(181 days)
The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.
The provided text is a 510(k) Summary for a Surgical Mask (K210908). This document describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based medical device.
Therefore, the information requested in your prompt regarding acceptance criteria and study proving an AI/ML device meets them (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on the physical and biological performance characteristics of the surgical masks. Here's a breakdown of the relevant information provided in relation to performance, but specifically for a surgical mask, not an AI device:
1. Table of acceptance criteria and reported device performance (for the Surgical Mask):
| Test | Acceptance Criteria | Reported Device Performance (Surgical Mask) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Viability $\geq$ 70% of blank | Viability of tested samples (PRS-WK002, PRS-WK017) $\geq$ 70% of the blank. 50% extract had higher viability than 100% extract. (Non-cytotoxic) |
| Sensitization | Non-sensitizing | No evidence of causing delayed dermal contact sensitization in guinea pigs for tested samples (PRS-WK002, PRS-WK017). (Non-sensitizing) |
| Irritation | Non-irritating | Irritation response category for tested samples (PRS-WK002, PRS-WK017) was Negligible for polar and non-polar extracts. (Non-irritating) |
| Performance Testing | ||
| Resistance to Penetration by Synthetic Blood (at 120 mmHg) | No penetration at 120 mmHg | Sterile Ear loop Non-edging (PRS-WK002): Pass at 120mmHg for 3 lots. |
| Non-sterile Ear loop Non-edging (PRS-WK017): Pass at 120mmHg for 3 lots. | ||
| Particulate Filtration Efficiency (PFE) | $\geq$98% | Sterile Ear loop Non-edging (PRS-WK002): 98.19%, 98.20%, 98.24% for 3 lots (Average 98.21%). |
| Non-sterile Ear loop Non-edging (PRS-WK017): 98.22%, 98.16%, 98.22% for 3 lots (Average 98.20%). | ||
| Bacterial Filtration Efficiency (BFE) | $\geq$98% | Sterile: Average 99.64%. |
| Non-sterile: Average 99.60%. | ||
| Individual lot results provided were all >99.5%. | ||
| Differential Pressure |
§ 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.