(42 days)
The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
The provided document is a 510(k) summary for the Moldex-Metric Model 1712 N95 Healthcare Particulate Respirator and Surgical Mask. It describes the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Device Performance (Model 1712) |
|---|---|---|---|
| Fluid Resistance | ASTM 1862 - 00a | 32 of 32 pass | 32 of 32 pass |
| Flammability | 16 CFR 1610 | Flame spread must be within upper and lower limits / No flame spread on 10 of 10 samples, meets Class I | No flame spread on 10 of 10 samples, meets Class I |
| Filter Efficiency (%) | NIOSH, 42 CFR Part 84 | > 95% Efficient | Average 98.95% efficient of 20 samples |
| Inhalation Breathing Resistance (mm H2O) | NIOSH, 42 CFR Part 84 | 99.9% | > 99.9% |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples were tested. Data provenance is not explicitly stated (e.g., country of origin), but the test was conducted in accordance with ASTM F 1862, a recognized international standard. The test appears to be prospective for the Model 1712.
- Flammability: 10 samples were tested. Data provenance is not explicitly stated, but the test was conducted in accordance with 16 CFR 1610. The test appears to be prospective for the Model 1712.
- Filter Efficiency: 20 samples were tested. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
- Breathing Resistance (Inhalation and Exhalation): 3 samples were tested for each. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
- Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): The document states these tests were conducted on predicate devices made from the same material. The specific number of samples for these predicate device tests is not detailed in this summary.
- Bacterial Filtration Efficiency: The document states this test was conducted using the Modified Greene and Vesley Method. The specific sample size is not detailed for the Model 1712 directly, but it indicates "Greater than 99.9%" results derived from "Test results show a bacterial filtration efficiency greater than 99.9%." It also notes that this test was "conducted using the Modified Green and Vesley Method... for the predicate devices."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes the performance testing of a physical device (respirator mask) against established technical standards and regulatory requirements. It does not involve human expert interpretation of medical images or data where "ground truth" is established by medical experts in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective measurement against specified physical and biological performance standards.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements and compliance with numerical or categorical standards (e.g., "32 of 32 pass," ">95% efficient," "Score of 0"). There is no subjective interpretation requiring an adjudication process for consensus among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a physical product (respirator mask), not an AI algorithm for diagnostic interpretation that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the device's performance was evaluated in a standalone manner against objective performance criteria. The tests (fluid resistance, flammability, filter efficiency, breathing resistance, biocompatibility, bacterial filtration efficiency) assess the physical and biological characteristics of the mask itself, without human-in-the-loop performance being a variable in these specific tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described are:
- Objective physical and biological measurements: This includes quantified values (e.g., percentage efficiency, pressure measurements in mm H2O) and qualitative assessments (e.g., pass/fail for fluid resistance, flame spread classification, biocompatibility scores) against established industry and regulatory standards (ASTM, NIOSH, CFR, ISO).
- Predicate device performance data: For some tests (like biocompatibility and bacterial filtration efficiency), the ground truth for the new device's substantial equivalence is established by demonstrating that it performs similarly to or better than a legally marketed predicate device, which itself met regulatory ground truth requirements.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and the testing described does not involve machine learning or AI that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.