(216 days)
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
Here's an analysis of the acceptance criteria and study information for the Actiprotect™ UF N95 Respirator, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fluid Penetration Resistance Standard (ASTM F1862) | Passed ASTM F1862 |
| Particulate Filtration Efficiency Standard (NIOSH 42 CFR 84.181) | Filters at least 95% of particulates (inherent to N95 classification) and passed NIOSH 42 CFR 84.181 |
| Bacterial Filtration Efficiency (BFE) Standard (MIL M36954C, ASTM F2101) | Passed MIL M36954C, ASTM F2101 |
| Flammability Standard (16 CFR 1610) | Passed 16 CFR 1610 |
| Breathing Resistance Standard (NIOSH 42 CFR 84.180) | Passed NIOSH 42 CFR 84.180 |
| Inactivation of Influenza A viruses (specific to Virucoat™) | Kills (inactivates) 99.99% of influenza A viruses (tested against H1N1, including 2009 pandemic strain) within one minute of contact with the surface. In vitro tests demonstrated 99.99% inactivation against various Influenza A and B strains (H1N1, H2N2, H3N2, H5N1, H5N9, and Influenza B strains) under tested contact conditions. |
| Biocompatibility (Cytotoxicity and Human Repeated Insult Patch Testing) | No adverse reactions reported during human repeated insult patch tests; no evidence of sensitization or irritation. Cytotoxicity tests (mentioned in conclusions) indicated safety. Product is safe for use in the intended application (based on cytotoxicity, patch tests, and toxicological review of ingredients). |
Study Information
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Sample Size used for the test set and the data provenance:
- Fluid Penetration Resistance (ASTM F1862): Not specified.
- Particulate Filtration Efficiency (NIOSH 42 CFR 84.181): Not specified.
- Bacterial Filtration Efficiency (MIL M36954C, ASTM F2101): Not specified.
- Flammability (16 CFR 1610): Not specified.
- Breathing Resistance (NIOSH 42 CFR 84.180): Not specified.
- Influenza Virus Inactivation (In vitro): Not specified.
- Human Repeated Insult Patch Tests: Not specified.
- Data Provenance: The document indicates that the tests (Fluid Penetration, Particulate Filtration, Bacterial Filtration, Flammability, Breathing Resistance) are standardized tests (e.g., ASTM, NIOSH, MIL). The Human Repeated Insult Patch Tests are clinical tests conducted, but the location or specific institution is not mentioned, so the country of origin is unknown. The influenza inactivation tests were performed "in vitro (laboratory) tests."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not directly applicable to the types of tests reported. The studies described are primarily bench/laboratory tests (e.g., filtration efficiency, fluid penetration, flammability, virus inactivation) adhering to standardized protocols, and biocompatibility tests (human repeated insult patch tests). These types of tests do not typically involve human experts establishing a "ground truth" in the way an imaging study or diagnostic accuracy study would. The pass/fail criteria are defined by the standards themselves.
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Adjudication method for the test set:
- Not applicable as the tests are objective, standardized measurements with predefined pass/fail criteria. There isn't a subjective "assessment" by experts that would require adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection."
- Effect size of human readers improvement: Not applicable, as no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical N95 respirator, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance tests described (filtration, resistance, flammability, virus inactivation, biocompatibility) are inherent to the physical device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests (filtration, fluid resistance, etc.), the "ground truth" is defined by the established criteria of the standardized test methods (e.g., ASTM, NIOSH, MIL standards). A device "passes" if its measured performance meets or exceeds these pre-defined thresholds.
- For the influenza inactivation, the "ground truth" is the measured viral reduction percentage (99.99%) in controlled in vitro laboratory conditions, compared against a baseline.
- For the biocompatibility tests, the "ground truth" for safety is the absence of adverse reactions (sensitization or irritation) in human subjects and the results of cytotoxicity tests.
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The sample size for the training set:
- This question is not applicable to the device described. The Actiprotect™ UF N95 Respirator is a physical medical device, not a machine learning algorithm that requires a "training set" of data.
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How the ground truth for the training set was established:
- 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.