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 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.

AI/ML Overview

This document describes a sterilization pouch (Rexam Self-Seal Tyvek Pouch) and its comparison to a predicate device, focusing on its ability to maintain sterility and the effectiveness of its self-seal tape closure. It does not describe an AI medical device, but rather a physical sterilization product. Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, data provenance) are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" that proves the device meets them, while acknowledging the non-AI nature of the device.

Acceptance Criteria and Device Performance for Rexam Self-Seal Tyvek Pouch

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Seal Strength	Statistically analyzed at a 95% confidence level, indicating both products were significantly above the minimum seal strength limit.
Seal Integrity	Performed as well as the predicate device (Medi-Oxide™ Pouch).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. The text mentions "the seal strength test results were statistically analyzed" and "performed as well as the Medi-Oxide™ Pouch on the seal integrity tests," implying a test set was used, but the specific number of pouches tested is not provided.
Data Provenance: Not explicitly stated. Given the context of a 510(k) submission, it is assumed to be internal testing conducted by Rexam Medical Packaging. It is retrospective in the sense that the testing was performed and then the results were submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable: This is a physical device where performance (seal strength, seal integrity) is measured through objective, quantifiable tests, not subjective interpretation requiring human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not Applicable: As no human interpretation requiring adjudication was involved, this is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not Applicable: This is not an AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable: This is not an AI device. The tests performed ("seal strength" and "seal integrity") are inherently standalone in the sense that they assess the physical properties of the pouch without human intervention during the measurement, but this is a different context than AI standalone performance.

7. The Type of Ground Truth Used

Objective Measurement (Physical Device Performance): The ground truth was established by direct physical measurements against predefined limits or comparative performance against a predicate device for properties like seal strength and seal integrity.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI device, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: This is not an AI device, so there is no concept of a "training set" or ground truth establishment for it in this context.

Summary

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REXAM

K962600

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 RoadMundelein, IL 60060-9735
Contact Person:	Quality and Regulatory Manager
Phone Number:	(847) 362-9000
Fax Number:	(847) 918-4660

Device Information:

Trade Name:	Rexam Self-Seal Tyvek1 Pouch
Common Name:	Self-Seal Tyvek®/Film Sterilization Pouchwith 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:

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

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REXAM

Intended Use:

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.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).