The REXAM Fracture Resistant Pouch 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.

The chemical process indicator on the REXAM Fracture Resistant 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 predicate device and the REXAM Fracture Resistant Pouch are constructed of sterilizable kraft paper sealed to the polypropylene surface of a polyester-polypropylene plastic film lamination. Three sides of the pouch are sealed during manufacture. There are two versions of the REXAM Fracture Resistant Pouch: (1) a final heat seal closure of the paper and plastic film laminate components, and (2) a final self-seal closure employing a pressure sensitive self-seal tape assembled on the paper component and sealed to the polyester layer of the plastic film laminate. Both types of final closures are applied by the health care provider.

A chemical sterilization process indicator for steam or ethylene oxide sterilization, or both, may be incorporated to monitor exposure to the sterilant.

AI/ML Overview

Here's an analysis of the REXAM Fracture Resistant Pouch based on the provided text, outlining the acceptance criteria and study details:

This document is a 510(k) summary for a medical device, the REXAM Fracture Resistant Pouch. It's important to note that the type of "acceptance criteria" and "study" discussed here relate to the performance characteristics of the physical medical device (a sterilization pouch), not to the performance of an AI/ML algorithm. Therefore, many of the questions related to AI/ML studies (like MRMC studies, standalone AI performance, ground truth establishment for AI, and expert qualifications for AI ground truth) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Film Properties (e.g., tensile, puncture)	Equivalent to predicate device.
Seal Strength	Equivalent to predicate device.
Film Fracture Rate (pre-sterilization and post-sterilization)	Minimum of a 10-fold reduction in plastic film laminate fracture during peel-open compared to the predicate device.
Biocompatibility/Safety (through U.S. Pharmacopeia Agar Diffusion and Elution Testing)	Plastic film lamination is proven to be safe.

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

The document does not explicitly state a numerical "sample size" for the specific film property, seal strength, or fracture rate tests. It mentions "All analyses were performed at a 95% confidence level," which implies statistical testing, but the raw number of units tested is not provided.

Sample Size: Not explicitly stated numerically.
Data Provenance: The tests were conducted internally by REXAM Medical Packaging. The data is thus prospective in the sense that the tests were performed on the newly developed device. The country of origin for the data is implicitly USA as the manufacturer is based in Illinois, USA.

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

This question is not applicable. The "ground truth" for this physical device is based on objective, quantifiable physical and chemical tests (e.g., measuring tensile strength, seal strength, fracture rates, and biocompatibility through standardized methods like U.S. Pharmacopeia Agar Diffusion and Elution Testing) rather than expert interpretation of medical images or other subjective data. No human experts were required to "establish ground truth" in the way they would for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for resolving discrepancies in human expert interpretation, often in diagnostic studies. The performance of this device was assessed through objective physical and chemical measurements; thus, no subjective adjudication was necessary.

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

This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes a physical medical device (a sterilization pouch) and its performance through material science and functional tests, not an AI system.

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

This question is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human input. This document does not describe an AI algorithm or system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Objective physical measurements: Tensile strength, puncture resistance, seal strength, fracture rates.
Standardized chemical/biological tests: U.S. Pharmacopeia Agar Diffusion and Elution Testing for safety/biocompatibility.
In essence, the ground truth is derived from established scientific and engineering testing standards and protocols for medical device materials and function.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is a physical product, not an AI/ML model that requires training data.

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

This question is not applicable for the same reason as above; there is no training set.

Summary

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REXAM

K973440

510(k) Summary

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

The assigned 510(k) number is:

Applicant Information:

Name:	REXAM Medical Packaging
Address:	1919 S. Butterfield RoadMundelein, IL 60060-9735
Contact Person:	Denis G. DykeV.P., Quality and Regulatory Affairs
Phone Number:	(847) 918-4606
FAX Number:	(847) 362-1848
Date Prepared:	September 9, 1997

Device Information:

Trade Name:	REXAM Fracture Resistant Pouch
Common Name:	Sterilization Pouch with or without ChemicalSterilization Process Indicator
Classification Name:	Sterilization Wrap, Chemical Sterilization Process Indicator

Predicate Device:

Trade Name:	Registered trademark of REXAM Medical Packaging:REXAM INTEGRA® Pack and OptiPeel®
	Registered trademark of Allegiance Healthcare Corp.
	DualPeel®
Manufacturer:	REXAM Medical Packaging

Device Description:

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REXAM

of the pouch are sealed during manufacture. There are two versions of the REXAM Fracture Resistant Pouch: (1) a final heat seal closure of the paper and plastic film laminate components, and (2) a final self-seal closure employing a pressure sensitive self-seal tape assembled on the paper component and sealed to the polyester layer of the plastic film laminate. Both types of final closures are applied by the health care provider.

A chemical sterilization process indicator for steam or ethylene oxide sterilization, or both, may be incorporated to monitor exposure to the sterilant.

Intended Use:

The REXAM Fracture Resistant Pouch is a device intended to be used to enclose another medical device that is to be steam or ethylene oxide 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 its use.

The chemical process indicator on the REXAM Fracture Resistant 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 of the sterilization conditions as measures by these parameters is indicated by a visible change in the device.

Comparison of Technological Characteristics:

Sterilization pouches for gaseous-type sterilization are typically composed of a porous microbial barrier such as paper and a transparent, plastic film laminate. The plastic film laminate is typically composed of a polyester film component adhesively laminated to a polypropylene film component.

The REXAM Fracture Resistant Pouch has the same intended use as the

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REXAM

REXAM MEDICAL PACKAGING 1919 S BUTTERFIELD ROAD MUNDELEIN IL 60060 USA FAX 1 847 362 1848 1 847 362 9000

predicate sterilization pouch but differs technologically through the use of a new polypropylene film component in the plastic film laminate. This improved component reduces fracture resistance upon pouch peel-open. All other components as well as the sterilization pouch and plastic film laminate method of manufacture are identical.

The performance of the REXAM Fracture Resistant Pouch was measured by film properties, seal strength, and film fracture rate pre-sterilization and post-sterilization, 270°F pre-vacuum steam and 100% ethylene oxide. All analyses were performed at a 95% confidence level, and the results illustrate equivalent plastic film laminate tensile and puncture properties, and sterilization pouch seal strengths. The REXAM Fracture Resistant Pouch differs technologically from the predicate sterilization pouch by providing a minimum of a 10 fold reduction in plastic film laminate fracture during peel-open. Through U.S. Pharmacopeia Agar Diffusion and Elution Testing, the plastic film lamination is proven to be safe.

The polypropylene film component change within the plastic film laminate produces an substantially equivalent sterilization pouch with a technological improvement in film fracture resistance upon opening that is safe and effective.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 20 1997

Ms. Andrea Haferkamp Quality and Requlatory Manaqer Rexam Medical Packaging 1919 South Butterfield Road Mundelein, Illinois 60060-9735

Re: K973440 Trade Name: Rexam Fracture Resistant Pouch Requlatory Class: II Product Code: KCT Dated: September 9, 1997 Received: September 10, 1997

Dear Ms. Haferkamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Haferkamp

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing vour device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number (if known): Device Name: REXAM Fracture Resistant Pouch

Indications For Use:

oncurrence of CDRH, Office of Device Evaluation (ODE)

Qian S. Lam

510(k) Num

Prescription Use

Over-The-Counter-Use OR

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).