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510(k) Data Aggregation
(24 days)
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95
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.
This looks like a 510(k) premarket notification for N95 Particulate Respirators and Surgical Masks. The document provides acceptance criteria and performance data for these masks across several characteristics. Since this is a submission for a physical medical device (respirator/mask), the typical "study" that would prove the device meets acceptance criteria involves physical and material property testing, rather than a clinical trial or algorithm performance study.
Here's the breakdown of the requested information based on the provided text, adapted for the nature of this physical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (MFRN95 Models) |
|---|---|---|---|
| Fluid Resistance | ASTM 1862 - 00a | 32 of 32 pass (implies resisting penetration by synthetic blood) | Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, MFRN95-MLZ: 32 of 32 pass; Model MFRN95-SZ: 31 of 32 pass (Meets acceptance for most models, one model has one failure) |
| Flammability Class | 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 99.46% efficient of 40 samples |
| Breathing Resistance | NIOSH, 42 CFR Part 84 | ≤ 35.0 mm H2O @ 85 lpm (inhalation resistance); ≤ 25.0 mm H2O @ 85 lpm (exhalation resistance, implied by NIOSH N95 standard) | Average 12.5 mm H2O @ 85 lpm of 18 samples (inhalation, implying it's well below the limit) |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM 1862 - 00a): 32 samples per model tested.
- Flammability (16 CFR 1610): 10 samples.
- Filter Efficiency (NIOSH, 42 CFR Part 84): 40 samples.
- Breathing Resistance (NIOSH, 42 CFR Part 84): 18 samples.
The data provenance is not explicitly stated in terms of country of origin, but the tests refer to established US standards (ASTM, NIOSH, CFR) and were conducted by "Nelson Laboratories" for Bacterial Filtration Efficiency (though the table uses NIOSH for Filter Efficiency). Given the submission is to the FDA, it is presumed to be for the US market, and tests are likely conducted in US-based accredited laboratories or to US standards. All data appears to be prospective results from laboratory testing conducted on the device models for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this device. The "ground truth" for N95 respirators and surgical masks is established by standardized, objective physical and performance test methods (e.g., measuring filter efficiency with a particle counter, measuring flame spread with a direct flame application) defined by regulatory bodies and consensus organizations (NIOSH, ASTM, CFR). There are no human "experts" establishing a subjective ground truth for these specific performance metrics.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when there's ambiguity in classifying data, common in medical imaging or pathology. For physical performance tests of a mask, the results are quantitative measurements or pass/fail decisions based on objective criteria, not requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. An MRMC study is relevant to AI/software products that assist human readers (e.g., radiologists, pathologists). This submission is for a physical medical device (respirator/mask) and does not involve AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This device is a physical product and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective physical and performance test results derived from standardized laboratory methods (e.g., NIOSH, ASTM) against predefined quantitative thresholds. For example, for "Filter Efficiency," the ground truth is the measured percentage of particles filtered, compared to the >95% criterion. For "Fluid Resistance," it's the observation of synthetic blood penetration.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical device and does not involve a "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and design verification, but this is distinct from "training data."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" for this device.
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(47 days)
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
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 lavered 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.
Here's an analysis of the acceptance criteria and study information for the Inovel Health Care N95 Particulate Respirators and Surgical Masks based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (New Models) | Predicate Device Performance |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM 1862 - 00a | 32 of 32 pass | 32 of 32 pass | 32 of 32 pass |
| Flammability Class | 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 | No flame spread on 10 of 10 samples, meets Class I |
| Filter Efficiency (%) | NIOSH, 42 CFR Part 84 | > 95% Efficient | Average 99.33% efficient of 20 samples | Average 99.11% efficient of 20 samples |
| Breathing Resistance (mm H2O) | NIOSH, 42 CFR Part 84 | ≤ 35.0 mm H2O @ 85 lpm | Average 8.1 mm H2O @ 85 lpm of 3 samples | Average 11.3 mm H2O @ 85 lpm of 3 samples |
| Biocompatibility (Cytotoxicity) | ISO 10993 -- 1 | Score of 2 or less | Same as predicate device (Score of 0) | Score of 0 |
| Biocompatibility (Sensitization) | ISO 10993 -- 1 | Grade 1 (no different than control) | Same as predicate device (Grade 1) | Grade 1 |
| Biocompatibility (Primary Skin Irritation) | ISO 10993 -- 1 | Negligible | Same as predicate device (Negligible) | Negligible |
| Bacterial Filtration Efficiency | Modified Greene and Vesley Method. J Bacteriol 83:663-667 | Greater than 99.9% | Greater than 99.9% | Greater than 99.9% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples. Data provenance not explicitly stated (location of testing shown as "Inovel LLC" per the performance tests table, which is the manufacturer).
- Flammability Class: 10 samples. Data provenance not explicitly stated (location of testing shown as "Nelson Laboratories").
- Filter Efficiency: 20 samples. Data provenance not explicitly stated (location of testing shown as "NIOSH").
- Breathing Resistance: 3 samples. Data provenance not explicitly stated (location of testing shown as "NIOSH").
- Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): Sample size for these tests is not explicitly stated, but the results are reported as "Same as predicate device" which had "Score of 0" for cytotoxicity, "Grade 1" for sensitization, and "Negligible" for primary skin irritation. These tests were conducted on predicate devices made from the same materials. Locations of testing shown as "Nelson Laboratories" and "Northview Pacific Laboratories, Inc."
- Bacterial Filtration Efficiency: Sample size not explicitly stated, but results indicate "Test results show a bacterial filtration efficiency greater than 99.9%". Location of testing shown as "Nelson Laboratories".
The text doesn't specify if the data is retrospective or prospective, nor does it provide a country of origin beyond identifying the laboratories and the manufacturer's location (Culver City, California).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes performance testing based on established standards (ASTM, NIOSH, ISO, CFR) conducted by recognized laboratories. It does not mention "experts" establishing a "ground truth" in the way one might for diagnostic accuracy studies with human-interpreted data. The ground truth for these physical and biological performance characteristics is inherently defined by the test methods and regulatory standards themselves (e.g., a filter either achieves >95% efficiency or it doesn't, as measured by the specified NIOSH method).
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective, standardized laboratory tests. There is no mention of subjective interpretation of results that would require an adjudication method among multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (N95 respirator and surgical mask), not an AI-powered diagnostic tool, so such a study design is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is defined by the objective measurement criteria and standards outlined in the specified test methods (e.g., ASTM F 1862 for fluid resistance, 42 CFR Part 84 for filter efficiency and breathing resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility, and Modified Greene and Vesley Method for bacterial filtration efficiency). These are verifiable, quantitative measurements against regulatory and industry standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model, and therefore does not have 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.
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(12 days)
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
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.
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