(39 days)
The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.4970, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
primaGARD Surgical Gowns
The provided documents are an FDA 510(k) clearance letter for "PrimaGard Surgical Gowns." This document type does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it pertains to a physical medical device (surgical gowns) and not an AI/software-as-a-medical-device (SaMD).
Therefore, I cannot provide the requested information based on the given input. The 510(k) clearance process for surgical gowns primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance testing against recognized standards for characteristics like barrier performance, fluid resistance, and sterility, rather than through clinical studies with "test sets," "ground truth," or "expert consensus" as would be seen for AI/SaMD.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.