VIS-U-ALL II SELF SEAL POUCH

K070765 · STERIS Corporation · KCT · Oct 12, 2007 · General Hospital

Device Facts

• Record ID: K070765
• Device Name: VIS-U-ALL II SELF SEAL POUCH
• Applicant: STERIS Corporation
• Product Code: KCT · General Hospital
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Story

Sterilization containment pouch; Tyvek/plastic film construction; self-sealing design eliminates need for heat-sealing equipment. Used by healthcare providers to house medical devices during low-temperature sterilization in AMSCO V-PRO 1 system. Pouch allows sterilization agent penetration while maintaining sterile barrier post-process until point of use. No chemical indicators included.

Clinical Evidence

Bench testing only. Performance testing demonstrated the pouch is qualified for use in the AMSCO V-PRO 1 Low Temperature Sterilizer and performs equivalently to the predicate device.

Technological Characteristics

Tyvek/polymylar plastic film construction; 2.0mil film thickness; self-sealing closure mechanism; no chemical indicators; designed for low-temperature sterilization compatibility.

Indications for Use

Indicated for use by healthcare providers to contain medical devices during sterilization in the AMSCO V-Pro 1 Low Temperature Sterilization System and to maintain sterility of the enclosed device 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

• Surgicot Pouches, Peel Open, Breathable (K771032)
• Surgipeel Self Seal Packaging System (K820302)

Reference Devices

• AMSCO® V-PRO 1 Low Temperature Sterilization System (K062297)

Submission Summary (Full Text)

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#### 1. Device Name

| Trade Name: | Vis-U-All Self Seal Pouch |
|----------------------|--------------------------------------------------------|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product Code KCT). |

#### 2. Predicate Device

- Surgicot Pouches, Peel Open, Breathable (K771032) .
- Surgipeel Self Seal Packaging System (K820302) .

#### 3. Description of Device

The proposed Vis-U-All Self Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It permits sealing of the pouch without need of heat-sealing equipment. The purpose of this submission is to demonstrate the Vis-U-All Self Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297, cleared on October 4, 2007.

#### ব. Intended Use

The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

#### 5. Description of Safety and Substantial Equivalence

The materials of composition for the Vis-U-All Self Seal Pouch have not changed in their composition from the predicate, K771032. The plastic film (polymylar) thickness has changed to 2.0mil. The device has no chemical indicators.

Performance testing of the Vis-U-All Self Seal Pouch demonstrated that the proposed pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer and is as safe, as effective, and performs the same as the predicate device.

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2007

Patrick J. McCullagh, Ph.D. Vice President STERIS, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K070765

Trade/Device Name: Vis-U-All Self Seal Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 12, 2007 Received: September 13, 2007

Dear Dr. McCullagh:

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 - Dr. McCullagh

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 thus, permits vour 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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): K070765

Device Name:

Vis-U-All Self Seal Pouch

Indications For Use:

The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, AD
(Division Sign-Off)

Division of Anesthesiology General Hospital Infection Control, Dental Devices

510(k) Number: K070765

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Confidential