AESCULAP STERILCONTAINER SYSTEM

K062510 · Aesculap · FRG · Nov 17, 2006 · General Hospital

Device Facts

• Record ID: K062510
• Device Name: AESCULAP STERILCONTAINER SYSTEM
• Applicant: Aesculap
• Product Code: FRG · General Hospital
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Aesculap Sterilcontainer System is intended to enclose another medical device(s) that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device(s) until used. The Aesculap Sterilcontainer System has been validated for use in ozone sterilization systems (TSO3 125L) to include hinged devices and lumened devices as small as 3mm (diameter) and 550 mm (length).

Device Story

Aesculap Sterilcontainer System is a reusable container for enclosing medical devices during sterilization and storage. Constructed from anodized aluminum with disposable paper filters. Designed for use with TSO3 125L ozone sterilization systems. Healthcare providers place instruments into the container; the container is then processed through the ozone sterilization cycle. The system maintains the sterility of the enclosed devices until they are needed for clinical use. Benefits include protection of instruments and maintenance of a sterile barrier post-sterilization.

Clinical Evidence

Bench testing only. Validation conducted by TSO3 in their model 125L ozone sterilizer in accordance with FDA guidance and AAMI standards. Testing confirmed the container's ability to maintain sterility for hinged and lumened devices (3mm diameter, 550mm length) through the specified ozone sterilization cycle parameters.

Technological Characteristics

Materials: Anodized aluminum, disposable paper filters. Form factor: Modular container system (various sizes/baskets). Sterilization: Ozone (TSO3 125L). Connectivity: None. Software: None.

Indications for Use

Indicated for healthcare providers to enclose medical devices, including hinged and lumened devices (min 3mm diameter, 550mm length), for 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

• Aesculap Sterilcontainer System (K792558)
• Aesculap Sterilcontainer System (K053389)

Reference Devices

• TSO3 125L ozone sterilizer (K020875)

Submission Summary (Full Text)

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Sterilcontainer Ozone Indication

062510

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

Aesculap Sterilcontainer System (Ozone Indication) 24 October 2006

NOV 17 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 Ozone Sterilization is substantially equivalent to:

Aesculap Sterilcontainer System (K792558) & (K053389)

### DEVICE DESCRIPTION

The 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 ozone sterilization. The container is made from anodized aluminum and utilizes a disposable (sinqle use) paper filter.

### INDICATIONS FOR USE

The Aesculap Sterilcontainer System is intended to enclose another medical device(s) that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device(s) until used. The Aesculap Sterilcontainer System has been validated for use in ozone sterilization systems (TSO3 125L) to include hinged devices and lumened devices as small as 3mm (diameter) and 550 mm (length).

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## 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 and for use in flash sterilization in 510(k) #K053389. The anodized aluminum Aesculap Sterilcontainer was used by TSO3 in the validation of their 125L ozone sterilizer which was cleared in 510(k) #K020875. The version of the Aesculap container that is the subject of this submission is the same except for minor modifications to enhance the containers long-term compatibility with ozone sterilizer processing.

## PERFORMANCE DATA

The modified Aesculap Sterilcontainer system was fully validated for the additional indication of ozone sterilization by TSO3 in their model 125L sterilizer. This validation was conducted in accordance with FDA guidance and available AAMI standards by qualified testing laboratories.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2006

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

Re: K062510

Trade/Device Name: Aesculap Sterilcontainer System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 24, 2006 Received: October 25, 2006

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.

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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. 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 (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.

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 vours.

Sygti. Y. Michin Oms.

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: ______________K062510

# Device Name: Aesculap Sterilcontainer System

#### Indications for Use:

The Aesculap Steriloontainer System is intended to be used to enclose another medical devices and The Aesculab Stericontainer System is intended to allow sterilization on the enclosed medical devices and be sterilized by a heatincale provinced to and used. The Aesolapp Sterilismanner System has been also maintain sterliny of the enclosed devices) undridded. The Alocallar Concerner.
validated for use in an ozone sterlization system (TSO3 125L) to include hinged devices an as small as 3mm (diameter) and 550 mm (length).

The following validated parameters are based on the validation of the Aesculap® Sterilcontainer in an ozone sterilization cycle using a TSO3 125L Sterilizer.

| Phase | Typical values | Actual values |
|--------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------|
| 1 - Vacuum | Pressure: approx. 1 torr | 1 torr |
| 2 - Humidification | Pressure range: 31-44 torr | 34-35 torr |
| 3 - Injection | Ozone concentration range: 160 - 200 mg/L<br>Pressure range: 400-500 torr<br>Ozone dose injected: 85 mg/L | 170-173 mg/L<br>457-460 torr<br>85 mg/L |
| 4 - Exposure | Pressure range: 400-500 torr<br>Duration: approx. 15 minutes | 458-461 torr<br>15 minutes |
| 5 - Vacuum | Pressure: approx. 1 torr | 1 torr |
| 6 - Humidification | Pressure range: 31-44 torr | 34-37 torr |
| 7 - Injection | Ozone concentration range: 160 - 200 mg/L<br>Pressure range: 400-500 torr<br>Ozone dose injected: 85 mg/L | 170-177 mg/L<br>458-462 torr<br>85 mg/L |
| 8 - Exposure | Pressure range: 400-500 torr<br>Duration: approx. 15 minutes | 459-462 torr<br>15 minutes |
| 9 - Ventilation | | 21 minutes |

The following containers and accessories are included in this system:

Item Description FULL-SIZE LID W/RETENTION PLATE RED FULL-SIZE LID W/RETENTION PLATE BLUE FULL-SIZE LID W/RETENTION PLATE GREEN FULL-SIZE LID W/RETENTION PLATE GOLD FULL-SIZE LID W/RETENTION PLATE SILVER FULL-SIZE SOLID BOTTOM 90MM FULL-SIZE SOLID BOTTOM120MM FULL-SIZE SOLID BOTTOM135MM FULL-SIZE SOLID BOTTOM 187MM FULL-SIZE SOLID BOTTOM 247MM FULL-SIZE PERF BOTTOM90MM FULL-SIZE PERF BOTTOM 120MM FULL-SIZE PERF BOTTOM 135MM FULL-SIZE PERF BOTTOM 187MM EXTRA LONG CONTAINER PERF BOTTOM 187MM

Shula P. Murphy, 16

nesthesiology. General Hospital

Number: K 0i2 510

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FULL-SIZE PERF BOTTOM 247MM 1/1 SIZE PERF BASKET 485X253X76MM 1/1 SIZE PERF BASKET LID 489X257MM 1/1 SIZE PERF BASKET 540X253X36MM 1/1 SIZE PERF BASKET 540X253X56MM 1/1 SIZE PERF BASKET 540X253X76MM 1/1 SIZE PERF BASKET 540X253X106MM 1/1 SIZE PERF BASKET LID 544X257MM FULL-SIZE WIRE BASKET 30MM FULL-SIZE WIRE BASKET 50MM FULL-SIZE WIRE BASKET 70MM FULL-SIZE WIRE BASKET 100MM FULL-SIZE INSTRUMENT PAD SILICONE BASKET LINER FULL-SIZE 3/4-SIZE LID W/RETENTION PLATE RED 3/4-SIZE LID W/RETENTION PLATE BLUE 3/4-SIZE LID W/RETENTION PLATE GREEN 3/4-SIZE LID W/RETENTION PLATE GOLD 3/4-SIZE LID W/RETENTION PLATE SILVER 3/4-SIZE SOLID BOTTOM 90MM 3/4-SIZE SOLID BOTTOM 120MM 3/4-SIZE SOLID BOTTOM 135MM 3/4-SIZE PERF BOTTOM90MM 3/4-SIZE PERF BOTTOM 120MM 3/4-SIZE PERF BOTTOM 135MM 3/4 SIZE PERF BASKET 406X253X36MM 3/4 SIZE PERF BASKET 406X253X56MM 3/4 SIZE PERF BASKET 406X253X76MM 3/4 SIZE PERF BASKET 406X253X106MM 3/4 SIZE PERF BASKET LID 410X257MM 3/4-SIZE WIRE BASKET 25MM 3/4-SIZE WIRE BASKET 50MM 3/4-SIZE WIRE BASKET 70MM 3/4-SIZE WIRE BASKET 100MM 3/4-SIZE INSTRUMENT PAD 1/2-SIZE LID W/RETENTION PLATE RED 1/2-SIZE LID W/RETENTION PLATE BLUE 1/2-SIZE LID W/RETENTION PLATE GREEN 1/2-SIZE LID W/RETENTION PLATE GOLD 1/2-SIZE LID W/RETENTION PLATE SILVER 1/2-SIZE SOLID BOTTOM 90MM 1/2-SIZE SOLID BOTTOM120MM 1/2-SIZE SOLID BOTTOM 135MM 1/2-SIZE SQLID BOTTOM187MM 1/2-SIZE SOLID BOTTOM 247MM 1/2-SIZE PERF BOTTOM 90MM 1/2-SIZE PERF BOTTOM 120MM 1/2-SIZE PERF BOTTOM 135MM 1/2-SIZE PERF BOTTOM 187MM 1/2-SIZE PERF BOTTOM247MM 1/2-SIZE WIRE BASKET50MM 1/2-SIZE WIRE BASKET 30MM 1/2-SIZE WIRE BASKET 70MM

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1/2-SIZE WIRE BASKET100MM 1/2 SIZE PERF BASKET 243X253X36MM 1/2 SIZE PERF BASKET 243X253X56MM 1/2 SIZE PERF BASKET 243X253X76MM 1/2 SIZE PERF BASKET 243X253X106MM 1/2 SIZE PERF BASKET LID 247X257MM HALF-SIZE INSTRUMENT PAD SILICONE BASKET LINER 1/2-SIZE MINI-SIZE LID W/RETENTION PLATE RED MINI-SIZE LID W/RETENTION PLATE BLUE MINI-SIZE LID W/RETENTION PLATE GREEN MINI-SIZE LID W/RETENTION PLATE GOLD MINI-SIZE LID W/RETENTION PLATESILVER MINI-SIZE SOLID BOTTOM 30MM MINI-SIZE SOLID BOTTOM 57MM MINI-SIZE PERF BOTTOM 40MM MINI-SIZE PERF BOTTOM 38MM MINI-SIZE PERF BOTTOM 67MM MINI CONTAINER 310X140X67MM SILVER MINI-HALF WIRE BASKET WITH LID MICRO-INST BASKET W/LID 235X137X42MM MINI-SIZE PERF BASKETW/LID49MM MINI-SIZE INSTRUMENT PAD SILICONE PAD BLUE 470X230X30MM SILICONE MAT LONG F/MD375 JF232R SILICONE PAD 277X126X17 SILICONE PAD 250X239X17 ROUND PAPER FILTERS STRINGER OPEN 350X65MM STRINGER OPEN 150X65MM STRINGER OPEN 150X125MM STRINGER OPEN 200X125MM STRINGER CLOSED W/LOCK 100X65MM STRINGER CLOSED W/LOCK 150X125MM STRINGER CLOSED W/LOCK 200 X 125MM STRINGER CLOSED W/LOCK 300 X 125MM STRINGER CLOSED W/LOCK 250 X 125MM STRINGER CLOSED W/LOCK150 X 65MM

| Prescription Use | |
|-----------------------------|---|
| and/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)