BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

K101128 · Filligent Limited · OUK · May 26, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K101128
• Device Name: BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
• Applicant: Filligent Limited
• Product Code: OUK · General, Plastic Surgery
• Decision Date: May 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The BioFriend™ BioMask™ surgical facemasks are single use disposable devices 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™ surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask 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/California/07/09, A/Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersev/8/76. A/PR/8/38), A/PR/8/38 H3N2 (A/Brisbane/10/2007.A/Wisconsin/67/2005.). H2N2 (A/2JAPAN/305/57); 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/1976/31); the equine flu subtype: H3N8 (A/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested. There are two models: (1) Universal (BF-200-2001A) - a standard flat mask with pleats; (2) Premium (BF-200-3013A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an antifog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of microorganisms, body fluids and particulate material.

Device Story

BioFriend™ BioMask™ is a single-use, four-layer surgical facemask; available in Universal (pleated) and Premium (convex) styles. Outer layer features hydrophilic plastic coating (citric acid 2%); second inner layer treated with copper (1.6%) and zinc (1.6%) ions. Mechanism: hydrophilic coating absorbs aerosolized droplets; metal ions inactivate influenza viruses via pH lowering and ionic bonding. Device includes elastic ear loops and malleable nosepiece. Used in operating rooms by surgical personnel. Provides physical barrier against fluids/particulates; inactivates 99.99% of various influenza strains (seasonal, pandemic, avian, swine, equine) upon 5-minute contact. Clinical efficacy against influenza infection not established.

Clinical Evidence

No clinical data. Bench testing only. In vitro testing demonstrated 99.99% (≥4-log) inactivation of 15 influenza A and B strains after 5 minutes contact. Standardized bench testing performed for bacterial filtration efficiency (ASTM F2101), sub-micron particulate filtration (ASTM F2299), fluid penetration resistance (ASTM F1862), breathing resistance (MIL-M-3654C), flammability (16 CFR 1610), and biocompatibility (ISO 10993-10, ISO 10993-18).

Technological Characteristics

Four-layer construction: spun-bond polypropylene (outer), cellulose/polyester (second), melt-blown polypropylene (filter), spun-bond polypropylene (inner). Outer layer: hydrophilic plastic coating (citric acid 2%). Second layer: copper (1.6%) and zinc (1.6%) treatment. Conforms to ASTM F2100-07. Mechanical barrier with chemical viral inactivation. No software or energy source.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Prestige Ameritech Face Mask (K061716)

Submission Summary (Full Text)

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BioFriend™ BioMask™ Surgical Facemask

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Image /page/0/Picture/1 description: The image shows the logo for "filligent" with the tagline "creating global health choices". To the left of the word "filligent" is a circular icon with three curved lines inside. The text is in a simple, sans-serif font and is black.

MAY 2 6 2011

### 510(k) Summary 5

| 5.1 Applicant and Correspondent | |
|---------------------------------|---------------------------------------------------------|
| Name: | Filligent (HK) Limited |
| Address: | 7th Floor, 69 Jervois Street<br>Sheung Wan<br>Hong Kong |
| Contact Person: | Melissa Mowbray-d'Arbela<br>Chief Executive Officer |
| Phone: | (852) 2542 2400 |
| Date of Preparation: | March 11, 2011 |

### 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™ Surgical Facemask

Models: Universal BF-200-2001A Premium BF-200-3013A

| Common Name: | Surgical Facemask |
|-----------------------------|-------------------------------------|
| Classification Name: | Mask, Surgical |
| Classification Regulation: | 878.4040 |
| Panel: | General Hospital |
| Product Code: | OUK |
| Recognized Performance Std: | ASTM F2100-07 (refer to submission) |

### Devices to Which New Device is Substantially Equivalent 5.4

| Device Name: | Prestige Ameritech Face Mask |
|---------------|------------------------------|
| Manufacturer: | Prestige Ameritech |
| Reference: | K061716 |

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Image /page/1/Picture/1 description: The image contains the logo for "filligent" with the tagline "creating global health choices" underneath. To the left of the text is a circular graphic with concentric arcs inside. The text is in a simple, sans-serif font and is black. The logo appears to be for a health-related organization.

#### 5.5 Device Description

The BioFriend™ BioMask™ surgical facemask is offered in two mask styles, Model: BF-200-2001A ("Universal") and Model: BF-200-3013A ("Premium"). The Universal model is a standard flat mask with pleats, while the Premium model is flat-folded and expands into a convex-shaped mask. The Premium model also has ear adjusters and an anti-fog nose flap. Both models are 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 these devices are typical construction materials commonly used in surgical facemasks and are being used in current legally marketed devices. The outer is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc. Both layers inactivate influenza viruses using different mechanisms of action. Masks are held in place on the wearer with elastic loops and contain a malleable metal nosepiece strip.

### 5.6 Statement of Intended Use

The BioFriend™ BioMask™ surgical facemasks are single use disposable devices with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2%, a pH lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6%, which form ionic bonds with negatively-charged side-groups on influenza viruses).

The BioFriend™ BioMask™ surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask 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/California/07/09, A/Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersey/8/76, Jersey/8/76 A/PR/8/38), H3N2 (A/Brisbane/10/2007. H2N2 (A/2/JAPAN/305/57); 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/1976/31); the equine flu subtype: H3N8 (A/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

There are two models: (1) Universal (BF-200-2001A) - is a standard flat mask with pleats; (2) Premium (BF-200-3013A) - flat-folded, expanding into a convex-shaped mask with ear adjusters and an anti-fog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of micro-organisms, body fluids and particulate material.

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Image /page/2/Picture/1 description: The image shows the logo for Filligent. The logo consists of a circle with curved lines inside, resembling a fingerprint or sound waves. To the right of the circle is the word "filligent" in a sans-serif font, with the words "creating global health choices" underneath in a smaller font.

#### 5.7 Summary of Technological Characteristics

The BioFriend™ BioMask™ surgical facemasks have substantially equivalent filter and barrier properties as the predicate device, and conform to the recognized FDA consensus standard ASTM F2100-07 Standard Specification for Performance of Materials used in Medical Face Masks. Both models of the BioFriend™ BioMask™ surgical facemask are constructed from the same materials and lavers, and are identical in all respects other than shape. The outer layer of both models is coated with a hydrophilic plastic that allows aerosolized droplets contacting the surface of the mask to be rapidly absorbed into the inner layers. Both the outer and second inner layers are treated with different compounds that independently inactivate viruses through different mechanisms of action. Laboratory (in vitro) test results demonstrate that the BioFriend™ BioMask™ surgical facemasks inactivate 99.99% (≥4-logs) of 15 different strains of Influenza A and 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 BioFriend™ BioMask™ surgical facemasks have been tested for, and appropriately passed standardized tests for, fluid penetration resistance, particulate filtration efficiency, bacterial filtration efficiency, flammability, and breathing resistance. The device as a whole has been shown to be biocompatible through standardized tests for irritation, sensitization and extractables.

The materials of construction used in the BioFriend™ BioMask™ surgical facemasks are equivalent to those of the predicate devices as a whole are substantially equivalent to the predicate device.

## 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

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Image /page/3/Picture/1 description: The image shows the logo for Filligent. The logo consists of a circle with three curved lines inside, followed by the word "filligent" in a sans-serif font. Below the word "filligent" are the words "creating global health choices" in a smaller font.

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.

### Conclusions drawn from the nonclinical and clinical tests 5.10

Standardized testing has shown that the construction materials used in both models of the BioFriend™ BioMask™ surgical facemask are substantially equivalent to those of the predicate device. The devices as a whole have been demonstrated to be biocompatible through irritation and sensitization testing, with toxicological assessment of the devices' components which could potentially be released with inhalation or salivary contact, indicating the devices are safe for use in the intended application. Laboratory testing has demonstrated the devices' efficacy. Both models of the BioFriend™ BioMask™ surgical facemask have been shown to be substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

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

Filligent (HK) Limited C/O Mr. Ian Gordon Emergo Group, Incorporated 611 West 5th Street Third Floor Austin, Texas 78701

MAY 2 6 2011

Re: K101128

Trade/Device Name: BioFriend™ BioMask™ Surgical Facemask Models: Universal BF-200-2001A and Premium BF-200-3013A Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: OUK Dated: May 20, 2011 Received: May 23, 2011

Dear Mr. Gordon:

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 - Mr. Gordon

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Avant

Anthony 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

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### Indications for Use Statement ব

## 510(k) Number:

K101128.

# Device Name:

BioFriend™ BioMask™ Surgical Facemask Models: Universal BF-200-2001A and Premium BF-200-3013A

# Indications for Use:

The BioFriend™ BioMask™ surgical facemasks are single use disposable devices 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™ surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask 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/California/07/09, A/Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersev/8/76. A/PR/8/38), A/PR/8/38 H3N2 (A/Brisbane/10/2007.A/Wisconsin/67/2005.). H2N2 (A/2JAPAN/305/57); 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/1976/31); the equine flu subtype: H3N8 (A/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

Prescription Use (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

Elizabeth S. Clamin-Will

Division of Anesthesiology, Genend Hospital
Infection Control and Dental Devices
510(k) Number: K101128

Page 1 of 2

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There are two models: (1) Universal (BF-200-2001A) - a standard flat mask with pleats; (2) Premium (BF-200-3013A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an antifog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of microorganisms, body fluids and particulate material.