(119 days)
The Wellmien Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices.
Acceptance Criteria and Device Performance Study for Wellmien Surgical Mask (K101000)
This document describes the acceptance criteria and the study performed to demonstrate that the Wellmien Surgical Mask meets these criteria, as presented in the 510(k) submission K101000.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance of the predicate device (K060776) and relevant consensus standards. The study aimed to demonstrate substantial equivalence by showing comparable performance.
| Test | Acceptance Criteria (Predicate Device K060776) | Reported Device Performance (Wellmien Surgical Mask) | Status |
|---|---|---|---|
| Fluid Resistance Performance | Fluid Resistance | Fluid Resistance | Met |
| Particle Filtration Efficiency (PFE) | 96.8% | 99.8% | Met |
| Bacteria Filtration Efficiency (BFE) | At least 99.9% | 99.9% | Met |
| Differential Pressure (Delta P) | Average 2.34 (mm Water/cm²) | 3.7-4.0 (mm Water/cm²) | Met |
| Flammability | Class 1 None Flammable | Class 1 None Flammable | Met |
| Biocompatibility | Biocompatible | Biocompatible | Met |
Note on Acceptance Criteria: For some tests like Fluid Resistance and Biocompatibility, the acceptance criterion is a qualitative assessment (e.g., "Fluid Resistance" or "Biocompatible") rather than a specific numerical threshold explicitly stated as separate acceptance criteria for the predicate device within this document. The study demonstrates that the Wellmien device also meets this qualitative assessment. For Delta-P, the Wellmien device's measured range falls within a generally acceptable range for surgical masks and is considered comparable to the predicate device, even if the average numerical value is different.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards would inherently specify sample sizes for each test.
The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing facilities or contract labs. The study is a retrospective evaluation based on laboratory bench testing of the finished device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation involved objective laboratory performance tests against established standards, not interpretation by human experts to establish ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective clinical or imaging studies involving human readers. This information is not applicable as the study involved objective laboratory performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a physical device like a surgical mask.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study is typically associated with AI/software algorithms. This information is not applicable as the device is a physical surgical mask, and its performance is evaluated through material and filtration characteristics, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance tests was established by objective laboratory measurements against the specified consensus standards (e.g., ASTM F2101-07 for BFE, ASTM F2299-03 for PFE, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility, ASTM F1682-07 for fluid resistance). The performance of the predicate device also serves as a benchmark for substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable. The Wellmien Surgical Mask is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.