Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.

Device Description

Aesculap's Reusable Sterile Container Filters allows for thorough penetration and evacuation of sterilants, while maintaining an effective barrier against microbial contamination. The Ulters are circular in shape and can be used for up to 2,200 washing and sterlilization cycles. Aesculages Reusable filters are to be used in conjunction with Aesculan's Sterilcontainer System (K792558).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Reusable Sterilecontainer Filter.

It's important to note that the provided documents are a 510(k) Summary and FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies in the way one might see for novel AI/software devices. Therefore, many of the typical "acceptance criteria" and "study" elements you'd expect for an AI device are not explicitly present or are addressed differently in this context.

Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary for a physical medical device (a filter), not an AI/software device. As such, "acceptance criteria" here refers to the demonstrated performance aspects relevant to the device's function as a sterilization wrap, primarily barrier effectiveness and reusability. There are no performance metrics like sensitivity, specificity, or AUC that would be associated with an AI device.

Acceptance Criteria (Implied)	Reported Device Performance
Barrier against microbial contamination	Effective barrier maintained through 2,200 uses.
Thorough penetration and evacuation of sterilant (steam)	Allows for thorough penetration and evacuation of sterilant.
Durability/Reusability	Maximum of 2,200 uses/washing and sterilization cycles.
Compatibility with Aesculap SterilContainer System	For use with Aesculap SterilContainer in prevacuum steam sterilization.
Sterilization Cycle Compatibility	For use at 273°F for 5 minutes (as per Indications for Use).

Study Details (Based on the provided 510(k) Summary)

Given that this is a 510(k) for a physical filter, the "study" described is a demonstration of performance to support substantial equivalence, rather than a clinical effectiveness study. The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This implies that the 'study' likely involved in-house testing to demonstrate the claims made for the filter's performance (e.g., barrier integrity after multiple cycles).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided 510(k) summary. The claim is for "a maximum of 2,200 uses," which suggests that filters were subjected to at least this many cycles in testing. The number of individual filters tested is not mentioned.
- Data Provenance: Not specified. Typically, such testing would be conducted in a laboratory setting by the manufacturer (Aesculap®, Inc., which is based in Center Valley, PA, USA). It would be considered prospective testing for the purpose of validating the device.
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 in the context of this device. Ground truth for barrier effectiveness and reusability would be established through laboratory methods (e.g., microbial challenges, physical integrity tests) performed by engineers and technicians, not clinical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies primarily to expert review in diagnostic studies.
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 is not an AI/software device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be established through objective laboratory testing. This would include methods to assess:
  - Microbial Barrier Effectiveness: E.g., bacterial challenge tests, aerosol particle penetration tests.
  - Physical Integrity and Durability: E.g., visual inspection, tensile strength tests, burst strength tests, and other physical property measurements after repeated sterilization cycles to ensure the filter remains intact and functional.
  - Sterilant Penetration: Tests to confirm steam can pass through the filter effectively.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.

Summary

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DEC 1 3 2004

Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The string appears to be "K041623". The characters are written in black ink on a white background. The handwriting is somewhat messy and the characters are not perfectly aligned.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

REUSABLE STERILECONTAINER FILTER

14 June 2004

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Matthew M. HullRequlatory Affairs Manager800-258-1946 (phone) x5072610-791-6882 (fax)
TRADE NAME:	Aesculap Reusable Sterilecontainer Filter
COMMON NAME:	Reusable Filter
DEVICE CLASS:	Class II
PRODUCT CODE:	FRG
CLASSIFICATION:	880.6850 - Sterilization Wrap
REVIEW PANEL:	General Hospital and Personal Use Devices

INTENDED USE

DEVICE DESCRIPTION

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

SUBSTANTIAL EQUIVALENCE

Aesculap believes that the Reusable Sterilcontainer Filter (when used in the Aesculap Stericontainer System) is substantially equivalent in its intended use, function, and basic operating principles to the following predicate devices:

Aesulap's Sterilcontainer System (K792558) .
Johnson & Johnson's Sterion container (K850289) .
Medline's Steriset container (K010825) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "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.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2004

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

Re: K041623

Trade/Device Name: Reusable Sterilcontainer Filter Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 12, 2004 Received: November 15, 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 I tease to act rised that that your device complies with other requirements mount that I Drima may Federal statutes and regulations administered by other Federal agencies. or the Act of any I oderal bike Act's requirements, including, but not limited to: registration r ou interesting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) Frins fotor will and in JOThe Sognifial equivalence of your device of your device to a premaired news are 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), rl you donto 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,

Qur
Shia-Lien, Ph.D.

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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Reusable Sterilcontainer Filter

510(k) Premarkel Notification

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reusable Sterilcontainer Filter

Indications for Use:

Indications for Use:
Aesculap's Reusable Steriloontainer Filter (JK090) is a PTFE (Polytetrafilurrethylene) filter Aesculap's Reusable Sterilon and evecuation of the steriliant (steriland (steam.
that allows for thorough penetration and evecuation of the sterilent (steam Assedaps steasure over against microbial contamination for a maximum of 2,200
that allows for thorough peneration for maximum of 2,200
maintaining an effective barins that alows for thereegy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - uses. This filter is for uses at 273° F.
sterilization cycle for 5 minutes at 273° F.

× Over-the-Counter Use or Prescription Use_

(per 21 CFR 801.109)

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

Senette Michie ms.

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

510(k) Number:

(Optional Formal 3-10-98)

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).