VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

K173633 · STERIS Corporation · FRC · Feb 28, 2018 · General Hospital

Device Facts

• Record ID: K173633
• Device Name: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Feb 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time. VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132° C pre-vacuum steam sterlization cycles utilizing a biological indicator or both a biological and integrating indicator from the following list. - 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company - . 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company - Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc. - . Celerity 20 Steam Biological Indicator - . VERIFY STEAM Integrating Indicator VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterlization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator. The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

Device Story

Reusable aluminum test pack; contains tortuous path spiral for air removal/steam penetration challenge. Used in healthcare facilities to monitor pre-vacuum steam sterilization cycles. Input: steam sterilization process conditions. Device houses biological indicators (BI) and/or chemical integrating indicators. User places assembled pack in sterilizer; performs 4-minute 270°F/132°C cycle (or 10-minute cycle with specific sleeve assembly). Post-cycle, user removes indicators. BI is activated (media release) and incubated in external reader (Celerity Steam Incubator) to detect optical signal confirming viability. Integrating indicator is visually inspected for color change (dark bar in ACCEPT window). Output: pass/fail sterilization result. Benefits: ensures sterilization efficacy; prevents use of improperly sterilized instruments.

Clinical Evidence

Bench testing only. Simulated use studies compared the performance of biological and chemical indicators within the Reusable Test Pack against the AAMI 16 towel test pack. Results confirmed the Reusable Test Pack provides an equivalent or greater challenge to the sterilization process than the AAMI 16 pack and that indicators within the pack perform equivalently to those in the AAMI 16 pack.

Technological Characteristics

Aluminum chamber with removable aluminum plug and permanently pressed aluminum cap containing a precision-machined spiral for tortuous path air removal. Dimensions accommodate biological and chemical indicators. Reusable. No electronic components or software in the pack itself; used with external biological indicator readers.

Indications for Use

Indicated for routine monitoring of pre-vacuum steam sterilization cycles in healthcare facilities and testing air removal efficiency of pre-vacuum steam sterilizers.

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

• Dana Reusable Test Pack (K133267)

Reference Devices

• VERIFY STEAM Integrating Indicator (K152630)
• 3M ATTEST Rapid Readout Biological Indicators (K092944)
• Smart-Read EZTest Self Contained Biological Indicators (K130135)
• VERIFY Bowie Dick Indicator Strip (K120592)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2018

STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K173633

Trade/Device Name: VERIFY™ All-in-One STEAM Reusable Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 26, 2018 Received: January 29, 2018

Dear Jennifer Nalepka:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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) K173633

Device Name

VERIFY All-In-One STEAM Reusable Test Pack

### Indications for Use (Describe)

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is desing the air removal efficiency of pre-vacuum sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132° C pre-vacuum steam sterlization cycles utilizing a biological indicator or both a biological and integrating indicator from the following list.

- 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
- . 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
- Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
- . Celerity 20 Steam Biological Indicator
- . VERIFY STEAM Integrating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterlization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

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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# STERIS®

## 510(k) Summary For VERIFY™ All-in-One STEAM Reusable Test Pack

## Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

## Manufacturing Facility

STERIS Corporation Franklin Park Facility 11457 Melrose Ave. Franklin Park, IL 60131 Phone: [phone]

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist

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

February 21, 2018 Submission Date:

Premarket Notification Number: K173633

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | VERIFY™ All-in-One <b>STEAM</b> Reusable Test Pack |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) |

#### 2. Predicate Device

K133267 Dana Reusable Test Pack

#### Description of Device 3.

The VERIFY All-in-One STEAM Reusable Test Pack (formerly identified as the Dana Reusable Test Pack) consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity 20 Steam Biological Indicator (subject of a separate, concurrent 510(k) premarket notification) with or without the VERIFY STEAM Integrating Integrator (cleared under K152630).

The Celerity 20 Steam Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 Steam Biological Indicator and Incubator are subjects of separate 510(k) premarket notifications.

The VERIFY STEAM Integrating Integrator (cleared in K152630) is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY |STEAM Integrating Integrator may be included in the pack and processed according to the pack's instructions for use.

The user will place the assembled VERIFY All-in-One STEAM Reusable Test Pack containing the Celerity 20 Steam Biological Indicator with or without the VERIFY STEAM Integrating Integrator into the sterilizer chamber and perform a 4-minute 270°F pre-vacuum steam sterilization cycle.

At the end of the cycle, the user will remove the Celerity 20 Steam Biological Indicator and the VERIFY |STEAM Integrating Integrator from the pack. The Celerity 20 Steam Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The

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activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.

The VERIFY |STEAM Integrating Integrator will be evaluated for a passing or failing result by observing the dark bar of the device. If the dark bar enters the ACCEPT (OK) window, the integrator is read as a PASS. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL.

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

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of prevacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 1140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device for 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

- . 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
- 3M ATTEST Super Rapid Read Biological Indicators catalog number ● 1492V manufactured by 3M Company
- Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
- Celerity 20 Steam Biological Indicator
- VERIFY |STEAM | Integrating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY |STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Reusable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine

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monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

#### 5. Summary of Technical Characteristics

A comparison of technical characteristics are summarized in Table 5-1.

| Feature | VERIFY All-In-One<br>STEAM Reusable Test<br>Pack<br>(K173633) | Dana Reusable Test<br>Pack<br>(K133267) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indication for<br>Use | The VERIFY All-In-One<br>STEAM Reusable Test<br>Pack, when used with a<br>VERIFY Bowie Dick<br>Indicator Strip, is designed<br>for testing the air removal<br>efficiency of pre-vacuum<br>steam sterilizers. The<br>indicator will demonstrate<br>complete dye migration<br>when proper sterilization<br>conditions are met and<br>proper vacuum is<br>achieved. If there is<br>inadequate vacuum such<br>that would result in a 2°C<br>(+1°C/-0°C) temperature<br>difference between the<br>center of the<br>ANSI/AAMI/ISO 1140-<br>5:2007 Standard Test Pack<br>and the drain temperature<br>at the beginning of the<br>final minute of a three and<br>a half minute cycle, the<br>indicator will demonstrate<br>incomplete dye migration<br>(incomplete color change<br>in the indicator window).<br>The test parameters used<br>for validating this device<br>for 134°C for 3.5 minutes<br>with a 2 minute dry time.<br>VERIFY All-In-One<br>STEAM Reusable Test<br>Pack is designed to<br>challenge steam<br>sterilization process in | The Dana Reusable Test<br>Pack is designed to<br>challenge steam<br>sterilization process in<br>healthcare facilities. It is<br>intended to be used for<br>routine monitoring of pre-<br>vacuum steam sterilization<br>cycles. It is validated to be<br>used in 4 minute 270°F<br>pre-vacuum steam<br>sterilization cycles with a<br>3M Attest Super Rapid<br>Readout Biological<br>Indicator 1492V along<br>with or without SteriScan<br>Integrators. | The proposed and predicate<br>devices are identical. The<br>current premarket<br>notification is to add the use<br>of the Celerity 20 Steam<br>Biological Indicator<br>(submitted in a separate,<br>concurrent premarket<br>notification) in the VERIFY<br>All-In-One STEAM<br>Reusable Test Pack.<br>The following claims for use<br>of the VERIFY All-In-One<br>Reusable Test Pack have<br>been previously cleared:<br>Bowie Dick Indicator when<br>used with the VERIFY<br>Bowie Dick Indicator Strip<br>(K120592)<br>Routine Monitoring of a 4-<br>minute 270°F/132°C pre-<br>vacuum steam sterilization<br>cycle when used with:<br>• 3M ATTEST Rapid Readout<br>Biological Indicators<br>catalog number 1292<br>manufactured by 3M<br>Company (K092944)<br>• Smart-Read EZTest Self<br>Contained Biological<br>Indicators for steam<br>manufactured by<br>MesaLabs, Inc.<br>(K130135) |
| Feature | VERIFY All-In-One<br>STEAM Reusable Test<br>Pack<br>(K173633) | Dana Reusable Test<br>Pack<br>(K133267) | Comparison |
| | healthcare facilities. It is<br>intended to be used for<br>routine monitoring of pre-<br>vacuum steam sterilization<br>cycles. It is validated to<br>be used in 4-minute<br>270°F/132°C pre-vacuum<br>steam sterilization cycles<br>utilizing a biological<br>indicator, integrating<br>indicator or both a<br>biological and integrating<br>indicator from the<br>following list.<br>3M ATTEST Rapid<br>Read Biological<br>Indicators catalog<br>number 1292<br>manufactured by 3M<br>Company 3M ATTEST Super<br>Rapid Read Biological<br>Indicators catalog<br>number 1492V<br>manufactured by 3M<br>Company Smart-Read EZTest<br>Self Contained<br>Biological Indicators<br>for steam manufactured<br>by MesaLabs, Inc. Celerity 20 Steam<br>Biological Indicator VERIFY STEAM<br>Integrating Indicator | | VERIFY STEAM<br>Integrating Indicator<br>(K102761) Routine Monitoring of a 10-<br>minute 270°F/132°C pre-<br>vacuum steam sterilization<br>cycle when used with the<br>additional polypropylene<br>sleeve assembly and the 3M<br>ATTEST Rapid Readout<br>Biological Indicator catalog<br>number 1292 (K103321)<br><br>NOTE: In previous<br>submissions, the VERIFY<br>All-In-One STEAM<br>Reusable Pack was referred<br>to as the Dana Reusable Test<br>Pack and the VERIFY<br>STEAM Integrating<br>Integrator was called the<br>SteriScan Integrator. |
| | VERIFY All-In-One<br>STEAM Reusable Test<br>Pack is designed to<br>challenge the steam<br>sterilization process in<br>healthcare facilities. It is<br>intended to be used for<br>routine monitoring of pre-<br>vacuum steam sterilization<br>cycles. It is validated to<br>be used in 4-minute<br>270°F/132°C pre-vacuum<br>steam sterilization cycles | | |
| Feature | VERIFY All-In-One<br><b>STEAM</b> Reusable Test<br>Pack<br>(K173633) | Dana Reusable Test<br>Pack<br>(K133267) | Comparison |
| | <b>STEAM</b> Integrating<br>Indicator.<br><br>The VERIFY All-In-One<br><b>STEAM</b> Reusable Test<br>Pack employing the All-<br>in-One PV10 Assembly (a<br>disposable polypropylene<br>sleeve assembly) with a<br>3M ATTEST Rapid<br>Readout Biological<br>Indicator catalog number<br>1292 can be used for<br>routine monitoring of 10-<br>Minute 270°F/132°C pre-<br>vacuum steam sterilization<br>cycles. The polypropylene<br>sleeve assembly is<br>intended to be used only<br>with the VERIFY All-In-<br>One <b>STEAM</b> Reusable<br>Test Pack. | | |
| General<br>Design | Aluminum chamber that<br>can be sealed at one end<br>using a removable<br>aluminum plug. The other<br>end has a permanently<br>pressed in aluminum cap<br>with a precision machined<br>spiral that provides a<br>tortuous path for air<br>removal. The aluminum<br>chamber is large enough to<br>contain a biological<br>indicator and chemical<br>indicator. | Aluminum chamber that<br>can be sealed at one end<br>using a removable<br>aluminum plug. The other<br>end has a permanently<br>pressed in aluminum cap<br>with a precision machined<br>spiral that provides a<br>tortuous path for air<br>removal. The aluminum<br>chamber is large enough to<br>contain a biological<br>indicator and chemical<br>indicator. | Identical configuration |

## Table 5-1 Summary of pack Physical Description and Technological Properties

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| Feature | VERIFY All-In-One<br>STEAM Reusable Test<br>Pack<br>(K173633) | Dana Reusable Test<br>Pack<br>(K133267) | Comparison |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biological<br>Indicator | 3M ATTEST Rapid Read Biological<br>Indicators catalog number 1292<br>manufactured by 3M Company 3M ATTEST Super Rapid Read Biological<br>Indicators catalog number 1492V<br>manufactured by 3M Company Smart-Read EZTest Self Contained<br>Biological Indicators for steam manufactured<br>by MesaLabs, Inc. Celerity 20 Steam Biological Indicator | 3M ATTEST Super Rapid<br>Read Biological Indicators<br>catalog number 1492V<br>manufactured by 3M<br>Company | The proposed and predicate<br>devices are identical. The<br>current premarket<br>notification is to add the use<br>of the Celerity 20 Steam<br>Biological Indicator<br>(submitted in a separate,<br>concurrent premarket<br>notification) in the VERIFY<br>All-In-One STEAM<br>Reusable Test Pack.<br>The following BIs were<br>cleared in previous<br>submissions: 3M ATTEST Rapid Read<br>Biological Indicators<br>catalog number 1292<br>manufactured by 3M<br>Company (K092944) Smart-Read EZTest Self<br>Contained Biological<br>Indicators for steam<br>manufactured by<br>MesaLabs, Inc.<br>(K130135) |
| Chemical<br>Indicator | VERIFY STEAM<br>Integrating Indicator | VERIFY STEAM<br>Integrating Indicator<br>(previously branded as the<br>Steriscan Integrating<br>Integrator) | Same |

#### 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 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Simulated Use | Performance of the BI in the Reusable Test Pack is<br>equivalent to the performance of the BI in the AAMI 16<br>towel test pack. | PASS |
| | Performance of the chemical integrator in the Reusable<br>Test Pack is equivalent to the performance of the chemical<br>integrator in the AAMI 16 towel test pack. | PASS |
| | Reusable Test Pack provides an equivalent or greater<br>challenge than the AAMI 16 towel test pack. | PASS |
| BI in pack vs BI outside<br>of pack | Reusable Test Pack provides a greater challenge to the<br>process than the BI itself. | PASS |

Table 5-2. Summary of Non-clinical Testing

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| Test | Acceptance Criteria | Conclusion |
|----------------------------------|-----------------------------------------------------------------------------------------------|------------|
| CI in pack vs CI outside of pack | Reusable Test Pack provides a greater challenge to the process than the integrator by itself. | PASS |

#### 7. Conclusion

The VERIFY All-in-One STEAM Reusable Test Pack has met the established performance criteria. Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device, Dana Reusable Test Pack cleared in K133267 Class II (21 CFR 880.2800, Product code FRC).