SELF SEAL STERILIZATION POUCH

K023025 · Granton Medical , Ltd. · FRG · Mar 4, 2003 · General Hospital

Device Facts

• Record ID: K023025
• Device Name: SELF SEAL STERILIZATION POUCH
• Applicant: Granton Medical , Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.

Device Story

Self-seal sterilization pouch; used by healthcare providers to enclose medical instruments prior to sterilization. Input: medical device to be sterilized. Operation: pouch provides barrier to maintain sterility of contents post-processing. Output: sterilized, enclosed medical device. Used in clinical settings; facilitates safe storage and transport of sterilized instruments. Benefits patient by maintaining sterility of devices used in procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterilization pouch designed for 121°C gravity steam or ethylene oxide sterilization. Complies with ANSI/AAMI ST-46 and ST-41 recommendations for sterilization packaging.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices requiring sterilization via 121°C gravity steam or ethylene oxide, in accordance with ANSI/AAMI ST-46 or ST-41 standards.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Granton Medical Limited C/O Mr. E. J. Smith Smith & Associates P.O. Box 4341 Crofton, Maryland 21114

MAR 0 4 2003

Re: K023025

Trade/Device Name: Self Seal Sterilization Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: December 12, 2002 Received: December 16, 2002

Dear Mr. Smith:

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. Smith

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/dsma/dsmamain.html

Sincerely vours.

Susan Punrer

Susan Runner, DDS, MA Interim 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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## 510(k) Number:

Device Name: Self Seal Sterilization Pouch

Classification Panel: 80 KCT

## Indications for Use:

The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

Qun Si hin

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

510(k) Number. K023025