(199 days)
This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.
The provided text describes the acceptance criteria and performance of the CiRx® Surgical Mask based on non-clinical testing. It does not mention any studies involving AI, human readers with or without AI assistance, or the creation of ground truth by experts in a clinical context. Therefore, many of the requested fields cannot be filled from the given document.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Test (Test Methodology) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Synthetic Blood Penetration Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | Pass at 160 mmHg. Synthetic blood penetration was not seen. Four lots were tested, with 32 out of 32 passing for each lot. |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | Pass, ≥ 99.7%. Four lots were tested. |
| Particle Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% | Pass, ≥ 99.814%. Four lots were tested. |
| Differential Pressure (Delta P) (ASTM F2100-19) |
§ 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.