AESCULAP STERILCONTAINER S

K093649 · Aesculap · FRG · May 11, 2010 · General Hospital

Device Facts

• Record ID: K093649
• Device Name: AESCULAP STERILCONTAINER S
• Applicant: Aesculap
• Product Code: FRG · General Hospital
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Aesculap Sterilcontainer S 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 V-PRO 1 and V-PRO 1 Plus Systems.

Device Story

Aesculap Sterilcontainer S is a reusable aluminum container system for sterilizing and storing medical devices. Used in clinical settings by healthcare providers. Encloses instruments during sterilization cycles in V-PRO 1 and V-PRO 1 Plus systems; maintains sterility post-processing until use. System includes accessories like silicon mats, baskets, trays, and racks. Benefits include protection of sterilized instruments and maintenance of sterile barrier.

Clinical Evidence

Bench testing only. Validation conducted for V-PRO 1 and V-PRO 1 Plus sterilization systems in accordance with FDA guidance and AAMI standards by a qualified testing laboratory.

Technological Characteristics

Non-anodized aluminum container; disposable polypropylene filter. Includes accessories: silicon mats, baskets, trays, racks. Compatible with V-PRO 1 and V-PRO 1 Plus sterilization systems. No software or electronic components.

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization and maintenance of sterility. Compatible with V-PRO 1 and V-PRO Plus systems. Supports specific lumen configurations: ≥1mm ID/≤125mm length, >2mm ID/<250mm length, and ≥3mm ID/≤400mm length. Maximum 20 lumens per load.

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 STERRAD 100S Compatiable Sterilcontainer (K040865)

Submission Summary (Full Text)

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Aesculap Sterilcontainer S for PRO 1 & V-PRO Plus Systems

2093649/5001

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ﺎ

#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

| | Aesculap Sterilcontainer S for<br>V-PRO 1 and V-PRO 1 Plus<br>November 24, 2009 | | MAY 11 2010 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|--|-------------|
| 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 S | | |
| COMMON NAME: | Sterilization Container Wrap | | |
| CLASSIFICATION NAME: | Wrap, Sterilization | | |
| REGULATION NUMBER: | 880.6850 | | |
| PRODUCT CODE: | FRG | | |

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to:

- . Aesculap STERRAD 100S Compatiable Sterilcontainer (K040865).
# DEVICE DESCRIPTION

The Aesculap Sterilcontainer S 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 V-PRO 1 and V-PRO 1 Plus sterilization systems. The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.

# 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 V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer S System includes accessories such as silicon mats, baskets, trays, and racks.

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# TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}

The Aesculap Sterilcontainer S is compatible for use in V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer is offered in similar shapes and sizes as the predicate devices. The material used for the V-PRO 1 and V-PRO 1 Plus Compatible Aesculap Sterilcontainer S is the same as that used to manufacture the predicate devices.

# PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap Sterilcontainer S was completed. The Aesculap Steriicontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# MAY 1 1 2010

Ms. Kathy Racosky Regulatory Affairs Specialist Aesculap, ® Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K093649

Trade/Device Name: Aesculap Sterilcontantainer S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 22, 2010 Received: April 23, 2010

Dear Ms. Kathy 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kathy 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Ruaren

for

Anthony D. Watson, B.S., M.S., M.B.A 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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K0936049/s001

#### A. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Aesculap Sterilcontainer S

# Indication for Use:

The Aesculap Sterilcontainer S 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 V-PRO 1 and V-PRO Plus Systems.

The Sterilcontainer S is recommended for surface and lumens:

≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and < 250 mm in length ≥ 3mm internal diameter and ≤ 400 mm in length

Lumen Cycle - The maximum number of lumens per load is 20 lumens.

The attached table identifies which Sterilcontainer S may be sterilized in the V-PRO 1 and V-PRO Plus Systems.

Prescription Use

and/or Over-the-Counter Use ×

(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)

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

510(k) Number: kD93649

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| Item # | Description | Total loaded<br>container<br>weight (lbs) |
|-------------------|---------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 $1/4$ ") | 19.65 |
| JM441 | Full Size Perforated Bottom 120mm (5 $1/2$ ") | 19.65 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 19.65 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 19.65 |
| JM740 | $3/4$ Size Perforated Bottom 90mm (4 $1/4$ ") | 19.65 |
| JM741 | $3/4$ Size Perforated Bottom 120mm (5 $1/2$ ") | 19.65 |
| JM742 | $3/4$ Size Perforated Bottom 135mm (6") | 19.65 |
| JM340 | $1/2$ Size Perforated Bottom 90mm (4 $1/4$ ") | 19.65 |
| JM341 | $1/2$ Size Perforated Bottom 120mm (5 $1/2$ ") | 19.65 |
| JM342 | $1/2$ Size Perforated Bottom 135mm (6") | 19.65 |
| JM344 | $1/2$ Size Perforated Bottom 187mm (8") | 19.65 |
| JM092 | $1/4$ Size Perforated Bottom with Lid (2") | 19.65 |
| JM094 | $1/4$ Size Perforated Bottom with Lid (2 $1/2$ ") | 19.65 |
| JM187 | Mini Bottom 30mm (1 $1/2$ ") | 7.70 |
| JM188 | Mini Bottom 57mm (3") | 7.70 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.70 |
| JM489 | Full Size Lid | |
| JM789 | $3/4$ Size Lid | |
| JM389 | $1/2$ Size Lid | |
| See JM092 & JM094 | $1/4$ Size Lid | |
| JM174 | Mini lid | |
| JM020 | Extra Long Mini Lid | |

# Sterilecontainer S Compatible with V-PRO 1 and V-PRO Plus

# Compatible Accessories

.

| | Compatible Accessories |
|-------------------|------------------------|
| | V-PRO & V-PRO Plus |
| Baskets | X |
| Trays | X |
| Insert boxes | X |
| Metal Brackets | X |
| Metal Partitions | X |
| Posts | X |
| Silicone Brackets | X |
| Racks | X |
| Stringers | X |