SECURE-WRAP (TM) STERILIZATION WRAP

K971483 · American Threshold Industries, Inc. · FRG · Jun 24, 1997 · General Hospital

Device Facts

• Record ID: K971483
• Device Name: SECURE-WRAP (TM) STERILIZATION WRAP
• Applicant: American Threshold Industries, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

This device is 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 maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.

Device Story

Secure-Wrap Sterilization Wrap is a protective barrier material used by healthcare providers to enclose medical instruments prior to sterilization. The wrap allows the penetration of sterilizing agents (steam or ethylene oxide) while acting as a microbial barrier to maintain the sterility of the enclosed items until they are needed for clinical use. It is used in hospital or clinical settings to facilitate the safe processing and storage of surgical or diagnostic equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterilization wrap material designed for steam and ethylene oxide compatibility. Functions as a permeable barrier to sterilants and a microbial barrier to contaminants.

Indications for Use

Indicated for use by healthcare providers to wrap medical devices requiring sterilization via steam or ethylene oxide, maintaining sterility until point of 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1997 Ms. Frances Mayhew Ouality Assurance Manaqer American Threshold Industries, Incorporated 240 Sardis Road Enka, North Carolina 28728

K971483 Re : Secure-Wrap® Sterilization Wrap Trade Name: Regulatory Class: II Product Code: FRG Dated: April 23, 1997 Received: April 23, 1997

Dear Ms. Mayhew:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Mayhew

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Alatrust

Time Ulat Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _ Secure-Wrap Sterilization Wrap

Indications For Use:

This device is 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 maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number

Prescription Use (Pcc 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)