(30 days)
The MASC Surgical Mask 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 MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.
This document is a 510(k) Premarket Notification for a surgical mask (MASC Surgical Mask, K211984). It's a regulatory submission to the FDA, not a study report for an AI/ML medical device. Therefore, the information requested about acceptance criteria and study proving device meets acceptance criteria, specifically related to AI/ML devices, cannot be fulfilled from this document.
However, I can extract information regarding performance testing for this physical medical device (surgical mask) as outlined in the provided text.
Here's the relevant information from the document related to the MASC Surgical Mask's performance:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862 | Fluid Resistance | 160mmHg | Passed |
| ASTM F2101 | Bacterial Filtration Efficiency | $\ge$ 98% | Passed |
| ASTM F2299 | Particulate Filtration Efficiency | $\ge$ 98% | Passed |
| EN 14683 | Differential Pressure (Delta P) | < 6.0 mm H2O/cm² | Passed |
| 16 CFR Part 1610 | Flammability | Class 1 ($\ge$ 3.5 seconds) | Passed |
| ISO 10993-5 | Cytotoxicity | Reactivity grade should not be greater than grade 2 | Passed (Non-cytotoxic) |
| ISO 10993-10 | Irritation | The difference between the test article and the control mean score is 1.0 or less | Passed (Non-irritating) |
| ISO 10993-10 | Sensitization | Grading score is 0 | Passed (Non-sensitizing) |
2. Sample size used for the test set and the data provenance:
- Sample Size: For Fluid Resistance, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, and Flammability tests, three non-sequential lots of 32 units each were tested, totaling 96 units for each of these performance tests (e.g., "Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg").
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective, as these terms are more applicable to clinical studies. These are laboratory-based performance tests of the physical mask.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to the performance testing of a surgical mask, which relies on standardized physical and biological tests rather than expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements according to specified ASTM, EN, and ISO standards.
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 is for a surgical mask, not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the surgical mask performance is defined by the acceptance criteria of the established international standards (ASTM, EN, ISO, and CFR) for physical and biological properties. For example, for Bacterial Filtration Efficiency, the "ground truth" is a measured efficiency of $\ge$ 98% when tested according to ASTM F2101.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 25, 2021
Mid-America Safety Corp. % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K211984
Trade/Device Name: MASC Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 23, 2021 Received: June 25, 2021
Dear Prithul Bom:
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 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.
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MASC Surgical Mask
Indications for Use (Describe)
The MASC Surgical Mask 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K211984
510(k) Summary
| Sponsor Information: | Mid-America Safety Corp.800 Greenleaf Ave.Elk Grove Village, 60007 |
|---|---|
| Contact Person: | Phil Fan, CEO847-979-8606 |
847-979-8606 Phil@midamericasafety.com
Summary Preparation Date: 5/7/2021 Type of 510(k) Submission:Traditional 510 (k)
Device Name/Classification:
| Classification Name: | Surgical Apparel |
|---|---|
| Common Name: | Surgical Mask |
| Proprietary Name: | MASC Surgical Mask |
| Model | NFR03U-01A, NFR03U-01B |
| Classification Panel: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II, 21 CFR 878.4040 |
Leqally Marketed Predicate Device:
| Classification Name: | Surgical Apparel |
|---|---|
| Common Name: | Surgical Face Mask |
| Model: | YX011, YX121 |
| Classification Panel: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II, 21 CFR 878.4040 |
| 510 (k) number: | K202161 |
| Manufacturer: | Hunan EEXI Technology & Service Co., Ltd. |
Image /page/3/Picture/11 description: The image shows the word "MASC" in white letters against a red background. The letters are large and bold, filling most of the frame. The font appears to be sans-serif, and the overall design is simple and eye-catching. The red background provides a strong contrast to the white letters, making the word stand out.
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Image /page/4/Picture/2 description: The image shows the word "MASC" in white letters on a red background. The letters are large and bold, and they take up most of the space in the image. The background is a solid red color, and it provides a strong contrast to the white letters. The image is simple and easy to read.
Indications for Use:
The MASC Surgical Mask is intended to be worn to protect bot the patient and the healthcare personnel from transfer of microorqanisms, 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.
Device Description:
The MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.
Technological Characteristic Comparison:
| Item(s) | Subject DeviceMASC Surgical Mask | Predicate DeviceHunan EEXI Technology &Service Co.,Ltd.Surgical Face Mask | Comparison |
|---|---|---|---|
| 510(k) # | K211984 | K202161 | |
| Commercial Name | MASC Surgical Mask | Surgical Face Mask | |
| Common Name | Surgical mask | Surgical Face mask | Same |
| Regulation Name | Surgical apparel | Surgical apparel | Same |
| Regulation Class | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Product Code | FXX | FXX | Same |
Table 1 Comparison of Subject and Predicate Devices
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Image /page/5/Picture/2 description: This image shows a comparison of two surgical masks. The MASC surgical mask is a three-ply, nonwoven, flat pleated mask that consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
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Image /page/6/Picture/1 description: The image shows the word "MASC" in white letters against a red background. The letters are bold and sans-serif. The background is a solid red color, and the letters are evenly spaced.
800 GREENLEAF AVE, ELK GROVE VILLAGE IL 60007 www.midamericasafety.com, info@midamericasafety.com
| Intended Use / | The MASC Surgical Mask is | The Surgical Face Masks are | Same | |
|---|---|---|---|---|
| Indications for Use | intended to be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. This face maskis intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device provided non-sterile. | intended to be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These masksare intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device provided non-sterile. | ||
| Design feature | Ear-loop, Tie-on | Ear-loop, Tie-on | Same | |
| Type of use | Over-The-Counter Use (21 CFR801 Subpart C) | Over-The-Counter Use (21 CFR801 Subpart C) | Same | |
| Material Composition | ||||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middle layer | Melt-blown polypropylene filter | Melt-blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | Polyethylene and wire | Polyethylene and wire | Same | |
| Ear loop | Elastic Polyester/spandex blend | Elastic fiber | Similar | |
| Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Specifications | ||||
| Mask Style | Flat Pleated | Flat Pleated | Same | |
| Length | $17.5cm \pm 1.0 cm$ | $17.5cm \pm 1.0cm$ | Same | |
| Width | $9.5cm \pm 1.0cm$ | $9.5cm \pm 1.0 cm$ | Same | |
| Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| Color | Blue | Blue | Same | |
| Ear-loop | $16.5cm \pm 2.5cm$ | |||
| Tie-On | $10.0mm\pm 3mm x 87.0 cm\pm5.0cm$ | |||
| Performance | ||||
| Performance Testing | Level 3-ASTM F2100-19 | Level 3-ASTM F2100-19 | Same | |
| Fluid Resistance | Three non-sequential lots of 32(total of 96, AQL 4.0) passed at160mmHg -- ASTM F1862Lot 09142020-03U: 32/32 passedLot 10052020-03U: 32/32 passedLot 10072020-03U: 32/32 passed | Meet the ASTM F2100Requirements for Level 3Classification, ) passed at160mmHg -- ASTM F1862 | Same | |
| Bacterial FiltrationEfficiency | Three non-sequential lots of 32(total of 96, AQL 4.0) passed at ≥98% - ASTM F2101Lot 09142020-03U: 32/32 passedat 99.9%Lot 10052020-03U: 32/32 passedat 99.9%Lot 10072020-03U: 32/32 passedat 99.9% | Meet the ASTM F2100Requirements for Level 3Classification, passed at ≥98% -ASTM F2101 | Same | |
| Particulate FiltrationEfficiency | Three non-sequential lots of 32(total of 96, AQL 4.0) passed at ≥98% - ASTM F2299Lot 09142020-03U: 32/32 passedat 99.6 %Lot 10052020-03U: 32/32 passedat 99.9%Lot 10072020-03U: 32/32 passedat 99.9 % | Meet the ASTM F2100Requirements for Level 3Classification, passed at ≥98% -ASTM F2299 | Same | |
| Differential Pressure(Delta P) | Three non-sequential lots of 32(total of 96, AQL 4.0) passed at<6.0 H2O/cm2 – ASTM F2100 /EN 14683:2019, Annex CLot 09142020-03U:32/32 passed at 4.6mm H2O/ cm2Lot10052020-03U:32/32 passed at 4.6mm H2O / cm2Lot 10072020-03U:32/32 passed at 4.7mm H2O / cm2 | Meet the ASTM F2100Requirements for Level 3Classification, passed at <6.0H2O/cm2 – ASTM F2100 / EN14683:2019, Annex C | Same | |
| Flammability | Three non-sequential lots of 32(total of 96 ear- loop NFR03U-01A)passed Class 1 16 CFR 1610Lot 09142020-03U: 32/32 passedLot10052020-03U: 32/32 passedLot 10072020-03U: 32/32 passed | Passed | Class 1 16 CFR 1610 | Same |
| Flammability | Three non-sequential lots of 32(total of 96 tie-on NFR03U-01B)passed Class 1 16 CFR 1610Lot 09142020-03B: 32/32 passedLot10052020-03B: 32/32 passedLot 10072020-03B: 32/32 passed | Passed | Class 1 16 CFR 1610 | Same |
| Cytotoxicity | Comply with ISO 10993-5Non-cytotoxic. | Comply with ISO 10993-5Non cytotoxic. | Same | |
| Irritation | Comply with ISO 10993-10Non-irritating | Comply with ISO 10993-10Non irritating. | Same | |
| Sensitization | Comply with ISO 10993-10Non-sensitizing | Comply with ISO 10993-10Non sensitizing | Same |
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Image /page/7/Picture/2 description: The image shows the acronym "MASC" in white letters against a red background. The letters are large and bold, filling most of the frame. The background is a solid red rectangle, providing a stark contrast to the white letters.
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Image /page/8/Picture/1 description: The image shows the word "MASC" in white letters on a red background. The letters are large and bold, and they take up most of the space in the image. The background is a solid red color, and there are no other objects or details in the image. The image is simple and straightforward, with a clear focus on the word "MASC".
800 GREENLEAF AVE, ELK GROVE VILLAGE IL 6000 www.midamericasafety.com, info@midamericasafety.com
Based on the comparison of the proposed and predicate device, the ear-loops pose a possible technological difference as the predicate does not specify the type of elastic fiber which might comprise their ear-loop.
Summary of Non-Clinical Performance Testing
Performance tests were performed to verify that the device meets the acceptance criteria.
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Image /page/9/Picture/2 description: The image shows the word "MASC" in white letters on a red background. The letters are large and bold, and they take up most of the space in the image. The background is a solid red color, and there are no other objects or details in the image. The image is simple and straightforward, with a clear focus on the word "MASC".
Table 2 provides a listing of the standards used in the performance testing.
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks |
|---|---|
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| ISO 22609 | Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| EN 14683 | Standard Test Method for Differential Pressure |
| 16 CFR Part 1610 | Standard for the Flammability of Clothing |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
Table 2: Standard Test Methodologies
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862 | Fluid Resistance | 160mmHg | Passed |
| ASTM F2101 | Bacterial Filtration Efficiency | $\ge$ 98% | Passed |
| ASTM F2299 | Particulate Filtration Efficiency | $\ge$ 98% | Passed |
| EN 14683 | Differential Pressure (Delta P) | < 6.0 mm H2O/cm² | Passed |
| 16 CFR Part 1610 | Flammability | Class 1 ( $\ge$ 3.5 seconds) | Passed |
| ISO 10993-5 | Cytotoxicity | Reactivity grade should not begreater than grade 2 | Passed |
| ISO 10993-10 | Irritation | The difference between the testarticle and the control meanscore is 1.0 or less | Passed |
| ISO 10993-10 | Sensitization | Grading score is 0 | Passed |
Summary of Clinical Testing
Not applicable; no clinical testing was performed.
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Image /page/10/Picture/2 description: The image shows the word "MASC" in white letters against a red background. The letters are large and bold, and they take up most of the space in the image. The red background is a solid color, and there are no other objects or details in the image. The image is simple and straightforward, with a clear focus on the word "MASC".
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Hunan EEXI Technology & Service Co, Ltd. Surgical Face Mask of cleared under K202161.
§ 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.