(97 days)
Not Found
No
The description focuses on the physical construction and chemical properties of the mask, specifically the anti-influenza agent. There is no mention of any computational or algorithmic processes that would involve AI or ML.
No.
The device is a surgical mask intended to protect from the transfer of microorganisms, body fluids, and particulates, and has an anti-influenza agent to inactivate specific pathogens. Its purpose is protective, not therapeutic, as it does not treat or cure a disease or condition, but rather aims to prevent the transmission of pathogens.
No
A diagnostic device identifies a condition or disease. This device is a mask designed to protect the user from microorganisms and body fluids, and to inactivate influenza viruses, not to diagnose a medical condition.
No
The device is a physical surgical mask with added chemical properties, not a software application.
Based on the provided information, the Cufitec Surgical Mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates. While it has an anti-influenza agent that inactivates viruses on the mask surface in laboratory tests, this is a function of the mask itself, not a diagnostic test performed on a sample from the patient.
- Mechanism of Action: The anti-influenza agent acts on the viruses that come into contact with the mask surface. It does not analyze or detect substances within a biological sample (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- IVD Definition: IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Cufitec Surgical Mask does not perform this function.
- Performance Studies: The performance studies focus on the mask's physical properties (filtration, fluid resistance) and the antiviral efficacy on the mask surface. There are no studies related to diagnosing or monitoring a patient's health.
- Predicate Device: The predicate device is another surgical facemask, not an IVD.
The mention of "in vitro tests" in the intended use refers to laboratory testing of the mask's antiviral properties outside of a clinical setting, not a diagnostic test performed on a patient sample.
N/A
Intended Use / Indications for Use
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.
The Cufitec Surgical Mask inactivates 99.90% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:
Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions.
Correlations between in vitro testing results and any clinical event has not been tested.
Product codes
OUK
Device Description
The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Bench Testing:
The performance testing includes flammability, fluid resistance, bacterial filtration efficiency (BFE), and particle filtration efficiency (PFE). Results of the performance testing met all acceptance criteria per ASTM and ISO standards.
Antiviral testing:
Chemical characterization was conducted to assess the safety of the device is worn. The test included analysis of solids released into airflow through the mask as well as analysis of extracts by saline and hexane. The results of the study support the biological safety of the device.
Limit of Quantitation (LOO) was designed to determine the limit of active ingredient (CuI) on the mask using uncoated surgical masks. Results demonstrated that the LOQ was 0.048 µg/cm².
Neutralization Validation was performed to validate the neutralization buffer (SCDLP) medium. The results demonstrated that the neutralizer effectively neutralized the antiviral effect of eluted antiviral agent.
Antiviral efficacy was designed to assess both "fresh" and "aged" test articles which were tested against nine subtypes of influenza viruses. The results demonstrate that all test articles met the acceptable criteria of achieving 99.99% reduction of the viruses at 5 minutes' contact.
Determination of resistant strains was performed to determine the strains, out of nine subtypes of influenza. most resistant to both fresh" and aqed" masks. The results show that the three most resistant strains to the device are Influenza A (H3N2): A/Kitakyusyu/159/93, A/HongKong/8/68, and A/Udorn/307/72.
Simulated breathing test was designed to assess the antiviral efficacy of the device after simulated breathing using fresh" and aged" articles aqainst the three most resistant strains of Influenza as well as A/H1N1 (A/Virginia/ATCC2/2009) and Influenza B (B/Lee/40). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.
Repeated exposure testing was conducted to assess both "fresh" and "aged" articles against repeated exposure to Influenza viruses (5 subtypes). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.
Uniform distribution validation was designed to determine the concentration of active ingredient, currous iodide (CuI) on the surqical mask. Results show that the concentration of CuI was sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples.
Minimum effective concentration testing was conducted to determine the minimum effective concentration of CuI on the surgical mask using three different concentrations against the influenza viruses). The minimum concentration of CuI on the mask is sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 3, 2019
NBC Meshtec Inc. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St. Suite 200 Gardena, California 90248
Re: K182766
Trade/Device Name: Cufitec Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OUK Dated: December 13, 2018 Received: December 17, 2018
Dear Takahiro Haruyama:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Cutifec Surgical Mask
Indications for Use (Describe)
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.
The Cufitec Surgical Mask inactivates 99.90% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:
Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions.
Correlations between in vitro testing 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) | ☐ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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3
510(k) Summary
1: SUBMITTER INFORMATION
| 510(k) Owner/Applicant | NBC Meshtec, Inc.
2-50-3 Toyoda, Hino-shi
Tokyo, JAPAN, 191-0053
Tel: +81-42-582-1374 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| NBC Meshtec Correspondent | Tomokazu Nagao, Ph.D.
Biology Dept. Manager, R&D
NBC Meshtec, Inc. |
| Official US Correspondent | Takahiro Haruyama
Globizz Corporation
1411 W. 190th St., #200
Gardena, CA 90248
Tel: (310) 538-3860
Email: register@globizz.net |
| Date Prepared | December 21, 2018 |
2: DEVICE INFORMATION
| Trade Name | Cufitec® Surgical Mask |
|---|---|
| 510(k) Number | K182766 |
| Common Name | Surgical Mask with Antimicrobial/Antiviral Agent |
| Classification Name | Surgical Apparel |
| Regulation | 21 CFR 878.4040 |
| Review Panel | General Hospital |
| Product Code | OUK |
| Device Class | Class II |
3: PREDICATE DEVICE
| Trade Name | BioFriend™ BioMask™ Surgical Facemask
Models: Universal BF 200-2001A, Premium BF-200-3013A |
|--------------|-----------------------------------------------------------------------------------------------|
| Manufacturer | Filligent (HK) Limited |
| Reference | K101128 |
4
4: DEVICE DESCRIPTION
The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.
5: INDICATIONS FOR USE
Table A. Comparison of indications for use statements.
| Cufitec® Surgical Mask
Subject Device | BioFriend™ BioMask™ Surgical Facemask
Predicate Device (K101128) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Cufitec® Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and particulates and has an anti-influenza agent (active ingredient: CuI at 0.5% wt. concentration) on the outer and inner mask layers. | 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 Cufitec® Surgical Mask inactivates 99.99% of the following influenza viruses on five minutes' contact with the surface of the facemask in laboratory ( in vitro ) tests against the following influenza viruses:
Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; | 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/8/79, A/PR/8/38), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), 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 flue 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. |
| under tested contact conditions. Correlations between in vitro testing results and any clinical event has not been tested. | |
5
6: COMPARISON OF DEVICE CHARACTERISTICS
| Manufacturer | NBC Meshtec Inc. | Filligent (HK) Limited | Significant Differences |
|---|---|---|---|
| Trade Name | Cufitec® Surgical Mask | ||
| (Subject Device) | BioFriend™ BioMask™ | ||
| Surgical FaceMask | |||
| (Predicate Device) | |||
| 510(k) No. | K182766 | K101128 | Same regulatory pathway. |
| Product Code | OUK | OUK | Same. |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same. |
| IFU Statement | (See Section 5 above.) | (See Section 5 above.) | Both the subject and predicate |
| devices are intended to protect | |||
| from the transfer of | |||
| microorganisms, body fluids, | |||
| and particulate materials. Both | |||
| devices have an antiviral agent | |||
| which inactivates 99.99% of | |||
| influenza viruses at 5 minutes' | |||
| contact with the mask surface | |||
| under tested contact | |||
| conditions. |
The primary differences are the
active ingredients used and the
strains of viruses tested. |
| Construct | 4-ply pleated mask with
antiviral agent
(L: 8.8 cm x W: 17.5 cm) | 4-ply pleated mask with
antiviral agent
(L: 10 cm x W: 17.5 cm) | Both the subject and predicate
devices follow similar
constructs and are composed
of materials commonly used in
the construction of surgical
facemasks in current legally
marketed devices. The added
antiviral agents in both devices
are indicated to inactivate
99.99% of influenza virus
strains at 5 minutes' contact
with the mask surface under
tested conditions.
The primary differences are the
active ingredients used and the
layers which are coated to
create the desired effect. |
| Outer layer material | Rayon fabric with CuI
antiviral agent | Spun-bond polypropylene
with hydrophilic plastic | |
| 2nd layer material | Polypropylene | Cellulose/polyester with
copper and zinc | |
| 3rd layer material | Polypropylene | Melt-blown polypropylene | |
| Inner layer material | Rayon fabric with CuI
antiviral agent | Spun-bound
polypropylene | |
| Nosepiece material | Polyethylene | Metal | |
| Ear loops material | Polyurethane and nylon | Elastic, not made with
natural rubber latex | |
| Active Antiviral Agent | Outer and inner layers:
0.5% CuI (cuprous iodide) | Outer layer: citric acid 2%
2nd layer: copper 1.6%
and zinc 1.6% | |
| Sterility | Non-sterile | Non-sterile | Same. |
| Shelf Life | 12 months | 12 months | Same. |
| Trade Name | Cufitec® Surgical Mask
(Subject Device) | BioFriend™ BioMask™
Surgical FaceMask
(Predicate Device) | Significant Differences |
| Performance Testing | | | |
| Fluid Resistance | ASTM F1862 | ASTM F1862 | Same. |
| Bacterial Filtration
Efficiency | ASTM F2101 | ASTM F2101 | Same. |
| Particulate
Filtration Efficiency | ASTM F2299 | ASTM F2299 | Same. |
| Delta Pressure | MIL-M-36945C | MIL-M-36945C | Same. |
| Flammability | Class 1, 16 CFR Part 1610 | Class 1, 16 CFR Part 1610 | Same. |
| | B/Lee/40 | B/Lee/40 | Same. |
| Tested Antiviral
Efficacy
(≥4 log kill) | A/WS/33,
A/Virginia/ATCC2/2009,
A/Kitakyusyu/159/93,
A/Udorn/307/72,
A/Hong Kong/8/68,
A/Victoria/210//09,
A/Virginia/ATCC6/2012,
B/Taiwan/2/62 | A/New Jersey/8/76,
A/California/07/09,
A/PR/8/34,
A/Swine/1976/31,
A/Brisbane/59/2007,
A/Wisconsin/10/98,
A/Brisbane/10/2007,
A/Wisconsin/67/2005,
A/2/JAPAN/305/57,
NIBRG-14,
A/Turkey/Wisconsin/1996,
A/Duck/PA/10218/84,
A/Equine/2/Miami/63,
B/Florida/4/2006 | There are differences in the
number and subtypes of
influenza strains tested for
antiviral efficacy. |
| Clinical Testing | Not applicable. | Not applicable. | Same – clinical testing is not
required to support the
subject device. |
| Biocompatibility Testing | | | |
| Sensitization | ISO 10993-10 | ISO 10993-10 | Same. |
| Irritation | ISO 10993-10 | ISO 10993-10 | Same. |
| Ocular Irritation | ISO 10993-10 | Not available. | Subject device was tested for
ocular irritation in accordance
to ISO 10993-10. |
| Chemical
Characterization | ISO 10993-18 | ISO 10993-18 | Same. |
Table B. Comparison of technological characteristics to the predicate device.
6
Table 5C. Comparison of performance and biocompatibility testing.
7
7: SUMMARY OF NON-CLINICAL TESTING
Performance Bench Testing:
The performance testing includes flammability, fluid resistance, bacterial filtration efficiency (BFE), and particle filtration efficiency (PFE). Results of the performance testing met all acceptance criteria per ASTM and ISO standards.
Antiviral testing:
Chemical characterization was conducted to assess the safety of the device is worn. The test included analysis of solids released into airflow through the mask as well as analysis of extracts by saline and hexane. The results of the study support the biological safety of the device.
Limit of Quantitation (LOO) was designed to determine the limit of active ingredient (CuI) on the mask using uncoated surgical masks. Results demonstrated that the LOQ was 0.048 µg/cm².
Neutralization Validation was performed to validate the neutralization buffer (SCDLP) medium. The results demonstrated that the neutralizer effectively neutralized the antiviral effect of eluted antiviral agent.
Antiviral efficacy was designed to assess both "fresh" and "aged" test articles which were tested against nine subtypes of influenza viruses. The results demonstrate that all test articles met the acceptable criteria of achieving 99.99% reduction of the viruses at 5 minutes' contact.
Determination of resistant strains was performed to determine the strains, out of nine subtypes of influenza. most resistant to both fresh" and aqed" masks. The results show that the three most resistant strains to the device are Influenza A (H3N2): A/Kitakyusyu/159/93, A/HongKong/8/68, and A/Udorn/307/72.
Simulated breathing test was designed to assess the antiviral efficacy of the device after simulated breathing using fresh" and aged" articles aqainst the three most resistant strains of Influenza as well as A/H1N1 (A/Virginia/ATCC2/2009) and Influenza B (B/Lee/40). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.
Repeated exposure testing was conducted to assess both "fresh" and "aged" articles against repeated exposure to Influenza viruses (5 subtypes). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.
Uniform distribution validation was designed to determine the concentration of active ingredient, currous iodide (CuI) on the surqical mask. Results show that the concentration of CuI was sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples.
Minimum effective concentration testing was conducted to determine the minimum effective concentration of CuI on the surgical mask using three different concentrations against the influenza viruses). The minimum concentration of CuI on the mask is sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact.
7: CONCLUSION
The Cufitec® Surgical Mask and the predicate device are similar in intended use, technological characteristics, and composition of construction materials. Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical performance tests demonstrate that the Cufitec® Surgical Mask is substantially equivalent to the referenced predicate device and is therefore as safe, as effective, and performs as well as or better than the predicate.