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510(k) Data Aggregation
(396 days)
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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(s), provided non-sterile.
The proposed device (model: ZSFM 23) is blue color, four-layer, 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 device (model: ZSFM 24) is blue color, three-layer, 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: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device 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 polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device 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 Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Surgical Mask (Models ZSFM23 and ZSFM24)
Manufacturer: Wuhan Zonsen Medical Products Co., Ltd
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (ZSFM 23 - Level 3) | Reported Performance (ZSFM 23) | Acceptance Criteria (ZSFM 24 - Level 1) | Reported Performance (ZSFM 24) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% | ≥95% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% |
| Differential Pressure | < 6.0 mmH₂O/cm² | PASS: Lot 1: 4.86; Lot 2: 4.83; Lot 3: 4.87 (mmH₂O/cm²) | < 5.0 mmH₂O/cm² | PASS: Lot 1: 4.5; Lot 2: 4.5; Lot 3: 4.5 (mmH₂O/cm²) |
| Sub-micron Particulate Filtration Efficiency | ≥98% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% | ≥95% | PASS: Lot 1: 98.5%; Lot 2: 98.6%; Lot 3: 98.6% |
| Synthetic Blood Penetration | Pass at 160 mm Hg | PASS: Lot 1: 32/32 pass at 160 mm Hg; Lot 2: 32/32 pass at 160 mm Hg; Lot 3: 32/32 pass at 160 mm Hg | Pass at 80 mm Hg | PASS: Lot 1: 32/32 pass at 80 mm Hg; Lot 2: 32/32 pass at 80 mm Hg; Lot 3: 32/32 pass at 80 mm Hg |
| Flammability | Class 1 | PASS: Class 1 | Class 1 | PASS: Class 1 |
| Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. |
| Sensitization | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For performance tests, three non-consecutive lots were tested for each model (ZSFM23 and ZSFM24). Within each lot, a sample size of 32 was used for each performance test (BFE, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability). For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number of masks, but "the device" was evaluated.
- Data Provenance: Not specified in the provided text (e.g., country of origin for the testing facilities, specific dates). The study appears to be a prospective evaluation of newly manufactured devices/lots, rather than a retrospective analysis of existing data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This device (Surgical Mask) involves performance testing against established industry standards and biological evaluations, not diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is defined by the objective pass/fail criteria of the specified ASTM, EN, and ISO standards.
4. Adjudication Method
- Again, this is not applicable for performance testing of a physical medical device like a surgical mask. Results are determined by standardized laboratory methods and measurements, not by human expert adjudication of subjective findings.
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 AI systems that assist human interpretation (e.g., in radiology). The submitted device is a physical product (surgical mask) whose performance is evaluated against material standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm or software device. The "standalone performance" is the direct physical and biological performance of the surgical mask itself, as measured by the specified tests.
7. The Type of Ground Truth Used
- The "ground truth" for the acceptance criteria and evaluation is derived from established international standards and regulatory guidance for medical face masks. Specifically:
- ASTM F2100-20 (Standard Specification for Performance of Materials Used In Medical Face Masks)
- ASTM F1862-17 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
- EN 14683:2019 (Requirements and Test Methods of Differential Pressure of Medical Face Mask)
- ASTM F2101-19 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
- ASTM F2299-17 (Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates)
- 16 CFR Part 1610-2008 (Flammability of clothing textiles)
- ISO 10993-5:2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
- The "ground truth" is therefore objective, measurable, and defined by these recognized scientific and regulatory benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set. The masks are physical products subject to direct 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.
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