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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

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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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

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

Ask a specific question about this device