(114 days)
The Medical 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.
The Medical Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.
The model of proposed device, Ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose clamp 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 metal core plastic.
The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.
The provided text is a 510(k) summary for a Medical Mask (K210020). It describes the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically focusing on non-clinical performance standards for medical face masks.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for this medical mask are based on established performance standards for surgical masks, primarily ASTM F2100-19 (Standard Specification For Performance of Materials used in Medical Face Masks) for Level 3 categorization, and other supporting standards for specific properties.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (for Level 3) | Reported Device Performance (K210020) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | > 98% | > 98% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | > 98% | > 98% |
| Differential Pressure (Breathability) (EN 14683:2019) | 98% is the ground truth for BFE at Level 3). The tests themselves are the means of establishing whether the mask meets these pre-defined physical and biological performance characteristics. There isn't a team of human "experts" establishing a "ground truth" through consensus in the way there would be for, say, medical imaging interpretation. The experts involved would be laboratory technicians and engineers performing validated tests according to the standards. |
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Adjudication Method for the Test Set:
- Not applicable. Performance testing of physical products against defined standards does not involve an adjudication method in the same way clinical trials or image readings might. The results are quantitative measurements or pass/fail determinations based on predefined criteria.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. The document explicitly states: "No clinical tests were performed." MRMC studies are typically used for diagnostic devices involving human interpretation of medical data (e.g., radiology AI tools). This device is a medical mask, which is evaluated based on its physical and biological barrier properties.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is slightly misapplied to a medical mask. If interpreted as "was the device's performance evaluated independently of human use for its intended function (e.g., filtration efficiency tested on a machine)?" then yes. The performance metrics like BFE, PFE, fluid resistance, flammability, differential pressure, and biocompatibility are all measured in a standalone laboratory setting, independent of human interaction during the test itself. The mask's performance is the algorithm in this context – its material composition and design dictate its performance.
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The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on pre-defined, internationally recognized technical standards and specifications. These standards (e.g., ASTM F2100-19 for medical face masks) lay out the specific performance thresholds (e.g., >98% BFE, >98% PFE,
§ 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.