(63 days)
The TotalShield II Zippered Surgical Toga and /or TotalShield II Surgical Hood is for use with the TotalShield II Surgical Helmet and/or TotalShield 11 Surgical Helmet with LED Lighting as the TotalShield II Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
TotalShield II Surgical Helmet System
This document is an FDA 510(k) clearance letter for the TotalShield II Surgical Helmet System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter focuses on the regulatory aspects of device clearance, such as product codes, regulatory class, general controls, and compliance with federal statutes and regulations. It also includes the "Indications for Use" for the device, which describes its intended purpose.
Therefore, I cannot provide the requested information based on the text provided. The document does not contain the details of performance testing or clinical studies.
§ 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.