Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2JJP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Device Description

Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic clastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Device Performance	Comments
Fluid Penetration Resistance (ASTM F1862)	Passed	Standardized test
Particulate Filtration Efficiency (NIOSH 42 CFR 84.181)	Passed	Standardized test
Bacterial Filtration Efficiency (BFE) (MIL M36954C, ASTM F2101)	Passed	Standardized test
Virus Filtration Efficiency (VFE) (MIL M36954C, ASTM F2101)	Passed	Standardized test
Flammability (16 CFR 1610)	Passed	Standardized test
Breathing Resistance (NIOSH 42 CFR 84.180)	Passed	Standardized test
Biocompatibility (Cytotoxicity)	Demonstrated to be biocompatible	Through cytotoxicity testing
Biocompatibility (Human Repeated Insult Patch Testing)	No adverse reactions; no evidence of sensitization or irritation	During studies with occlusive patches
Influenza A Virus Inactivation	Kills (inactivates) 99.99% of influenza A viruses within one minute of contact with the surface of the respirator.	In vitro testing against multiple influenza A subtypes (H1N1, H2N2, H3N2, H5N1, H5N9) and one Influenza B strain.

Study that proves the device meets the acceptance criteria:

The document describes a series of nonclinical bench tests and clinical (biocompatibility) tests.

2. Sample size used for the test set and the data provenance:

Fluid Penetration Resistance, Particulate Filtration Efficiency, BFE, VFE, Flammability, Breathing Resistance: The document states "standardized tests" were performed and the device "passed." Specific sample sizes for these tests are not provided in the document. The data provenance is implied to be from laboratory testing as part of the device's manufacturing and regulatory submission. No specific country of origin for this testing data is explicitly stated, though the manufacturer is based in France and the applicant in the USA.
Biocompatibility (Cytotoxicity): The document states "cytotoxicity" testing was conducted. Specific sample sizes are not provided. The provenance is laboratory testing.
Biocompatibility (Human Repeated Insult Patch Tests): The document states "Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches." Specific subject sample sizes are not provided. The provenance is clinical testing on human subjects.
Influenza A Virus Inactivation (In vitro testing): The document states "In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses..." The number of samples/replicates for the in-vitro testing is not provided. The provenance is laboratory testing, in vitro.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided in the document. The tests performed are primarily objective performance benchmarks (e.g., filtration efficiency, flammability, virus inactivation rates) or biocompatibility studies, which do not typically involve human experts establishing a "ground truth" in the way, for example, a diagnostic imaging study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. As mentioned above, these are not studies that would typically require an adjudication method. Outcomes are generally based on pass/fail criteria against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC comparative effectiveness study was not done. The device is an N95 respirator with a virucidal coating, not an AI-assisted diagnostic tool using human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A standalone performance evaluation was done for the device itself against established physical, chemical, and biological performance criteria (e.g. filtration efficiency for particulates, bacteria, and viruses; fluid penetration; flammability; breathing resistance; virus inactivation). These tests are "algorithm only" in the sense that they measure the device's inherent performance without human interpretation as part of the primary measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for most of the performance tests (e.g., filtration, fluid resistance, flammability, breathing resistance) is defined by the standardized test methods and their predetermined pass/fail criteria. For the virus inactivation claims, the ground truth is established by in vitro laboratory assays rigorously measuring reduction in viral infectivity. For biocompatibility, the ground truth is established by absence of cytotoxic effects or adverse skin reactions according to established toxicology and dermatological assessment protocols.

8. The sample size for the training set:

There is no mention of a training set as this product is not a machine learning or AI-based device. The testing described is for the physical and biological performance of a medical device (respirator).

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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K081923/S2 Supplement 4

ctiprotect UF N95 Respirator GlaxoSmithKline Consumer Healthcare, L.P.

JUL - 1 2009

Image /page/0/Picture/3 description: The image contains the logo for GlaxoSmithKline. The logo consists of the letters "gsk" in a stylized font, placed inside of a dark, circular shape. To the right of the circular shape, the words "GlaxoSmithKline" are written in a smaller, sans-serif font.

GlaxoSmithKline

1500 Littleton Road Parsippany, NJ 07054-3884

Tel. 973 889 2100 Fax. 973 889 2390 www.gsk.com

6. 510(k) Summary

6.1 Applicant and Correspondent:

Name:

GlaxoSmithKline Consumer Healthcare

Address: 1500 Littleton Road Parsippany, NJ 07054-3884

Contact Person: Zinatara A. Manji, M.S., Pharm.D. Director, Regulatory Affairs

Phone: (973)-889-2100

Date of Preparation: June 24, 2009

6.2 Manufacturer:

Sperian Protection Armor SAS Zl de la Gare 22940 Plaintel France

Doc ID 0b00233c807674db

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6.3 Name of Device:

Trade/Proprietary/Model Name:

Common Name:

Actiprotect™ UF N95 Respirator Double Strap, Flat Fold

Filtering Facepiece Respirator

Classification Name:

Filtering Facepiece Respirator for Use by Healthcare Workers (21 CFR 878.4040) Product Code MSH

Devices to Which New Device is Substantially Equivalent: 6.4

Willson ONE-Fit Flat Folded Healthcare Particulate Respirator and Surgical Mask Model HC-NB095F & HC-NB295F (K070782).

6.5 Device Description:

ર્ણ વિશ્વર ભાગમાં આવેલું એક ગામનાં છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના Statement of Intended Use:

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A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

6.7 Summary of the Technological Characteristics:

Actiprotect™ UF N95 Respirator has the same filtering and barrier properties as the predicate device, Willson ONE-Fit Flat Folded Healthcare Particulate Respirator and Surgical Mask. In addition, Actiprotect™ UF N95 Respirator offers the protection of a coating on its outermost surface to capture and inactivate influenza viruses on contact with the surface.

Actiprotect™ UF N95 Respirator has been tested for and passed standardized tests for fluid penetration resistance, particulate filtration efficiency, bacterial filtration efficiency (BFE), virus filtration efficiency (VFE), flammability, and breathing resistance.

The materials of construction used in Actiprotect™ UF N95 Respirator are substantially equivalent to those of the predicate device. The device as a whole has been demonstrated to be biocompatible by cytotoxicity and human repeated insult patch testing.

6.8 Brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

. Fluid Penetration Resistance - ASTM F1862
Particulate Filtration Efficiency NIOSH 42 CFR 84.181 .
Bacterial Filtration Efficiency MIL M36954C. ASTM F2101 ●
. Virus Filtration Efficiency - MIL M36954C, ASTM F2101
Flammability 16 CFR 1610 .
Breathing Resistance NIOSH 42 CFR 84.180

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6.9 Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches. There were no adverse reactions reported during the studies. The outcome of these tests revealed no evidence of sensitization or irritation.

6.10 Conclusions drawn from the nonclinical and clinical tests:

Cytotoxicity and human repeated insult patch tests plus a toxicological review of data on the product's ingredients indicates the product is safe for use in the intended application. Bench testing demonstrated the product's efficacy. Actiprotect™ UF N95 Respirator has been shown to be substantially equivalent to the predicate device.

Doc ID 0b00233c807674db

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing.

Public Health Service

JUI - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zinatara A. Manji, M.S., PharmaD Director of Regulatory Affairs GlaxoSmithKline Consumer Healthcare LP 1500 Littleton Road Parsippany, New Jersey 07054

Re: K081923

Trade/Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: June 17, 2009 Received: June 17, 2009

Dear Dr. Manji:

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 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 - Dr. Manji

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony D. Anton her

Susan Runner, D.D.S., M.A. Acting 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): K081923

Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold

Indications For Use:)".

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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 Evaluation (ODE)

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

Page 1 of

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.