AESCULAP STERILCONTAINER SYSTEM

K053389 · Aesculap, Inc. · FRG · Feb 15, 2006 · General Hospital

Device Facts

• Record ID: K053389
• Device Name: AESCULAP STERILCONTAINER SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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 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.

Device Story

Reusable sterilization container system; anodized aluminum construction; includes solid bottom, perforated lid with filter retention plates, and single-use paper filters. Used to enclose medical instruments (stainless steel lumens, hinged, knurled) during pre-vacuum steam flash sterilization. Operated by healthcare providers in clinical settings. Protects instruments during sterilization process and maintains sterility post-processing. Compatible with wire mesh baskets, trays, and racks. Output is a sterilized, protected instrument set ready for clinical use.

Clinical Evidence

Bench testing only. Validation conducted in accordance with FDA guidance and AAMI standards to confirm efficacy of the container system for pre-vacuum steam flash sterilization. Comparative testing performed against predicate devices to demonstrate similar performance characteristics.

Technological Characteristics

Anodized aluminum container system; includes solid bottom, perforated lid with filter retention plates, and disposable paper filters. Compatible with wire mesh baskets, trays, and racks. Features gasketed, latching lids with tamper-evident seals. Designed for pre-vacuum steam flash sterilization.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices, including stainless steel lumens (>3mm ID, <400mm length), hinged, and knurled instruments, for sterilization via pre-vacuum steam flash sterilization and maintenance of sterility until use.

Regulatory Classification

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.

Predicate Devices

• Case Medical Steritite Container with Flashtite Valve (K022978)
• Riley Medical Flashpak Container System (K871202)
• Aesculap Sterilcontainer System (K792558)

Submission Summary (Full Text)

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K053389

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.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>610-984-9072 (phone)<br>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 [phone]. 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 [phone] or [phone] 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

K053389