(50 days)
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 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.
This document is a 510(k) summary for the DemeMASK Surgical Mask. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered device. Therefore, many of the requested categories related to AI device studies (like expert adjudication, MRMC studies, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the physical properties of the surgical mask, along with details about the studies conducted to demonstrate these properties.
1. Table of Acceptance Criteria and the Reported Device Performance (Bench Testing for DemeMASK Surgical Mask)
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | 29 out of 32 passed in 160 mm Hg | 32 out of 32 passed in 160 mm Hg | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299) | ≥98% | ≥99% | Pass |
| Bacterial filtration efficiency (ASTM F2101-19) | ≥98% | ≥99% | Pass |
| Differential pressure (MIL-M-36954) | < 6.0 mmH2O/cm² | Average 3.6 mmH2O/cm² | Pass |
| Flame spread (16 CFR 1610) | Class 1 Non-Flammable | Class 1 Non-Flammable | Pass |
Biocompatibility Testing
| Test | Acceptance Criteria (Implied by Predicate) | Reported Device Performance | Result |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5) | Device is non-cytotoxic (based on predicate device comparison) | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Skin Sensitization Test (ISO 10993-10) | Device is non-sensitizing (based on predicate device comparison) | Under the conditions of the study, the device is non-sensitizing. | Pass |
| Skin Irritation Test (ISO 10993-10) | Device is non-irritating (based on predicate device comparison) | Under the conditions of the study, the device is non-irritating. | Pass |
2. Sample size used for the test set and the data provenance
- Resistance to penetration by synthetic blood (ASTM F1862): 32 samples were tested.
- Other performance tests (ASTM F2299, ASTM F2101-19, MIL-M-36954, 16 CFR 1610): The specific sample sizes are not explicitly stated in this summary for each test, but standard test methods typically involve a representative number of samples.
- Biocompatibility tests (ISO 10993-5, ISO 10993-10): Sample sizes are not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are typically bench tests performed on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are bench tests for physical properties of a surgical mask, not a device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. These are objective bench tests, not involving human adjudication of results.
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
Not applicable. This document pertains to a surgical mask, not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document pertains to a surgical mask, not an algorithm.
7. The type of ground truth used
For the performance tests, the "ground truth" is established by the objective measurements obtained through standardized laboratory test methods (e.g., measuring filtration efficiency, pressure differential, and synthetic blood penetration). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo (though not human clinical in this case) tests.
8. The sample size for the training set
Not applicable. This document pertains to a physical medical device (surgical mask) and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a surgical mask.
{0}------------------------------------------------
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 Corporation14175 NW 60th AvenueMiami Lakes, FL. 33014 |
|---|---|---|
| B. | Contact Person: | Tracy ChadwrickPhone: 305-824-1048Tracy.Chadwrick@demetech.us |
| C. | Date Summary Prepared: | July 23, 2020 |
| D. | DeviceTrade 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: | K173062Non 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
{4}------------------------------------------------
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&QManufacturingCorporation | 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 FaceMasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device provided non-sterile. | The Surgical Face Masks areintended for single use byoperating room personneland other general healthcareworkers to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, blood andbody fluids, and particulatematerials. | Similar |
| Material | |||
| Outer facinglayer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Meltblown polypropylene filter | Meltblown polypropylene filter | Same |
| Inner facinglayer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Galvanized wire coated withpolyethylene | White aluminum strip withPolypropylene covering | Similar |
| Ear loops/Ties | Spandex and Nylon - Notmade from natural rubberlatex | Urethane Elastic - Notmade from naturalrubber latex | Similar |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification andDimension | Length: 17.5 cm±1 cmWidth: 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 |
{5}------------------------------------------------
| Device | DemeMASK | Predicate Device | Comparison |
|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | Pass at 160 mmHg(Level 3 Fluid Resistance) | Pass at 120 mmHg(Level 2 Fluid Resistance) | Different |
| Particulate FiltrationEfficiencyASTM F2299 | Pass at ≥99% | Pass at 99.74% | Similar |
| Bacterial FiltrationEfficiencyASTMF2101 | Pass at ≥99% | Pass at 99.4% | Similar |
| DifferentialPressure (Delta P)MIL-M-36954C | Average 3.6 mmH₂O/cm² | Average 2.7 mmH₂O/cm² | Similar |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Same |
| BiocompatibilityISO 10993-5 andISO 10993-10 | Under the conditions of thestudies employed, thedevice is non-cytotoxic, non-sensitizing, and non-irritating. | Under the conditions of thestudies employed, the deviceis non-cytotoxic, non-sensitizing, and non-irritating. | Same |
l. Table of Conformity to Standards
| Standards | Name |
|---|---|
| ASTMF1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volume at aKnown Velocity) |
| ASTM F2100-19 | Standard Specification for Performance of Materials Used inMedical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency(BFE) of Medical Face Mask Materials Using a Biological Aerosol ofStaphylococcus 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 skinsensitization |
| MIL-M-36954C | Differential Pressure (Delta-P) |
{6}------------------------------------------------
| Standard Test Method for Determining the Initial Efficiency of Materials Used | |
|---|---|
| ASTMF2299/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 penetrationby synthetic bloodASTM F1862 | 32 out of 32 passed in160 mm Hg | 29 out of 32 passed in160 mm Hg | Pass |
| Sub-micron particulatefiltration efficiency at0.1 micronASTM F2299 | ≥99% | ≥98% | Pass |
| Bacterial filtrationefficiencyASTM F2101-19 | ≥99% | ≥98% | Pass |
| Differential pressureMIL-M-36954 | Average 3.6 mmH2O/cm² | < 6.0 | Pass |
| Flame spread16 CFR 1610 | Class 1Non-Flammable | Class 1Non-Flammable | Pass |
K. Table of Biocompatibility Testing
| Standards | Proposed Device | Result |
|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, thedeviceis non-cytotoxic. | Pass |
| Skin Sensitization TestISO 10993-10 | Under the conditions of the study, thedeviceis non-sensitizing. | Pass |
| Skin Irritation TestISO 10993-10 | Under the conditions of the study, thedeviceis non-irritating. | Pass |
{7}------------------------------------------------
- Clinical Tests Performed L. No clinical study is included in this submission.
M. Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device K173062, Nonwoven Surgical Mask manufactured by V&Q Manufacturing Corporation.
§ 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.