VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK

K073618 · STERIS Corporation · FRC · Jan 7, 2009 · General Hospital

Device Facts

• Record ID: K073618
• Device Name: VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jan 7, 2009
• 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 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included. The challenge pack is not intended for routine monitoring of the V-PRO 1 Sterilizer. It has been tested and validated solely for use in periodic testing of the V-PRO 1 Sterilizer.

Device Story

Challenge pack containing a biological indicator (SCBI) and a process indicator (CI) for vaporized hydrogen peroxide (VH2O2) sterilization. Used by healthcare providers to qualify Amsco V-PRO 1 sterilizers after installation, repair, or relocation. Device placed in empty chamber; sterilization cycle performed. Post-cycle, CI checked for immediate color change; SCBI activated using mechanical activator to release growth media. SCBI incubated at 55-60°C; media color change (purple to yellow) or turbidity indicates sterilization failure. Three successful consecutive cycles required for system qualification. Benefits include verification of sterilizer performance post-maintenance.

Clinical Evidence

No clinical data. Bench testing only. Validation performed to confirm the challenge pack's ability to verify the Amsco V-PRO 1 Low Temperature Sterilization System performance following installation, relocation, or repair.

Technological Characteristics

Challenge pack containing a self-contained biological indicator (SCBI) and a class 1 process indicator (CI). SCBI utilizes growth media and biological spores. Mechanical activator used to rupture media ampoule. Incubation required at 55-60°C. Standalone device; no software or connectivity.

Indications for Use

Indicated for periodic qualification testing of the Amsco V-PRO 1 Low Temperature Sterilization System following installation, relocation, malfunction, or major repair. Not for routine monitoring. Used in empty sterilization 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

• STERRAD® Sterilizer CycleSure® Test Pack (K051643)

Submission Summary (Full Text)

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JAN - 7 2009

# 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:

John R. Scoville. Fellow Regulatory Affairs Telephone: [phone] Fax No: [phone]

Summary Date: January 05, 2009 Submission: K073618

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 <span style="border: 1px solid black;">VH2O2</span> Sterilization Processes |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common/usual Name: | Challenge Pack. |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC). |

### 2. Predicate Device

STERRAD® Sterilizer CycleSure® Test Pack, K051643, August 19, 2005.

### 3. Description of Device

The Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is used by healthcare providers for periodic qualification testing of the Amsco® V-PROM 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. It is designed to be placed into an otherwise empty chamber.

The user places the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes into the Amsco V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the Verify Vaporized VH2O2 Process Indicator (CI) and the Verify® Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes (SCBI) contained in the challenge pack are retrieved. The CI is accessed for a passing color change immediately. The results of the CI, a class 1 indicator, do not provide proof of Sterilizer qualification. 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 medium 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 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure if the media changes from purple to yellow and/or if the media is turbid. The V-PRO 1

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Sterilizer passes qualification testing when three Challenge Pack SCBIs, processed in separate sterilization cycles, signal sterile results.

#### Intended Use 4.

The Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes is intended for qualification testing of the Amsco V-PRO™ 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included.

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

### 5. Description of Safety and Substantial Equivalence

The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes has the same or similar intended use, type of BI, method to increase the resistance of the BI, packaging, and resistance characteristics as compared to its predicate device the STERRAD® Sterilizer CycleSure® Test Pack.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

John R. Scoville, Jr. Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

JAN - 7 2009

Re: K073618

Trade/Device Name: Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: December 17, 2008 Received: December 18, 2008

Dear Mr. Scoville:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Scoville

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely gours

Susan Kang

Ginette Y. Michaud, M. D. Division Acting 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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STERIS Response to 02/06/08 Request for Additional Information K073618 / Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes

# Indications for Use

510(k) Number (if known): K073618

Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Device Name: Sterilization Processes

Indications For Use:

The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization The Verrily Brological filthcation Chancilgo Fack for Paper.2017 V-PRO 1 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included.

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy, R
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

K073618

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CONFIDENTIAL

B-2