REUSABLE STERILCONTAINER FILTER MODEL #JK090

K041623 · Aesculap, Inc. · FRG · Dec 13, 2004 · General Hospital

Device Facts

• Record ID: K041623
• Device Name: REUSABLE STERILCONTAINER FILTER MODEL #JK090
• Applicant: Aesculap, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.

Device Story

Aesculap Reusable Sterile Container Filter is a circular PTFE component designed for integration into Aesculap SterilContainer systems. It functions as a barrier during prevacuum steam sterilization, facilitating sterilant penetration and evacuation while preventing microbial contamination. The filter is reusable for up to 2,200 sterilization cycles. It is intended for use in clinical settings where the SterilContainer system is employed for instrument sterilization. The device provides a durable, reusable alternative to single-use sterilization wraps, potentially reducing waste and operational costs for healthcare facilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Circular PTFE (Polytetrafluoroethylene) filter; designed for use with Aesculap SterilContainer systems; supports prevacuum steam sterilization cycles (5 minutes at 273°F); reusable for up to 2,200 cycles.

Indications for Use

Indicated for use as a PTFE filter in Aesculap SterilContainer systems during prevacuum steam sterilization cycles (5 minutes at 273°F) to allow sterilant penetration and evacuation while maintaining a microbial barrier for up to 2,200 uses.

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)
• Johnson & Johnson Sterion container (K850289)
• Medline Steriset container (K010825)

Submission Summary (Full Text)

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## DEC 1 3 2004

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

### REUSABLE STERILECONTAINER FILTER

14 June 2004

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|---------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>Requlatory Affairs Manager<br>800-258-1946 (phone) x5072<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap Reusable Sterilecontainer Filter |
| COMMON NAME: | Reusable Filter |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | FRG |
| CLASSIFICATION: | 880.6850 - Sterilization Wrap |
| REVIEW PANEL: | General Hospital and Personal Use Devices |

#### INTENDED USE

Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.

#### DEVICE DESCRIPTION

Aesculap's Reusable Sterile Container Filters allows for thorough penetration and evacuation of sterilants, while maintaining an effective barrier against microbial contamination. The Ulters are circular in shape and can be used for up to 2,200 washing and sterlilization cycles. Aesculages Reusable filters are to be used in conjunction with Aesculan's Sterilcontainer System (K792558).

#### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

#### SUBSTANTIAL EQUIVALENCE

Aesculap believes that the Reusable Sterilcontainer Filter (when used in the Aesculap Stericontainer System) is substantially equivalent in its intended use, function, and basic operating principles to the following predicate devices:

- Aesulap's Sterilcontainer System (K792558) .
- Johnson & Johnson's Sterion container (K850289) .
- Medline's Steriset container (K010825) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "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.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2004

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

Re: K041623

Trade/Device Name: Reusable Sterilcontainer Filter Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 12, 2004 Received: November 15, 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.

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Page 2 -- Mr. Hull

Please be advised that FDA's issuance of a substantial equivalence determination does not I tease to act rised that that your device complies with other requirements mount that I Drima may Federal statutes and regulations administered by other Federal agencies. or the Act of any I oderal bike Act's requirements, including, but not limited to: registration r ou interesting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) Frins fotor will and in JOThe Sognifial equivalence of your device of your device to a premaired news are 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), rl 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 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,

Qur
Shia-Lien, Ph.D.

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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Reusable Sterilcontainer Filter

510(k) Premarkel Notification

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

# Device Name: Reusable Sterilcontainer Filter

## Indications for Use:

Indications for Use:
Aesculap's Reusable Steriloontainer Filter (JK090) is a PTFE (Polytetrafilurrethylene) filter Aesculap's Reusable Sterilon and evecuation of the steriliant (steriland (steam.
that allows for thorough penetration and evecuation of the sterilent (steam Assedaps steasure over against microbial contamination for a maximum of 2,200
that allows for thorough peneration for maximum of 2,200
maintaining an effective barins that alows for thereegy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - uses. This filter is for uses at 273° F.
sterilization cycle for 5 minutes at 273° F.

× Over-the-Counter Use or Prescription Use_

(per 21 CFR 801.109)

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

Senette Michie ms.

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

510(k) Number:

(Optional Formal 3-10-98)