Actiprotect™ UC 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 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer laver of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Device Description

Actiprotect™ UC 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 elastic straps are stapled or welded to the edge of the respirator and are used to secure the respirator to the user's face.

AI/ML Overview

The provided text describes the Actiprotect™ UC N95 Respirator, a filtering facepiece respirator. The information focuses on its substantial equivalence to predicate devices and its performance in various nonclinical tests, rather than a typical AI-driven diagnostic device study. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for each criterion. Instead, it describes various tests performed and implies that the device passed these tests, leading to a determination of substantial equivalence. The key performance claims relate to filtration efficiency and virus inactivation.

Acceptance Criterion (Implied)	Reported Device Performance
Fluid Penetration Resistance	Passed ASTM F1862
Particulate Filtration Efficiency	Passed NIOSH 42 CFR 84.181
Bacterial Filtration Efficiency (BFE)	Passed MIL M36954C, ASTM F2101
Flammability	Passed 16 CFR 1610
Breathing Resistance	Passed NIOSH 42 CFR 84.180
Virus Inactivation (Influenza A)	Kills (inactivates) 99.99% of Influenza A viruses within one minute of contact with the surface. Includes specific H1N1 (including 2009 pandemic strain), H2N2, H3N2, H5N1, H5N9 subtypes.
Virus Inactivation (Influenza B)	99.99% kill (inactivation) on the surface against specific Influenza B strains under tested contact conditions.
Biocompatibility (Cytotoxicity)	Demonstrated biocompatible
Biocompatibility (Skin Sensitization/Irritation)	No evidence of sensitization or irritation in Human Repeated Insult Patch Tests.

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

Nonclinical Tests (Fluid Penetration, Filtration Efficiency, Flammability, Breathing Resistance): The document does not specify the sample sizes used for these tests. It simply states that the tests were conducted and passed according to the referenced standards (e.g., ASTM F1862, NIOSH 42 CFR 84.181). The data provenance is implied to be laboratory testing as part of the device development and regulatory submission process.
Virus Inactivation: This was an "In vitro (laboratory)" test. The document does not specify the sample size (e.g., number of respirators tested) but lists a variety of Influenza A and B subtypes/strains that were tested. Data provenance is laboratory testing.
Biocompatibility (Human Repeated Insult Patch Tests): The document states "samples of the respirator materials" were used. No specific number of human subjects is provided, but it indicates "There were no adverse reactions reported during the studies." The data provenance is from clinical (human) testing, likely conducted by the manufacturer or a contracted lab.

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

This section is not applicable as the device is a medical respirator, not an AI diagnostic device that requires expert interpretation for ground truth. Performance is determined by objective physical and chemical tests (e.g., filtration, virus inactivation, material biocompatibility).

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

This section is not applicable as the device is not an AI diagnostic device requiring human adjudication of results. Test results are based on standardized laboratory protocols.

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

This section is not applicable. The device is a personal protective equipment (respirator), not an AI system designed to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant. The submission explicitly states: "No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection."

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

This section is not applicable. The device is a physical product (respirator), not an algorithm or AI system.

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

The "ground truth" for this device is based on objective measurements and standardized test methods dictated by regulatory requirements and established scientific principles for respirators and material safety.

For Filtration and Physical Performance: Compliance with standards (e.g., NIOSH 42 CFR 84.181 for particulate filtration efficiency, ASTM F1862 for fluid penetration). The "ground truth" is the quantitative measurement obtained per the standard.
For Virus Inactivation: Laboratory in vitro tests demonstrating a 99.99% reduction in live virus on the surface under controlled conditions. The "ground truth" is the measured reduction in viral infectivity.
For Biocompatibility: Results from established in vitro (cytotoxicity) and in vivo (human repeated insult patch tests) methods, indicating safety for human contact. The "ground truth" is the absence of adverse reactions or toxic effects according to these tests.

8. The sample size for the training set

This section is not applicable as this is not an AI or machine learning device that requires a training set.

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

This section is not applicable as there is no training set for this type of device.

Summary

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JUL - 2 2010

510(k) Summary 6.

6.1 Applicant and Correspondent

Name:	GlaxoSmithKline Consumer Healthcare
Address:	1500 Littleton RoadParsippany, NJ 07054-3884
Contact Person:	Zinatara A. Manji, M.S., Pharm.D.Director, Regulatory Affairs
Phone:	(973)-889-2322
Fax:	(973)-889-2501
E-mail:	zinatara.a.manji@gsk.com

Date of Preparation: July 1, 2010

6.2 Manufacturer:

Sperian Protection Armor SAS ZI de la Gare 22940 Plaintel France

6.3 Name of Device:

Trade/Proprietary/Model Name:	Actiprotect™ UC N95 RespiratorDouble Strap, Flat fold
Common Name:	Filtering Facepiece Respirator
Classification Name:	Filtering Facepiece Respirator for Use byGeneral Public in Public Health MedicalEmergencies (21 CFR 880.6260) Product CodeORW

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Devices to Which New Device is Substantially Equivalent: 6.4

Actiprotect™ UF N95 Respirator (K081923), GlaxoSmithKline Consumer Healthcare

3M 8670F Respirator for Use by the General Public in Public Health Medical Emergencies (K062070), 3M Health Care

6.5 Device Description:

Statement of Intended Use 6.6

Actiprotect™ UC 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 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne

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particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Summary of the Technological Characteristics 6.7

Actiprotect™ UC N95 Respirator has the same intended use/indications as the predicate devices, Actiprotect™ UF N95 Respirator and 3M 6870F Respirator for Use by the General Public in Public Health Medical Emergencies. 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™ UC N95 Respirator is intended for use by the general public in public medical health emergencies.

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 UC N95 Respirator are identical to those of the predicate device, Actiprotect UF N95 Respirator. 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, AST M F2101
. Flammability - 16 CFR 1610
Breathing Resistance NIOSH 42 CFR 84.180 ●

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Brief discussion of the clinical tests submitted, referenced, or 6.9 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 ingredient indicates the product is safe for use in the intended application. Bench testing demonstrated the product's efficacy. Actiprotect™ UC N95 Respirator has been shown to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Zinatara Manji Director, Regulatory Affairs Glaxosmithkline Consumer Healthcare 1500 Littleton Road Parsippany, New Jersey 07054-3884

JUL-- 2 2010

Re: K093189

Trade/Device Name: Actiprotect™ UC N95 Respirator, Double Strap Flat Fold Regulation Number: 21 CFR 880.6260 Regulation Name: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies Regulatory Class: II Product Code: ORW Dated: June 18, 2010 Received: June 21, 2010

Dear Ms. Manii:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Ms. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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): K093189

Device Name: Actiprotect™ UC N95 Respirator, Double Strap Flat Fold For Use by the General Public in Public Health Medical Emergencies

Indications For Use:

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)

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Anisanomical Devices

K09318

Doc ID 0900233c80861fca

510(k) Number:

Regulation Number and Section

§ 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.

(a)
Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.(b)
Classification. Class II (special controls). The special controls are:(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.