MERTEX-PLUS REUSABLE SURGICAL DRAPE

K012237 · Mercan AB · KKX · Oct 15, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012237
• Device Name: MERTEX-PLUS REUSABLE SURGICAL DRAPE
• Applicant: Mercan AB
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Sewing Source Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Device Story

Reusable surgical drapes designed to isolate surgical incision sites from contamination. Constructed from Maxima ESD-AT and Mertex-Plus E5533-R materials. Used in clinical/surgical settings to cover patients. Requires reprocessing and packaging between uses. Provides a physical barrier to maintain sterile fields during surgical procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable surgical drape; materials: Maxima ESD-AT and Mertex-Plus E5533-R; physical barrier function; non-sterile (requires reprocessing).

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial or other contamination during surgical procedures.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Reference Devices

• Maxima ESD-AT
• Mertex-Plus E5533-R

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 & Human Services. The logo consists of a stylized eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2001

Mercan AB C/O Mr. Jeffrey O Stull International Personal Protection, Incorporated 10907 Wareham Court Austin, Texas 78739

Re: K012237

Trade/Device Name: Mertex-Plus Nonsterile Reuseable Surgical Drape Regulation Number: 878.4370 Regulation Name: Nonsterile Surgical Drape; Sterilization Wrappers Regulatory Class: II Product Code: KKX Dated: July 15, 2001 Received: July 17, 2001

Dear Mr. Stull:

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.

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.

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You must comply with all the Act's requirements, including, but not limited to: registration 1 ou inust comply with and and (21 CFR Part 801); good manufacturing practice and ilsuing (21 es ready in the quality systems (QS) regulation (21 CFR Part 820); and if requirements 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Kunroe

Timothy A. Ulatowski 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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## Sewing Source Custom Reusable Surgical Drapes based on the both the Maxima ESD-AT and Mertex-Plus E5533-R Materials

Reference: K012237

## Statement of Intended Use

The Sewing Source Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Qutin S. lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .