(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.
§ 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.