(72 days)
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper 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 has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks.
The Flash 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 "Flash" prevacuum steam sterilization. The container is made from anodized aluminum and utilizes a disposable (single use) paper filter. The container system consists of a solid bottom, a perforated lid w/ filter retention plate, and disposable paper filter. Accessories such as trays, baskets, and racks can be used with it.
This 510(k) summary provides information on the Aesculap Sterilcontainer System (Flash Indication). The device is a reusable sterilization container system intended for use with "Flash" prevacuum steam sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statement that the validation was conducted in accordance with "FDA quidance and available AAMI standards" and that the testing demonstrated "similar performance characteristics and prove efficacy of the Aesculap container" compared to a predicate device. Specific numerical acceptance criteria are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In accordance with FDA guidance and AAMI standards for flash sterilization. | "fully validated for the additional indication of flash sterilization in a prevacuum steam cycle." |
| Efficacy of the Aesculap container for flash sterilization. | "comparative testing was done on a predicate device to demonstrate similar performance characteristics and prove efficacy of the Aesculap container." |
| Maintain sterility of enclosed device until used. | Device is "intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used." |
| Compatibility with specific instrument types (stainless steel lumens, hinged, knurled). | "validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length)." |
| Compatibility with prevacuum (steam) flash sterilization. | "compatible for use in pre-vacuum (steam) flash sterilization." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the performance studies. It mentions that "The Aesculap Sterilcontainer system was fully validated... Additionally comparative testing was done on a predicate device." The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The validation was conducted "by a qualified testing laboratory," but details about expert involvement or qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. The study focused on the performance of the device itself rather than human reader performance with or without AI assistance, as this is a physical medical device (sterilization container), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense, the performance study conducted for the sterilization container can be considered a standalone assessment of the device's ability to sterilize and maintain sterility. The device itself (the container) is the primary subject of the performance evaluation. There's no AI algorithm involved, so "standalone" here refers to the device's intrinsic mechanical/sterilization performance.
7. The Type of Ground Truth Used
The ground truth for this type of device would typically be established through microbiological testing (e.g., sterility testing using biological indicators or culture methods) to confirm the complete inactivation of microorganisms, and physical/chemical integrity testing to ensure the container maintains sterility under various conditions. While not explicitly detailed, the statement "fully validated... in accordance with FDA quidance and available AAMI standards" implies the use of such established scientific methods for ground truth.
8. The Sample Size for the Training Set
This information is not applicable. Sterilization containers are not "trained" in the way AI models are. Their performance is inherent in their design and manufacturing, and validated through physical and microbiological testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
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FEB 1 5 2006
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
Aesculap Sterilcontainer System (Flash Indication)
20 January 2006
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Matthew M. Hull610-984-9072 (phone)610-791-6882 (fax) |
| TRADE NAME: | Aesculap Sterilcontainer System |
| COMMON NAME: | Sterilization Container |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | FRG |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Sterilcontainer System for Flash Sterilization is substantially equivalent to:
Case Medical Steritite Container with Flashtite Valve (K022978)
Riley Medical Flashpak Container System (K871202)
Aesculap Sterilcontainer System (K792558)
DEVICE DESCRIPTION
The Flash 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 "Flash" prevacuum steam sterilization. The container is made from anodized aluminum and utilizes a disposable (single use) paper filter. The container system consists of a solid bottom, a perforated lid w/ filter retention plate, and disposable paper filter. Accessories such as trays, baskets, and racks can be used with it.
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INDICATIONS FOR USE
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper filters) intended to be used to enclose another medical device that is to be sterlized 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 has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks.
TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}
This is exactly the same Aesculap sterilization container system that was cleared for use in prevacuum and gravity steam in 510(k) # K792558. The Aesculap container and the Case Medical container are both made from anodized aluminum while the Flashpak is made from plastic. All of these container systems are compatible with wire mesh baskets and other instrument organizer inserts. All three container systems are offered in a similar range of sizes. All three devices have gasketed lids that latch and offer tamper-evident features.
PERFORMANCE DATA
The Aesculap Sterilcontainer system was fully validated for the additional indication of flash sterilization in a prevacuum steam cycle. This validation was conducted in accordance with FDA quidance and available AAMI standards by a qualified testing laboratory. Additionally comparative testing was done on a predicate device to demonstrate similar performance characteristics and prove efficacy of the Aesculap container.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle faces to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K053389
Trade/Device Name: Aesculap Sterilcontainer System for Flash Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 3, 2006 Received: February 6, 2006
Dear Mr. Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your and have determined the device is substantially equivalent (for the referenced above and nel in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to tray 20, 20, 20, 2017 reclassified in accordance with the provisions of Amendments, or to act roomstic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, therefore, market the device, subject to the general approvial application (the Act. The general controls provisions of the Act include controls provided be a 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 N' (PMA), it may be subject to such additional controls. Existing major regulations afficuing (1 Mr), it hay of backed of Federal Regulations, Title 21, Parts 800 to 398. In your device ear of router announcements concerning your device in the lycgral Register.
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Page 2 -- Mr. Matthew M. Hull
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that I Dr. o letermination that your device complies with other requirements Incall that I DAT has made a actess and regulations administered by other Federal agencies. of the Act of ally I oderal banks and sigments, including, but not limited to: registration 1 od inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rate 007), labality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by some (Sections (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) I mis letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. - The PDF 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 8/1), rr 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 maj South 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,
Susan Runne
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: _______________________________________________________________________________________________________________________________________________________________ K053389
Device Name: Aesculap Sterilcontainer System for Flash
Indications for Use:
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting The Aesculap Otchloontainon is a reading to a reading plates, and disposable paper of a solid bottom, a penofatod ille in merical device that is to be sterilized miters) intended to be used to enclose the allow sterilization of the enclosed device by a nealthcare provider. It is intonuba to alevice until used. This container has been and also maintain Stomley of the one of the one instruments (stainless validated with Stamood Stock farnone, mings of than 400 mm in length). steen lumens or groater than o min in for use in pre-vacuum (steam) flash sterilization. This Container System is compatible for as a min as baskets, trays, and racks.
The following containers (lids & bottoms) were validated for pre-vacuum Flash sterilization:
Full Size: Lid JK489/ Bottoms JK440, JK441, JK442, and JK444 Three-Quarter Size: Lid JK789/ Bottoms JK740, JK741, and JK742 Frirec-Qualter Olzo. Eld 6(1)769, JK340, JK341, JK341, JK342, and JK344 Mini Containers: Lid JK174/ Bottoms JK187 and JK188
| Prescription Use | |
|---|---|
| and/or Over-the-Counter Use | X |
(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)
Shula V. Maughn 2/15/05
TV General Hospital,
Medical Social Services
§ 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).