(142 days)
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are in comparison to predicate devices, rather than explicit numerical thresholds. The study demonstrates performance comparable to or better than these predicates.
| Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (American Threshold Fluid Resistant Mask) |
|---|---|
| Water Resistance (Impact Penetration Test) | |
| Average % increase in blotter weight (compared to Tecnol Fluid Resistant Mask) | 2.64% (Study 1), 9.15% (Study 2) |
| Differential Pressure (Delta P Test) | |
| Average differential pressure (compared to Tecnol Fluid Resistant Mask) | 2.19 (Study 1), 2.54 (Study 2) |
| Latex Particle Challenge (Filtration Efficiency) | |
| 1.0 micron particle size filtration efficiency (compared to predicate claim of >95%) | Polyolefin Inner Facing: 99.3% |
| Cellulosic Inner Facing: 99.2% | |
| 0.1 micron particle size filtration efficiency (compared to predicate claim of >95%) | Polyolefin Inner Facing: 98.4% |
| Cellulosic Inner Facing: 99.2% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of masks tested) for each experiment (Water Resistance, Differential Pressure, Latex Particle Challenge). It only reports averages.
- Data Provenance: The studies were performed by Nelson Laboratories, a third-party testing facility. The data provenance (country of origin, retrospective/prospective) is not specified beyond this. Given the context of a 510(k) submission, these would be prospective tests conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical product (fluid-resistant mask) and its performance is evaluated through objective laboratory tests against established standards or predicate devices, not by expert interpretation or consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.
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 document describes a physical medical device (fluid-resistant mask), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device. The "standalone" performance refers to the mask's inherent physical properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through standardized laboratory testing procedures and comparison to the performance of legally marketed predicate devices.
- Water Resistance: Measured by the percent increase in blotter weight after water impact.
- Differential Pressure: Measured as the air exchange differential (Delta P).
- Latex Particle Challenge: Measured by the filtration efficiency for specific particle sizes.
The predicate devices (Tecnol Fluid Resistant Surgical Mask K874608 and 3M Fluid Resistant Mask K910110) serve as the benchmark for "truth" in terms of acceptable market performance. The text also mentions that the masks filter "at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes," implying this is a general performance claim for such masks, which the new device meets or exceeds.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI algorithm involved, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.