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Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.

Various types of surgical drapes

The provided text is a 510(k) Premarket Notification for "Surgical Drapes." This document is focused on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) pathway for medical devices largely relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This process typically involves comparing the new device's technological characteristics and indications for use to those of the predicate device. Performance data, if included, is often used to support the claim of substantial equivalence rather than to meet specific, quantitatively defined "acceptance criteria" through a comprehensive clinical study.

Therefore, the requested information elements related to acceptance criteria, specific device performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable to this document. The document describes the device, its intended use, and compares it to a predicate device (Webster Enterprises – K864899) to demonstrate substantial equivalence, focusing on similarities in features and materials rather than statistical performance against predefined acceptance criteria.

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