(111 days)
The Surgical Face Mask is intended for single use by operation 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 Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.
This document is a 510(k) Premarket Notification for a Surgical Face Mask. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in AI/ML medical device submissions. However, this document is for a physical medical device (a surgical face mask), not an AI/ML device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable and are not present in the provided text.
This document focuses on the performance of the surgical face mask based on established ASTM and ISO standards for biocompatibility and barrier protection.
Here's a breakdown of the available information based on your request, with a clear indication of what is not applicable for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides two tables: "Table 1 Summary of Biocompatibility Test Results" and "Table 2 Summary of Performance Testing".
Table 1: Summary of Biocompatibility Test Results
| Test/Purpose | Test Method/Standard | Acceptance Criteria | Result |
|---|---|---|---|
| In Vitro Cytotoxicity Test | ISO 10993-5: 2009 | Reduction of cell viability shall be not more than 30%. | Passed: No Cytotoxicity Observed |
| Skin Sensitization Test | ISO 10993-10: 2010 | The skin reactions grades shall be less than 1. | Passed: No Skin Sensitization Observed |
| Skin Irritation Test | ISO 10993-10: 2010 | The irritation response category shall be slight or less. | Passed: No Skin Irritation Observed |
Table 2: Summary of Performance Testing (for Level 2 Mask - as per ASTM F2100-19)
| Performance Test/Purpose | Test Standard | Acceptance Criteria | Test Results (Lot #1) | Test Results (Lot #2) | Test Results (Lot #3) |
|---|---|---|---|---|---|
| Bacterial Filtration | ASTM F2101-2019 | Level 2: >98% | MIN: 98.99% AVG: 99.53% | MIN: 98.46% AVG: 99.10% | MIN: 98.36% AVG: 99.2% |
| Differential Pressure | EN 14683 Annex C | Level 2: 98% | MIN: 98.99% AVG: 99.58% | MIN: 98.30% AVG: 99.25% | MIN: 98.45% AVG: 99.11% |
| Resistance to Penetration | ASTM F1862/F1862M-17 | Level 2: 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg |
| Seal strength of immediate package | ASTM F88/F88M-15 | Seal strength >= 2N/15mm | MIN: 2.2 AVG: 3.04 | MIN: 3.2 AVG: 3.54 | MIN: 2.2 AVG: 2.9 |
| Seal leak of immediate package | ASTM F1929-15 | No apparent solution channel through the whole seal edge in the whole seal area | No | No | No |
| EO ECH Residue | ISO 10993-7:2008 | EO residue |
§ 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.