(195 days)
The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses).
The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/Californial04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional BF-200-3013AN is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The respirator is comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.
Here's a breakdown of the acceptance criteria and study information for the BioFriend™ BioMask™ N95 Surgical Respirator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document details performance against recognized standards, specifically ASTM F2100-11 for Medical Face Masks and NIOSH 42 CFR 84 for Respirator Certification. It also includes virucidal efficacy claims.
| Description | Test Method | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (N95 Surgical Respirator Professional BF-200-3013AN) |
|---|---|---|---|
| ASTM F2100-11 Medical Face Mask Standards (Level 3) | |||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101 | > 99% (3M N95); 99.9% (BioMask Predicates) | > 99.9 % |
| Sub-micron (0.1 µm) Particulate Filtration Efficiency | ASTM F2299 | N/A (3M N95); 99.7% (BioMask Predicates) | > 99.9 % |
| Differential Pressure (Delta-P) | MIL-M-36954C | 4.9 mm H2O/cm² (3M N95); 2.6 mm H2O/cm² (BioMask Predicates) | 4.9 mm H2O/cm² |
| Resistance to Penetration by Synthetic Blood | ASTM F1862 | 160 mm Hg | 160 mm Hg |
| Flame Spread | 16 CFR Part 1610 | Class 1 | Class 1 |
| NIOSH 42 CFR Part 84 - N95 Respirator Standards | |||
| Particulate Filtration Efficiency (NaCl) | 42 CFR 84.181 | Pass (3M N95); N/A (BioMask Predicates) | 98 % |
| Breathing Resistance (Inhalation) | 42 CFR 84.180 | Pass (3M N95); N/A (BioMask Predicates) | 8.0 mm H2O |
| Breathing Resistance (Exhalation) | 42 CFR 84.180 | Pass (3M N95); N/A (BioMask Predicates) | 8.9 mm H2O |
| Virucidal Efficacy | In vitro laboratory tests | 99.99% viral inactivation at 5 minutes | 99.99% (≥4-logs) inactivation of 15 influenza strains |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations," implying standardized and sufficient sample sizes as per GLP.
- Data Provenance: The tests were conducted by independent laboratories:
- Nelson Laboratories Inc., Salt Lake City, UT, USA: For bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
- Microbiotest Inc., Sterling, VA, USA: For Virucidal Efficacy testing.
- Retrospective or Prospective: These appear to be prospective nonclinical laboratory tests specifically conducted for the device's clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This section is Not Applicable as the studies described are non-clinical, laboratory-based performance tests of the device's physical and antimicrobial properties, not assessments requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the standardized test methods themselves.
4. Adjudication Method for the Test Set:
This section is Not Applicable for the same reasons as point 3. There is no human interpretation or adjudication required for these objective performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies presented are laboratory performance tests of the device's material properties and virucidal efficacy, not clinical studies involving human readers or patient cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This concept typically applies to AI/software as a medical device. Since the device is an N95 surgical respirator, and not an AI algorithm, this section is Not Applicable. The performance described is the standalone performance of the physical device.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Standardized Test Methods and Definitions: The "ground truth" for parameters like BFE, PFE, differential pressure, fluid penetration, and flame spread is defined by the specific ASTM, MIL, 16 CFR, and NIOSH standards and their associated methodologies.
- Laboratory-Confirmed Viral Inactivation: For virucidal efficacy, the "ground truth" is the empirically measured reduction in viable virus particles (e.g., cell culture assays) after contact with the mask material under controlled laboratory conditions, as observed and quantified by Microbiotest Inc.
8. The Sample Size for the Training Set:
This section is Not Applicable. The BioFriend™ BioMask™ N95 Surgical Respirator is a physical medical device, not an AI/machine learning model that requires a 'training set.' Its performance characteristics are determined through manufacturing specifications and subsequent testing against established standards.
9. How the Ground Truth for the Training Set Was Established:
This section is Not Applicable as there is no training set for this type of 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.