(78 days)
The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
The provided text describes the acceptance criteria and performance data for the Motex Anti-Fog Surgical Face Mask.
1. A table of acceptance criteria and the reported device performance
| Test item (Performance Level 3) | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Bacterial filtration efficiency | ≥ 98% | ≥99% | Pass |
| Differential pressure (Delta-P) | < 5 mm H2O/cm² | 2.6 mm H2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres | ≥ 98% | 99.75% | Pass |
| Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result | Fluid resistant claimed at 80, 120, 160 mm Hg | Fluid Resistant claimed at 160 mm Hg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |
| In vitro Cytotoxicity Test | Pass ISO 10993-5:2009 | Pass ISO 10993-5:2009 | Pass |
| Skin Sensitization Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10:2010 | Pass |
| Skin Irritation Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10:2010 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of masks tested) for each non-clinical test. The tests are described as "Performance Testing summary" and "Biocompatibility Testing." Given the nature of these tests for medical devices, they were likely conducted in a controlled laboratory setting. The manufacturer is Modern Healthcare Corp., located in Hsin-Chu City, Taiwan. The provenance of the data is therefore Taiwan, and the tests were prospective in nature, performed to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is based on non-clinical, objective performance tests (e.g., filtration efficiency, pressure differential, flame spread) and biocompatibility tests, not subjective expert assessment of images or medical cases.
4. Adjudication method for the test set
This information is not applicable as the evaluation is based on objective performance tests with predefined pass/fail criteria, not subjective human assessment 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or image analysis, which is not the case for a surgical face mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test for an algorithm was not done. This medical device is a physical product (a surgical face mask), not a software algorithm.
7. The type of ground truth used
The ground truth used for verifying the device's performance relies on objective measurements and standardized test methods. These include:
- ASTM F2101-14 for Bacterial filtration efficiency.
- MIL-M-36954C, Section 4.4.1.2 for Differential pressure.
- ASTM F2299-03 for Sub-micron particulate filtration efficiency.
- ASTM F1862-17 or ISO 22609:14 for Resistance to penetration by synthetic blood.
- 16 CFR Part 1610 for Flame spread.
- ISO 10993-5:2009 for In vitro Cytotoxicity Test.
- ISO 10993-10:2010 for Skin Sensitization Tests and Skin Irritation Tests.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device (surgical face mask), not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.
August 26, 2020
Modern Healthcare Corp. % Ke-Min Jen Contact Person Chinese European Industrial Research Society No. 58, Fu-Chiun St Hsin-Chu City, Taiwan 30067 Taiwan
Re: K201549
Trade/Device Name: Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 2, 2020 Received: June 9, 2020
Dear Ke-Min Jen:
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 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
510(k) Number (if known) K201549
Device Name
Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop
Indications for Use (Describe)
The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is 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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Image /page/3/Picture/0 description: The image shows the word "Modern" in a stylized font. The "M" is a curvy shape, and the rest of the letters are in a sans-serif font. There is a circled R symbol to the right of the word, indicating that it is a registered trademark. The word and symbol are in black, and the background is white.
510(K) Summary
| Submission Date: | 08/22/2020 |
|---|---|
| K201549 | |
| SUBMITTER INFORMATION: | |
| Company Name: | Modern Healthcare Corp. |
| Company Address: | No. 751, Sec. 2, Chung Chou Rd., Tien Chung Town,Chang-Hwa County, 52045, Taiwan |
| Contact Person: | Dr. Jen, Ke-MinPhone: + 886-4-8752116ceirs.jen@msa.hinet.net |
| Device Trade Name: | Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop |
| Device Common Name: | Surgical Mask |
| Class: | Class II |
| Classification: | 21 CFR 878.4040Surgical Mask |
| Product Code: | FXX |
Predicate Devices:
Surgical Face Mask, type: Tie-on, Ear-loop K063043, Modern Healthcare Corp.
Device Description:
The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
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Image /page/4/Picture/1 description: The image shows the word "Modern" in a stylized, bold, black font. The "M" is designed with curved lines, and a circled "R" trademark symbol is located to the upper right of the word. The font is sans-serif and the overall design is clean and contemporary.
Indications for Use:
The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Non-Clinical Tests Performed:
- . Performance Testing summary
| Test item (Performance Level 3) | Test method | Pass criteria | Test results /Verdict |
|---|---|---|---|
| Bacterial filtration efficiency | ASTM F2101-14 | ≥ 98% | ≥99% / Pass |
| Differential pressure (Delta-P) | MIL-M-36954C,Section 4.4.1.2 | < 5 mm H2O/cm² | 2.6 mm H2O/cm² /Pass |
| Sub-micron particulate filtrationefficiencyat 0.1 µm of Polystyrene Latex Spheres | ASTM F2299-03 | ≥ 98% | 99.75% / Pass |
| Resistance to penetration by syntheticblood, minimum pressure in mm Hgfor pass result | ASTM F1862-17 ISO22609:14 | Fluid resistant claimedat 80, 120, 160 mm Hg | Fluid Resistantclaimed at 160 mm Hg/ Pass |
| Flame spread | 16 CFR Part 1610 | Class 1 | Class 1 / Pass |
Biocompatibility Testing ●
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
-
- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity,
-
- Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
-
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
Clinical Tests Performed:
No clinical trials were conducted.
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Image /page/5/Picture/1 description: The image shows the word "Modern" in a stylized font. The "M" is a unique shape, and there is a registered trademark symbol next to the "n". The text is in black and the background is white. The font is sans-serif.
| Description | Subject device | Predicate device | Comparison result |
|---|---|---|---|
| 510(k) number | K201549 | K063043 | -- |
| Product trade name | Motex Anti-Fog Surgical FaceMask, type: Tie-on, Ear-loop | Surgical Face Masktype: Tie-on, Ear-loop | Similar |
| Manufacturer | Modern Healthcare Corp. | Modern Healthcare Corp. | Same |
| Classification name | MASK, SURGICAL | MASK, SURGICAL | Same |
| Product Code | FXX | FXX | Same |
| Device Class | 2 | 2 | Same |
| Regulation number | 878.4040 | 878.4040 | Same |
| Indications for Use | The Motex Anti-Fog Surgical FaceMask is intended to be worn toprotect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids, andparticulate material. These facemasks are intended for use ininfection control practices to reducepotential exposure to blood and bodyfluids. The face mask is single use,disposable device, provided non-sterile. | The surgical face mask ofdifferent colors (green, white,blue and pink) is a deviceintended to be worn byoperating room personnel duringsurgical procedures to protectboth the surgical patient and theoperation room personnel fromtransfer of microorganisms, bodyfluid and particulate material. | Same |
| Material composition | Inner layer: Bicomponent thermal-bonded nonwoven (PP/PE)Filter layer: PolypropyleneMelt-blownOuter layer: PolypropyleneSpunbond (blue, green,white, pink color)Anti-Fog film: EP coated PolyethyleneNose band: Steel wire coated withPolyethylene resinEar loop: SpandexTie strip: Polypropylene Spunbond | Inner layer: PolypropyleneSpunbondFilter layer: PolypropyleneMelt-blownOuter layer: PolypropyleneSpunbond (blue, green,white, pink color)Nose band: malleablealuminum wireEar loop: SpandexTie strip: PolypropyleneSpunbond | Similar |
| Anti-Fog function | Yes | No | Different |
| Dimensions | Length: 165±5 mmWidth: 95 ±2 mm | Length: 165±5 mmWidth: 95 ±2 mm | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design features | Ear-loop & Tie-on | Ear-loop & Tie-on | Same |
| Performance level 3 testing | |||
| Fluid Resistance (mm Hg) | 160 | 160 | Same |
| Particulate FiltrationEfficiency at 0.1 micron(%) | Average 99.75% | Average 96.8% | Different |
| Bacterial FiltrationEfficiency (%) | Higher than 99% | Higher than 99% | Same |
| Differential Pressure(Delta-P) Test (mmH2O/cm²) | Average 2.6 | Average 2.6 | Same |
| Flame spread | Class 1 (No Flame Spread) | Class 1 (No Flame Spread) | Same |
| Biocompatibility testing | |||
| In vitro Cytotoxicity Test | Pass ISO 10993-5:2009 | Pass ISO 10993-5 | Same |
| Skin Sensitization Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10 | Same |
| Skin Irritation Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10 | Same |
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Image /page/6/Picture/1 description: The image shows the word "Modern" in a stylized font. The "M" is a unique design, resembling a stylized heart shape. The rest of the letters are in a sans-serif font, and there is a circled "R" symbol next to the "n", indicating a registered trademark.
Substantial Equivalence:
The subject device is the same as the predicate device with respect to the indications for use, product dimensions, mask style, design features, fluid resistance, bacterial filtration efficiency, differential pressure (Delta-P) test, and flame spread. The major differences between the new and the predicate devices are the material composition, the anti-fog function, and particulate filtration efficiency.
The differences of the material composition are inner layer and nose band. The inner layer is made of the bicomponent thermal-bonded nonwoven (PP/PE) to increase particulate filtration efficiency to 99.75%, which value is higher than 96.8% of the predicate device. By adding a film of EP coated polyethylene on the outer surface of outer layer, the new device can effectively decrease the fog formation on the user's glasses due to breath. The differences of materials mentioned above do not raise any new safety and effectiveness concerns for the subject device.
The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of the Motex Anti-Fog Surgical Face Mask to that of the legally marketed predicate device K063043.
Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device the Motex Anti-Fog Surgical Face Mask in 510(k) K201549, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K063043."
§ 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.