AESCULAP PRIMELINE CONTAINER LTD.

K073168 · Aesculap, Inc. · KCT · Apr 28, 2008 · General Hospital

Device Facts

• Record ID: K073168
• Device Name: AESCULAP PRIMELINE CONTAINER LTD.
• Applicant: Aesculap, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Apr 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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 Story

Reusable sterilization container system; encloses medical devices for sterilization; compatible with pre-vacuum steam and flash sterilization cycles. System components: solid/perforated bottoms, perforated lid with filter retention plates, reusable PTFE filters, and accessories (mats, baskets, trays, racks). Lid manufactured from Radel R 5000/5008 (polyphenylsulfone resin). Used in clinical settings by healthcare providers to maintain device sterility post-sterilization. Provides physical protection and barrier for instruments during processing.

Clinical Evidence

Bench testing only. System validated for steam and flash sterilization in pre-vacuum cycles per FDA guidance and AAMI standards by a qualified testing laboratory. No clinical data presented.

Technological Characteristics

Materials: Radel R5000/5008 (polyphenylsulfone) lid, reusable PTFE filter. Form factor: Rigid container system with solid/perforated bases and perforated lids. Compatibility: Pre-vacuum steam and flash sterilization. Accessories: Silicon mats, baskets, trays, racks. No software or electronic components.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during pre-vacuum steam and flash sterilization processes and to maintain sterility of the enclosed devices until use. Compatible with specific container configurations with a maximum load of 35 lbs and defined lumen specifications.

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

• Aesculap Sterilcontainer System (Flash Indication) (K053389)
• Reusable SterilContainer Filter (K041623)
• Rigid Container System (K944864)
• Aesculap Sterilcontainer System (K792558)

Submission Summary (Full Text)

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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.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap SterilContainer with PrimeLine Lids |
| COMMON NAME: | Sterilization Container |
| CLASSIFICATION NAME: | Sterilization Wrap Containers, Trays, Cassettes &<br>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

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.

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### INDICATIONS FOR USE

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.

# 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 [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 Division of 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,

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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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.

| 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 cycles<br>Flash (Non porous)<br>270°F Temp, 3 min. Exposure | ½ size Lid<br>(11 in x 11 in)<br>Art. No. JP021 – JP027 | JK340 (2 in height)<br>JK341 (4 in height)<br>JK342 (5 in height)<br>JK343 (6 in height)<br>JK344 (8 in height)<br>JK346 (9 in height) | 2 SS lumens<br>≥ 3mm I.D. x ≤200mm L |
| Flash (mixed)<br>270°F Temp, 4 min. Exposure | ¾ size Lid<br>(18 in x 11 in)<br>Art. No. JP011 – JP017 | JK740 (4 in height)<br>JK741 (5 in height)<br>JK742 (6 in height) | 2 SS lumens<br>≥3 mm I.D. x ≤ 400mm L |
| Prevacuum<br>Stacking should not exceed 16-18" height<br>270°FTemp, 4min.Exposure, 15 min. Dry | Full size Lid<br>(22 in x 11 in)<br>Art. No. JP001 – JP007 | JK440 (4 in height)<br>JK441 (5 in height)<br>JK442 (6 in height)<br>JK444 (8 in height)<br>JK446 (10 in height) | 2 SS lumens<br>≥3 mm I.D. x ≤ 400mm L |
| Sterilization Cycle | Lid Size | Perforated Base to be used with Lid | |
| Stacking should not exceed 16-18" height<br>Prevacuum<br>270°FTemp, 4 min. Exposure, 15 min. Dry | ½ size Lid<br>(11 in x 11 in)<br>Art. No. JP021 – JP027 | JN340 (2 In height)<br>JN341 (4 in height)<br>JN342 (5 in height)<br>JN343 (6 in height)<br>JN344 (8 in height)<br>JN346 (9 in height) | 2 SS lumens<br>≥3 mm I.D. x ≤200mm L |
| | ¾ size Lid<br>(18 In x 11 in)<br>Art. No. JP011 –JP017 | JN740 (4 in height)<br>JN741 (5 in height)<br>JN742 (6 in height) | 2 SS lumens<br>≥ 3mm I,D. x ≤ 400mm L |
| | Full size Lid<br>(22 in x 11 in)<br>Art: No. JP001–JP007 | JN440 (4 in height)<br>JN441 (5 in height)<br>JN442 (6 in height)<br>JN444 (8 in height)<br>JN446 (10 in height) | 2 SS lumens<br>≥3 mm I.D. x ≤ 400mm L |