(116 days)
No
The device description focuses on the physical construction and chemical treatments of the mask materials for viral inactivation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed to inactivate influenza viruses upon contact, which indicates a therapeutic rather than just a barrier function.
No
Explanation: This device is a face mask intended to provide a barrier for the respiratory tract against microorganisms, body fluid, and particulate materials, and also to inactivate viruses. It does not diagnose any condition.
No
The device is a physical face mask with active chemical coatings, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by children to cover the nose and mouth and provide a barrier for the respiratory tract against microorganisms, body fluid, and particulate materials. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Mechanism of Action: While the mask has active ingredients that inactivate viruses on the mask surface (which is an in vitro test described in the performance section), the primary function for the user is as a physical barrier. The inactivation happens on the device itself, not on a patient sample for diagnostic purposes.
- Lack of Diagnostic Purpose: The device does not analyze a biological sample (like blood, urine, or tissue) to diagnose a disease, condition, or state of health.
- Device Description: The description focuses on the physical construction and materials of a face mask.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration, breathing resistance, fluid resistance, flammability, biocompatibility) and the in vitro viricidal activity on the mask surface. There are no studies related to diagnosing a condition in a patient.
- Predicate Devices: The predicate devices listed are also surgical face masks, which are not IVDs.
The mention of "in vitro tests" in the performance section refers to laboratory tests performed on the mask material to demonstrate its viricidal properties, not a diagnostic test performed on a patient sample.
N/A
Intended Use / Indications for Use
The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.
The Innonix Anti-Influenza Child's Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, equine 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). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the face mask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.
Product codes (comma separated list FDA assigned to the subject device)
OUK, OXZ
Device Description
The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise 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-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).
Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and 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
Children (recommended ages 5-10)
Intended User / Care Setting
Healthcare setting with appropriate adult supervision.
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)
The Innonix Anti-Influenza Child's Face Mask underwent non-clinical testing to verify it met specified standards. The non-clinical tests conducted include:
- ISO 10993-10: Tests for irritation and skin sensitization. Results: Not an irritant or sensitizer.
- ISO 10993-18: Chemical characterization of materials. Results: All extracted chemicals had margin of safety greater than 1.
- ASTM F2101: Bacterial Filtration Efficiency. Results: 99.5% (>99% acceptance criteria).
- ASTM F2299: Sub-micron Particulate Filtration Efficiency. Results: >99.5% (>99% acceptance criteria).
- ASTM F1862: Fluid Penetration Resistance. Results: Fluid Resistant 160mm Hg (>80 mm Hg acceptance criteria).
- MIL-M-3654C: Breathing Resistance. Results: 2.5 mm H2O/cm² (99.5%
- Fluid Resistance: 160mm Hg
- Differential Pressure: 2.5 mm H2O/cm²
- Inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact.
- Inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact.
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.
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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
November 29, 2019
Innonix Technologies Limited Reid Borsel US Agent For Innonix Technologies 10017 Sorrel Ave Potomac, Maryland 20854
Re: K192105
Trade/Device Name: Innonix Antiviral Child's Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OUK, OXZ Dated: October 30, 2019 Received: October 30, 2019
Dear Reid Borsel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192105
Device Name Innonix Anti-Influenza Child's Face Mask
Indications for Use (Describe)
The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.
The Innonix Anti-Influenza Child's Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avine and equine influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, 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/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). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the facemask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K192105
| Date Summary was Prepared: | November 28, 2019 | |
|---|---|---|
| Submitter's Name: | Innonix Technologies Limited | |
| (formerly Filligent Limited) | ||
| Submitter's Address: | 13/F, LiFung Centre, 2 On Ping Street | |
| Siu Lek Yuen, Shatin | ||
| Hong Kong | ||
| Submitter's Telephone: | Phone +852 2542 2401 | |
| Fax +852 2542 2411 | ||
| US Contact Name: | Reid von Borstel (US Agent for Innonix Technologies Ltd) | |
| rvonborstel@usa.net | ||
| 301-412-4060 | ||
| Trade or Proprietary Name: | Innonix Anti-Influenza Child's Face Mask | |
| Model: BF-200-3015A and BF-200-2005A | ||
| 510(k) Number | K192105 | |
| Device Classification Name: | Pediatric/Child Face Mask with Antimicrobial/Antiviral Agent | |
| Classification Name: | CFR 21 878.4040 | |
| Panel: | General Hospital | |
| Product Code: | OUK | |
| OXZ | ||
| Predicate Device: | Device Name | 510(k) Number |
| Primary Predicate: | ||
| BioFriendTM BioMaskTM Surgical | ||
| Facemask OUK | ||
| Models: Universal BF-200-2001. | ||
| Premium BF-200-3013 | K101128 | |
| Reference Device: | ||
| Prestige Ameritech Pediatric/Child's | ||
| Face Mask OXZ | K160100 |
1. Device Description
The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise 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-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).
4
Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
2. Indication for Use
The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.
The Innonix Anti-Influenza Child's Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, equine 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). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the face mask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.
5
Technological Characteristic Comparison 3.
Comparison of the predicate device, BioFriend™ BioMask™ Surgical Facemask Models: Premium BF-200-3013A and Universal BF-200-2001A to Innonix Anti-Influenza Child's Face Mask, Models: BF-200-3015A and BF-200-2005A
| | BioFriend ™™ BioMask ™™
Surgical Facemask Convex
Model: BF-200-3013A and BF-200-
2001A | Innonix Anti-Influenza Child's
Face Mask,
Model: BF-200-3015A and BF-
200-2005A | Comparison of Subject
Device to Predicate |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Predicate
| K101128 | K192105 | N/A |
| Product Code | OUK | OUK
OXZ | Same: Both predicate and
subject devices use
identical virus-inactivating
materials in the first and
second active layers, and
the inner two textile layers
are identical as well.
Different: The subject
device is intended to be
worn by children.
The predicate device is a
medical device to be used
by adults. |
| Date Approved | May 26, 2011 | November 29, 2019 | N/A |
| Description | The BioFriend™ BioMask™ surgical
facemask is offered in two mask
styles, Models: Universal BF-200-
2001A and Premium BF-200 3013A.
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 comprise 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 latex free and are
typical construction materials
commonly used in surgical
facemasks and being used in current
legally marketed devices, and are
not made with natural rubber latex.
The outer active layer of the
facemask is coated with a
hydrophilic plastic containing citric
acid. The second inner layer is
treated with copper and zinc ions.
Both layers inactivate influenza
viruses using different mechanisms
of action. | The Innonix Anti-Influenza Child's
Face Mask is offered in two
styles, Model: BF-200-3015A is
flat-folded 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. Model: BF-
200-2005A is a standard flat
pleated mask. Both models
comprise 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
being used in current legally
marketed devices, and are not
made with natural rubber latex.
The outer active layer of the
facemask is coated with a
hydrophilic plastic containing
citric acid. The second inner layer
is treated with copper and zinc
ions. Both layers inactivate | Same: Both predicate and
subject devices use
identical virus-inactivating
materials in the first and
second active layers. All
four textile layers are
identical in the predicate
and subject masks.
Different: The subject
device is intended to be
worn by children, and is
appropriately smaller than
this predicate, which is of
an appropriate size to be
used by adults. |
6
| | BioFriend ™™ BioMask ™™
Surgical Facemask Convex
Model: BF-200-3013A and BF-200-
2001A | Innonix Anti-Influenza Child's
Face Mask,
Model: BF-200-3015A and BF-
200-2005A
influenza viruses using different
mechanisms of action. | Comparison of Subject
Device to Predicate | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | (BF-200-2001A) - is a standard flat | 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% and zinc
1.6%, which form ionic bonds with
negatively-charged side-groups on
influenza viruses).
The BioFriend ™™ BioMask™™ surgical
facemasks kill (inactivate) 99.99% of
Influenza viruses (≥4-logs difference
versus identical but untreated mask
textiles) 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/04/2009,
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/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.
There are two models: (1) Universal | A/Brisbane/59/2007, | The Innonix Anti-Influenza Child's
Face Mask (Models BF-200-
3015A and BF-200-2005A) is a
single use, disposable device that
is intended to be worn by children
(recommended ages 5-10) to
cover the nose and mouth to
provide a barrier for the
respiratory tract for
microorganisms, body fluid and
particulate materials. The mask is
specifically for child or pediatric
patients to provide protection for
the respiratory tract. This face
mask is recommended for use in
a healthcare setting with
appropriate adult supervision.
The Innonix Anti-Influenza Child's
Face Mask has hydrophilic plastic
coating (active ingredient: citric
acid 2%, a pH lowering agent)
that rapidly absorbs aerosol
droplets away from the outer
surface of the mask and a
second inner layer treated with
metal ions (active ingredients:
copper 1.6% and zinc 1.6%) that
inactivate influenza viruses.
The Innonix Anti-Influenza Child's
Face Mask inactivated 99.99% of
tested influenza viruses (≥4 log
difference versus identical
untreated control mask textiles)
within five minutes of 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 (A/California/04/2009,
A/Brisbane/59/2007, | Same: Both predicate and
subject devices use
identical virus-inactivating
materials in the first and
second active layers. All
four textile layers are
identical in the predicate
and subject masks.
Different: The subject
device is intended to be
worn by children, and is
appropriately smaller.
The predicate device is a
medical device of an
appropriate size to be used
by adults. |
| mask with pleats; (2) Premium (BF- | A/Wisconsin/10/1998, A/New | | | | |
| 200-3013A) - flat-folded, expanding | Jersey/8/1976, | | | | |
| into a convex-shaped mask with ear | A/Puerto Rico/8/1934), H3N2 | | | | |
| adjusters and an anti-fog nose flap. | (A/Brisbane/10/2007, | | | | |
| No clinical studies have been | A/Wisconsin/67/2005), H2N2 | | | | |
| conducted comparing the ability of | (A/2/Japan/305/1957); the bird flu | | | | |
| an untreated facemask and these | subtypes: H5N1 (NIBRG-14), | | | | |
| facemasks to protect the wearer | H9N2 | | | | |
| from Influenza infection. They are | (A/Turkey/Wisconsin/1966). | | | | |
7
| | BioFriend™ BioMask™
Surgical Facemask Convex
Model: BF-200-3013A and BF-200-
2001A | Innonix Anti-Influenza Child's
Face Mask,
Model: BF-200-3015A and BF-
200-2005A | Comparison of Subject
Device to Predicate |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | 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. | 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).
The mask also inactivated
99.99% of Measles virus strain
ATCC VR-24 and Coronavirus
229E strain ATCC VR-740 within
one minute of contact with the
surface of the facemask in
laboratory in vitro tests.
Correlation between in vitro
results and any clinical event has
not been tested. | |
| Outer (First)
Layer | Spun-bond Polypropylene with
Hydrophilic Plastic Coating | Spun-bond Polypropylene with
Hydrophilic Plastic Coating | Identical |
| Second Layer | Spunlace Cellulose/Polyester
Treated with Copper and Zinc | Spunlace Cellulose/Polyester
Treated with Copper and Zinc | Identical |
| Third
(Filtration)
Layer | Melt-blown Polypropylene 18 g/m² | Melt-blown Polypropylene: 18
g/m² | Identical |
| Inner (Fourth)
Layer | Spun-bond Polypropylene | Spun-bond Polypropylene | Identical |
| Fastening | Synthetic Elastic Ear Loops (not
made with natural rubber latex) | Synthetic Elastic Ear Loops (not
made with natural rubber latex) | Identical |
| Nose Strip | Malleable Aluminum Wire | Malleable Aluminum Wire | Identical |
| Bacterial
Filtration
(ASTM F2101) | 99.9% | 99.5% | Identical |
| | BioFriend™ BioMask™
Surgical Facemask Convex
Model: BF-200-3013A and BF-200-
2001A | Innonix Anti-Influenza Child's
Face Mask,
Model: BF-200-3015A and BF-
200-2005A | Comparison of Subject
Device to Predicate |
| Particulate
Filtration
(ASTM F2299) | 99.7% | >99.5% | Identical |
| Differential
Pressure
(Delta P)
(MIL M36954C) | 2.6 mm H2O/cm² | 2.5 mm H2O/cm² | Identical |
| Fluid
Resistance
(ASTM F2101) | Fluid Resistant
160mm Hg (>80 mm Hg) | Fluid Resistant
160mm Hg (>80 mm Hg) | Identical |
| Flammability
(16 CFR 1610) | Class 1 | Class 1 | Identical |
| Irritation
(ISO 10993) | Not an irritant | Not an irritant | Identical |
| Sensitization
(ISO10993) | Not a sensitizer | Not a sensitizer | Identical |
| Extractables
(ISO10993) | All extracted chemicals had margin
of safety greater than 1 | All extracted chemicals had
margin of safety greater than 1 | Identical |
8
The Indication for Use and technological features of the Innonix Anti-Influenza Child's Face Mask are similar to the legally marketed predicate devices. The four textile layers are identical to those of the predicate mask, the Filligent BioFriend™ BioMask ™Surgical Facemask, and the Innonix Anti-Influenza Child's Face Mask has child-appropriate size and other characteristics similar to the Prestige Ameritech Pediatric/Child's Face Mask. The Innonix Anti-Influenza Child's Face Mask and the respective predicate devices have similar intended uses and methods of operation.
4. Summary of Non-Clinical Testing
The Innonix Anti-Influenza Child's Face Mask was tested to verify the subject device met the standards listed below:
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | Tests for irritation and skin | ||
| sensitization | Not an irritant or sensitizer | Not an irritant or sensitizer | |
| ISO 10993-18 | Chemical characterization of | ||
| materials | All extracted chemicals had | ||
| margin of safety greater than 1 | All extracted chemicals had | ||
| margin of safety greater than 1 | |||
| ASTM F2101 | Bacterial Filtration Efficiency | >99% | 99.5% |
| ASTM F2299 | Sub-micron Particulate | ||
| Filtration Efficiency | >99% | >99.5% | |
| ASTM F1862 | Fluid Penetration | ||
| Resistance | Fluid Resistant | ||
| (>80 mm Hg) | Fluid Resistant | ||
| 160mm Hg | |||
| MIL-M-3654C | Breathing Resistance | ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization |
-
ISO 10993-18, Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
MECHANICAL PERFORMANCE
- ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks A
- A ASTM F2101, Bacterial Filtration Efficiency
- A ASTM F2299, Sub-micron Particulate Filtration Efficiency
- A ASTM F1862, Fluid Penetration Resistance
- A MIL-M-3654C, Breathing Resistance
- A 16 CFR 1610, Flammability Testing
SAFETY TESTING FOR PEDIATRIC USE
- EN71-1, Safety of Toys. Mechanical and Physical Properties A
- A EN71-3, Chemical Testing (Migration of Certain Elements)
- A CPSC-CH-E1002-08 Total Lead Content Analysis
- A CPSC-CH-E1001-09.3 Phthalate Analysis DEHP, DBP, DINP, DnOP, and DnHP
In addition to the tests listed above that were performed on the subject device, a study of viricidal activity during simulated use was conducted to verify maintenance of the viricidal activity (≥4-logs versus identical but untreated mask textiles) of the mask textiles during repeated exposure to simulated nasal secretions and saliva over a period of 8 hours.
5. Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10
6. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.