AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

K040865 · Aesculap · FRG · Dec 6, 2004 · General Hospital

Device Facts

• Record ID: K040865
• Device Name: AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
• Applicant: Aesculap
• Product Code: FRG · General Hospital
• Decision Date: Dec 6, 2004
• 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 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 with the Sterrad 100S.

Device Story

Reusable sterilization container system; designed to enclose medical devices during sterilization and storage. Constructed from non-anodized aluminum; utilizes disposable single-use polypropylene filter. Compatible with Sterrad 100S sterilization process. Used by healthcare providers in clinical settings to maintain device sterility until point of use. Protects enclosed instruments during sterilization cycle and subsequent storage; ensures sterility maintenance.

Clinical Evidence

Bench testing only. Testing performed per FDA Draft Guidance for the Preparation of Premarket Notifications 510(k)'s for sterilization containers to demonstrate substantial equivalence.

Technological Characteristics

Non-anodized aluminum container; disposable single-use polypropylene filter. Available in various sizes (full, 3/4, 1/2, 1/4). Compatible with Sterrad 100S sterilization process.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization and to maintain sterility of the enclosed devices until use. Compatible with Sterrad 100S sterilization processes.

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

• Allegiance Healthcare (Genesis)
• Case Medical (SteriTite)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC - 6 2004

Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The string appears to be "K040866". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.

#### C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)

## AESCULAP STERILCONTAINER FOR STERRAD

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, RAC<br>800-258-1946 x 5072 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Sterrad Compatible Aesculap Sterilcontainer |
| COMMON NAME: | Sterilization Container Wrap |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 80 FRG |
| CLASSIFICATION: | 880.6850 - Wrap, Sterilization |
| REVIEW PANEL: | General Hospital |

# INDICATIONS FOR USE

The Aesculap Sterilcontainer is a reusable sterilization container system 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 with the Sterrad 1005.

# DEVICE DESCRIPTION

The Sterrad 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 the Sterrad sterilization processes (100S). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.

# PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Sterrad Compatible Aesculap Sterilcontainer was completed. Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market.

{1}------------------------------------------------

SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Sterrad Compatible Aesculap Sterilcontainer is Aesoulap ', inc. believes that the Stericontainers. Additionally we feel it Substantially oquivalent to the sterilization containers marketed by Allegiance Healthcare (Genesis) and Case Medical (SteriTite).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

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

Re: K040865

Trade/Device Name: Aesculap Sterrad 100S Compatible Sterilcontainer Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 11, 2004 Received: November 12, 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.

{3}------------------------------------------------

Page 2 - Mr. Hull

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. or the rever mply 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 and ibuing (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirents as 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), rr you 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/dsma/dsmamain.html

Sincerely yours,

Sina Qumpe

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

{4}------------------------------------------------

Page 1 of 1

#### INDICATIONS FOR USE STATEMENT B.

510(k) Number: K040865/S2

### Device Name: Aesculap Sterrad Compatible Sterilcontainer

#### Indication for Use:

The Aesculap Sterilcontainer is a reusable sterilization container system intended 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 with the Sterrad 100S.

| SterilContainer Sterrad 100S Compatible Containers | | |
|----------------------------------------------------|-----------------------------------------|-------------------|
| Description | Size (L"xW"xH") | Item # |
| Full Size Perforated Bottom | 23 x 11 x 4 | JM440 |
| Full Size Perforated Bottom | 23 x 11 x $5 \frac{1}{3}$ | JM441 |
| Full Size Perforated Bottom | 23 x 11 x 6 | JM442 |
| Full Size Perforated Bottom | 23 x 11 x 8 | JM444 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x 4 | JM740 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$ | JM741 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x 6 | JM742 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 4 | JM340 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$ | JM341 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 6 | JM342 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 8 | JM344 |
| ¼ Size Perforated Bottom with Lid | 12 x 7 x $2 \frac{1}{2}$ | JM094 |
| ¼ Size Perforated Bottom with Lid | 12 x 7 x 5 | JM096 |
| Full Size Lid | | JM489 |
| ¾ Size Lid | | JM789 |
| ½ Size Lid | | JM389 |
| ¼ Size Lid | | See JM094 & JM096 |

Prescription Use or Over-the-Counter Use

X

(per 21 CFR 801.109)

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

Smith M. Chan acting chief inc BR 12-03-04
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Den

510(k) Number: K040865