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

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.

Summary

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K063747

Image /page/0/Picture/1 description: The image shows the word "INOVEL" in a bold, sans-serif font. Below the word "INOVEL" is the phrase "Different by design." The text is black and the background is white.

10111 WEST JEFFERSON BOULEVARD, CULVER CITY, CALIFORNIA 90232 FELEPHONE 866-546-6835 FAX 310-837-0468 www.inovelmerical co

October 31, 2006

12 - 1

510(k) Summary

Submitter: Inovel LLC 10111 W. Jefferson Blvd. Culver City, CA 90232-3509

JAN 1 2 2007

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 and Surgical Masks models 1510 (K062665), 1511,1512,1513,1517(K061859), 3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, and 3104N95-LP (K051182), These products have also been tested and approved by NIOSH as N95 Respirators

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Image /page/1/Picture/0 description: The image shows the word "inovel" in a bold, sans-serif font. Below the word "inovel" is the phrase "Different by design." The text is black and the background is white.

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 are TC-84A-4100 and TC-84A-4101.

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 Mcthod for evaluation of bacterial filtration efficiency of surgical masks.

Intended 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 healtheare personnel from the transfer of microorganisms, body fluids and particulate material.

I imitations:
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 configuration, materials and components are the same for both the previously cleared device and the Inovel device models for which clearance is being requested including the same color of straps.

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 identical materials.

12 -- 2

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Revised Page 12-3

Image /page/2/Picture/1 description: The image is a black and white image that appears to be a highly magnified view of a surface. The surface is covered in small, dark spots or particles, which are scattered randomly across the image. The background is white, which provides a high contrast to the dark spots. The spots are of varying sizes and shapes, and they are not evenly distributed across the image.

1011 WLS FJEFFFRSON BOOLEVARD, CULVER CITY, CALIFORNIA 90232
TELEPHONE - 866 546 6835 - FAX (310 837 0468 - - www.movesmedical com

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510(k) Summary (continued)

Device and Predicate Devices Descriptions/ Comparisons

Description
	Inovel Health Care N95Particulate Respirators andSurgical Masks, modelsMFRN95-S, MFRN95-XS,MFRN95-ML, MFRN95-A,MFRN95-SZ, MFRN95-MLZ	Inovel Health Care N95Particulate Respirators andSurgical Masks, models 15101511, 1512, 1513, 1517,3211N95-S, 3212N95-M/L	Inovel Health Care N95Particulate Respirators andSurgical Masks, models3000N95-XS, 3001N95-S,3002N95-M, 3003N95-L,3004N95-LP, 3101N95-S,3102N95-M/L, 3104N95-LP
Materials
Outer CoverFabrics	Ethylene-Vinyl AcetateCopolymer, extruded	Ethylene-Vinyl AcetateCopolymer, extruded	Polypropylene Spunbond andEthylene-Vinyl AcetateCopolymer, extruded
Nosepiece	Polyethylene foam	Polyethylene foam	Polyethylene foam
Headband	Various colors elastic, latexfree	Various colors elastic, latex free	Various colors elastic, latex free
Specification &Dimensions	Overall width: $4 5/8 - 7 3/4$inches	Overall width: $4 5/8 - 7 3/4$inches	Overall width: $4 5/8 - 7 3/4$inches
	Overall height: $4 3/4 - 5 1/2$inches	Overall height: $4 3/4 - 5 1/2$inches	Overall height: $4 3/4 - 5 1/2$inches
Mask Style	Molded Cup	Molded Cup	Molded Cup
Design Features	Dual synthetic rubber orsingle elastic head strap	Dual synthetic rubber or singleelastic head strap	Dual synthetic rubber or singleelastic head strap
NIOSH Certification#	TC-84A-4100TC-84A-4101	TC-84A-4333TC-84A-4338TC-84A-0013	TC-84A-4102TC-84A-4103

Risks to Health

PerformanceCharacteristics	Test Method	Acceptance criteria/ Results	Predicate Device Results	Predicate Device Results
Inovel Health Care N95Particulate Respirators andSurgical Masks modelsMFRN95-S, MFRN95-XS,MFRN95-ML, MFRN95-A,MFRN95-SZ, MFRN95-MLZ			Inovel Health Care N95Particulate Respirators andSurgical Masks models 1510,1511, 1512, 1513, 1517,3211N95-S, 3212N95-M/L	Inovel Health Care N95Particulate Respirators andSurgical Masks models3000N95-XS, 3001N95-S,3002N95-M, 3003N95-L,3004N95-LP, 3101N95-S,3102N95-M/L, 3104N95-LP
Fluid ResistancePerformance	ASTM 1862 - 00a	Models MFRN95-S, MFRN95-XS,MFRN95-ML, MFRN95-A, ,MFRN95-MLZ: 32 of 32 passModel MFRN95-SZ:31 of 32 pass	Models 1510, 1511, 1513 and1517, 3211N95-S,3212N95-M/L: 32 of 32 passModel 151231 of 32 pass	32 of 32 pass
FlammabilityClass	16 CFR 1610	Flame spread must be withinupper and lower limits/ No flamespread on 10 of 10 samples,meets Class I	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Flame spread must be withinupper and lower limits/ No flamespread on 10 of 10 samples,meets Class I
Filter Efficiency(%)	NIOSH, 42 CFRPart 84	> 95% Efficient/ average99.46% efficient of 40 samples	> 95% Efficient/ average98.58% efficient of 17 samples	> 95% Efficient/ average99.11% efficient of 20 samples
BreathingResistance(mm H2O)	NIOSH, 42 CFRPart 84	≤ 35.0 mm H2O @ 85 lpm/average 12.5 mm H2O @ 85 lpmof 18 samples	≤ 35.0 mm H2O @ 85 lpm/average 10.3 mm H2O @ 85lpm of 3 samples	≤ 35.0 mm H2O @ 85 lpm/average 11.3 mm H2O @ 85 Ipmof 3 samples

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inovel, LLC C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

JAN 1 2 2007

Re: K063747

Trade/Device Name: Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: January 2, 20067 Received: January 3, 2007

Dear Mr. Lehtonen:

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 ta2898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehtonen

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 yours,

Suttey. Michian Omd

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

510(k) Number (if known): KO63747

Device Name: Health Care N95 Particulate Respirators and Surgical Masks, models Health Caro 1059 Functions ML, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ

Indications for Use:

The various models of Inovel Type N95 Healthcare Particulate Respirators and The Various Intodess of mover 17per 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 during "Surgiour" procedures eanisms, body fluids and particulate material.

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

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)

Shala H. Murphy, D

on of Anesthesiology. General H tion Control, Dental E

K063747

Page 1 of 1

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.