(30 days)
The Disposable 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 Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are non-sterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains head ties, ear loops or ear bands to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex.
This document pertains to the 510(k) summary for the Savvy Mask - Level 3 Surgical Mask. The information provided is primarily focused on the device's technical and performance characteristics compared to a predicate device, rather than the evaluation of an AI or software device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Item | Acceptance Criteria | Proposed Device - Savvy Mask Performance | Result |
---|---|---|---|
Level 3 Fluid Resistance (ASTM F1862) | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 31/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass. | Pass |
Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
Differential Pressure (ASTM F2100/EN 14683:2019) | AQL 4%, single sampling plan, 29/32 pass |
§ 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.