(195 days)
Not Found
No
The description focuses on the physical construction and chemical properties of the mask for viral inactivation, with no mention of AI or ML.
No.
The device is intended to reduce exposure to pathogenic biological airborne particulates and protect against the transfer of microorganisms, not to treat a disease or medical condition in a patient. While it inactivates viruses on its surface, its primary stated purpose is protection and reduction of exposure for the wearer.
No
Explanation: The device is an N95 surgical respirator designed to inactivate viruses and protect the wearer from airborne particulates, not to diagnose medical conditions.
No
The device description clearly outlines a physical medical device (a surgical respirator) with multiple layers of material and active chemical ingredients. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by individuals to reduce exposure to airborne particulates and protect against the transfer of micro-organisms, body fluids, and particulate material. This is a protective device worn on the body.
- Device Description: The description details a physical mask with layers and materials designed for filtration and inactivation of viruses on the surface.
- Lack of Diagnostic Function: An IVD is a device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on biological samples.
- "In vitro" in the text: The text mentions "in vitro tests" when describing the laboratory testing of the mask's ability to inactivate viruses on its surface. This refers to testing done outside of a living organism, which is a common method for evaluating the efficacy of materials or substances. It does not mean the device itself is an IVD.
The device is clearly described as a surgical respirator, which is a type of personal protective equipment (PPE).
N/A
Intended Use / Indications for Use
The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses).
The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/Californial04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional BF-200-3013AN is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
ONT
Device Description
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The respirator is comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Nonclinical tests:
- Bacterial Filtration Efficiency ASTM F2101
- Sub-micron Particulate Filtration Efficiency ASTM F2299
- Fluid Penetration Resistance ASTM F1862
- Breathing Resistance MIL-M-3654C
- Flammability Testing -- 16 CFR 1610
- Biocompatibility - Irritation - ISO 10993-10
- Biocompatibility Sensitization ISO 10993-10
- Biocompatibility - Chemical Characterization - ISO 10993-18
- Breathing Resistance NIOSH 42 CFR 84.180
- Particulate Filtration Efficiency NIOSH 42 CFR 84.181
Key results:
- Bacterial Filtration Efficiency: > 99.9%
- Sub-micron (0.1 µm) Particulate Filtration Efficiency: > 99.9%
- Differential Pressure (Delta-P): 4.9 mm H2O/cm²
- Resistance to Penetration by Synthetic Blood: 160 mm Hg
- Flame Spread: Class 1
- Particulate Filtration Efficiency (NaCl): 98 %
- Breathing Resistance: 8.0 mm H2O (Inhalation), 8.9 mm H2O (Exhalation)
Clinical tests: Not applicable.
Virucidal Efficacy testing was carried out at Microbiotest Inc., Sterling, VA. All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations. The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% (≥4-logs) of 15 different strains of Influenza A and Influenza B viruses, including the circulating 2009 pandemic H1N1, recent vaccine isolates, major reassortments and avian, swine and equine isolates after 5 minutes contact with the mask surface.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency: > 99.9 %
Sub-micron (0.1 µm) Particulate Filtration Efficiency: > 99.9 %
Differential Pressure (Delta-P): 4.9 mm H2O/cm²
Resistance to Penetration by Synthetic Blood: 160 mm Hg
Flame Spread: Class 1
Particulate Filtration Efficiency (NaCl): 98 %
Breathing Resistance: 8.0 mm H2O (Inhalation), 8.9 mm H2O (Exhalation)
Inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests.
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.
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MAR 1 8 2013
5. 510(k) Summary
5.1 Applicant and Correspondent
Filligent (HK) Limited Name:
7th Floor, 69 Jervois Street Address: Sheung Wan Hong Kong
Kai Deusch, M.D., Ph.D. Contact Person: Chief Executive Officer
Phone: (852) 2542 2400
Date of Preparation: August 28, 2012
5.2 Manufacturer
Filligent (HK) Limited 7th Floor, 69 Jervois Street Sheung Wan Hong Kong
5.3 Name of Device
Trade/Proprietary/Model Name: BioFriend™ BioMask™ N95 Surgical Respirator
Model: Professional BF-200-3013AN
N95 Respirator, Filtering Facepiece Respirator Common Name: N95 Respirator With Antimicrobial/Antiviral Agent Classification Name: Filtering Facepiece Respirator for Use by Healthcare Workers Classification Regulation: 878.4040 Panel: General Hospital Device Class: Class II Product Code: ONT Recognized Performance Std: ASTM F2100-11, NIOSH 42 CFR 84 (refer to submission)
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Devices to Which New Device is Substantially Equivalent 5.4
| Device Name: | BioFriend™ BioMask™ "Premium" BF-200-3013A (Convex) |
|---|---|
| Manufacturer: | Filligent (HK) Limited |
| Reference: | K101128 |
| Device Name: | BioFriend™ BioMask™ "Universal" BF-200-2001A (Flat) |
| Manufacturer: | Filligent (HK) Limited |
| Reference: | K101128 |
| Device Name: | 1870 3M N95 Health Care Particulate Respirator and Surgical Mask |
| Manufacturer: | 3M Company |
| Reference: | K063023 |
ર્સ Device Description
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The respirator is comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.
5.6 Statement of Intended Use
The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses).
The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/Californial04/2009,
2
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A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.
5.7 Summary of Technological Characteristics
The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses). Both the outer and second inner layers are treated with different compounds that independently inactivate viruses through different mechanisms of action.
The manufacturing methods and construction materials used in the BioFriend™ BioMask™ N95 surgical respirator Professional BF-200-3013AN, are identical to those used in the following FDAapproved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A (K101128). Filligent (HK) Limited is the manufacturer of these predicate devices and has complete documentation with respect to the manufacturing methods and materials employed. The above BioFriend™ BioMask™ facemasks are identically comprised of four layers of the same material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. The BioFriend™ BioMask™ N95 surgical respirator is also identical in structural shape and design to the following FDA-approved predicate: the BioFriend™ BioMask™ Premium model (BF-200-3013A, convex), except that the meitblown material used in the third layer of the N95 respirator model has
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increased filtration specifications (18g/m² meltblown polypropylene increased to a 50g/m² mettblown polypropylene) to meet the standards required for NIOSH Respirator Certification.
The anti-viral/anti-influenza materials used in the first two active layers of the BioFriend™ BioMask™ N95 surgical respirator are identical in all respects to those of the following FDAapproved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A (K101128). Both the outer and second inner layers are treated with different compounds that independently inactivate viruses through different mechanisms of action. Laboratory (in vitro) tests conducted demonstrate that, as the active layers are identical in all respects and processed by identical manufacturing methods to those in the above predicates, the BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% (≥4-logs) of 15 different strains of Influenza A and Influenza B viruses, including the circulating 2009 pandemic H1N1, recent vaccine isolates, major reassortments and avian, swine and equine isolates after 5 minutes contact with the mask surface.
The construction materials used to provide the mechanical filtration in the BioFriend™ BioMask™ N95 surgical respirator - the polypropylene and meltblown materials - are also identical or similar to all of the following predicate devices: the NIOSH-certified Type N95 3M 1870 N95 Health Care Particulate Respirator and Surgical Mask (K063023), and the BioFriend™ BioMask™ surgical facemasks - Universal BF-200-2001A and Premium BF-200-3013A (K101128). The device as a whole is substantially equivalent to all of the predicate devices.
The device as a whole is comprised of identical materials and is processed by identical manufacturing methods to the predicates: the BioFriend™ BioMask™ surgical facemasks Universal BF-200-2001A and Premium BF-200-3013A (K101128), and have been previously approved as biocompatible by irritation and sensitization testing, and toxicological assessment of the products ingredients potentially released with inhalation or salivary contact, and indicates that the facemask and respirator products are safe for use in the intended application. Filligent (HK) Limited is the manufacturer of the predicate devices: the BioFriend™ BioMask™ surgical facemasks - Universal BF-200-2001A and Premium BF-200-3013A (K101128), and has complete documentation with respect to the manufacturing methods and materials employed. Therefore the BioFriend™ BioMask™ N95 surgical respirator raises no new safety issues. The device as a whole is substantially equivalent to these predicate devices.
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5.8 Brief description of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
- Bacterial Filtration Efficiency ASTM F2101 .
- Sub-micron Particulate Filtration Efficiency ASTM F2299 .
- Fluid Penetration Resistance ASTM F1862 .
- Breathing Resistance MIL-M-3654C .
- . Flammability Testing -- 16 CFR 1610
- . Biocompatibility - Irritation - ISO 10993-10
- Biocompatibility Sensitization ISO 10993-10 .
- . Biocompatibility - Chemical Characterization - ISO 10993-18
- Breathing Resistance NIOSH 42 CFR 84.180 .
- Particulate Filtration Efficiency NIOSH 42 CFR 84.181 .
5.9 Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Not applicable.
5.10 Conclusions drawn from the nonclinical and clinical tests
The performance testing demonstrates that the BioFriend™ BioMask™ N95 surgical respirator is substantially equivalent to the FDA-approved predicate devices, and that it conforms to the recognized FDA consensus standard ASTM F2100-11 Standard Specification for Performance of Materials used in Medical Face Masks and the NIOSH Respirator Certification - 42 CFR 84 -Approval of Respiratory Protective Devices.
The BioFriend™ BioMask™ N95 surgical respirator has been tested for, and appropriately conforms to the requirements set out in ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and NIOSH Respirator Certification 42 CFR 84 -Approval of Respiratory Protective Devices. Performance testing on the BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN has assessed bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. These tests are defined in the FDA Guidance for Industry and FDA Staff, Surgical Masks - Premarket Notification 510(k) Submissions and in the
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FDA-recognized consensus standard, ASTM F2100-11 Standard Specification for Performance of Materials used in Medical Face Masks and the NIOSH Respirator Certification - 42 CFR 84 -Approval of Respiratory Protective Devices. Tests were conducted at Nelson Laboratories Inc., Salt Lake City, UT. Virucidal Efficacy testing was carried out at Microbiotest Inc., Sterling, VA. All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations.
The construction materials used to provide the mechanical filtration in the BioFriend™ BioMask™ N95 surgical respirator - the polypropylene and meltblown materials - are also identical or similar to all of the following predicate devices: the NIOSH-certified Type N95 3M 1870 N95 Health Care Particulate Respirator and Surgical Mask (K063023), and the BioFriend™ BioMask™ surgical facemasks - Universal BF-200-2001A and Premium BF-200-3013A (K101128) The BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN is substantially equivalent as a whole to the predicate devices and is comprised of identical materials and processed by identical manufacturing methods to the following FDA-approved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A. Filligent (HK) Limited is the manufacturer of these predicate devices and has complete documentation with respect to the manufacturing methods and materials employed. Therefore the BioFriend™ BioMask™ N95 surgical respirator raises no new safety issues. The BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN is substantially equivalent as a whole to the above predicate devices.
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Table 5.1: Performance to ASTM F2100 Level 3 Barrier Medical Facemask - Comparison of the BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN to the Predicate Device, the BioFriend™ BioMask™ Surgical
Facemask Model: Premium BF-200-3013A (K101128) and the 1870 3M N95 Health Care Particulate Respirator and Surgical Mask (K063023)
| Description | Test Method | BioFriend™
BioMask™
N95 Surgical
Respirator
Professional
BF-200-3013AN | BioFriend ™
BioMask™ Surgical
Facemasks
Universal
BF-200-2001A and
Premium
BF-200-3013A | 1870 3M N95
Health Care
Particulate
Respirator and
Surgical Mask |
|-------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | | K122702 | K101128 | K063023 |
| Product Code | | ONT | OUK | MSH |
| NIOSH Certificate
Number | | TC-84A-6252 | | TC-84A-3844 |
| Bacterial Filtration
Efficiency | ASTM F2101 | > 99.9 % | 99.9 % | > 99 % |
| Sub-micron
(0.1 µm) Particulate
Filtration Efficiency | ASTM F2299 | > 99.9 % | 99.7 % | Information Not
Declared |
| Differential Pressure
(Delta-P) | MIL-M-36954C | 4.9 mm H2O/cm² | 2.6 mm H2O/cm² | 4.9 mm H2O/cm² |
| Resistance to
Penetration by
Synthetic Blood | ASTM F1862 | 160 mm Hg | 160 mm Hg | 160 mm Hg |
| Flame Spread | 16 CFR Part
1610 | Class 1 | Class 1 | Class 1 |
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Table 5.2: Performance to NIOSH 42 CFR Part 84 - N95 Respirator - Comparison of the BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN to the Predicate Device, the BioFriend™ BioMask™ Surgical Facemask Model: Premium BF-200-3013A (K101128) and the 1870 3M N95 Health Care Particulate Respirator and Surgical Mask (K063023)
| Description | Test Method | BioFriend™
BioMask™
N95 Surgical
Respirator
Professional
BF-200-3013AN | BioFriend™
BioMask™ Surgical
Facemasks
Universal
BF-200-2001A and
Premium
BF-200-3013A | 1870 3M N95
Health Care
Particulate
Respirator and
Surgical Mask |
|------------------------------------------------|---------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | | K122702 | K101128 | K063023 |
| Product Code | | ONT | OUK | MSH |
| NIOSH Certificate
Number | | TC-84A-6252 | | TC-84A-3844 |
| Particulate
Filtration Efficiency
(NaCl) | 42 CFR 84.181 | 98 % | N/A | Pass |
| Breathing
Resistance | 42 CFR 84.180 | 8.0 mm H2O
(Inhalation)
8.9 mm H2O
(Exhalation) | N/A | Pass. |
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2013
Kai Deusch, M.D., Ph.D. Chief Executive Officer Filligent (HK) Limited 700 Floor 69 Jervois Street Sheung Wan, Hong Kong
Re: K122702
Trade/Device Name: BioFriend 101 BioMask 114 N95 Surgical Respirator Model: Professional BF-200-3013AN Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: January 14, 2013 Received: February 28, 2013
Dear Dr. Deusch:
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.
9
Page 2 - Dr. Deusch
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 devicerelated 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure -
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Indications for Use Statement
510(k) Number (if known):
Device Name:
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BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN
Indications for Use:
The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses).
The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/Californial04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional BF-200-3013AN is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.
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Image /page/11/Picture/0 description: The image shows the logo for "filligent" with a circle on the left that has three curved lines inside of it. To the right of the circle is the word "filligent" in a bold, sans-serif font. Below the word "filligent" are the words "creating global health choices" in a smaller font. The logo is black and white.
Prescription Use _ (21 CFR 801 Subpart D) AND/OR
Over-The Counter Use × (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation
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Elizabeth គ 2013.03.18 4'00'
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number;_ 1122702