DEROYAL DRAPES, STERILE, NON-STERILE

K030365 · Deroyal Industries, Inc. · KKX · Apr 29, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030365
• Device Name: DEROYAL DRAPES, STERILE, NON-STERILE
• Applicant: Deroyal Industries, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

DeRoyal Drapes are patient protective coverings used to isolate incision against contamination during surgical procedures. DeRoyal will receive the nonsterile drapes from the converter made to DeRoyal's specification and use them in Convenience Kits that are sterilized, market the nonsterile to other OEM customers, and market sterile drapes individually packaged.

Device Story

DeRoyal Drapes are sterile or non-sterile patient protective coverings designed to isolate surgical incision sites from contamination. Used in clinical settings during surgical procedures to maintain a sterile field. Provided as individually packaged sterile drapes, components within sterilized Convenience Kits, or as non-sterile drapes for OEM customers. Device acts as a physical barrier to prevent cross-contamination between patient and surgical environment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Surgical drapes composed of protective materials designed to isolate incision sites. Form factor varies by specific drape configuration. Sterilization provided for individually packaged units and Convenience Kits.

Indications for Use

Indicated for use as patient protective coverings to isolate surgical incision sites from 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.

Submission Summary (Full Text)

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Public Health Service

APR 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Audrey Daniels Regulatory Specialist DeRoyal Industries, Incorporated 200 DeBusk Lane Powell, Tennessee 37849

Re: K030365

Trade/Device Name: DeRoyal Drapes, Sterile, Non-Sterile Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 27, 2003 Received: April 4, 2003

Dear Ms. Daniels:

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 - Ms. Daniels

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 vour 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.

Patricius Cucentello

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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## Indications for Use Statement

## me: DeRoval Drap

rapes are patient protective coverings used to isolate incision against contamination during surgical procedures.

DeRoyal will receive the nonsterile drapes from the converter made to DeRoyal's cification and use them in Convenience Kits that are sterilized, market the nonsterile to other OEM customers, and market sterile drapes individually packaged.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Qian S. Lin

Division Sign Infection Control

510(k) Number: K030263