(265 days)
The ivi N3003 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The ivi N6006 Surgical Mask is single-use, disposable device, provided non-sterile, and intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "ivi N3003 Surgical Face Mask" and "ivi N6006 Surgical Mask" does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
The document is a standard FDA clearance letter for a Class II medical device (surgical masks), focusing on:
- Substantial equivalence determination.
- Regulatory requirements (registration, listing, GMP, labeling, etc.).
- Indications for Use for both mask models.
- Paperwork Reduction Act information.
It does not describe the technical performance of the masks (e.g., filtration efficiency, breathability) or any studies related to proving such performance beyond stating their intended use for protection against microorganisms, body fluids, and particulate material. There is no mention of AI, machine learning, or software-driven device performance.
Therefore, I cannot provide the requested information, which typically applies to AI/ML device submissions, based on the content of 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.