(266 days)
Not Found
No
The description focuses on the physical properties of the respirator and the chemical coating for virus inactivation, with no mention of AI or ML.
No.
The device is a respirator intended to reduce exposure to airborne particulates and protect against splash/spray, not to treat or cure a medical condition. It explicitly states it is "not an antiviral drug" and "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."
No
This device is a respirator designed to protect the wearer from airborne particulates and inactivate viruses on its surface, not to diagnose a medical condition.
No
The device description clearly outlines a physical respirator made of multiple layers of non-woven fabric with a coating, straps, and ultrasonic sealing. It is a tangible hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Actiprotect™ UC N95 Respirator is a physical barrier designed to filter airborne particulates and inactivate viruses on its surface. It is worn on the face and does not involve testing samples taken from the body.
- Intended Use: The intended use is to protect the wearer from exposure to airborne particulates and splash/spray of body fluids, and to inactivate viruses on the respirator's surface. This is a protective function, not a diagnostic one.
- Performance Studies: The performance studies described focus on the inactivation of viruses on the respirator's surface and skin irritation from the materials, not on the detection or measurement of substances in biological samples.
While the device utilizes an "in vitro" test to demonstrate its effectiveness against viruses on its surface, this refers to a laboratory test performed on the device itself, not a diagnostic test performed on a patient sample.
N/A
Intended Use / Indications for Use
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 particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Product codes
ORW
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.
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
General public in public health medical emergencies
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)
Nonclinical tests:
- 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
Clinical tests: - 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.
Key Results:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUL - 2 2010
510(k) Summary 6.
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)-889-2322 |
| 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 Respirator
Double Strap, Flat fold |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Filtering Facepiece Respirator |
| Classification Name: | Filtering Facepiece Respirator for Use by
General Public in Public Health Medical
Emergencies (21 CFR 880.6260) Product Code
ORW |
1
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:
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.
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
2
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 ●
3
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:
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.
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:
8