(50 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML technology.
No
The device is a surgical face mask intended to protect against transferring microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed for therapeutic purposes like treating or diagnosing a disease.
No
The device is a surgical face mask designed to protect against transfer of microorganisms and fluids, not to diagnose a condition or disease.
No
The device description clearly states it is a physical, 3-ply surgical mask made of polypropylene and spandex/nylon, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from 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.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are relevant to a protective device, not a diagnostic one.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Disposable Surgical Face Masks are 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 the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.
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
To protect both the patient and healthcare personnel.
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)
Bench testing was conducted including Resistance to penetration by synthetic blood (ASTM F1862), Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299), Bacterial filtration efficiency (ASTM F2101-19), Differential pressure (MIL-M-36954), and Flame spread (16 CFR 1610). Biocompatibility testing included Cytotoxicity (ISO 10993-5), Skin Sensitization Test (ISO 10993-10), and Skin Irritation Test (ISO 10993-10). All tests passed their respective acceptance criteria. No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance (ASTM F1862): Pass at 160 mmHg (Level 3 Fluid Resistance)
Particulate Filtration Efficiency (ASTM F2299): Pass at ≥99%
Bacterial Filtration Efficiency (ASTMF2101): Pass at ≥99%
Differential Pressure (Delta P) (MIL-M-36954C): Average 3.6 mmH₂O/cm²
Flammability (16 CFR 1610): Class 1
Biocompatibility (ISO 10993-5 and ISO 10993-10): non-cytotoxic, non-sensitizing, and non-irritating.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2020
DemeTECH Corporation Tracy Chadwrick Quality Director 14175 NW 60th Avenue Miami Lakes, Florida 33014
Re: K201479
Trade/Device Name: DemeMASK Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 16, 2020 Received: July 21, 2020
Dear Tracy Chadwrick:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Elizabeth F. Claverie, MS 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) K201479
Device Name DemeMASK Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Face Masks are 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 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92.
| A. | Applicant: | DemeTECH Corporation
14175 NW 60th Avenue
Miami Lakes, FL. 33014 |
|----|------------------------|------------------------------------------------------------------------|
| B. | Contact Person: | Tracy Chadwrick
Phone: 305-824-1048
Tracy.Chadwrick@demetech.us |
| C. | Date Summary Prepared: | July 23, 2020 |
| D. | Device
Trade Name: | DemeMASK Surgical Mask |
| | Common Name: | Surgical Face Mask |
| | Regulatory Information | |
| | Classification Name: | Surgical Face Mask |
| | Classification: | Class II |
| | Product code: | FXX |
| | Regulation Number: | 878.4040 |
| | Review Panel: | Surgical Apparel |
| E. | Predicate Device: | |
| | 510(k)
Trade Name: | K173062
Non Woven Face Mask (Model: VQN0185W (earloop) |
| | Manufacturer: | V&Q Manufacturing Corporation |
| | Address: | #B1614 Optical Valley Time Square |
F. Device Description:
The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.
Wuhan, Hubei, CHINA
Contact Type: Surface Device - Intact Skin Contact Duration: Limited - Less than 24 hours
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G. Indications for Use:
The Disposable Surgical Face Masks are 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 the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
H. Technological Characteristic Comparison
| Device | DemeMASK | Predicate Device | Comparison |
|---|---|---|---|
| 510 (k) | K201479 | K173062 | N/A |
| Manufacturer | DemeTECH Corporation | V&Q | |
| Manufacturing | |||
| Corporation | N/A | ||
| Product Name | Surgical Face Mask | Surgical Face Mask | Same |
| Classification | Class II Device, FXX | ||
| (21 CFR 878.4040) | Class II Device, FXX | ||
| (21 CFR 878.4040) | Same | ||
| Indications for Use | The Disposable Surgical Face | ||
| Masks are 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 the potential | |||
| exposure to blood and body | |||
| fluids. This is a single use, | |||
| disposable device provided non- | |||
| sterile. | The Surgical Face Masks are | ||
| intended for single use by | |||
| operating room personnel | |||
| and other general healthcare | |||
| workers to protect both | |||
| patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, blood and | |||
| body fluids, and particulate | |||
| materials. | Similar | ||
| Material | |||
| Outer facing | |||
| layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Meltblown polypropylene filter | Meltblown polypropylene filter | Same |
| Inner facing | |||
| layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Galvanized wire coated with | ||
| polyethylene | White aluminum strip with | ||
| Polypropylene covering | Similar | ||
| Ear loops/Ties | Spandex and Nylon - Not | ||
| made from natural rubber | |||
| latex | Urethane Elastic - Not | ||
| made from natural | |||
| rubber latex | Similar | ||
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification and | |||
| Dimension | Length: 17.5 cm±1 cm | ||
| Width: 9.5 cm±1 cm | 175mm X 95 mm | Same | |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
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| Device | DemeMASK | Predicate Device | Comparison |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | Pass at 160 mmHg | ||
| (Level 3 Fluid Resistance) | Pass at 120 mmHg | ||
| (Level 2 Fluid Resistance) | Different | ||
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | Pass at ≥99% | Pass at 99.74% | Similar |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTMF2101 | Pass at ≥99% | Pass at 99.4% | Similar |
| Differential | |||
| Pressure (Delta P) | |||
| MIL-M-36954C | Average 3.6 mmH₂O/cm² | Average 2.7 mmH₂O/cm² | Similar |
| Flammability | |||
| 16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| ISO 10993-5 and | |||
| ISO 10993-10 | Under the conditions of the | ||
| studies employed, the | |||
| device is non-cytotoxic, non- | |||
| sensitizing, and non-irritating. | Under the conditions of the | ||
| studies employed, the device | |||
| is non-cytotoxic, non- | |||
| sensitizing, and non-irritating. | Same |
l. Table of Conformity to Standards
| Standards | Name |
|---|---|
| ASTM | |
| F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to |
| Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a | |
| Known Velocity) | |
| ASTM F2100-19 | Standard Specification for Performance of Materials Used in |
| Medical Face Masks | |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency |
| (BFE) of Medical Face Mask Materials Using a Biological Aerosol of | |
| Staphylococcus aureus | |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for Irritation and skin |
| sensitization | |
| MIL-M-36954C | Differential Pressure (Delta-P) |
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| Standard Test Method for Determining the Initial Efficiency of Materials Used | |
|---|---|
| ASTM | |
| F2299/F2299M-03 | in Medical Face Masks to Penetration by Particulates Using Latex Spheres |
Table of Performance Testing-Bench J.
| Standards | DemeMask | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance to penetration | |||
| by synthetic blood | |||
| ASTM F1862 | 32 out of 32 passed in | ||
| 160 mm Hg | 29 out of 32 passed in | ||
| 160 mm Hg | Pass | ||
| Sub-micron particulate | |||
| filtration efficiency at | |||
| 0.1 micron | |||
| ASTM F2299 | ≥99% | ≥98% | Pass |
| Bacterial filtration | |||
| efficiency | |||
| ASTM F2101-19 | ≥99% | ≥98% | Pass |
| Differential pressure | |||
| MIL-M-36954 | Average 3.6 mmH2O/cm² |