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510(k) Data Aggregation
(30 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are non-sterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains head ties, ear loops or ear bands to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex.
This document pertains to the 510(k) summary for the Savvy Mask - Level 3 Surgical Mask. The information provided is primarily focused on the device's technical and performance characteristics compared to a predicate device, rather than the evaluation of an AI or software device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Proposed Device - Savvy Mask Performance | Result |
|---|---|---|---|
| Level 3 Fluid Resistance (ASTM F1862) | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 31/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass. | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
| Differential Pressure (ASTM F2100/EN 14683:2019) | AQL 4%, single sampling plan, 29/32 pass < 5.0 mm H2O/cm² | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at <6.0 H2O/cm². Lot 1: 32/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass. (Note: Performance reported as <6.0 H2O/cm² while acceptance criteria is <5.0 H2O/cm², but the "Result" column states "Pass". This might indicate a slight discrepancy in reporting or that the predicate also passed at a similar level accepted by the FDA). | Pass |
| Class 1 Flammability (16 CFR 1610) | Class 1 < 3.5 second burn time | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610. Lot 1: Class 1, IBE; Lot 2: Class 1, IBE; Lot 3: Class 1, IBE. | Pass |
Biocompatibility Testing:
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non-Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
2. Sample Size for Test Set and Data Provenance:
The sample size for the test set varied by performance characteristic:
- For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: Three non-sequential lots were tested, with 32 units per lot, for a total of 96 units for each test.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective benchtop performance tests conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the document describes physical performance testing of a surgical mask, not a software or AI device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
This is not applicable for the described benchtop performance testing. The "acceptance criteria" themselves serve as the standard against which each test result is evaluated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a surgical mask, not an AI-assisted diagnostic or clinical decision support tool.
6. Standalone (Algorithm Only) Performance:
This is not applicable as the device is a surgical mask, not an algorithm or software. It is a passive device.
7. Type of Ground Truth Used:
The "ground truth" for the performance characteristics of the surgical mask is the measurement against established industry standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683:2019, 16 CFR 1610) and the specific acceptance criteria defined for these tests. For biocompatibility, it's the results from established biocompatibility tests (ISO 10993 series) against the criteria of non-cytotoxic, non-sensitizing, and non-irritating.
8. Sample Size for the Training Set:
This is not applicable as the device is a surgical mask and does not involve a training set as would be found in machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as above.
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