(30 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 Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are non-sterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains head ties, ear loops or ear bands to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex.
This document pertains to the 510(k) summary for the Savvy Mask - Level 3 Surgical Mask. The information provided is primarily focused on the device's technical and performance characteristics compared to a predicate device, rather than the evaluation of an AI or software device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Proposed Device - Savvy Mask Performance | Result |
|---|---|---|---|
| Level 3 Fluid Resistance (ASTM F1862) | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 31/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass. | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 pass; Lot 2: 32/32 pass; Lot 3: 32/32 pass. | Pass |
| Differential Pressure (ASTM F2100/EN 14683:2019) | AQL 4%, single sampling plan, 29/32 pass < 5.0 mm H2O/cm² | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at <6.0 H2O/cm². Lot 1: 32/32 pass; Lot 2: 30/32 pass; Lot 3: 31/32 pass. (Note: Performance reported as <6.0 H2O/cm² while acceptance criteria is <5.0 H2O/cm², but the "Result" column states "Pass". This might indicate a slight discrepancy in reporting or that the predicate also passed at a similar level accepted by the FDA). | Pass |
| Class 1 Flammability (16 CFR 1610) | Class 1 < 3.5 second burn time | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610. Lot 1: Class 1, IBE; Lot 2: Class 1, IBE; Lot 3: Class 1, IBE. | Pass |
Biocompatibility Testing:
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non-Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
2. Sample Size for Test Set and Data Provenance:
The sample size for the test set varied by performance characteristic:
- For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: Three non-sequential lots were tested, with 32 units per lot, for a total of 96 units for each test.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective benchtop performance tests conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the document describes physical performance testing of a surgical mask, not a software or AI device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
This is not applicable for the described benchtop performance testing. The "acceptance criteria" themselves serve as the standard against which each test result is evaluated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a surgical mask, not an AI-assisted diagnostic or clinical decision support tool.
6. Standalone (Algorithm Only) Performance:
This is not applicable as the device is a surgical mask, not an algorithm or software. It is a passive device.
7. Type of Ground Truth Used:
The "ground truth" for the performance characteristics of the surgical mask is the measurement against established industry standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683:2019, 16 CFR 1610) and the specific acceptance criteria defined for these tests. For biocompatibility, it's the results from established biocompatibility tests (ISO 10993 series) against the criteria of non-cytotoxic, non-sensitizing, and non-irritating.
8. Sample Size for the Training Set:
This is not applicable as the device is a surgical mask and does not involve a training set as would be found in machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as above.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 18, 2021
Texas MedPlast LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213406
Trade/Device Name: Savvy Mask - Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 18, 2021 Received: October 19, 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.
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,
Clarence W. Murray, III, Ph.D. 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) K213406
Device Name Savvy Mask - Level 3 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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K213406 510(k) SUMMARY
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92:
l. SUBMITTER
Texas MedPlast LLC 6630 Roxburgh Drive #171 Houston, TX 77041 USA Tel: +1.832.288.2106 Fax: N/A
| Contact Person: | Diego Olmos |
|---|---|
| Date Prepared: | September 15, 2021 |
ll. DEVICE
| Name of Device: | Savvy Mask - Level 3 Surgical Mask |
|---|---|
| Classification Name: | Surgical Apparel |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FXX |
. PREDICATE DEVICE
| Predicate Manufacturer: | DemeTECH Corporation |
|---|---|
| Predicate Trade Name: | DemeMASK Surgical Mask |
| Predicate 510(k): | K201479 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are non-sterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains head ties, ear loops or ear bands to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex.
V. 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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
| Feature | Subject Device | Predicate Device(K201479) | Result |
|---|---|---|---|
| Indications for Use | The Disposable Surgical FaceMasks are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to bloodand body fluids. This is asingle use, disposable deviceprovided non-sterile. | The Disposable SurgicalFace Masks are intendedto be worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable deviceprovided non-sterile. | Same |
| Materials | |||
| Inner Facing Layer | Polyethylene/PolyesterNonwoven | Spun-bond polypropylene | Similar (seeconclusion) |
| Middle Layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| Outer Facing Layer | Polyethylene/PolyesterNonwoven | Spun-bond polypropylene | Similar (seeconclusion) |
| Nose piece | Galvanized wire coated withpolyethylene | Galvanized wire coatedwith polyethylene | Same |
| Ear loop | Spandex and Nylon - Notmade from natural rubberlatex | Spandex/nylon | Same |
| Head ties- Tie On | Polyethylene/Polyester nonwoven | N/A | Predicateoffers only earloops |
| Ear Band | Polyethylene/PolyesterNonwoven | N/A | Predicateoffers only earloop |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Color | White | White | Same |
| Dimension (Width),Adult | 9.5 cm ± 1.0 cm | 9.5 cm ± 1.0 cm | Same |
| Dimension (Length),Adult | 17.5 cm ± 1.0 cm | 17.5 cm ± 1.0 cm | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 3 | Same |
Table 1 – Comparison of Technological Characteristics
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VII. PERFORMANCE DATA
The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.
| Item | Proposed Device -Savvy Mask | Acceptance Criteria | Predicate Device(K201479) | Result |
|---|---|---|---|---|
| Level 3 FluidResistancePerformanceASTM F1862 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at 160mmHgLot 1: 31/32 passLot 2: 30/32 passLot 3: 31/32 pass | AQL 4%, singlesampling plan, 29out of 32 Pass at160mmHg | Pass at 160 mmHg(Level 3 FluidResistance) | Pass |
| ParticulateFiltrationEfficiencyASTM F2299 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98%Lot 1:32/32 passLot 2:32/32 passLot 3:32/32 pass | ≥ 98% | Pass at ≥99% | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98% -Lot 1:32/32 passLot 2:32/32 passLot 3:32/32 pass | ≥ 98% | Pass at ≥99% | Pass |
| DifferentialPressureASTMF2100/EN14683:2019 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at <6.0$H2O/cm2$Lot 1:32/32 pass | AQL 4%, singlesampling plan, 29/32pass< 5.0 mm $H20/cm²$ | MIL-M-36954CAverage 3.6mm $H2O/cm2$ | Pass |
Table 2 – Benchtop Performance Testing
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| 30/32 passLot 3:31/32 pass | ||||
|---|---|---|---|---|
| Class 1Flammability16 CFR 1610 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed Class 116 CFR 1610Lot 1: Class 1, IBELot 2: Class 1, IBELot 3: Class 1, IBE | Class 1< 3.5 secondburn time | Class 1 | Pass |
(Vol 018)
Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
| Table 3 - Biocompatibility Testing | ||
|---|---|---|
| ------------------------------------ | -- | -- |
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
(Vol 015)
Table 4 - Summary of Non-Clinical Performance Testing
The following standards have been used to evaluate the Savvy Mask Surgical Mask:
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| ASTM F2100 | Standard Specification for Performance of Materials Used inMedical Face Masks |
|---|---|
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of FixedVolume at a Known Velocity) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency ofMaterialsUsed in Medical Face Masks to Penetration by Particulates UsingLatex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency(BFE)of Medical Face Mask Materials, Using a BiologicalAerosol of Staphylococcus aureus |
| EN 14683:2019 | Standard Test Method for Differential Pressure |
| 16 CFR Part 1610 | Standard for Flammability |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity of medical devices |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The conclusions drawn from the performance data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device K201479, DemeMASK Surqical Face Mask manufactured by DemeTECH 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.