(10 days)
The various models of Inovel/Cardinal Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are 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 Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from 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 (for double headband) and polyester elastic (for single head strap) which is sewn to the mask. The inside nosepiece is a closed cell foam.
Here's an analysis of the provided 510(k) summary for the Inovel Health Care N95 Particulate Respirators and Surgical Masks, answering your questions:
Acceptance Criteria and Device Performance Study for Inovel Health Care N95 Particulate Respirators and Surgical Masks
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristics | Test Method | Acceptance Criteria | Reported Device Performance (Inovel Health Care N95) |
|---|---|---|---|
| Fluid Resistance (mmHg) | ASTM 1862 - 00a @ 160 mm Hg | 29 of 32 pass | 29 of 32 pass / 32 of 32 pass (depending on interpretation of combined results) |
| Flammability Class | 16 CFR 1610 | Flame spread must be within upper and lower limits / No flame spread on 10 of 10 samples | No flame spread on 10 of 10 samples, meets Class I |
| Filter Efficiency (%) | NIOSH, 42 CFR Part 84 | > 95% Efficient | average 99.11% efficient of 20 samples (model 3000N95-XS) |
| Breathing Resistance (mm H2O) | NIOSH, 42 CFR Part 84 | ≤ 35.0 mm H2O @ 85 lpm | average 3.5 mm H2O @ 85 lpm of 3 samples |
| Biocompatibility: Cytotoxicity | ISO 10993 – 1 (specifically -5) | Score of 2 or less | Score of 0 |
| Biocompatibility: Sensitization | ISO 10993 – 1 (specifically -10) | Grade 1 (no different than control) | Grade 1 |
| Biocompatibility: Irritation | ISO 10993 – 1 (specifically -10) | Negligible | Negligible |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples (test set for Inovel device). Data provenance is not explicitly stated as country of origin, but the tests were performed by "Nelson Laboratories." This indicates a third-party laboratory testing. The study is prospective in the sense that these specific devices were manufactured and then tested.
- Flammability: 10 samples. Data provenance: "Nelson Laboratories."
- Filter Efficiency: 20 samples (for model 3000N95-XS). Data provenance: "NIOSH."
- Breathing Resistance: 3 samples. Data provenance: "NIOSH."
- Biocompatibility (Cytotoxicity, Sensitization, Irritation): The specific sample sizes for these tests are not provided in the document. Data provenance: "Nelson Laboratories" and "Northview Pacific Laboratories, Inc. (Coordinated by Nelson Laboratories)".
This is a premarket notification for a medical device; therefore, the studies are inherently prospective, conducted specifically to demonstrate substantial equivalence for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission for a medical face mask does not involve "expert consensus" for establishing ground truth in the way a diagnostic imaging AI algorithm would. Instead, the "ground truth" is established by adherence to recognized, validated standards and test methods (e.g., ASTM, NIOSH, ISO). The "experts" are the certified laboratories and their operators who perform these standardized tests according to established protocols. Their qualification is implicit in their accreditation and ability to perform these specific standard tests.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation). For the performance metrics of a medical face mask, the tests are objective and quantitative based on standardized protocols (e.g., measuring filter efficiency, fluid penetration). Therefore, an "adjudication method" as you've defined it is not applicable here. The results are directly measured and compared against the acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not applicable to this type of device (N95 respirator and surgical mask). These studies are typically used to evaluate the diagnostic performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. This submission focuses on the physical and functional performance characteristics of the mask itself.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" usually refers to AI algorithms, in the context of this device, the performance characteristics (filter efficiency, breathing resistance, fluid resistance, flammability, biocompatibility) are all objectively measured by the device alone using standardized methods. There is no "human-in-the-loop" aspect to these physical performance tests. Therefore, all reported performance data effectively represent "standalone" device performance relative to its specified mechanical and material properties.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective, standardized test methods and established regulatory requirements. This includes:
- Physical/Mechanical Test Standards: ASTM F 1862 (Fluid Resistance), 16 CFR 1610 (Flammability).
- Functional Performance Standards: NIOSH 42 CFR Part 84 (Filter Efficiency and Breathing Resistance) for N95 certification.
- Biocompatibility Standards: ISO 10993 – 1, -5, -10 (Cytotoxicity, Sensitization, Irritation).
The "ground truth" is whether the device successfully meets these universally accepted and quantitatively defined standards.
8. The Sample Size for the Training Set
This submission is for a physical medical device (mask) and not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and manufacturing processes are developed through engineering and materials science, not by training on data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable to the Inovel Health Care N95 Particulate Respirators and Surgical Masks.
§ 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.