(78 days)
Aearo Surgical N95 Respirators, N9508C and N9511 are NIOSH approved N95 respirators intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.
Here's an analysis of the provided text regarding the Aearo Company N9508C and N9511C Surgical N95 Respirators, broken down into the requested sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (N9508C and N9511C) |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F-1862 @ 80 mmHg | 29 of 32 must pass (no fluid penetration) | 32 of 32 passed (no fluid penetration) |
| Flammability Class | 16 CFR 1610 | Flame spread must be within upper and lower control limits; meets Class I | No flame spread on 10 of 10 samples, meets Class I |
| Filter Efficiency | NIOSH, 42CFR Part 84 | >95% Efficient | PASS (>95% Efficient, due to NIOSH N95 approval) |
| Breathing Resistance (Exhalation) | NIOSH 42CFR Part 84 | $\le$ 25 mm H2O @ 85 lpm | PASS ($\le$ 25 mm H2O @ 85 lpm, due to NIOSH N95 approval) |
| Breathing Resistance (Inhalation) | NIOSH 42CFR Part 84 | $\le$ 35 mm H2O @ 85 lpm | PASS ($\le$ 35 mm H2O @ 85 lpm, due to NIOSH N95 approval) |
| Bacterial Filtration Efficiency | ASTM F2101-01 | >99.9% | >99.9% on all samples tested |
| Biocompatibility: Cytotoxicity | ISO-10993-1 (Agar Overlay) | Cytotoxicity score of 2 or less | Score of 0 (no detectable reactivity) |
| Biocompatibility: Sensitization | ISO-10993-1 (Closed Patch) | No visible change, Score of 0 | No visible change, Score of 0 (None of the patched animals had any visible change at the test site 48 hours after the challenge dose, using albino guinea pigs) |
| Biocompatibility: Primary Skin Irritation | ISO-10993-1 (Dermal Irritation, 16 CFR 1500 modified) | Negligible, Score of 0 | Negligible, Score of 0 (No irritation evident on intact or abraded skin after 24 or 72 hours, using 3 rabbits) |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F-1862): 32 masks tested. The provenance is not explicitly stated as retrospective or prospective, but due to it being part of a 510(k) submission for a new device, it would be considered prospective testing specifically for this device. The country of origin for the data is not specified beyond "Nelson Laboratories" which is a US-based lab.
- Flammability (16 CFR 1610): 10 samples tested. (Prospective testing by Nelson Laboratories, US).
- Filter Efficiency (NIOSH 42CFR Part 84): Not explicitly stated, but would be part of the NIOSH certification process for N95 respirators. The NIOSH approval numbers (TC-84A-4268 and TC-84A-4261) indicate the device has met these requirements. (Prospective testing, likely US-based for NIOSH certification).
- Breathing Resistance (NIOSH 42CFR Part 84): Not explicitly stated, but part of NIOSH certification. (Prospective testing, likely US-based).
- Bacterial Filtration Efficiency (ASTM F2101-01): "All samples tested," exact number not specified, but typically involves multiple replicates. (Prospective testing by Nelson Laboratories, US).
- Biocompatibility (ISO-10993):
- Cytotoxicity: "None of the mask samples tested," exact number not specified. (Prospective testing by Nelson Laboratories, US).
- Primary Skin Irritation: 3 rabbits. (Prospective testing by AppTec Laboratory Services, US).
- Delayed Hypersensitivity/Sensitization: Albino guinea pigs (number not specified, but usually several for animal studies). (Prospective testing by Northview Pacific Laboratories, US).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For this type of device (Surgical N95 Respirators), the "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM, NIOSH, ISO standards) rather than expert consensus on medical images or clinical outcomes.
- The experts involved are the qualified laboratory personnel performing these rigorous, standardized tests. Their qualifications are inherent in their ability to correctly execute these specific test methods and interpret their results according to the standards. No specific number or individual qualifications are provided for these lab personnel in the document, as the focus is on the adherence to established test methodologies.
4. Adjudication Method for the Test Set
Not applicable for this type of device testing. The results are quantitative measurements or direct observations (e.g., presence/absence of fluid penetration, flame spread, irritation) that either meet or do not meet predefined criteria. There is no subjective interpretation requiring an adjudication process.
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 is relevant for diagnostic devices that rely on human interpretation, often with AI assistance, rather than for performance testing of physical protective equipment.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical N95 respirator, not an algorithm or AI system. The performance tests are themselves "standalone" in the sense that they measure the physical properties and performance of the respirator without a human-in-the-loop component for interpreting the device's function.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on:
- Standardized Test Methodologies: The acceptance criteria and performance measurements are derived directly from established international and national standards (ASTM, NIOSH, ISO, CFR) for the performance of medical devices and personal protective equipment.
- Physical Measurements and Chemical/Biological Assays: The ground truth is confirmed through objective laboratory measurements and assays (e.g., measuring pressure drop, bacterial filtration efficiency, observing fluid penetration, analyzing cellular reactions).
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (respirator), not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
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.