The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid and perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene filters) 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 in pre-vacuum steam and flash sterilization. The SterilContainer System includes accessories such as silicon mats, baskets, trays, and racks.

Device Description

The Aesculap SterilContainer with PrimeLine Lid is used in conjunction with Aesculap's Sterilcontainer System (K792558 & K944864). The PrimeLine Container Lid is designed to be compatible for use with pre-vacuum steam and pre-vacuum flash sterilization. The lid is manufactured from Radel R 5000/5008 and utilizes a reusable polytetrafluoroethylene (PTFE) filter.

AI/ML Overview

The provided document is a 510(k) summary for the Aesculap SterilContainer with PrimeLine Lids. It's a premarket notification for a medical device and describes its substantial equivalence to existing predicate devices. The document highlights the device's technological characteristics and performance data related to sterilization, but it does not contain the specific information required to answer all sections of your prompt.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of sterilization validation. However, it does not explicitly state "acceptance criteria" with numerical targets and then report performance against those targets in a formal table. Instead, it states that the device was "fully validated" against FDA guidance and AAMI standards for steam and flash sterilization.

Acceptance Criteria (Inferred from indication for use and validation statement)	Reported Device Performance (Summary)
Compatibility with pre-vacuum steam sterilization	"fully validated for the steam... sterilization in a prevacuum steam... cycle"
Compatibility with pre-vacuum flash sterilization	"fully validated for the... flash sterilization in a... prevacuum... flash cycle"
Maintenance of sterility of enclosed device	"intended to... maintain sterility of the enclosed device until used." (Implied by validation)
Sterilization of enclosed device	"intended to allow sterilization of the enclosed device" (Implied by validation)
Specific cycle parameters for Flash (Non-porous, 270°F, 3 min)	Validated for these parameters with specific lid/base sizes and lumen configurations (see Indications for Use table)
Specific cycle parameters for Flash (Mixed, 270°F, 4 min)	Validated for these parameters with specific lid/base sizes and lumen configurations (see Indications for Use table)
Specific cycle parameters for Prevacuum (270°F, 4 min exposure, 15 min dry)	Validated for these parameters with specific lid/base sizes and lumen configurations (see Indications for Use table)
Maximum load for all container configurations	"A combined maximum load validated for all container configurations is 35lbs."
Number of lumens and their configuration (for various cycle types/sizes)	Validated for 2 SS lumens, ≥3mm I.D. x ≤200mm L or ≤400mm L (see Indications for Use table)

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

The document states, "The Aesculap Sterilcontainer system was fully validated for the steam and flash sterilization in a prevacuum steam and flash cycle." It also indicates that this validation was conducted "by a qualified testing laboratory." However, specific sample sizes (e.g., number of cycles, number of containers tested) for the validation study are not provided. The provenance of the data is that it was generated during product validation (likely in the US based on the FDA submission) by a qualified testing laboratory, and it would be prospective data collected specifically for the purpose of demonstrating device performance.

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

This information is not available in the provided document. Sterilization validation typically involves scientific and engineering principles, often with industry standards (like AAMI) serving as the "ground truth" for successful sterilization. There is no mention of human experts establishing ground truth in the context of this device's performance data.

4. Adjudication method for the test set:

This information is not available in the provided document. Adjudication methods are typically relevant for studies involving human assessment or interpretation (e.g., medical imaging classification). For device performance validation related to sterilization, "adjudication" in the sense of expert consensus on an output is not typically a component. The success/failure of sterilization (e.g., through biological indicator testing) is typically objective.

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 is not applicable to this device. The Aesculap SterilContainer with PrimeLine Lids is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not have been performed.

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

This is not applicable to this device. This is a physical medical device. It does not involve an algorithm or AI that would have standalone performance.

7. The type of ground truth used:

The ground truth used for this type of device validation would be based on established scientific principles of sterilization effectiveness and compliance with recognized standards (e.g., FDA guidance, AAMI standards for sterilization). This would involve demonstrating the killing of microbial spores (e.g., using biological indicators) and maintaining sterility over time. It's not "expert consensus" in the sense of diagnostic interpretation, nor is it pathology or outcomes data in the clinical sense.

8. The sample size for the training set:

This is not applicable. This is a physical device, not an AI model requiring a training set.

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

This is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process.

Summary

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Ko 73168

Page 1 of 2

APR 2 8 2008

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

Aesculap SterilContainer with PrimeLine Lids November 8, 2007

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 with PrimeLine Lids
COMMON NAME:	Sterilization Container
CLASSIFICATION NAME:	Sterilization Wrap Containers, Trays, Cassettes &Other Accessories
REGULATION NUMBER:	880.6850
PRODUCT CODE:	KCT

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the SterilContainer with PrimeLine Lids is substantially equivalent to:

Aesculap Sterilcontainer System (Flash Indication) (K053389)

Reusable SterilContainer Filter (K041623)

Rigid Container System (K944864)

Aesculap Sterilcontainer System (K792558)

DEVICE DESCRIPTION

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INDICATIONS FOR USE

TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s))

The Aesculap PrimeLine Container Lid is made from Radel R5000/5008 and is similar to Aesculap's Tufflite lid which is manufactured from Jadex. Both are a polyphenylsulfone resin. The PrimeLine Container Lid is compatible for use with pre-vacuum steam and pre-vacuum flash sterilization. Aesculap's Sterilization Container System was cleared for use in pre-vacuum steam and pre-vacuum flash. The PrimeLine Container Lid utilizes an integrated reusable PTFE filter. The reusable PTFE filter is the same as Aesculap's Reusable Sterilcontainer Filter. The PrimeLine Container Lid is offered in a similar range of sizes as the predicates.

PERFORMANCE DATA

The Aesculap Sterilcontainer system was fully validated for the steam and flash sterilization in a prevacuum steam and flash cycle. 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2008

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

Re: K073168

Trade/Device Name: Aesculap Sterilcontainer with PrimeLine Lids Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 9, 2008 Received: April 10, 2008

Dear Ms. 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.

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Suitte K. Michael Dnas.

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 A.

510(k) Number:

Device Name: Aesculap Sterilcontainer with PrimeLine Lids

Indications for Use:

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A combined maximum load validated for all container configurations is 35lbs.
Sterilization Cycle Parameters	Lid Size	Solid Base to be used with Lid	Max No. of Lumens Lumen Configuration
No stacking recommended for flash cyclesFlash (Non porous)270°F Temp, 3 min. Exposure	½ size Lid(11 in x 11 in)Art. No. JP021 – JP027	JK340 (2 in height)JK341 (4 in height)JK342 (5 in height)JK343 (6 in height)JK344 (8 in height)JK346 (9 in height)	2 SS lumens≥ 3mm I.D. x ≤200mm L
Flash (mixed)270°F Temp, 4 min. Exposure	¾ size Lid(18 in x 11 in)Art. No. JP011 – JP017	JK740 (4 in height)JK741 (5 in height)JK742 (6 in height)	2 SS lumens≥3 mm I.D. x ≤ 400mm L
PrevacuumStacking should not exceed 16-18" height270°FTemp, 4min.Exposure, 15 min. Dry	Full size Lid(22 in x 11 in)Art. No. JP001 – JP007	JK440 (4 in height)JK441 (5 in height)JK442 (6 in height)JK444 (8 in height)JK446 (10 in height)	2 SS lumens≥3 mm I.D. x ≤ 400mm L
Sterilization Cycle	Lid Size	Perforated Base to be used with Lid
Stacking should not exceed 16-18" heightPrevacuum270°FTemp, 4 min. Exposure, 15 min. Dry	½ size Lid(11 in x 11 in)Art. No. JP021 – JP027	JN340 (2 In height)JN341 (4 in height)JN342 (5 in height)JN343 (6 in height)JN344 (8 in height)JN346 (9 in height)	2 SS lumens≥3 mm I.D. x ≤200mm L
	¾ size Lid(18 In x 11 in)Art. No. JP011 –JP017	JN740 (4 in height)JN741 (5 in height)JN742 (6 in height)	2 SS lumens≥ 3mm I,D. x ≤ 400mm L
	Full size Lid(22 in x 11 in)Art: No. JP001–JP007	JN440 (4 in height)JN441 (5 in height)JN442 (6 in height)JN444 (8 in height)JN446 (10 in height)	2 SS lumens≥3 mm I.D. x ≤ 400mm L

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).