(116 days)
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 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.
This document is a 510(k) premarket notification for the Innonix Anti-Influenza Child's Face Mask, detailing its acceptance criteria and non-clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 > 1 | All extracted chemicals had margin of safety > 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 (160 mm Hg) |
| MIL-M-3654C | Breathing Resistance | <2.6 mm H2O/cm² | 2.5 mm H2O/cm² |
| 16 CFR 1610 | Flammability Testing | Pass - Class 1 | Pass - Class 1 |
| EN71-1 | Safety of Toys. Mechanical and Physical Properties | Pass | Pass |
| EN71-3 | Chemical Testing (Migration of Certain Elements) | Pass | Pass |
| CPSC-CH-E1002-08 | Total Lead Content Analysis | Pass | Pass |
| CPSC-CH-E1001-09.3 | Phthalate Analysis | Pass (DEHP, DBP, BBP, DINP, DnOP, and DnHP) | Pass (for all listed phthalates) |
| Viral Inactivation | (Influenza A & B, Measles, Coronavirus 229E) | ≥4 log reduction (99.99%) in specified timeframes | ≥4 log reduction (99.99%) |
| Viricidal Activity Maintenance | During simulated use (8 hours) | Maintain viricidal activity (≥4-logs vs untreated) | Maintained viricidal activity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test conducted on the final device. The studies were non-clinical (laboratory-based) tests of the device's material properties and viral inactivation capabilities. The data provenance is laboratory (in vitro) testing, without specifying the country of origin. The data is prospective in the sense that controlled experiments were performed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the non-clinical tests is established by standardized laboratory test methods and their defined acceptance criteria, not by expert consensus in clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device is evaluated through objective, quantitative non-clinical laboratory tests, not through human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a child's face mask, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance tests were standalone in the sense that they evaluated the device's intrinsic properties and capabilities (e.g., filtration efficiency, fluid resistance, viral inactivation) without human intervention in its mechanism of action.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Standardized Test Methods and Criteria: Established by recognized organizations such as ISO, ASTM, MIL, 16 CFR, EN, and CPSC. These standards define the expected performance metrics for safety and effectiveness.
- Quantitative Measurement: Laboratory measurements (e.g., percent filtration, pressure differentials, viral log reduction) provide objective ground truth.
- Comparative Efficacy: For viral inactivation, the "ground truth" for efficacy is expressed as a ≥4 log difference (99.99% inactivation) compared to identical untreated control mask textiles.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set. The mask is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth establishment for such a set.
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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
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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
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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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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 StreetSiu Lek Yuen, ShatinHong Kong | |
| Submitter's Telephone: | Phone +852 2542 2401Fax +852 2542 2411 | |
| US Contact Name: | Reid von Borstel (US Agent for Innonix Technologies Ltd)rvonborstel@usa.net301-412-4060 | |
| Trade or Proprietary Name: | Innonix Anti-Influenza Child's Face MaskModel: 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: | OUKOXZ | |
| Predicate Device: | Device Name | 510(k) Number |
| Primary Predicate:BioFriendTM BioMaskTM SurgicalFacemask OUKModels: Universal BF-200-2001.Premium BF-200-3013 | K101128 | |
| Reference Device:Prestige Ameritech Pediatric/Child'sFace 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).
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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.
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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 ConvexModel: BF-200-3013A and BF-200-2001A | Innonix Anti-Influenza Child'sFace Mask,Model: BF-200-3015A and BF-200-2005A | Comparison of SubjectDevice to Predicate | |
|---|---|---|---|
| FDA Predicate# | K101128 | K192105 | N/A |
| Product Code | OUK | OUKOXZ | Same: Both predicate andsubject devices useidentical virus-inactivatingmaterials in the first andsecond active layers, andthe inner two textile layersare identical as well.Different: The subjectdevice is intended to beworn by children.The predicate device is amedical device to be usedby adults. |
| Date Approved | May 26, 2011 | November 29, 2019 | N/A |
| Description | The BioFriend™ BioMask™ surgicalfacemask is offered in two maskstyles, Models: Universal BF-200-2001A and Premium BF-200 3013A.The Universal model is a standardflat mask with pleats, while thePremium model is flat-folded andexpands into a convex-shapedmask. The Premium model also hasear adjusters and an anti-fog noseflap. Both models comprise fourlayers of material: an outer layer ofspun-bond polypropylene, a secondlayer of cellulose/polyester, a thirdlayer of melt-blown polypropylenefilter material and an inner (fourth)layer of spun-bound polypropylene.All of the construction materials usedin this device are latex free and aretypical construction materialscommonly used in surgicalfacemasks and being used in currentlegally marketed devices, and arenot made with natural rubber latex.The outer active layer of thefacemask is coated with ahydrophilic plastic containing citricacid. The second inner layer istreated with copper and zinc ions.Both layers inactivate influenzaviruses using different mechanismsof action. | The Innonix Anti-Influenza Child'sFace Mask is offered in twostyles, Model: BF-200-3015A isflat-folded and expands into aconvex-shaped mask withpolyamide/spandex elastic head-loops to secure the mask to theuser's face, and a malleablealuminum strip positioned abovethe nose for a tighter seal aroundthe nose and face. Model: BF-200-2005A is a standard flatpleated mask. Both modelscomprise four layers of material:an outer layer of spun-bondpolypropylene, a second layer ofcellulose/polyester, a third layerof melt-blown polypropylene filtermaterial and an inner (fourth)layer of spun-boundpolypropylene. All of theconstruction materials used inthis device are typicalconstruction materials commonlyused in surgical facemasks andbeing used in current legallymarketed devices, and are notmade with natural rubber latex.The outer active layer of thefacemask is coated with ahydrophilic plastic containingcitric acid. The second inner layeris treated with copper and zincions. Both layers inactivate | Same: Both predicate andsubject devices useidentical virus-inactivatingmaterials in the first andsecond active layers. Allfour textile layers areidentical in the predicateand subject masks.Different: The subjectdevice is intended to beworn by children, and isappropriately smaller thanthis predicate, which is ofan appropriate size to beused by adults. |
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| BioFriend ™™ BioMask ™™Surgical Facemask ConvexModel: BF-200-3013A and BF-200-2001A | Innonix Anti-Influenza Child'sFace Mask,Model: BF-200-3015A and BF-200-2005Ainfluenza viruses using differentmechanisms of action. | Comparison of SubjectDevice to Predicate | |||
|---|---|---|---|---|---|
| Intended Use | (BF-200-2001A) - is a standard flat | The BioFriend™™ BioMask™™ surgicalfacemasks are single use disposabledevices with a hydrophilic plasticcoating on the outer layer (activeingredient: citric acid 2%, a pHlowering agent), and a second innerlayer treated with metal ions (activeingredients: copper 1.6% and zinc1.6%, which form ionic bonds withnegatively-charged side-groups oninfluenza viruses).The BioFriend ™™ BioMask™™ surgicalfacemasks kill (inactivate) 99.99% ofInfluenza viruses (≥4-logs differenceversus identical but untreated masktextiles) on five minutes contact withthe surface of the facemask inlaboratory (in vitro) tests against thefollowing seasonal, pandemic, avian,swine and equine influenza viruses:Influenza A subtypes and strains:H1N1 (the 2009 pandemic flusubtype A/California/04/2009,A/Brisbane/59/2007,A/Wisconsin/10/1998, A/NewJersey/8/1976,A/PuertoRico/8/1934), H3N2(A/Brisbane/10/2007,A/Wisconsin/67/2005), H2N2(A/2/Japan/305/1957); the bird flusubtypes: H5N1 (NIBRG-14), H9N2(A/Turkey/Wisconsin/1966), H5N2(A/Duck/PA/10218/84); the swine flusubtype: H1N1(A/Swine/1976/1931); the equine flusubtype: H3N8(A/Equine/2/Miami/1963); andInfluenza 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'sFace Mask (Models BF-200-3015A and BF-200-2005A) is asingle use, disposable device thatis intended to be worn by children(recommended ages 5-10) tocover the nose and mouth toprovide a barrier for therespiratory tract formicroorganisms, body fluid andparticulate materials. The mask isspecifically for child or pediatricpatients to provide protection forthe respiratory tract. This facemask is recommended for use ina healthcare setting withappropriate adult supervision.The Innonix Anti-Influenza Child'sFace Mask has hydrophilic plasticcoating (active ingredient: citricacid 2%, a pH lowering agent)that rapidly absorbs aerosoldroplets away from the outersurface of the mask and asecond inner layer treated withmetal ions (active ingredients:copper 1.6% and zinc 1.6%) thatinactivate influenza viruses.The Innonix Anti-Influenza Child'sFace Mask inactivated 99.99% oftested influenza viruses (≥4 logdifference versus identicaluntreated control mask textiles)within five minutes of contact withthe surface of the facemask inlaboratory (in vitro) tests againstthe following seasonal,pandemic, avian, swine andequine influenza viruses:Influenza A subtypes and strainsH1N1 (A/California/04/2009,A/Brisbane/59/2007, | Same: Both predicate andsubject devices useidentical virus-inactivatingmaterials in the first andsecond active layers. Allfour textile layers areidentical in the predicateand subject masks.Different: The subjectdevice is intended to beworn by children, and isappropriately smaller.The predicate device is amedical device of anappropriate size to be usedby 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). |
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| BioFriend™ BioMask™Surgical Facemask ConvexModel: BF-200-3013A and BF-200-2001A | Innonix Anti-Influenza Child'sFace Mask,Model: BF-200-3015A and BF-200-2005A | Comparison of SubjectDevice to Predicate | |
|---|---|---|---|
| intended to be worn by operatingroom personnel during surgicalprocedures, to protect both thesurgical patient, and the operatingroom personnel, from the transfer ofmicro-organisms, body fluids andparticulate material. | H5N2 (A/Duck/PA/10218/84); theswine flu subtype: H1N1(A/Swine/1976/1931); the equineflu subtype: H3N8(A/Equine/2/Miami/1963); andInfluenza B strains:(B/Florida/4/2006, B/Lee/1940).The mask also inactivated>99.99% of Measles virus strainATCC VR-24 and Coronavirus229E strain ATCC VR-740 withinone minute of contact with thesurface of the facemask inlaboratory in vitro tests.Correlation between in vitroresults and any clinical event hasnot been tested. | ||
| Outer (First)Layer | Spun-bond Polypropylene withHydrophilic Plastic Coating | Spun-bond Polypropylene withHydrophilic Plastic Coating | Identical |
| Second Layer | Spunlace Cellulose/PolyesterTreated with Copper and Zinc | Spunlace Cellulose/PolyesterTreated with Copper and Zinc | Identical |
| Third(Filtration)Layer | Melt-blown Polypropylene 18 g/m² | Melt-blown Polypropylene: 18g/m² | Identical |
| Inner (Fourth)Layer | Spun-bond Polypropylene | Spun-bond Polypropylene | Identical |
| Fastening | Synthetic Elastic Ear Loops (notmade with natural rubber latex) | Synthetic Elastic Ear Loops (notmade with natural rubber latex) | Identical |
| Nose Strip | Malleable Aluminum Wire | Malleable Aluminum Wire | Identical |
| BacterialFiltration(ASTM F2101) | 99.9% | 99.5% | Identical |
| BioFriend™ BioMask™Surgical Facemask ConvexModel: BF-200-3013A and BF-200-2001A | Innonix Anti-Influenza Child'sFace Mask,Model: BF-200-3015A and BF-200-2005A | Comparison of SubjectDevice to Predicate | |
| ParticulateFiltration(ASTM F2299) | 99.7% | >99.5% | Identical |
| DifferentialPressure(Delta P)(MIL M36954C) | 2.6 mm H2O/cm² | 2.5 mm H2O/cm² | Identical |
| FluidResistance(ASTM F2101) | Fluid Resistant160mm Hg (>80 mm Hg) | Fluid Resistant160mm 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 marginof safety greater than 1 | All extracted chemicals hadmargin of safety greater than 1 | Identical |
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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 skinsensitization | Not an irritant or sensitizer | Not an irritant or sensitizer |
| ISO 10993-18 | Chemical characterization ofmaterials | All extracted chemicals hadmargin of safety greater than 1 | All extracted chemicals hadmargin of safety greater than 1 |
| ASTM F2101 | Bacterial Filtration Efficiency | >99% | 99.5% |
| ASTM F2299 | Sub-micron ParticulateFiltration Efficiency | >99% | >99.5% |
| ASTM F1862 | Fluid PenetrationResistance | Fluid Resistant(>80 mm Hg) | Fluid Resistant160mm Hg |
| MIL-M-3654C | Breathing Resistance | <2.6 mm H2O/cm² | 2.5 mm H2O/cm² |
| 16 CFR 1610 | Flammability Testing | Pass - Class 1 | Pass - Class 1 |
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| EN71-1 | Safety of Toys. Mechanicaland Physical Properties | Pass | Pass |
|---|---|---|---|
| EN71-3 | Chemical Testing (Migrationof Certain Elements) | Pass | Pass |
| CPSC-CH-E1002-08 | Total Lead Content Analysis | Pass | Pass |
| CPSC-CH-E1001-09.3 | Phthalate Analysis DEHP,DBP, BBP, DINP, DnOP,and DnHP | Pass | Pass |
The Innonix Anti-Influenza Child's Face Mask has been shown to the following standards, practices, and guidance:
BIOCOMPATIBILITY
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ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
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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.
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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.
§ 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.