(72 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
The provided document is a 510(k) Premarket Notification for a Surgical Mask. It details the device's technical specifications, intended use, and a comparison to predicate devices, along with performance and biocompatibility testing. The document does not describe an AI/ML-driven medical device, but rather a traditional medical device (a surgical mask).
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through physical and performance testing, rather than through a clinical study involving AI/ML performance metrics.
Here's a breakdown of the information that is available related to the device's performance, as per the tables in the document, interpreted as "acceptance criteria" and "reported performance" for a surgical mask:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)
The document presents performance data for two models of the surgical mask (0868F and 0866F), which align with different performance levels (Level 1 and Level 3, respectively, based on ASTM F2100 standards).
| Test Item | Acceptance Criteria (Level 1 for 0868F) | Reported Performance (0868F) | Acceptance Criteria (Level 3 for 0866F) | Reported Performance (0866F) |
|---|---|---|---|---|
| Performance Testing | ||||
| Fluid Resistance (ASTM F1862) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE, ASTM F2299) | ≥ 95% (at 0.1 µm) | Pass (≥ 95%) | ≥ 98% (at 0.1 µm) | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (BFE, ASTM F2101) | ≥ 95% | Pass (≥ 95%) | ≥ 98% | Pass (≥ 98%) |
| Differential Pressure (ΔP, EN 14683 / ASTM F2100) |
§ 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.