Search Results
Found 1 results
510(k) Data Aggregation
(129 days)
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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 Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.
This document is a 510(k) Pre-Market Notification for a surgical mask, not an AI/ML device, so many of the requested categories (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable.
Here's the information based on the provided text, focusing on the acceptance criteria and performance of the Sovereign America Surgical Mask (Models 2000SM2 and 2000SM3):
1. Table of acceptance criteria and the reported device performance:
The device performance is compared against ASTM F2100-19 standards for Level 2 and Level 3 surgical masks, and against the predicate device (K160269).
Model 2000SM2 (Level 2 Performance)
| Testing Standard | Acceptance Criteria (ASTM F2100 Level 2) | Reported Device Performance (Sovereign America Surgical Mask Model 2000SM2) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29/32 pass at 120 mm Hg | 32/32 pass at 120 mm Hg |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.1 - 99.9% |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.55 - 99.91% |
| Differential Pressure (EN 14683/MIL-M-36954C) | < 6.0 mm H2O/cm² | 2.5 - 3.3 mm H2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
Model 2000SM3 (Level 3 Performance)
| Testing Standard | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Sovereign America Surgical Mask Model 2000SM3) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29/32 pass at 160 mm Hg | 31/32 pass at 160 mm Hg |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.1 - 99.9% |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.55 - 99.91% |
| Differential Pressure (EN 14683/MIL-M-36954C) | < 6.0 mm H₂O/cm² | 2.5 - 3.3 mm H₂O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
Biocompatibility Testing (Both Models)
| Testing Items | Standards | Acceptance Criteria (Implied by standard and "Pass") | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Intracutaneous Reactivity | ISO 10993-10:2010 | Non-Irritating | Pass (Non-Irritating) |
| Kligman Maximization Sensitization | ISO 10993-10:2010 | Non-Sensitizing | Pass (Non-Sensitizing) |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862):
- Model 2000SM2: "32/32 passed" (implies a sample size of 32 surgical masks for this test).
- Model 2000SM3: "31/32 passed" (implies a sample size of 32 surgical masks for this test).
- For other performance tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility), specific sample sizes are not explicitly stated in the document, beyond the implication that testing was conducted on samples of the device.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It refers to "Non-Clinical Testing" which implies laboratory testing of the physical products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical medical device (surgical mask) that undergoes laboratory performance testing against recognized consensus standards (e.g., ASTM F2100, ISO 10993), not a diagnostic algorithm requiring expert "ground truth" establishment in the traditional sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device or a diagnostic requiring adjudication of human reader interpretations. Performance is measured directly from laboratory tests.
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 surgical mask, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is defined by the recognized consensus standards themselves (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683/MIL-M-36954C, 16 CFR 1610, ISO 10993 series). The device's physical properties and performance characteristics are directly measured and compared against these predefined numerical and qualitative criteria.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable.
Ask a specific question about this device
Page 1 of 1