Search Results
Found 1 results
510(k) Data Aggregation
(101 days)
The Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) 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 a single use, disposable device(s), provided non-sterile.
The proposed device (model: 15604F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15704F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15604F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15704F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and performance data for a Level 3 Fluid Resistant Procedure/Surgical Mask (models 15604F, 1570F). This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Result 1 (Model: 15604F) | Result 2 (Model: 15704F) |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.5%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.74%, Lot2: 99.85%, Lot3: 99.85% for 3 non-consecutive lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.4%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.7%, Lot2: 99.8%, Lot3: 99.7% for 3 non-consecutive lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | < 6.0 mmH2O/cm² | PASS (Lot1: 4.57 mmH2O/cm², Lot2: 4.72 mmH2O/cm², Lot3: 4.72 mmH2O/cm² for 3 non-consecutive lots) | PASS (Lot1: 4.60 mmH2O/cm², Lot2: 4.70 mmH2O/cm², Lot3: 4.70 mmH2O/cm² for 3 non-consecutive lots) |
| Flammability (16 CFR 1610) | Assess the resistance of a mask to ignition | Class 1 | PASS (Class 1 for 3 non-consecutive lots) | PASS (Class 1 for 3 non-consecutive lots) |
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) | PASS (Under the conditions of the study, the device is non-irritating.) |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability tests, a sample size of 32 per lot was used, across 3 non-consecutive lots.
- For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number but the results indicate "Under the conditions of the study."
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications and was similar to the predicate device. The document does not specify the country of origin of the test data or explicitly state whether the studies were retrospective or prospective, but these are standard laboratory tests conducted to evaluate product performance. Given the context of a 510(k) submission, these are typically prospective tests conducted on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for the performance of a surgical mask is established by validated standardized testing methods (e.g., ASTM, EN, ISO standards), not by expert consensus in a medical imaging or diagnostic sense. The results are quantitative measurements against predefined criteria.
4. Adjudication method for the test set
This information is not applicable. As these are objective, quantitative laboratory tests based on recognized standards, an adjudication method for reconciling expert opinions is not relevant. The results are measured values compared against specific acceptance criteria.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical imaging) where human interpretation is involved. For a surgical mask, the performance is evaluated through physical and biological laboratory tests, not human interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical medical product (a surgical mask), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective measurements against established industry standards and regulatory requirements. These include:
- ASTM F1862 (Fluid Resistance)
- ASTM F2299 (Particulate Filtration Efficiency)
- ASTM F2101 (Bacterial Filtration Efficiency)
- EN 14683 Annex C (Differential Pressure)
- 16 CFR 1610 (Flammability)
- ISO 10993 (Biocompatibility - Cytotoxicity, Irritation, Sensitization)
8. The sample size for the training set
Not Applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product subject to standardized performance testing.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for this type of device, the concept of establishing ground truth for a training set does not apply.
Ask a specific question about this device
Page 1 of 1