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.

Device Description

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.

AI/ML Overview

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

Performance Characteristics	Test Method	Acceptance Criteria	Reported Device Performance (Inovel Health Care N95)
Fluid Resistance (mmHg)	ASTM 1862 - 00a @ 160 mm Hg	29 of 32 pass	29 of 32 pass / 32 of 32 pass (depending on interpretation of combined results)
Flammability Class	16 CFR 1610	Flame spread must be within upper and lower limits / No flame spread on 10 of 10 samples	No flame spread on 10 of 10 samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFR Part 84	> 95% Efficient	average 99.11% efficient of 20 samples (model 3000N95-XS)
Breathing Resistance (mm H2O)	NIOSH, 42 CFR Part 84	≤ 35.0 mm H2O @ 85 lpm	average 3.5 mm H2O @ 85 lpm of 3 samples
Biocompatibility: Cytotoxicity	ISO 10993 – 1 (specifically -5)	Score of 2 or less	Score of 0
Biocompatibility: Sensitization	ISO 10993 – 1 (specifically -10)	Grade 1 (no different than control)	Grade 1
Biocompatibility: Irritation	ISO 10993 – 1 (specifically -10)	Negligible	Negligible

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.

Summary

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K051182

Image /page/0/Picture/1 description: The image shows the logo for "iNovel" with the tagline "Different by design." The logo is in a sans-serif font and appears to be slightly pixelated. The tagline is in a smaller, italicized font and is located below the main logo.

MAY 1 9 2005

10111 WEST JEFFERSON ROULEVARD, CULVER CITY, CALIFORNIA 90232 TELEPHONE BRE BRACHARTSTAR FAX 240-337 -0468 www.inevelmsdici31.com

April 29, 2005

12 - 1

510(k) Summary

Submitter:

Inovel 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.

Model Numbers:	3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, 3104N95-LP, FRN95-SEZ, FRN95-MLEZ, FRN95-AEZ, FRN95-XS, FRN95-S, FRN95-ML and FRN95-A
----------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Common Name:

Health Care N95 Particulate Respirator and Surgical Mask.

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 the Aearo Co. Pleats Plus mask model 1050 and 1050S [(510(k)K041855] and Gerson Isolair APR type N95 mask model 2735 [510(k)K960778)]. These two products have also been tested and approved by NIOSH as N95 Respirators.

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Image /page/1/Picture/1 description: The image shows the logo for "inovEL" in a bold, sans-serif font. The letters are blocky and geometric, with a pixelated texture. Below the main logo, in a smaller font, is the tagline "Different by design."

10111 WEST JEFFERSON BOULEVARD, CULVER CITY, CALIFORNIA 90232 TELEPHONE 866-546-6835 FAX 310-837-0468 www.inovelmedical.com

12-2

Description:

510(k) Summary (Continued)

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR 84. The certification numbers are TC-84A-4101 and TC-84A-4103 (for single head strap) and TC-84A-4100 and TC-84A-4102 (for double head straps) for a type N95 Particulate Respirator.

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 1863 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood, conducted by Nelson Laboratories. Breathing resistance was tested by NIOSH in accordance to 42 CFR 84.

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 color of the previously cleared devices are white and the Inovel are blue or multi-color. The head strap color of the cleared device is vellow and the Inovel device models are various colors as described in pages 2 - 2 through 2 - 5.

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 051182

Image /page/2/Picture/1 description: The image shows the word "inovel" in a stylized font. Below the word "inovel" is the phrase "Different by design." The text is in black and white.

10111 WEST JEFFERSON BOULEVARD, CUI.VER CITY, CALIFORNIA 90282
TELEPHONE 800-640-8835 FAX 310-837-0468 www.shovelmedical.com

12 - 3

510(k) Summary (continued)

Device and Predicate Devices Descriptions/ Comparisons

Description	Inovel Health Care N95Particulate Respirators andSurgical Masks, various models(15)	Gerson Isolair APR Type N95model 2735, 510(k) K960778	Aearo Co. Pleats Plus 1050 and1050S, 510(k) K041855
Materials
Fabrics	Spunbond polypropylene,Meltblown polypropylene	White nonwoven polyester,Meltblown polypropylene	White spundbond polypropylene,Meltblown polypropylene
Nosepiece	Polyethylene foam	Closed cell foam	Tie wire
Headband	Various colors elastic, latex free	Yellow elastic, latex free	White Elastic, latex free
Specification &Dimensions	Various sizes (14.75" - 15.625"circumference)	Small (13.75" circumference)	Small ( 13.5" circumference)Large (15.5" circumference)
Mask Style	Molded Cup	Molded Cup	Flat pleated
Design Features	Dual synthetic rubber or singleelastic head strap	Dual elastic head strap	Dual elastic head strap
NIOSHCertification#	TC-84A-4100 thru TC-84A-4103	TC-84A-160	TC-84A-2630

Risks to Health

........

PerformanceCharacteristics	Test Method	Acceptance criteria/ Results	Predicate DeviceResults	Predicate DeviceResults
		Inovel Health Care N95Particulate Respirators andSurgical Masks various models(15)	Gerson Isolair APRType N95 model2735, 510(k)K960778	Aero Co. PleatsPlus 1050 and1050S, 510(k)K041855
Fluid ResistancePerformance(mmHg)	ASTM 1862 - 00a @160 mm Hg	29 of 32 pass/32 of 32 pass	32/32 pass	31/32 pass @ 120mmHg
FlammabilityClass	16 CFR 1610	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Meets Class I	Meets Class I
Filter Efficiency(%)	NIOSH, 42 CFRPart 84	> 95% Efficient/ average99.11% efficient of 20 samples(model 3000N95-XS)	Average 98.86%efficient of 20samples	Average 99.11%efficient of 20samples
BreathingResistance(mm H2O)	NIOSH, 42 CFRPart 84	≤ 35.0 mm H2O @ 85 lpm/average 3.5 mm H2O @ 85 lpmof 3 samples	Average 15.2 mmH2O on 3 samples	Average 3.5 mmH2O on 3 samples
Biocompatibility	ISO 10993 — 1	Cytotoxicity, score of 2 or less/Score of 0	N/A	Score of 0
		Sensitization, Grade 1 (nodifferent than control)/ Grade 1	N/A	Score of 0 (closedpatch test)
		Primary Skin Irritation,Negligible/Negligible	N/A	Negligible

,在线上的

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K051182

Image /page/3/Picture/1 description: The image shows the logo for "iNovel" with the tagline "Different by design." The logo is in a blocky, pixelated font, giving it a retro or digital feel. The tagline is in a smaller, more cursive font, positioned below the main logo.

10111 WEST JEFFERSON ROULEVARD, CUILVER CITY, CALIFORNIA 90232 TELEPHONE 685-546-6835 FAX 3 16-337 -0468 www.inovelmedical.com

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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-4100 through TC-84A-4103.

	Tests Performed	Laboratory
1.	Fluid Resistance - Resistance of Liquid(Synthetic Blood Penetration Resistance)ASTM F 1862.	Nelson Laboratories
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• Cytotoxicity ISO 10993 – 5	Nelson Laboratories
	• Sensitization ISO 10993 – 10	Northview Pacific Laboratories, Inc.(Coordinated by Nelson Laboratories
	• Irritation ISO 10993 – 10	Northview Pacific Laboratories, Inc.(Coordinated by Nelson Laboratories

Safety/ Effectiveness:

The devices have a filtration equivalent to the previously cleared Aearo Co. Pleats Plus model 1050 and 1050S and Gerson Isolair APR model 2735 Particulate Respirator and Surgical mask. They are NIOSH approved and meet the CDC guidelines for TB.

Conclusion:

The basic construction and material used in the cleared devices is basically 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 - 7.

... ... ... ...

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Image /page/4/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2005

Inovel, LLC C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K051182

Trade/Device Name: Inovel Health Care N95 Particulate Respirators and Surgical Masks, Various Models Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: May 6, 2005 Received: May 9, 2005

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 Amendinently, or or us as a cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Nr.), it may be basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish 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 modified in any Federal statutes and regulations administered by other Federal agencies. or the Act of all - outs 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 ting (2) 02 1 0 1 1 1 1 1 1 1 1 4 quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrent 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) Prinstet notification. The FDA finding of substantial equivalence of your device to a premiaries included 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), rr you don't 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 may obtain 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,

Chih-Lin, Ph.D.

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): KO51 | 82

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

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Bvaluation (ODE)

Shirley A. Murphy, R

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) 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.