(201 days)
Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
The Myflon Surgical Mask Level 3 is blue in color, composed of three-layers, a flat-pleated type mask, utilizing ear loops for wearing. The Myflon Surgical Mask Level 3 materials consist of an outer cover (polypropylene spunbond, blue), middle filtration layer (polypropylene, melt-blown, white), and inner cover comfort/support layer web (polypropylene spunbond, white). Each mask has stretchable elastic laminate (Spunbond/elastic film/spunbond bond) ear loops to secure the mask over the user's mouth and nose and includes a polyethylene/ polypropylene coated wire nosepiece to provide a firm fit over the face and nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
The provided text is a 510(k) summary for a surgical mask (Myflon Surgical Mask Level 3). It details the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing. It does not describe an AI/ML-driven medical device, an algorithm's performance, or any human-in-the-loop studies. Therefore, I cannot extract the information required to answer your specific questions related to AI/ML device acceptance criteria and study details.
The document explicitly states: "No clinical tests were performed." and describes the product as a physical surgical mask, not a software or AI device.
Therefore, I am unable to provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study and effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The acceptance criteria and performance data provided in the document pertain to the physical properties of the surgical mask, such as barrier testing (fluid resistance, particle filtration, bacterial filtration), flammability, differential pressure, and biocompatibility.
Here is the table of acceptance criteria and reported device performance for the surgical mask (as provided in the document), which is the only relevant information from the text:
Acceptance Criteria and Reported Device Performance (Myflon Surgical Mask Level 3)
| Test | Standard/Regulation | Acceptance Criteria | Results |
|---|---|---|---|
| Barrier Testing | |||
| Fluid resistance | ASTM F1862 | Pass at 160mmHg | Passed |
| Particle Filtration Efficiency | ASTM F2299 | Pass $\geq$ 98% | Passed |
| Bacterial Filtration Efficiency | ASTM F2101 | Pass $\geq$ 98% | Passed |
| Safety Testing | |||
| Flammability Class | 16 CFR 1610 | Class 1 ($\geq$ 3.5 seconds) | Passed - Class I Non-Flammable |
| Physical Testing | |||
| Differential Pressure Delta-P | EN14683 | Passed <6.0 H2O/cm2 | Passed |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Comply with ISO 10993-5 | Non-cytotoxic |
| Irritation | ISO 10993-10 | Comply with ISO 10993-10 | Non-irritating |
| Sensitization | ISO 10993-10 | Comply with ISO 10993-10 | Non-sensitizing |
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January 23, 2022
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi % W. Rogers Owner Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K212111
Trade/Device Name: Myflon Surgical Mask Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 8, 2021 Received: December 13, 2021
Dear W. Rogers:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
51 0(k) Number (if known) K212111
Device Name Myflon Surgical Mask Level 3
Indications for Use (Describe)
Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K212111 510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Myflon Surgical Mask Level 3, 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Feliks Plastik Lam Ve Amb Mal San Ve Tic A.S.Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110Eskisehir TurkeyEstablishment Registration Number: 3017355692 |
|---|---|
| Contact Person: | Ali Serdar SerteserManager+90 533 209 72 95 |
| 510(k) Number: | K212111 |
| Designated SubmissionCorrespondent: | W. Victoria RogersRogers Consulting11110 Arranmore CoveRoanoke, Indiana 46783574-265-8356 |
| Date: | January 20, 2022 |
| Subject Device: | Myflon Surgical Mask Level 3 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Mask |
| Product Code: | FXX |
| Regulation Number: | (21 CFR 878.4040) |
| Review Panel: | General & Plastic Surgery |
| Regulation Class: | Class II |
| Predicate Device: | Freudenberg Surgical Mask (K210063) |
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| Purpose and | |
|---|---|
| Device Description: | The Myflon Surgical Mask Level 3 is blue in color, composedof three-layers, a flat-pleated type mask, utilizing ear loopsfor wearing. The Myflon Surgical Mask Level 3 materialsconsist of an outer cover (polypropylene spunbond, blue),middle filtration layer (polypropylene, melt-blown, white),and inner cover comfort/support layer web (polypropylenespunbond, white). Each mask has stretchable elastic laminate(Spunbond/elastic film/spunbond bond) ear loops to secure themask over the user's mouth and nose and includes apolyethylene/ polypropylene coated wire nosepiece to providea firm fit over the face and nose. This face mask is a singleuse, disposable device, provided non-sterile. This device is notmade with natural rubber latex. |
| Intended Use and | |
| Indication for Use: | Myflon Surgical Mask Level 3 is intended to beworn to protect both the patient and healthcare |
| personnel from transfer of microorganisms, body | |
| fluids and particulate material. This face mask isintended for use in infection control practices | |
| to reduce the potential exposure to blood and | |
| body fluids. This is a single use, disposable | |
| device provided nonsterile. |
Technological
Characteristics Comparison:
| Subject Device | Primary Predicate Device | Remark | |
|---|---|---|---|
| Myflon Surgical MaskLevel 3, K2112111 | Freudenberg Surgical MaskK210063 | ||
| ASTM 2100Level 3 Mask | 3 | 3 | Same |
| Intended Use/Indications forUse | Myflon Surgical Mask Level3 is intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. This face mask is | The Freudenberg SurgicalMask is intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulate | Same |
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| intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile. | material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile. | ||
|---|---|---|---|
| Outer Materials | Polypropylene spunbond, blue | Spun-bond polypropylene | Similar |
| Filter Media | Polypropylene, melt-blown, white | Melt blown polypropylene | Same |
| Inner Material | Polypropylene spunbond, white | Spun-bond polypropylene | Same |
| Nose Piece | Polyethylene/ polypropylene coated wire | Malleable polyethylene coated wire | Similar |
| Ear Loops | Spunbond/elastic film/spunbond bond | Polyester spandex blend | Similar |
| Specifications | Length: 175mmWidth: 95mm | Length: 175 mm +/- 1mmWidth: 95 mm +/- 1mm | Same |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Color | Blue | White | Different |
| Sterilization | Non-sterile | Non-sterile | Same |
Summary of Non-Clinical Testing:
- The product was tested in alignment with "Guidance for Industry and o FDA Staff - Surgical Masks - Premarket Notification [510(k)] Submission" Guidance Document
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- O Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part O 10: Tests For Irritation And Skin Sensitization
- ASTM F2100-19, Standard Specification for Performance Of O Materials Used In Medical Face Masks
- ASTM F1862-17, Standard Test Method for Resistance of Medical O Face Masks to Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683: European standard for face masks O
- ASTM F2101-19, Standard Test Method for Evaluating The O Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial O efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
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- 16 CFR 1610, Standard for the Flammability of clothing textiles. O
| Bench Testing | |||
|---|---|---|---|
| Test | Standard/Regulation | AcceptanceCriteria | Results |
| Barrier Testing -Fluid resistance | ASTM F1862 | Pass at 160mmHg | Passed |
| Barrier Testing-Particle FiltrationEfficiency | ASTM F2299 | Pass $\geq$ 98% | Passed |
| Barrier Testing -Bacterial FiltrationEfficiency | ASTM F2101 | Pass $\geq$ 98% | Passed |
| Safety Testing -Flammability Class | 16 CFR 1610 | Class 1 ( $\geq$ 3.5seconds) | Passed - Class I Non-Flammable |
| Physical Testing -DifferentialPressure Delta-P | EN14683 | Passed <6.0H2O/cm2 | Passed |
| Biocompatibility | |||
| Test | Standard | AcceptanceCriteria | Results |
| Safety Testing -Cytotoxicity | ISO 10993-5 | Comply with ISO10993-5 | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-cytotoxic |
| Safety Testing -Irritation | ISO 10993-10 | Comply with ISO10993-10 | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-irritating |
| Safety Testing -Sensitization | ISO 10993-10 | Comply with ISO10993-10 | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-sensitizing |
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Clinical Tests:
No clinical tests were performed. O
Substantial Equivalence Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the Myflon Surgical Mask Level 3 is as safe, as effective, and performs as well as or better than the predicate device.sa
§ 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.