(113 days)
When properly worn, the surgical face masks are intent and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
Magnum is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in a single color – blue.
The inner and outer layers are made of spun-bond polypropylene non-woven fabric, and the middle layer is made of melt blown filter media. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PVC coated aluminum wire.
The model 2200 is level 2 surgical face mask and the model 2300 is level 3 surgical face mask. Both these models are provided with ear loops to hold and fit the face mask in place over the user's mouth and nose. The ear loops are made of knitted elastic.
The model 1200 is level 2 surgical face mask and the model 1300 is level 3 surgical face mask. Both these models are provided with tie back to hold and fit the face mask in place over the user's mouth and nose. The tie back string is made of spun-bond polypropylene non-woven fabric.
The dimensions of the test item are: length- 172 ± 3 mm and width- 95 ± 3 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
The provided text describes the acceptance criteria and performance data for Magnum surgical masks in their 510(k) submission to the FDA. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides two tables (Table 2 and what is labeled as "Table 2" but is actually a third table, both on page 9) summarizing the performance testing for different models (Level 3 models 1300 and 2300, and Level 2 models 1200 and 2200). I will combine these into a single table for clarity, indicating the specific level for the criteria.
| Test Performed | Acceptance Criteria (Level 3 Models) | Reported Performance (Model 1300) | Reported Performance (Model 2300) | Acceptance Criteria (Level 2 Models) | Reported Performance (Model 1200) | Reported Performance (Model 2200) | Overall Result |
|---|---|---|---|---|---|---|---|
| Fluid resistance (ASTM F1862/F1862M-17) | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03(2017)) | ≥ 98% | > 98% | > 98% | ≥ 98% | > 98% | > 98% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | > 98% | > 98% | ≥ 98% | > 98% | > 98% | Pass |
| Differential pressure (ΔP) (EN 14683 Annex C: 2019) | 98% filtration efficiency, pass at 160 mmHg fluid resistance) and safety (e.g., non-cytotoxic, non-sensitizing). Compliance with these numerical or qualitative thresholds constitutes meeting the acceptance criteria. |
8. The sample size for the training set
Not applicable. This is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.