(216 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the respirator and its coating, with no mention of AI or ML technologies.
No.
The device is a respirator intended to reduce exposure to airborne particulates and inactivate viruses on its surface, not to treat or cure a disease in the wearer.
No
This device is a respirator designed to protect the wearer from pathogenic biological airborne particulates and inactivate viruses on its surface, not to diagnose a medical condition.
No
The device is a physical respirator with a chemical coating, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to cover the nose and mouth to reduce wearer exposure to airborne particulates and protect from splash and spray of body fluids. This is a physical barrier function.
- Mechanism of Action: The device works by filtering particulates and inactivating viruses on its surface through a coating. This is a direct interaction with the environment and the virus, not a test performed in vitro on a sample from the human body to diagnose a condition.
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease, monitoring treatment, or screening for conditions. This device does not perform such tests.
While the device utilizes in vitro testing to demonstrate its efficacy against viruses on its surface, the device itself is not an IVD. It's a personal protective equipment (PPE) with an added virucidal function.
N/A
Intended Use / Indications for Use
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 (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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ONT
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 elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
occupational use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- . Fluid Penetration Resistance - ASTM F1862
- . Particulate Filtration Efficiency - NIOSH 42 CFR 84.181
- . Bacterial Filtration Efficiency - MIL M36954C, ASTM F2101
- . Flammability - 16 CFR 1610
- . Breathing Resistance - NIOSH 42 CFR 84.180
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.
Bench testing demonstrated the product's efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Kills (inactivates) 99.99% of influenza A viruses.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/3 description: The image shows the logo for GlaxoSmithKline. The logo consists of the letters "gsk" in white, set against a black circle. To the right of the circle, the full name "GlaxoSmithKline" is written in black.
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: September 30, 2009
6.2 Manufacturer:
Sperian Protection Armor SAS ZI de la Gare 22940 Plaintel France
1
6.3 Name of Device:
| Trade/Proprietary/Model Name: | Actiprotect™ UF N95 Respirator
Double Strap, Flat Fold |
|-------------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Filtering Facepiece Respirator |
| Classification Name: | Filtering Facepiece Respirator for Use by
Healthcare Workers (21 CFR 878.4040)
Product Code ONT |
Devices to Which New Device is Substantially Equivalent: 6.4
Actiprotect™ UF N95 Respirator K081923
6.5 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 elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
6.6 Statement of Intended Use:
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 (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 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
2
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 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 filters at least 95% of particulates and has a coating on its outermost surface to capture and inactivate influenza viruses on contact with the surface. The predicate device is an N95 respirator: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold.
Actiprotect™ UF N95 Respirator has been tested for and passed standardized tests for fluid penetration resistance, particulate filtration efficiency, bacterial filtration efficiency (BFE), flammability, and breathing resistance.
The materials of construction used in Actiprotect™ UF N95 Respirator are identical to those of the predicate. Therefore the subject device is substantially equivalent to the predicate device. The device as a whole has been demonstrated to be biocompatible by cytotoxicity and human repeated insult patch testing.
Brief discussion of the nonclinical tests submitted. referenced. 6.8 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
- . Flammability - 16 CFR 1610
- . Breathing Resistance - NIOSH 42 CFR 84.180
3
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 0,2010
Zinatara A. Manji Ph.D. Director, Regulatory Affairs GlaxoSmithKline Consumer Healthcare GlaxoSmithKline 1500 Littleton Road Parsippany, New Jersey 07054-3884
Re: K093161
Trade/Device Name: Actiprotect TM UF N95 Respirator, Double Strap Flat Fold Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: March 25, 2010 Received: March 26, 2010
Dear Dr. Zinatara A. 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. 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.
5
Page 2- Dr. Zinatara A. 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 (OS) 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 vours,
Susan Runner
*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
6
Indications for Use
510(k) Number (if known):
Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold
Indications For Use:
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 (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 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 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
signature
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Controloberated Bavices
510(k) Number: k09316