(12 days)
The various models of Inovel 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 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.
Analysis of Inovel Healthcare N95 Particulate Respirators and Surgical Masks (K061859)
This document describes the acceptance criteria and the study that proves the Inovel Healthcare N95 Particulate Respirators and Surgical Masks (models 1511, 1512, 1513, & 1517) meet those criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance | ASTM 1862 - 00a | For models 1511, 1513, 1517: 32 of 32 pass. For model 1512: 31 of 32 pass. | Models 1511, 1513, and 1517: 32 of 32 pass. Model 1512: 31 of 32 pass. |
| Flammability Class | 16 CFR 1610 | Flame spread must be within upper and lower limits/ No flame spread (meets Class I). | No flame spread on 10 of 10 samples, meets Class I. |
| Filter Efficiency (%) | NIOSH, 42 CFR Part 84 | > 95% Efficient | Average 98.58% efficient of 17 samples. |
| Breathing Resistance (mm H2O) | NIOSH, 42 CFR Part 84 | ≤ 35.0 mm H2O @ 85 lpm | Average 10.3 mm H2O @ 85 lpm of 3 samples. |
| Biocompatibility (Cytotoxicity) | ISO 10993 - 1/5 | Score of 2 or less (Predicate device acceptance criteria). Same as predicate device's accepted score. | Score of 0 (from predicate device, as testing was done on same material). |
| Biocompatibility (Sensitization) | ISO 10993 - 1/10 | Grade 1 (no different than control) (Predicate device acceptance criteria). Same as predicate device's accepted grade. | Grade 1 (from predicate device, as testing was done on same material). |
| Biocompatibility (Primary Skin Irritation) | ISO 10993 - 1/10 | Negligible (Predicate device acceptance criteria). Same as predicate device's accepted finding. | Negligible (from predicate device, as testing was done on same material). |
| Bacterial Filtration Efficiency | Modified Greene and Vesley Method. J Bacteriol 83:663-667 | Test results show a bacterial filtration efficiency greater than 99.9%. | Greater than 99.9%. |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance:
- Models 1511, 1513, 1517: 32 samples.
- Model 1512: 32 samples.
- Provenance: Testing was conducted by Inovel LLC. The data is based on direct testing of the devices.
- Flammability: 10 samples.
- Provenance: Testing was conducted by Nelson Laboratories. The data is based on direct testing of the devices.
- Filter Efficiency: 17 samples.
- Provenance: NIOSH, 42 CFR Part 84. The data is based on direct testing of the devices.
- Breathing Resistance: 3 samples.
- Provenance: NIOSH, 42 CFR Part 84. The data is based on direct testing of the devices.
- Biocompatibility: Not explicitly stated for specific test set. The submission states, "Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission." This implies that the biocompatibility data is derived from the predicate device's testing using identical materials.
- Provenance: Nelson Laboratories, Northview Pacific Laboratories, Inc. (Coordinated by Nelson Laboratories). Data is based on predicate device testing.
- Bacterial Filtration Efficiency: Not explicitly stated for specific test set. The results are presented as a general statement of "greater than 99.9%."
- Provenance: Nelson Laboratories. The data is based on direct testing of the devices using the Modified Greene and Vesley Method.
All tests appear to be prospective for the purpose of demonstrating substantial equivalence for this 510(k) submission unless otherwise stated (e.g., biocompatibility testing on predicate device). The country of origin of the data is not explicitly stated but implies laboratories in the USA (e.g., NIOSH, Nelson Laboratories).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This submission relates to the performance of medical devices (respirators/surgical masks) through laboratory testing, rather than an AI/CAD device requiring expert interpretation of medical images or data. Therefore, the concept of "experts used to establish ground truth" in the way it is typically applied to AI/CAD studies (e.g., radiologists interpreting images) is not applicable here.
The "ground truth" for these tests is established by recognized national and international standards and validated laboratory methodologies (e.g., ASTM, NIOSH regulations, ISO standards, Modified Greene and Vesley Method). The laboratories performing these tests (Inovel LLC, NIOSH, Nelson Laboratories, Northview Pacific Laboratories) are considered experts in their respective fields of material testing and regulatory compliance. The "qualifications" of these entities are their accreditations and adherence to these standardized protocols.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. This is not applicable to the laboratory performance testing of physical devices as described in this 510(k) summary. The results of the tests are quantitative measurements or direct observations according to specified protocols, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for physical medical devices (respirators/surgical masks), not an AI or CAD system that would involve human readers interpreting data with or without AI assistance. The study focuses on direct physical and biological performance characteristics of the mask according to established standards.
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 and surgical mask, not an algorithm or AI system. Its performance is evaluated through laboratory testing of its physical properties and filtration capabilities.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on:
- Standardized Test Methods: Adherence to established scientific and regulatory standards (e.g., ASTM F 1862 for fluid resistance, 16 CFR 1610 for flammability, NIOSH 42 CFR Part 84 for filter efficiency and breathing resistance, ISO 10993 for biocompatibility, Modified Greene and Vesley Method for bacterial filtration efficiency).
- Objective Measurements: These standards define objective criteria and methodologies for measuring specific performance attributes (e.g., percentage efficiency, resistance in mm H2O, pass/fail for penetration, grade/score for biocompatibility).
- NIOSH Certification: The devices are also certified by NIOSH, which represents an independent verification of compliance with specific performance requirements for respirators.
8. The Sample Size for the Training Set
This question is not applicable. This 510(k) submission describes the performance testing of a physical medical device. There is no "training set" in the context of machine learning or AI models. The materials and design of the devices are developed and manufactured, and then their performance is tested against established criteria.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device submission.
§ 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.