(88 days)
The Shoe Cover is a device intended to be worn by hospital personnel from transfer of procedures to protect both the patient and the hospital personnel from transfer of materials.
Shoe Cover
This document is a 510(k) clearance letter from the FDA for a "Shoe Cover" device. As such, it is not a study report or clinical trial. Therefore, it does not contain information regarding detailed acceptance criteria, device performance metrics (such as sensitivity, specificity, AUC), sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically found in reports for devices utilizing AI or complex algorithms.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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)."
The core of this FDA clearance is substantial equivalence to a predicate device, not a demonstration of specific performance metrics against pre-defined acceptance criteria through a quantitative study with the details requested. Such an extensive study as described in the prompt is generally not required for Class I devices cleared under the substantial equivalence pathway, especially not for a device like a shoe cover.
Given this context, I cannot provide the requested information from the provided document. The document describes a regulatory clearance process, not a performance study.
§ 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.