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510(k) Data Aggregation
(59 days)
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs 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(s) and provided non-sterile.
Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Savewo ClassicMASK:
Description of the Acceptance Criteria and Study
The Savewo ClassicMASK is a 3-layered surgical mask intended to protect both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The device underwent non-clinical testing to demonstrate its performance against established standards, specifically the ASTM F2100-19 standard for Level 3 surgical masks, and to ensure biocompatibility and flammability compliance. The study aims to prove substantial equivalence to a predicate device (Single-use Surgical Mask, K200923) by meeting the outlined acceptance criteria for various performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5:2009 - Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Sensitization | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-sensitizing | Pass (Non-sensitizing) |
| Irritation | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-irritating | Pass (Non-irritating) |
| Performance Tests | |||
| Bacterial filtration efficiency (BFE) (%) | ASTM F2101-19 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | Passed at ≥98% | Lot 1: ≥99.9%, Lot 2: ≥99.9%, Lot 3: ≥99.9% |
| Particulate filtration efficiency (PFE) (%) | ASTM F2299/F2299M-03 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Pass at ≥98% | Lot 1: ≥99.6%, Lot 2: ≥99.7%, Lot 3: ≥99.7% |
| Differential pressure (mmH2O/cm²) | MIL-M-36945C, Military Specifications: Surgical Mask, disposable | Passed at <6 mmH2O/cm² | Lot 1: <4.11 mmH2O/cm², Lot 2: <4.19 mmH2O/cm², Lot 3: <4.08 mmH2O/cm² |
| Resistance to penetration by synthetic blood (mmHg) | ASTM F1862/F1862M-17 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | Passed at 160mm Hg | Lot 1: 32 out of 32 Pass, Lot 2: 31 out of 32 Pass, Lot 3: 31 out of 32 Pass |
| Flammability | 16 CFR Part 1610 - Standard for the Flammability of Clothing Textiles | Class 1 | Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1 |
| Other Tests | |||
| Accelerated aging test | ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | (Implied conformance) | (Not explicitly detailed, but stated as conforming) |
| Transportation test | ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems | (Implied conformance) | (Not explicitly detailed, but stated as conforming) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests (BFE, PFE, Differential Pressure, Synthetic Blood Resistance, Flammability): 3 non-consecutive lots were tested for each performance characteristic. For each lot, a sample size of 32 units was used.
- Data Provenance: The document does not explicitly state the country of origin of the data. The data appears to be from prospective testing conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for surgical masks is established by objective, standardized laboratory test methods (e.g., ASTM, ISO standards) that measure physical and biological barrier properties, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective assessment or interpretation by multiple readers (e.g., medical image analysis), not for objective laboratory performance tests of physical devices. The results are obtained directly from established test procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, where the AI's effect on human reader performance is being evaluated. The Savewo ClassicMASK is a physical barrier device, and its performance is evaluated through laboratory tests, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical product (a surgical mask), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance reported is the inherent performance of the device as measured by various laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests of the Savewo ClassicMASK is based on established industry standards and regulatory requirements. For example:
- Biocompatibility: ISO 10993 series standards.
- Bacterial Filtration Efficiency (BFE): ASTM F2101-19.
- Particulate Filtration Efficiency (PFE): ASTM F2299/F2299M-03.
- Differential Pressure: MIL-M-36945C.
- Resistance to Synthetic Blood Penetration: ASTM F1862/F1862M-17.
- Flammability: 16 CFR Part 1610.
These standards define the methodologies and the acceptable performance thresholds.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The tested masks were production samples, not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this physical device.
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