VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES

K103331 · STERIS Corporation · JOJ · Sep 1, 2011 · General Hospital

Device Facts

• Record ID: K103331
• Device Name: VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Sep 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Aunsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO max (Lumen, Non Lumen and Flexible Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers. The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the following cycles. [Table of cycles omitted for brevity as per instructions to concatenate]

Device Story

Device is a biological indicator process challenge device for vaporized hydrogen peroxide (VH2O2) sterilization. It contains a Verify V-PRO Chemical Indicator (CI) and a Verify V24 Self-Contained Biological Indicator (SCBI). Healthcare providers place the pack in an empty sterilizer chamber to perform qualification testing. Post-cycle, the CI is checked for color change; the SCBI is activated using a STERIS Verify SCBI HP activator, which seals the vial and releases growth media. The SCBI is incubated at 55-60°C for 24 hours. A pass is indicated by orange, non-turbid media; failure is indicated by a color change to yellow or turbidity. The device confirms the efficacy of sterilization cycles, ensuring the system is functioning correctly after installation or repair, thereby protecting patients from improperly sterilized instruments.

Clinical Evidence

Bench testing only. Resistance characterization confirmed the challenge pack resistance is equivalent or greater than biological models used for V-PRO 1 Plus and V-PRO maX cycles. Simulated use evaluation confirmed passing results for CI and SCBI under worst-case conditions. Process indicator performance evaluation confirmed complete color change under pass conditions and incomplete change under fail conditions.

Technological Characteristics

Biological indicator process challenge device containing a chemical indicator and a self-contained biological indicator (SCBI). SCBI requires external activation via a mechanical vial sealer/media releaser. Incubation required at 55-60°C. No electronic connectivity or software components.

Indications for Use

Indicated for qualification testing of Amsco V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems following installation, relocation, malfunction, or major repair. Not for routine monitoring. Used in empty sterilizer chambers.

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

• Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes (K092906)

Reference Devices

• Amsco V-PRO 1 (K073618)

Submission Summary (Full Text)

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SEP - 1 2011

STERIS®

# 510(k) Summary For Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

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

Contact:

Robert F. Sullivan. Senior Director, FDA Regulatory Affairs Telephone: [phone] Fax No: [phone]

Summary Date:

January 28, 2011

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

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#### 1. Device Name

| Trade Name: | Verify® Biological Indicator Challenge Pack for<br>Vaporized VH2O2 Sterilization Processes |
|----------------------|--------------------------------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI) Process Challenge Device |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) |

#### 2. Predicate Device

Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes, K092906, December 30, 2009.

#### 3. Description of Device

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is used by healthcare providers for qualification testing of the Amsco V-PROTM 1 Low Temperature Sterilization System, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen Cycles) and the V-PROT maX (Flexible, Lumen and Non Lumen Cycles) following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The user places the Verify Biological Indicator Challenge Pack into the Amsco V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the Verify V-PRO Chemical Indicator (CI) and the Verify V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is accessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the media ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60 ℃ for 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to yellow and/or if the media is turbid.

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#### 4. Intended Use

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1, the Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906) and the V-PRO100 maX (Flexible, Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers.

The Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes is intended for qualification testing of the following cycles.

| Sterilization Cycle | Sterilant/<br>Injection<br>(g) | #<br>Injections | Sterilant<br>Exposure Time<br>(min) |
|--------------------------------------------------------------------------------------|--------------------------------|-----------------|-------------------------------------|
| Amsco V-PRO 1 Cycle<br>Amsco V-PRO 1 Plus Lumen Cycle<br>Amsco V-PRO maX Lumen Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO 1 Plus Non Lumen Cycle<br>Amsco V-PRO maX Non Lumen Cycle | 2.1 | 4 | 12 |
| Amsco V-PRO maX Flexible Cycle | 2.1 | 4 | 12 |

### ട്. Description of Safety and Substantial Equivalence

No substantial changes were made to the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes design, cleared in K092906, for qualification in the V-PRO maX Sterilizer Flexible Cycle. The Verify Biological Indicator Challenge Pack for Vaporized |VH2O2 Sterilization Processes does not raise any new issues of safety and effectiveness. The performance data obtained through nonclinical tests and outlined below demonstrates the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes substantial equivalence to the predicate device.

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## K103331/S001 STERIS Response to 1/10/11 Request for Additional Informa Verify® Biological Indicator Challenge Pack for Vaporized [VH2O2 Sterilization Processes

### Summary of Nonclinical Tests:

| Test | Result |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance<br>Characterization | Pass<br>Challenge Pack resistance is equivalent or greater than the biological<br>model used to validate the Lumen and Non Lumen Cycles of the<br>V-PRO 1 Plus Low Temperature Sterilization System.<br>Challenge Pack resistance is equivalent or greater than the biological<br>model used to validate the Flexible Cycle of the V-PRO maX Low<br>Temperature Sterilization System |
| Simulated Use<br>Evaluation | Pass<br>The Verify V-PRO CI and Verify V24 SCBI yielded passing results<br>when evaluated under worst case simulated use conditions. |
| Process<br>Indicator<br>Performance<br>Evaluation | Pass<br>The Process Indicator in the Challenge Pack demonstrated a<br>complete color change under "Pass" conditions and an incomplete<br>color change under "Fail" conditions |

ીવુ

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Image /page/4/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" arranged around the perimeter. Inside the seal is a stylized symbol featuring three parallel lines that curve and converge, resembling a stylized human figure or a bird in flight.

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

Mr. Robert F. Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

EP - 1 2011

Re: K103331

Trade/Device Name: Verify® Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 25, 2011 Received: August 26, 2011

Dear Mr. Sullivan:

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.

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### Page 2 - Mr. Sullivan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm ! 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

L. Schultheis for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

### Device Name: Verify® Biological Indicator Challenge Pack for Vaporized WH2O2 Sterilization Processes

Indications For Use:

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Aunsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO max (Lumen, Non Lumen and Flexible Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers.

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the following cycles.

| Sterilization Cycle | Sterilant/<br>Injection<br>(g) | #<br>Injections | Sterilant<br>Exposure Time<br>(min) |
|------------------------------------|--------------------------------|-----------------|-------------------------------------|
| Amsco V-PRO I Cycle | | | |
| Amsco V-PRO 1 Plus Lumen Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO maX Lumen Cycle | | | |
| Amsco V-PRO 1 Plus Non Lumen Cycle | | | |
| Amsco V-PRO maX Non Lumen Cycle | 2.1 | 4 | 12 |
| Amsco V-PRO maX Flexible Cycle | 2.1 | 4 | 12 |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103331

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