(71 days)
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.
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.
This document is a 510(k) clearance letter from the FDA for a medical device called "primaGARD Surgical Equipment Covers." It is not a study report or clinical trial document, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, or ground truth establishment.
A 510(k) clearance signifies that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness. This process typically involves demonstrating equivalence to existing devices through a comparison of technological characteristics and, sometimes, limited performance testing against established standards, but not a full-scale clinical study with the details you've requested.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.