PRIMAGARD SURGICAL EQUIPMENT DRAPES

K022868 · Primeline Medical Products, Inc. · KKX · Nov 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022868
• Device Name: PRIMAGARD SURGICAL EQUIPMENT DRAPES
• Applicant: Primeline Medical Products, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.

Device Story

primaGARD Surgical Equipment Covers are non-sterile drapes composed of natural and/or synthetic materials. Used in operating rooms to cover surgical equipment; primary function is to isolate equipment from the sterile field, preventing contamination and maintaining sterile technique. Operated by surgical staff during procedures. Device acts as a physical barrier; no electronic or active components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-sterile surgical drapes; constructed from natural and/or synthetic materials; physical barrier design; no energy source; no software; no connectivity.

Indications for Use

Indicated for use as a protective covering for surgical equipment to isolate equipment from contaminating the sterile field during surgical procedures in an operating room environment.

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 8 2002

Ms. Brenda Lee Manager of RA/QA PrimeLine Medical Products, Incorporated 10707-100th Avenue, Suite 300 Edmonton, Alberta T5J 3M1 CANADA

Re: K022868

Trade/Device Name: primaGARD Surgical Equipment Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: August 29, 2002 Received: August 29, 2002

Dear Ms. Lee:

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. Lee

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 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 vours.

Susan Pease

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Statement of Indications for Use

## 510(k) Number: K022868

## Device Name: PrimeLine Medical Products Inc. primaGARD Surgical Equipment Covers

The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.

signature

Brenda Lee

October 16, 2002

Date

K022868 Premarket Notification (510K Number)

Olin Si Lin

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

510(k) Number: K022868

Market Notification: primaGARD Surgical Equipment Drape

Prime Line Medical Products Inc