The Aesculap Sterilcontainer is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the Sterrad 1005.

Device Description

The Sterrad Compatible Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the Sterrad sterilization processes (100S). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.

AI/ML Overview

This document is a 510(k) summary for the AESCULAP STERILCONTAINER FOR STERRAD, a reusable sterilization container system. It aims to demonstrate substantial equivalence to previously marketed devices. The performance data section states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Sterrad Compatible Aesculap Sterilcontainer was completed." It also claims that "Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market."

However, the provided text does not include specific acceptance criteria or detailed study results that would allow for a complete description fitting the requested format. It only states that testing was completed and found to be substantially equivalent. There is no information on sample sizes for test or training sets, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance.

Therefore, based on the provided text, a comprehensive answer to your request cannot be fully generated.

Based only on the provided text, here is what can be extracted, acknowledging the significant gaps in information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	Sterilization testing results demonstrate substantial equivalence to other Sterilization Containers currently on the market.
Not specified in the document	The device is compatible for use with the Sterrad 100S sterilization process.

Missing Information: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Sterrad Compatible Aesculap Sterilcontainer was completed." However, it does not detail what these "required tests" or their specific acceptance criteria were.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document generally describes a submission to the FDA for a device manufactured by Aesculap, Inc. in Center Valley, PA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

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:

No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was mentioned. This device is a sterilization container, not an AI-powered diagnostic tool, so an MRMC study and human reader improvement are not applicable in this context.

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

Not applicable. This device is a physical medical device (sterilization container), not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant.

7. The type of ground truth used:

The document implies that "Sterilization testing results" served as the basis for performance evaluation. For a sterilization container, ground truth would likely be established through direct microbiological testing to confirm sterility and maintenance of sterility, and physical compatibility tests with the specified sterilizer (Sterrad 100S). However, the specific methodology and outcomes are not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable/Not specified. (See point 8)

Summary

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DEC - 6 2004

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C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)

AESCULAP STERILCONTAINER FOR STERRAD

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Matthew M. Hull, RAC800-258-1946 x 5072 (phone)610-791-6882 (fax)
TRADE NAME:	Sterrad Compatible Aesculap Sterilcontainer
COMMON NAME:	Sterilization Container Wrap
DEVICE CLASS:	Class II
PRODUCT CODE:	80 FRG
CLASSIFICATION:	880.6850 - Wrap, Sterilization
REVIEW PANEL:	General Hospital

INDICATIONS FOR USE

DEVICE DESCRIPTION

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Sterrad Compatible Aesculap Sterilcontainer was completed. Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market.

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SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Sterrad Compatible Aesculap Sterilcontainer is Aesoulap ', inc. believes that the Stericontainers. Additionally we feel it Substantially oquivalent to the sterilization containers marketed by Allegiance Healthcare (Genesis) and Case Medical (SteriTite).

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K040865

Trade/Device Name: Aesculap Sterrad 100S Compatible Sterilcontainer Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 11, 2004 Received: November 12, 2004

Dear Mr. Hull:

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 - Mr. Hull

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. or the rever mply 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 and ibuing (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirents as 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), rr you 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/dsma/dsmamain.html

Sincerely yours,

Sina Qumpe

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 STATEMENT B.

510(k) Number: K040865/S2

Device Name: Aesculap Sterrad Compatible Sterilcontainer

Indication for Use:

The Aesculap Sterilcontainer is a reusable sterilization container system intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the Sterrad 100S.

SterilContainer Sterrad 100S Compatible Containers
Description	Size (L"xW"xH")	Item #
Full Size Perforated Bottom	23 x 11 x 4	JM440
Full Size Perforated Bottom	23 x 11 x $5 \frac{1}{3}$	JM441
Full Size Perforated Bottom	23 x 11 x 6	JM442
Full Size Perforated Bottom	23 x 11 x 8	JM444
¾ Size Perforated Bottom	$18 \frac{1}{4}$ x 11 x 4	JM740
¾ Size Perforated Bottom	$18 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$	JM741
¾ Size Perforated Bottom	$18 \frac{1}{4}$ x 11 x 6	JM742
½ Size Perforated Bottom	$11 \frac{1}{4}$ x 11 x 4	JM340
½ Size Perforated Bottom	$11 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$	JM341
½ Size Perforated Bottom	$11 \frac{1}{4}$ x 11 x 6	JM342
½ Size Perforated Bottom	$11 \frac{1}{4}$ x 11 x 8	JM344
¼ Size Perforated Bottom with Lid	12 x 7 x $2 \frac{1}{2}$	JM094
¼ Size Perforated Bottom with Lid	12 x 7 x 5	JM096
Full Size Lid		JM489
¾ Size Lid		JM789
½ Size Lid		JM389
¼ Size Lid		See JM094 & JM096

Prescription Use or Over-the-Counter Use

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Smith M. Chan acting chief inc BR 12-03-04
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Den

510(k) Number: K040865

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).