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.

Device Description

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.

AI/ML Overview

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.

Summary

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K061859

JUL 1 2 2006

June 27, 2006

12 - I

510(k) Summary

Submitter:

lnovel LLC 10111 W. Jefferson Blvd. Culver City, CA 90232-3509

Contact:

William Wawrzyniak Director Quality Assurance Telephone: 866-546-6835 Ext. 705 Fax: 310-837-0468 E-mail: billw@inovelmedical.com

Trade Name:

Inovel Health Care N95 Particulate Respirators and Surgical Masks, various models.

Common Name:

Health Care N95 Particulate Respirators and Surgical Masks.

Classification:

Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section – 21 CFR 878.4040

Substantial Equivalency:

Inovel Health Care N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators model 3001N95-S, 3002N95-M, 3003N95-L and 3004N95-LP [(510(K) K051182] These products have also been tested and approved by NIOSH as N95 Respirators.

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510(k) Summary (Continued)

Description:

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers is TC-84A-0013.

The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The devices have a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted by Nelson Laboratories using the Modified Green and Vesley Method for evaluation of bacterial filtration efficiency of surgical masks.

Intended Use:

Limitations:

These products do not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.

Comparison of Predicate Devices:

The outside cover of the previously cleared devices incorporate a nonwoven polypropylene material with a layer of an extruded plastic mesh and the Inovel models 1511, 1512. 1513 and 1517 incorporate an extruded plastic mesh without the nonwoven material on the outer cover. The head strap color of the cleared device is the same as the Inovel device models for which clearance is being requested.

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 - 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510(k) are manufactured from similar materials.

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K 061859

510(k) Summary (continued)

Device and Predicate Devices Descriptions/ Comparisons

Description	Inovel Health Care N95 ParticulateRespirators and Surgical Masks, models1511, 1512, 1513, 1517	Inovel Health Care N95 ParticulateRespirators and Surgical Masks, models3001N95-S, 3002N95-M, 3003N95-L,3004N95-LP
Materials
Outer Cover Fabrics	Spunbond polypropylene, Meltblownpolypropylene	Spunbond polypropylene, Meltblownpolypropylene
Nosepiece	Polyethylene foam	Polyethylene foam
Headband	Various colors elastic, latex free	Various colors elastic, latex free
Specification &	Overall width: 5 - 5 5/8 inches	Overall width: 5 - 5 5/8 inches
Dimensions	Overall height: $4 \frac{1}{4}$ - $5 \frac{1}{2}$ inches	Overall height: $4 \frac{1}{4}$ - $5 \frac{1}{2}$ inches
Mask Style	Molded Cup	Molded Cup
Design Features	Dual synthetic rubber	Dual synthetic rubber
NIOSH Certification#	TC-84A-0013	TC-84A-4102

Risks to Health

PerformanceCharacteristics	Test Method	Acceptance criteria/ Results	Predicate Device Results
Fluid ResistancePerformance	ASTM 1862 - 00a	Inovel Health Care N95 ParticulateRespirators and Surgical Masksvarious models (4)Models 1511, 1513 and 151732 of 32 passModel 151231 of 32 pass	Inovel Health Care N95 ParticulateRespirators and Surgical Masksvarious models (4)Models 3001N95-S, 3002N95-M,3003N95-L, 3004N95-LP32 of 32 pass
Flammability Class	16 CFR 1610	Flame spread must be within upperand lower limits/ No flame spreadon 10 of 10 samples, meets Class I	Flame spread must be within upperand lower limits/ No flame spreadon 10 of 10 samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFRPart 84	> 95% Efficient/ average 98.58%efficient of 17 samples	≥95% Efficient/ average 99.11%efficient of 20 samples
BreathingResistance(mm H2O)	NIOSH, 42 CFRPart 84	≤ 35.0 mm H2O @ 85 lpm/ average10.3 mm H2O @ 85 lpm of 3samples	≤ 35.0 mm H2O @ 85 lpm/ average11.3 mm H2O @ 85 lpm of 3samples
Biocompatibility *	ISO 10993 - 1	CytotoxicitySame as predicate deviceSensitizationSame as predicate devicePrimary Skin IrritationSame as predicate device	Cytotoxicity, score of 2 or less/Score of 0Sensitization, Grade 1 (no differentthan control)/ Grade 1Primary Skin Irritation,Negligible/Negligible
Bacterial FiltrationEfficeincy	Modified Greeneand VesleyMethod. JBacteriol 83:663-667	Test results show a bacterialfiltration efficiency greater than99.9%	Greater than 99.9%

Tests were conducted on Predicate Devices which are made from the same material as models
identified in this 510(k) submission.

12 - 3

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K061859

12 - 4

510(k) Summary (Continued)

Performance Tests:

These products were tested and certified by NIOSH as an approved N95 Respirator. It meets all the requirements prescribed in 42 CFR Part 84 and is assigned TC-84A-0013

Tests Performed	Laboratory
1. Fluid Resistance - Resistance of Liquid(Synthetic Blood Penetration Resistance)ASTM F 1862.	Inovel LLC
2. Filtration Efficiency (Particulate andBacterial) 42 CFR Part 84	NIOSH
3. Differential Pressure (Delta P) - BreathingResistance 42 CFR Part 84	NIOSH
4. Flammability 16 CFR 1610 (Class 1)	Nelson Laboratories
5. Biocompatibility* (tested onpredicate devices)Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-10)	Nelson LaboratoriesNorthview Pacific Laboratories, Inc(Coordinated by Nelson Laboratories)Northview Pacific Laboratories, Inc(Coordinated by Nelson Laboratories)
6. Bacterial Filtration EfficiencyModified Greene and VesleyMethod. J Bacteriol 83:663-667.	Nelson Laboratories

Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission.

Safety/ Effectiveness:

The devices have a filtration equivalent to the previously cleared Inovel LLC N95 Particulate Respirator and Surgical mask models 3001N95-M, 3003N95-L and 3004N95-LP 510(k) number K051182. They are NIOSH approved and meet the CDC guidelines for TB and Avian Flu exposure control.

Conclusion:

The basic construction and material used in the cleared devices are the same as in the new devices. The cleared devices and the new devices are also approved by NIOSH, and meets all other required tests. The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are substantially equivalent to those listed on page 2 - 4.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Inovel LLC C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087

Rc: K061859

Trade/Device Name: Health Care N95 Respirators and Surgical Masks Inovel Models 1511,1512,1513, & 1517

Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: June 29, 2006 Received: June 30, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Quy Solom for
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KO61859 510(k) Number (if known):

Device Name: Health Care N95 Particulate Respirators and Surgical Masks Inovel Models 1511,1512,1513 & 1517 Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Shade N. Murphy 1/2/04

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of Anesthesiology, General Hospital, Jon Control. Dental Devices ) Number.

Regulation Number and Section

§ 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.