC 61326:2013 -<br>• EN 55011:2009, Inc.<br>A1:2010<br>• EN 61000-3-2:2006,<br>Inc. A1:2009 and<br>A2:2009<br>• EN 61000-3-3:2013 | Electrical Safety and EMC<br>Testing<br>• IEC 61010-1 (2001)<br>Second Ed<br>• IEC 61010-2-010<br>(2003) Second Ed<br>Electromagnetic<br>compatibility<br>• USA Title 47, Code<br>of Federal<br>Regulations (2009)<br>for:<br>• Radiated Emissions<br>(FCC Part 15,<br>Subpart B, Class<br>A)<br>• Conducted<br>Emissions (FCC<br>Part 15, Subpart B,<br>Class A)<br>• IEC 61326: | Both meet relevant electrical<br>standards for safety,<br>emissions and compatibility<br>that were active at time of<br>submission. |

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| Table 5-2 Summary of Incubator Physical Description and Technological Properties | | | |
|----------------------------------------------------------------------------------|--|--|--|
| vs Reference Device | | | |

| Feature | VERIFY Incubator for<br>Assert SCBI<br>(proposed) | VERIFY Incubator for<br>Assert SCBI K163587<br>(Reference) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY<br>Incubator for Assert<br>VH2O2 Self Contained<br>Biological Indicators to<br>incubate and automatically<br>read VERIFY Assert<br>VH2O2 Self-Contained<br>Biological Indicators at 57 °C for a fluorescent result<br>within 20 minutes. | Use the VERIFY®<br>Incubator for Assert™<br>Self Contained Biological<br>Indicators SCBI to<br>incubate and automatically<br>read VERIFY Assert Self-<br>Contained Biological<br>Indicators at 57 °C for a<br>fluorescent result within<br>40 minutes. | Both are intended for<br>incubation and automatic<br>reading of specific self-<br>contained biological<br>indicators. |
| Basis of<br>Readout | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that<br>results from growing<br>biological indicator<br>organisms | Photodiode detects<br>fluorescence produced by<br>enzymatic activity that<br>results from growing<br>biological indicator<br>organisms | Same |
| Incubation<br>Temperature<br>Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage Range | 100-240 VAC with 12<br>VDC conversion. | 100-240 VAC with 12<br>VDC conversion. | Same |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - no<br>calibration by customer | Factory calibration - no<br>calibration by customer | Same |
| Incubation<br>Time | 20 minutes | 40 minutes | Reduced incubation time<br>testing, in accordance with<br>FDA guidance, is confirms<br>read time. |
| Fluorescence<br>Detection | UV LEDs are used to<br>excite the fluorescent<br>molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate<br>contained in the SCBI's<br>media. The emitted light<br>is detected by a<br>photodiode. | UV LEDs are used to<br>excite the fluorescent<br>molecule produced by<br>enzyme cleavage of the<br>fluorogenic substrate<br>contained in the SCBI's<br>media. The emitted light<br>is detected by a<br>photodiode. | Same |

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| K171587/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION<br>VERIFY® 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<br>(proposed) | Assert SCBI K163587<br>(Reference) | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| System<br>Operation | The reader/incubator wells<br>are arranged in 2 banks of<br>4 wells and preset to 57°C.<br>The measurement of<br>fluorescence is initiated by<br>placement of a VERIFY<br>Assert SCBI into any of<br>the incubation wells and<br>pressing the adjacent<br>"ACTION" button.<br>When an SCBI is placed<br>into a well, the auto-reader<br>detects its presence. Upon<br>pressing the button<br>associated with that well, a<br>blinking yellow light<br>indicates that incubation is<br>in process and the read<br>initiated.<br>A “positive” reading is<br>interpreted as an<br>indication of a potential<br>sterilization cycle failure.<br>A “positive” finding is<br>indicated to the user by<br>red light on the front panel<br>adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD<br>screen. The alarm must be<br>muted by the operator<br>when a positive result is<br>obtained. The LCD screen<br>provides instructions for<br>the user to turn off the<br>alarm for that specific<br>SCBI.<br>Should another BI become<br>“positive”, the alarm will<br>sound again and the above<br>actions are repeated.<br>If the result is not positive<br>at the end of the<br>incubation time, the result<br>is negative. Negative<br>results are identified by a<br>green light on the front<br>panel adjacent to the well<br>with the “negative” BI and<br>by text on the LCD. | The reader/incubator wells<br>are arranged in 2 banks of<br>4 wells and preset to 57°C.<br>The measurement of<br>fluorescence is initiated by<br>placement of a VERIFY<br>Assert SCBI into any of<br>the incubation wells and<br>pressing the adjacent<br>"ACTION" button.<br>When an SCBI is placed<br>into a well, the auto-reader<br>detects its presence. Upon<br>pressing the button<br>associated with that well, a<br>blinking yellow light<br>indicates that incubation is<br>in process and the read<br>initiated.<br>A “positive” reading is<br>interpreted as an<br>indication of a potential<br>sterilization cycle failure.<br>A “positive” finding is<br>indicated to the user by<br>red light on the front panel<br>adjacent to the well, by an<br>audible alarm, and by text<br>displayed on the LCD<br>screen. The alarm must be<br>muted by the operator<br>when a positive result is<br>obtained. The LCD screen<br>provides instructions for<br>the user to turn off the<br>alarm for that specific<br>SCBI.<br>Should another BI become<br>“positive”, the alarm will<br>sound again and the above<br>actions are repeated.<br>If the result is not positive<br>at the end of the<br>incubation time, the result<br>is negative. Negative<br>results are identified by a<br>green light on the front<br>panel adjacent to the well<br>with the “negative” BI and<br>by text on the LCD. | Same |

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| Feature | VERIFY Incubator for<br>Assert SCBI<br>(proposed) | VERIFY Incubator for<br>Assert SCBI K163587<br>(Reference) | Comparison |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication of<br>Results | Positive - audible alarm,<br>visual LED lights and<br>screen<br>Negative - no alarm,<br>visual indication with<br>LED lights and LCD<br>screen<br>User must acknowledge<br>results | Positive - audible alarm,<br>visual LED lights and<br>screen<br>Negative - no alarm,<br>visual indication with<br>LED lights and LCD<br>screen<br>User must acknowledge<br>results | Same |
| Compliance | Electrical Safety and EMC<br>Testing<br>IEC 61010-1 (2010)<br>Third Ed IEC 61010-2-010<br>(2013) Third Ed Electromagnetic<br>compatibility USA Title 47, Code<br>of Federal<br>Regulations (2007)<br>for: Radiated Emissions<br>(FCC Part 15,<br>Subpart B, Class A) Conducted<br>Emissions (FCC<br>Part 15, Subpart B,<br>Class A) IEC 61326:2013 -<br>EN 55011:2009, Inc.<br>A1:2010 EN 61000-3-2:2006,<br>Inc. A1:2009 and<br>A2:2009 | Electrical Safety and EMC<br>Testing<br>IEC 61010-1 (2010)<br>Third Ed IEC 61010-2-010<br>(2013) Third Ed Electromagnetic<br>compatibility USA Title 47, Code<br>of Federal<br>Regulations (2007)<br>for: Radiated Emissions<br>(FCC Part 15,<br>Subpart B, Class A) Conducted<br>Emissions (FCC<br>Part 15, Subpart B,<br>Class A) IEC 61326:2013 -<br>EN 55011:2009, Inc.<br>A1:2010 EN 61000-3-2:2006,<br>Inc. A1:2009 and<br>A2:2009 | 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 of<br>Incubation<br>Temperature | Maintain 55-60 °C for a minimum of 20 minutes<br>(incubation time of Verify Assert SCBI as stated<br>in K162701) | PASS |

Table 5-3. Summary of Non-clinical Testing

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| Test | Acceptance Criteria | Conclusion |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Qualification testing<br>with Verify Assert<br>SCBI | 20-minute fluorescent read meets >97%<br>alignment with 7-day growth results per FDA<br>guidance on reduced incubation time. | PASS |
| Qualification testing<br>with Verify Assert<br>SCBI | Pass testing with SCBI exposed to full cycle<br>exposure and negative growth result in incubator<br>Fail testing with SCBI exposed in abbreviated<br>cycle exposure and positive result in incubator | PASS |
| Alarm, LED and<br>Print function Test | Demonstrate proper function of alarms, LED and<br>print 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).