The Aesculap Sterilcontainer S 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 V-PRO 1 and V-PRO Plus Systems.

The Sterilcontainer S is recommended for surface and lumens:

≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and < 250 mm in length ≥ 3mm internal diameter and ≤ 400 mm in length

Lumen Cycle - The maximum number of lumens per load is 20 lumens.

Device Description

The Aesculap Sterilcontainer S 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 V-PRO 1 and V-PRO 1 Plus sterilization systems. The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.

AI/ML Overview

The provided text describes the Aesculap Sterilcontainer S, a reusable sterilization container system. However, it does not contain the detailed acceptance criteria or the specific study data that comprehensively demonstrates the device meets acceptance criteria in the format requested.

The document is a 510(k) summary and FDA communication, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report.

Here's a breakdown of what can be extracted and what information is missing based on your request:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document, a 510(k) summary and FDA clearance letter, confirms that the Aesculap Sterilcontainer S was validated for use with V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards, implying that the device met the performance requirements outlined in those standards for sterilization containers. However, the exact acceptance criteria and detailed performance results are not explicitly stated in this document.

For example, a sterilization container system would typically need to demonstrate:

Sterilization Efficacy: The container must allow for effective sterilization of enclosed devices (e.g., achieving a sterility assurance level (SAL) of $10^{-6}$ for specified cycles).
Maintenance of Sterility: The container must maintain the sterility of the enclosed devices for a specified period (e.g., 6 months, 1 year).
Material Compatibility: The container materials must be compatible with the sterilization process (e.g., V-PRO hydrogen peroxide plasma) without degradation or leaching.
Physical Integrity: The container must maintain its physical integrity after repeated sterilization cycles.
Filter Performance: The single-use polypropylene filter must effectively facilitate gas exchange while maintaining the sterile barrier.

The document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap Sterilcontainer S was completed. The Aesculap Sterilcontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory."

This indicates a study was performed, but the specifics are not provided. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Missing Information:

The provided text does not contain the following information required for your detailed request:

A table of acceptance criteria and the reported device performance: The document only generally states that "All required testing...was completed" and the device was "fully validated," implying it met relevant criteria, but no specific values or thresholds are given.
Sample size used for the test set and the data provenance: There is no mention of the number of containers or cycles tested, nor the country of origin of the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of study (related to physical sterilization efficacy) typically does not rely on human experts for ground truth in the same way an AI diagnostic device would. Ground truth would be established through biological indicator testing, chemical indicator evaluation, and sterility testing performed by qualified microbiology labs. The number and qualifications of such laboratory personnel are not mentioned.
Adjudication method for the test set: Not applicable for this type of device performance testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device, not an AI diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: While the text doesn't specify, for sterilization validation, ground truth would typically come from:
- Biological Indicator (BI) testing: Using highly resistant spores to confirm killing.
- Chemical Indicator (CI) changes: To visually confirm that sterilant conditions were met.
- Sterility Testing: Incubation of processed items to ensure no microbial growth.
- Physical Parameter Monitoring: Recording and verification of cycle parameters (temperature, pressure, time, sterilant concentration).
  The document only states "fully validated," which implies these methods were used but does not detail them.
The sample size for the training set: Not applicable, as this is a physical medical device, not an AI system that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided text confirms that performance testing and validation were conducted for the Aesculap Sterilcontainer S to demonstrate its compatibility and efficacy with V-PRO 1 and V-PRO 1 Plus sterilization systems, in accordance with FDA guidance and AAMI standards. However, it does not offer the granular detail concerning specific acceptance criteria, study sizes, methodologies, or ground truth establishment that your request specifies for an AI/diagnostic device.

Summary

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Aesculap Sterilcontainer S for PRO 1 & V-PRO Plus Systems

2093649/5001

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B. 510(k) SUMMARY (as required by 21 CFR 807.92)

	Aesculap Sterilcontainer S forV-PRO 1 and V-PRO 1 PlusNovember 24, 2009		MAY 11 2010
COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)
TRADE NAME:	Aesculap Sterilcontainer S
COMMON NAME:	Sterilization Container Wrap
CLASSIFICATION NAME:	Wrap, Sterilization
REGULATION NUMBER:	880.6850
PRODUCT CODE:	FRG

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to:

. Aesculap STERRAD 100S Compatiable Sterilcontainer (K040865).

DEVICE DESCRIPTION

INDICATIONS FOR USE

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 V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer S System includes accessories such as silicon mats, baskets, trays, and racks.

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TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}

The Aesculap Sterilcontainer S is compatible for use in V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer is offered in similar shapes and sizes as the predicate devices. The material used for the V-PRO 1 and V-PRO 1 Plus Compatible Aesculap Sterilcontainer S is the same as that used to manufacture the predicate devices.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap Sterilcontainer S was completed. The Aesculap Steriicontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2010

Ms. Kathy Racosky Regulatory Affairs Specialist Aesculap, ® Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K093649

Trade/Device Name: Aesculap Sterilcontantainer S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 22, 2010 Received: April 23, 2010

Dear Ms. Kathy Racosky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kathy Racosky

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Ruaren

for

Anthony D. Watson, B.S., M.S., M.B.A 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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K0936049/s001

A. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Aesculap Sterilcontainer S

Indication for Use:

The Sterilcontainer S is recommended for surface and lumens:

≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and < 250 mm in length ≥ 3mm internal diameter and ≤ 400 mm in length

Lumen Cycle - The maximum number of lumens per load is 20 lumens.

The attached table identifies which Sterilcontainer S may be sterilized in the V-PRO 1 and V-PRO Plus Systems.

Prescription Use

and/or Over-the-Counter Use ×

(per 21 CFR 801 Subpart D)

(per 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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: kD93649

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Item #	Description	Total loadedcontainerweight (lbs)
JM440	Full Size Perforated Bottom 90mm (4 $1/4$ ")	19.65
JM441	Full Size Perforated Bottom 120mm (5 $1/2$ ")	19.65
JM442	Full Size Perforated Bottom 135mm (6")	19.65
JM444	Full Size Perforated Bottom 187mm (8")	19.65
JM740	$3/4$ Size Perforated Bottom 90mm (4 $1/4$ ")	19.65
JM741	$3/4$ Size Perforated Bottom 120mm (5 $1/2$ ")	19.65
JM742	$3/4$ Size Perforated Bottom 135mm (6")	19.65
JM340	$1/2$ Size Perforated Bottom 90mm (4 $1/4$ ")	19.65
JM341	$1/2$ Size Perforated Bottom 120mm (5 $1/2$ ")	19.65
JM342	$1/2$ Size Perforated Bottom 135mm (6")	19.65
JM344	$1/2$ Size Perforated Bottom 187mm (8")	19.65
JM092	$1/4$ Size Perforated Bottom with Lid (2")	19.65
JM094	$1/4$ Size Perforated Bottom with Lid (2 $1/2$ ")	19.65
JM187	Mini Bottom 30mm (1 $1/2$ ")	7.70
JM188	Mini Bottom 57mm (3")	7.70
JM021	Extra Long Mini Bottom 73mm (3")	7.70
JM489	Full Size Lid
JM789	$3/4$ Size Lid
JM389	$1/2$ Size Lid
See JM092 & JM094	$1/4$ Size Lid
JM174	Mini lid
JM020	Extra Long Mini Lid

Sterilecontainer S Compatible with V-PRO 1 and V-PRO Plus

Compatible Accessories

	Compatible Accessories
	V-PRO & V-PRO Plus
Baskets	X
Trays	X
Insert boxes	X
Metal Brackets	X
Metal Partitions	X
Posts	X
Silicone Brackets	X
Racks	X
Stringers	X

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).