(356 days)
Earloop Mask and Tie-On Mask is intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.
Earloop Mask and Tie-On Mask is a single use non-sterile three layer mask with outer layer (Layer #1) and inner layer (Layer #3) made of spunbound polypropylene and a middle layer (Layer #2) made with meltblown polypropylene filter. Layer #1 has either no pigment (White) or a pigment (Either Blue or Green). There are 2 options for the mask to be secured on the user, either earloops or 2 sets of ties. Earloops are made of urethane elastic fiber and the ties are made of spunbound polypropylene. The nosepiece is a pliable aluminum strip covered by a polypropylene spunbound material and is encased between Layers # 1 and 2 and is affixed in place by ultrasonic heat seal. The three layers of material are pleated 3 times and Layer #3 is folded over the two other layers in front of the Layer #1. An edge material with 30 gsm spunbound polypropylene material is wrapped around the 3 layers at the 2 lateral edges. All 4 edges are ultrasonically heat sealed and ties or earloops are attached inside the edge material and ultrasonically heat sealed. All of the materials in the Standard Earloop Mask and the Standard Tie-On Mask are latex free. All materials are being used in currently marketed devices.
The provided document is a 510(k) Summary for the Protect U Guard Earloop and Tie-On Mask. It details the device's characteristics and performance to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards and outlined in the "Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions."
| Acceptance Criteria (Standard) | Reported Device Performance | Does Device Meet Criteria? |
|---|---|---|
| Fluid Resistance: ASTM F1862/F1862M 13 at 80 mm Hg | Passed 29 of 32 (Conforms to standard for fluid resistance at 80mm Hg) | Yes |
| Bacterial Filtration Efficiency (BFE): ASTM F2101 14 | 99.17% (Conforms to standard) | Yes |
| Differential Pressure (Delta-P) / Air Exchange: MIL-M-36954C | 3.79 mmH2O/cm² (Corresponds to a comfort level of warm, conforms to standard) | Yes |
| Particulate Filtration Efficiency (PFE): ASTM F2299/F2299M 03 (2010), 0.1 micron particles | 99.18% (Conforms to standard) | Yes |
| Flammability: 16 CFR Part 1610 (Class 1) | Passed as a Class 1 (Conforms to standard) | Yes |
| Biocompatibility: ISO 10993 Part 5 (cytotoxicity) | Non-cytotoxic (Conforms to standard) | Yes |
| Biocompatibility: ISO 10993 Part 10 (irritation) | Non-irritating (Conforms to standard) | Yes |
| Biocompatibility: ISO 10993 Part 10 (skin sensitization) | Non-sensitizing (Conforms to standard) | Yes |
| Latex: ASTM D6499-12 (Not made with natural rubber latex) | Not made with natural rubber latex (Conforms to standard) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples were tested for fluid resistance ("passed 29 of 32").
- For other tests (BFE, Delta-P, PFE, Flammability, Biocompatibility, Latex), specific sample sizes are not explicitly stated in the provided document. The document usually states "Tested at..." or "result was...", implying that testing was performed, but the number of units/samples involved for each test is generally missing.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that these are performance tests for a new device submission, it's highly probable they were prospective studies conducted specifically for this submission. The "Nelson Labs report following" for flammability suggests an independent testing laboratory was used, which is common for such evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the studies described are performance tests against established scientific and engineering standards for medical devices (e.g., ASTM, ISO, CFR, MIL-M). The "ground truth" for these tests isn't established by expert consensus on clinical cases, but rather by the objective measurement against predefined technical specifications and thresholds within these standards.
4. Adjudication Method for the Test Set
This is not applicable for this type of device and performance testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where human readers independently evaluate medical images or clinical data, and a disagreement resolution process is needed. Here, the tests are objective measurements of physical and filtration properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant for a surgical mask.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical surgical mask, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for these tests is based on objective measurements against established criteria and thresholds defined by recognized industry standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE, MIL-M-36954C for Delta-P, ASTM F2299 for PFE, 16 CFR Part 1610 for flammability, ISO 10993 for biocompatibility, ASTM D6499 for latex). These standards themselves provide the "ground truth" for what constitutes acceptable performance for a surgical mask.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (surgical mask), not an AI/ML algorithm that requires a training set. The descriptions are for product performance verification.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of 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.