(51 days)
The A Plus International, Inc. Solution Face Masks are designed as surgical apparel medical devices that are intended to fully cover the nose and mouth for infection control, and to be worn (for example) by operating room personnel during surgical procedures, so as to protect both the surgical patient as well as operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Solution Face Masks may be used as isolation masks, procedure masks, or dental face masks, but not as combination surgical and respirator masks. Solution Face Masks are intended as single use disposable devices and not intended for reuse of any kind.
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This document is a 510(k) premarket notification acceptance letter for a medical device (face masks). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This letter primarily focuses on the FDA's "substantial equivalence" determination to a legally marketed predicate device, indicating that the new device has similar technological characteristics and is safe and effective for its intended use. It does not elaborate on the specific performance studies and their results beyond stating that an equivalence determination has been made based on the submitted information.
§ 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.