(179 days)
Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.
Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE
This document is a 510(k) clearance letter from the FDA for various sterile and non-sterile surgical drapes. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- The sample size or ground truth establishment for a training set.
This document is solely an FDA clearance stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies that might have been conducted by the manufacturer to support their submission.
§ 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.