VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM

K090371 · STERIS Corporation · KCT · May 1, 2009 · General Hospital

Device Facts

• Record ID: K090371
• Device Name: VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM
• Applicant: STERIS Corporation
• Product Code: KCT · General Hospital
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The Vis -U-All Low Temperature Tyvck Sterilization Pouch for V-PRO 1 Sterilization System is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Device Story

Sterilization containment system consisting of Tyvek/plastic film pouches and tubing; used by healthcare providers to enclose medical devices prior to processing in Amsco V-PRO 1 Low Temperature Sterilization System. Device maintains sterility of processed items during handling and storage. Submission specifically qualifies these pouches for double-pouching applications. No active components; passive barrier technology.

Clinical Evidence

Bench testing only. Testing demonstrated safety and effectiveness of the pouches and tubing when used in a double-pouch configuration within the V-PRO 1 Sterilization System.

Technological Characteristics

Tyvek/plastic film sterilization containment pouches and tubing. Available in various dimensions (3"x7" to 12"x18" pouches; 3"x100' to 14"x100' tubing). Passive barrier technology; no energy source or software.

Indications for Use

Indicated for use by health care providers to enclose medical devices for sterilization in the Amsco V-PRO 1 Low Temperature Sterilization System and to maintain sterility during storage until use.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Vis-U-All Self Seal Pouch (K070765)
• D Vis-U-All Heat Seal Pouch and Tubing (K071087)

Submission Summary (Full Text)

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MAY

## - 1 2009 510(k) Summary For Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System

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

Contact:

John Robert (Jack) Scoville. Fellow, Regulatory Affairs Telephone:[phone] Fax No: [phone]

Summary Date:

February 12, 2009

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

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#### 1. Device Name

| Trade Name: | Vis-U-All Low Temperature Tyvek Sterilization<br>Pouch for V-PRO 1 Sterilization System |
|----------------------|-----------------------------------------------------------------------------------------|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product Code<br>KCT). |

#### 2. Predicate Device

- Vis-U-All Self Seal Pouch (K070765)
- D Vis-U-All Heat Seal Pouch and Tubing (K071087)

#### 3. Description of Device

The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the Amsco V-PRO 1 Low Temperature Sterilization System. The proposed pouch is available as either a self seal pouch, a heat seal pouch, or heat seal tubing.

The purpose of this submission is to demonstrate the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is safe and effective for double pouching.

#### 4. Intended Use

The Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The Vis -U-All Low Temperature Tyvck Sterilization Pouch for V-PRO 1 Sterilization System is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

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### 5. Description of Safety and Substantial Equivalence

The device models are identical to the cleared predicate dcvices K070765 and K071087.

Testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System demonstrated that the proposed pouches and tubing are safe and effective when double-pouched.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

Mr. John Robert Scoville, Jr. Fellow, Regulatory Affairs Steris Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K090371

Trade/Device Name: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System

Regulation Number: 21 CFR 880.6850

Regulation Name: Sterilization Wrap

Regulatory Class: II

Product Code: KCT

Dated: March 31, 2009

Received: April 1, 2009

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 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.

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### Page 2- Mr. Scoville

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 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

Susan Bunon

Susan Runner, D.D.S., MA 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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# Indications for Use

#### 510(k) Number (if known): K090371

### Device Name: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System

Indications For Use:

The Vis-U-All Low Temperature Tyvek Sterilization Pouches are sterilization containment pouches for use by the health care providers to enclose medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The pouches maintain the sterility of the enclosed device during normal handling and storage until the pouch is opened and the medical device is removed for use.

| Type | Size | Type | Size |
|------------------------------------------------|-----------|-----------------------------|------------|
| Pouch, Self<br>Seal and<br>Heat Seal,<br>Tyvek | 3" x 7" | Tubing, Heat<br>Seal, Tyvek | 3" x 100' |
| | 4" x 9" | | 4" x 100' |
| | 4" x 12" | | 6" x 100' |
| | 4'" x 22" | | 9" x 100' |
| | 6" x 10" | | 14" x 100' |
| | 8" x 12" | | |
| | 10" x 15" | | |
| | 12" x 18" | | |

Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A Murphy MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: