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510(k) Data Aggregation
(123 days)
The Velguard Surgical Face Mask is intended to be worn to protect 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 nonsterile.
The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Velguard Surgical Face Mask:
The document is an FDA 510(k) summary for the Velguard Surgical Face Mask (K210761). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a comprehensive clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Predicate K182515 Performance or Standard) | Reported Device Performance (Velguard Surgical Face Mask K210761) | Comparison / Outcome |
|---|---|---|---|
| Performance Testing (ASTM F2100-19 Level 3) | Subject device exceeded predicate device in one performance test. ASTM F2100-19 uses a different test method for measuring Delta-P (H2O/cm2). | ||
| Fluid Resistance (ASTM F1862) | 32/32 passed at 120 mmHg | Three lots passed at 160mm Hg | Similar; subject device exceeded fluid resistance of the predicate device. |
| Particulate Filtration Efficiency (ASTM F2299) | Pass at 99.7% @ 0.1 micron | Three lots passed at ≥98% @ 0.1 micron | Similar; both devices meet ASTM F2299. |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass at 99.9% | Three lots passed at ≥98% | Similar; both devices meet ASTM F2101. |
| Differential Pressure (EN 14683:2019, Annex C and ASTM F2100-19) | 4.0 mmH2O/cm2 (MIL-M-36954C) | Three lots passed at <5 Delta-P (mmH2O/cm2) | Similar; subject device utilized ASTM F2100-19 test methods. The value of <5 mmH2O/cm2 is the acceptance criteria for ASTM F2100 Level 3. |
| Flammability (16 CFR 1610) | Class 1 | Three lots passed – Class 1 | Same. |
| Biocompatibility (ISO 10993-1, -5, -10) | Non-cytotoxic, non-irritant, non-sensitizer | Non-cytotoxic, non-irritant, non-sensitizer | Same. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Non-clinical tests were conducted on 32 samples per lot, across three non-consecutive lots.
- Data Provenance: The document implies the data is prospective as it refers to tests conducted on the newly manufactured device. There is no explicit mention of the country of origin for the data generation, but the sponsor information indicates the manufacturer is in Tirupur, Tamil Nadu, India.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (510(k) for a surgical mask) relies on standardized laboratory testing rather than expert interpretation of images or clinical data for ground truth establishment. Therefore, there are no "experts" in the sense of clinical specialists like radiologists establishing ground truth in this context. The "ground truth" is established by the results of the specific physical, chemical, and biological tests performed according to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective, standardized laboratory results against pre-defined thresholds from consensus standards. There is no human interpretation or adjudication process for test results like one would find in a clinical study involving subjective assessments.
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 for a physical medical device (surgical face mask), not an AI/software device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established through adherence to recognized consensus standards for performance and biocompatibility (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series). These standards define the methodologies and acceptance criteria for evaluating the physical, chemical, and biological properties of surgical masks.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
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