The SteriSet Sterilizatoin Conatiner is intended to be used to ecnlose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".

Device Description

The containers are used for holding operating room instruments and/or textiles during vacuum-steam sterilization procedures and for maintaining sterility during storage and transport under proper hospital conditions.

AI/ML Overview

This document is a 510(k) Summary for the Wagner SteriSet Sterilization System. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data for a new device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies is largely not applicable to this type of regulatory submission in the provided text.

The document states: "The containers are identical to the Medline (K010825) and AMSCO (K823902) in design, materials, and intended use. All containers (Medline and AMSCO included) are manufactured by Wagner GmBH." This is the core argument for substantial equivalence, implying that since the predicate devices have established efficacy and safety, the identical Wagner device also meets those unstated criteria.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is absent:

A table of acceptance criteria and the reported device performance:
- Not applicable/Not provided directly. The document does not specify quantitative acceptance criteria (e.g., specific sterilization efficacy rates or sterility maintenance periods with numerical targets) or report performance against such criteria. The entire submission hinges on demonstrating "substantial equivalence" to predicate devices, meaning it is assumed to meet the same, unstated performance requirements as those predicates.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. There is no mention of a specific "test set" or experimental data from a study with a sample size for the Wagner SteriSet containers themselves. The reliance is on the substantial equivalence to predicate devices, which presumably underwent their own validation studies at the time of their clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. As no specific 'test set' or ground truth establishment study for the Wagner SteriSet is described, there's no mention of experts for this purpose.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. See point 3.
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 device is a sterilization container, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. For substantial equivalence, the "ground truth" is essentially that the predicate devices were deemed safe and effective based on their original reviews and market history.
The sample size for the training set:
- Not applicable/Not provided. There is no machine learning model or "training set" for this device.
How the ground truth for the training set was established:
- Not applicable/Not provided. See point 8.

In summary, the provided text from the 510(k) Summary explicitly focuses on demonstrating substantial equivalence based on design, materials, and intended use being identical to legally marketed predicate devices, not on presenting novel performance study data for the Wagner SteriSet. Therefore, the detailed study-related information requested is largely absent because it's not the purpose of this specific type of regulatory document.

Summary

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Image /page/0/Picture/0 description: The image shows the text "JUN 3 - 2005" at the top. Below that is the word "WAGNER" in large, stylized letters, followed by a black diamond shape with a white symbol inside. To the right of the diamond is the text "K041096". Finally, the text "510(k) Summary" is centered below the word "WAGNER".

Regulatory Information:

Device Name:
Proprietary Name:
Common:
Panel
Class:
ProCode:

Wrap, Sterilization Wagner SteriSet™ Sterilization System Sterilization Container 80 (General Hospital) II FRG

Company Information:

Wagner GmBH Schulstr. 16a D-80634 Munich, Germany Phone +49 (0) 89 163231 Fax +49 (0) 89 133099 Contact Name: Peter Wagner Contact Title: Managing Director Registration # 1000202929

Submission Correspondent:

Ms. Lara Simmons Simcon International 22411 60" Street Bristol, WI 53104 Phone: 847-682-0224 Fax: 262-843-4063 Email: Simcon1@att.net

Device Description

Design Features, which are identical to the above listed products, are as follows:

1. A 'hidden' lid that is a composite lid design that protects air/steam-permeable inner lid from direct physicals and biological challenges. The two lid components are separated by an air gap which allows air and steam to travel under the outer lid to the permeable portions of the inner lid where it enters (or exits) the container.

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WAGNER

1. A valve plate that allows air/steam permeability
1. A gasket that is made of low durometer soft silicone rubber that is in the inner lid that provides a secure barrier seal between container lid and bottom. The groshet is secured when the outer lid is attached to the container bottom.
1. Two handles, one at either end of the container, have a silicone rubber covering for thermal insulation and ease of handling.
1. An aluminum standoff rim is riveted to the container bottom to protect from damage and facilitates stacking.
1. A thermostatic condensate drain consisting of a neoprene seal with a bimetallic strip for opening and a counterspring for closing. The drain allows the release of condensate from the interior of the container during sterilization, and is closed during storage and handling of the containers.

Technical Data:

1. Container Assembly: When sealed the container assembly allows penetration fo air and steam into and out of the container for sterilization of its contents. The container has three major metal components:
- Bottom -- of deep drain aluminum, forms five sides of the container and a. seals to the inner lid by means of a gasket.
- b. Inner lid with container bottom, provides the sealed container with a means for air/seam permeability. Steam enters through the annulus formed between the outer and inner lids by the sprung pressure plate. The pressure plate retains the filter (if required) and seals in the inner lid to the container bottom.
- Outer lid protecs the inner lid from damage and/or contamination. C. Provides a mechanism to tlatch the inner lid to the container bottom.

4. Materials:

a. Aluminum (99+% pure) with an anodized coating for corrosion-resistance, is the primary material of construction. Hardware is of AIS 17-7 CrNI Stainless steel or nickel plated brass. Lid sealing gasket and handle insulation is of silicone rubber.

Substantial Equivalence:

The containers are identical to the Medline (K010825) and AMSCO (K823902) in design, materials, and intended use. All containers (Medline and AMSCO included) are manufactured by Wagner GmBH..

Biocompatibility:

Biocompatibility data is not required for this product, as it has been legally marketed since 1982 and has a well-established history of use.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Wagner GmbH C/O Ms. Lara N. Simmons Simcon International 22411 60" Street Bristol, Wisconsin 53104

Re: K041096

Trade/Device Name: Wagner Steriset Sterilization Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 20, 2005 Received: May 23, 2005

Dear Ms. Simmons:

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 - Ms. Simmons

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 your 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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): K041096

Device Name: Wagner Steriest Containers

Indications For Use: The SteriSet Sterilizatoin Conatiner is intended to be used to ecnlose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clup

(Division Sign-Off) and Control Olgh-Olf)
Division of Anesthesiology, General Hospital Anfection of Anesthesiology, Georgia

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510(k) Number K041096

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).