(714 days)
The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single-use only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
The KNH Surgical Face Mask (Models 1MMAB50DM2 (Level 1) and 1MMAB50DM3 (Level 2)) underwent non-clinical testing to demonstrate substantial equivalence to the predicate device K160269. The acceptance criteria and reported device performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | To ensure adequate resistance to fluids | 1MMAB50DM2 (Level 1): At least 29/32 pass at 80 mmHg for three non-consecutive lots | ||
| 1MMAB50DM3 (Level 2): At least 29/32 pass at 120 mmHg for three non-consecutive lots | Pass | Pass | ||
| Particulate Filtration Efficiency ASTM F2299 | To demonstrate adequate resistance to particulate transmission | 1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots | ||
| 1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots | Pass at Avg. 99.49 % (Level 1) | |||
| Pass at Avg. 99.31% (Level 2) | Pass | |||
| Bacterial Filtration Efficiency ASTM F2101 | To demonstrate adequate resistance to bacterial penetration | 1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots | ||
| 1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots | Greater than 99% (Level 1) | |||
| Greater Than 99% (Level 2) | Pass | |||
| Differential Pressure Mil M36945 Appendix C | To demonstrate adequate breathability | 1MMAB50DM2 (Level 1): At least 29/32 pass at 5 mmH₂O/cm² or less for three non-consecutive lots | ||
| 1MMAB50DM3 (Level 2): At least 29/32 pass at 6 mmH₂O/cm² or less for three non-consecutive lots | Pass at 2.5 to 2.9 mmH₂O/cm² (Level 1) | |||
| Pass at 2.7 to 3.7 mmH₂O/cm² (Level 2) | Pass | |||
| Flammability 16 CFR 1610 | To demonstrate adequate flammability resistance | At least 29/32 samples at class 1 | Class 1 | Pass |
| Biocompatibility Skin Sensitization ISO 10993-10 | To demonstrate low skin sensitization potential | Under the conditions of the test, not a sensitizer | Under the conditions of the study, not a sensitizer | Pass |
| Biocompatibility Skin Irritation 10993-10 | To demonstrate low skin irritation potential | Under the conditions of the test, not an irritant | Under the conditions of the study, not an irritant | Pass |
| Biocompatibility Cytotoxicity 10993-5 | To demonstrate low cytotoxicity | Under the conditions of the test, non-cytotoxic | Under the conditions of the study, non-cytotoxic | Pass |
2. Sample size used for the test set and the data provenance:
The document states criteria like "At least 29/32 pass at [value] for three non-consecutive lots" for several tests. This implies that for each of these tests, a sample size of 32 units per lot was used, and this was repeated for at least three non-consecutive lots. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, as these are technical performance tests on the manufactured device itself, rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission is for a surgical face mask and relies on objective, standardized laboratory performance tests according to established ASTM, Mil, and ISO standards, not expert interpretation of subjective data or images.
4. Adjudication method for the test set:
Not applicable. As noted above, the tests are objective laboratory performance measures with predefined pass/fail criteria, not subjective assessments requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a submission for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic or software-based device.
7. The type of ground truth used:
The ground truth for device performance is established by objective, standardized measurements against predefined values and criteria as specified in the referenced ASTM, Mil, and ISO standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency, ASTM F2101 for bacterial filtration efficiency, Mil-M-36945C Appendix C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993-5 and ISO 10993-10 for biocompatibility).
8. The sample size for the training set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The manufacturing process and material selection are validated through quality control and adherence to standards.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device. The quality and performance are established through adherence to manufacturing specifications and testing against recognized industry standards.
§ 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.