(78 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard surgical face mask. There is no mention of any computational or analytical functions that would involve AI/ML.
No.
The device's stated intended use is for protection against transfer of microorganisms and fluids, not for treating any specific medical condition or restoring health.
No.
This device is a surgical face mask, which is a protective barrier, not a tool for diagnosis. Its purpose is to prevent the transfer of microorganisms and particulate matter, and it does not analyze or interpret physiological data to identify a disease or condition.
No
The device description clearly outlines a physical, multi-layered surgical face mask with specific materials and dimensions, indicating it is a hardware device.
Based on the provided information, the Motex Anti-Fog Surgical Face Mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
- Performance Studies: The performance studies focus on the mask's ability to filter particles, resist fluid penetration, and its biocompatibility. These are all related to its function as a protective barrier.
- Lack of Diagnostic Elements: There is no mention of the mask being used to analyze samples (like blood, urine, or tissue), detect biomarkers, or provide any diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Motex Anti-Fog Surgical Face Mask does not perform any of these functions.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel / infection control practices (implied)
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)
Non-Clinical Tests Performed:
- Performance Testing summary:
- Test item: Bacterial filtration efficiency, Test method: ASTM F2101-14, Pass criteria: ≥ 98%, Test results /Verdict: ≥99% / Pass
- Test item: Differential pressure (Delta-P), Test method: MIL-M-36954C, Section 4.4.1.2, Pass criteria:
§ 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.
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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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie 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-Min |
| Phone: + 886-4-8752116 | |
| ceirs.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 878.4040 |
| Surgical 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.
4
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 |