REXAM SELF-SEAL TYVEK POUCH

K962600 · Rexam Medical Packaging, Inc. · KCT · Aug 9, 1996 · General Hospital

Device Facts

• Record ID: K962600
• Device Name: REXAM SELF-SEAL TYVEK POUCH
• Applicant: Rexam Medical Packaging, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is 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.

Device Story

Rexam Self-Seal Tyvek® Pouch serves as a sterile barrier system for medical devices. Constructed from medical-grade Tyvek® and polyethylene/polyester film; features pressure-sensitive self-seal tape closure for manual sealing by healthcare providers. Optional chemical sterilization process indicator provides visual confirmation of sterilization parameters. Used in clinical settings to enclose instruments prior to sterilization; maintains sterility until point of use. Device facilitates manual sealing as an alternative to heat sealing.

Clinical Evidence

Bench testing only. Seal strength and seal integrity tests were performed and compared to the predicate device. Seal strength results were statistically analyzed at a 95% confidence level, confirming performance significantly above minimum limits. No clinical data provided.

Technological Characteristics

Materials: Medical grade Tyvek® sealed to polyethylene/polyester film. Closure: One-inch wide pressure-sensitive self-seal tape. Optional chemical sterilization process indicator. Non-sterile device intended for use in sterilization processes.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices requiring sterilization in processes where non-cellulose pouches are appropriate; maintains sterility post-sterilization. Optional chemical indicator monitors sterilization process parameters.

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

• Medi-Oxide™ Pouch

Submission Summary (Full Text)

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# REXAM

*X962600*

AUG - 9 1996

## 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K962600

### Applicant Information:

- **Date Prepared:** August 5, 1996
- **Name:** Rexam Medical Packaging
- **Address:** 1919 S. Butterfield Road, Mundelein, IL 60060-9735
- **Contact Person:** Quality and Regulatory Manager
- **Phone Number:** [phone]
- **Fax Number:** [phone]

### Device Information:

- **Trade Name:** Rexam Self-Seal Tyvek¹ Pouch
- **Common Name:** Self-Seal Tyvek®/Film Sterilization Pouch with or without Chemical Sterilization Process Indicator
- **Classification Name:** Sterilization Wrap, Chemical Sterilization Process Indicator

### Predicate Device:

- **Trade Name:** Medi-Oxide™ Pouch
- **Manufacturer:** Cur*Med, Curwood, Inc., a Bemis Company

### Device Description:

The Rexam Self-Seal Tyvek® Pouch is constructed of medical grade Tyvek® sealed to polyethylene/polyester film. A chemical sterilization process indicator may be incorporated to monitor one or more of the sterilization process parameters. The final seal of the pouch is applied by the health care provider using the pressure sensitive self-seal tape closure. The self-seal tape closure facilitates manual sealing as an alternate method to heat sealing.

¹Tyvek is a registered trademark of E.I. duPont de Nemours & Company.

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# REXAM

## Intended Use:

The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is 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.

## Comparison of Technological Characteristics:

The Rexam Self-Seal Tyvek® Pouch and the Medi-Oxide™ Pouch are both constructed of medical grade Tyvek® sealed to polyethylene/polyester film. The pressure sensitive tape closure on the Rexam Self-Seal Tyvek® Pouch and the Medi-Oxide™ Pouch are both one inch in width, and the seal is applied by the customer in the same manner for both products. The Medi-Oxide™ Pouch is manufactured without a chemical sterilization process indicator, and the Rexam Self-Seal Tyvek® Pouch may be manufactured with or without a chemical sterilization process indicator.

The performance of the self-seal tape closure on the Rexam Self-Seal Tyvek® Pouch was measured by seal strength and seal integrity tests, and compared to the performance of the self-seal tape on the Medi-Oxide™ Pouch. The seal strength test results were statistically analyzed at a 95% confidence level, and the test results indicate that both products were significantly above the minimum seal strength limit. The Rexam Self-Seal Tyvek® Pouch performed as well as the Medi-Oxide™ Pouch on the seal integrity tests.

The information submitted includes data that demonstrates that the Rexam Self-Seal Tyvek® Pouch is as safe and effective as the legally marketed Medi-Oxide™ Pouch, and that there are no new issues raised of safety and efficacy.

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