(316 days)
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).
The provided text is a 510(k) summary for the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on laboratory performance testing rather than studies involving AI or human readers for diagnostic purposes.
Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria, in the context of an AI/human reader diagnostic device, cannot be extracted from this document. The document describes acceptance criteria and testing for a medical face mask, not a diagnostic AI device.
However, I can provide the acceptance criteria and the (laboratory) study results for the medical face mask as presented in the document:
1. A table of acceptance criteria and the reported device performance
Based on the "TABLE V: STANDARDS AND ACCEPTANCE CRITERIA" and the statement "The device met the acceptance criteria for both production lots and artificially aged samples" in the document, we can infer that the reported performance met these criteria. The document does not provide specific numerical results for each test, only that the acceptance criteria were met.
| Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|---|
| Bacterial filtration Efficiency (BFE) | ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | ≥ 98% | Met Criteria (≥ 98%) |
| Sub-micron particulate efficiency at 0.1 µm (PFE) | ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | ≥ 98% | Met Criteria (≥ 98%) |
| Blood Penetration | ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | @160 mm Hg | Met Criteria (@160 mm Hg) |
| Differential Pressure | EN 14683:2019 Annex C: Medical face masks - Requirements and test methods |
§ 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.