(416 days)
The Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows: Prevac Steam Sterilization 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time). Medline Item Numbers / gown color / lig. barrier protection / gown size: MDTGBS3CL / Ceil / AAMI Level 3 / Large; MDTGBS3CXL / Ceil / AAMI Level 3 / X-Large; MDTGBS3C2X / Ceil / AAMI Level 3 / XX-Large; MDTGBS3JL / Jade / AAMI Level 3 / Large; MDTGBS3JXL / Jade / AAMI Level 3 / X-Large; MDTGBS3J2X / Jade / AAMI Level 3 / XX-Large.
This document is a 510(k) clearance letter for the Blockade Surgical Gown and does not contain the specific information requested about acceptance criteria and a study proving a device meets those criteria for an AI/ML powered device.
The provided text pertains to a traditional medical device (a surgical gown) and focuses on regulatory clearance based on substantial equivalence to existing predicate devices, rather than a performance study involving acceptance criteria for an AI algorithm.
Therefore, I cannot extract the requested information from this document.
§ 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.