(129 days)
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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 Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.
This document is a 510(k) Pre-Market Notification for a surgical mask, not an AI/ML device, so many of the requested categories (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable.
Here's the information based on the provided text, focusing on the acceptance criteria and performance of the Sovereign America Surgical Mask (Models 2000SM2 and 2000SM3):
1. Table of acceptance criteria and the reported device performance:
The device performance is compared against ASTM F2100-19 standards for Level 2 and Level 3 surgical masks, and against the predicate device (K160269).
Model 2000SM2 (Level 2 Performance)
| Testing Standard | Acceptance Criteria (ASTM F2100 Level 2) | Reported Device Performance (Sovereign America Surgical Mask Model 2000SM2) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29/32 pass at 120 mm Hg | 32/32 pass at 120 mm Hg |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.1 - 99.9% |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.55 - 99.91% |
| Differential Pressure (EN 14683/MIL-M-36954C) | < 6.0 mm H2O/cm² | 2.5 - 3.3 mm H2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
Model 2000SM3 (Level 3 Performance)
| Testing Standard | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Sovereign America Surgical Mask Model 2000SM3) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29/32 pass at 160 mm Hg | 31/32 pass at 160 mm Hg |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.1 - 99.9% |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.55 - 99.91% |
| Differential Pressure (EN 14683/MIL-M-36954C) | < 6.0 mm H₂O/cm² | 2.5 - 3.3 mm H₂O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
Biocompatibility Testing (Both Models)
| Testing Items | Standards | Acceptance Criteria (Implied by standard and "Pass") | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Intracutaneous Reactivity | ISO 10993-10:2010 | Non-Irritating | Pass (Non-Irritating) |
| Kligman Maximization Sensitization | ISO 10993-10:2010 | Non-Sensitizing | Pass (Non-Sensitizing) |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862):
- Model 2000SM2: "32/32 passed" (implies a sample size of 32 surgical masks for this test).
- Model 2000SM3: "31/32 passed" (implies a sample size of 32 surgical masks for this test).
- For other performance tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility), specific sample sizes are not explicitly stated in the document, beyond the implication that testing was conducted on samples of the device.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It refers to "Non-Clinical Testing" which implies laboratory testing of the physical products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical medical device (surgical mask) that undergoes laboratory performance testing against recognized consensus standards (e.g., ASTM F2100, ISO 10993), not a diagnostic algorithm requiring expert "ground truth" establishment in the traditional sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device or a diagnostic requiring adjudication of human reader interpretations. Performance is measured directly from laboratory tests.
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 is a surgical mask, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is defined by the recognized consensus standards themselves (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683/MIL-M-36954C, 16 CFR 1610, ISO 10993 series). The device's physical properties and performance characteristics are directly measured and compared against these predefined numerical and qualitative criteria.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable.
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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 and Human Services logo. To the right of that 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.
August 19, 2021
Homtex, Inc. Jeremy Wootten President and CFO 2125 2nd Avenue SW Cullman, Alabama 35055
Re: K211066
Trade/Device Name: Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 16, 2021 Received: July 19, 2021
Dear Jeremy Wootten:
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, 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) K211066
Device Name
Sovereign America Surgical Mask, Model: 2000SM2
Indications for Use (Describe)
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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 801, Subpart D) |
|---|
| Over-The-Counter Use (81 CFR 801, Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
| * | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Indications for Use
510(k) Number (if known) K211066
Device Name
Sovereign America Surgical Mask, Model: 2000SM3
Indications for Use (Describe)
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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)
| ☐ Registration Use (Part 31 CFR 901.2, Subpart B) | ☑ One-Time-Coverage (31 CFR 901.2, Subpart C) |
|---|---|
| --------------------------------------------------- | ----------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
| * | 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."
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Image /page/4/Picture/0 description: The image shows a logo for Sovereign America. The logo features a shield with a red cross in the center and a blue upper portion. Below the shield, the words "SOVEREIGN AMERICA" are written in a simple font. Underneath the text, there is an image of an American flag and the words "MADE IN USA".
510(K) SUMMARY K211066
This 510(K) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Preparation Date:
August 10, 2021
2. Submitter:
Homtex, Inc. 2125 2nd Avenue SW Cullman AL 35055 Phone: 256-734-3937 Fax: 256-734-2043
Contact: Jeremy Wooten, President and CFO Email: jeremy.wootten@homtex.com
Proposed Devices: 3.
| 510(k) Number: | K211066 |
|---|---|
| Trade Name: | Sovereign America Surgical Mask, Model 2000SM2Sovereign America Surgical Mask, Model 2000SM3 |
| Common Name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Classification: | Class II |
| Product Code: | FXX |
Predicate Devices: 4.
| 510(k) Number: | K160269 |
|---|---|
| Trade Name: | San-M Package Co., Ltd. Level 2 and 3 Surgical Face Mask(Ear loops and Tie-on) |
| Common Name: | Surgical Mask |
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Regulation Number: 21 CFR 878.4040 Regulatory Class: Class II Product Code: FXX
5. Device Description:
The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.
Intended Use: 6.
Each Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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. Each proposed device is a single use, disposable device, provided non-sterile.
Comparison to Predicate Devices: 7.
Table 1: Summary of Technological Characteristics with the Predicate Device
| Feature | Level 2 | Level 3 | Level 2 | Level 3 | Comparison | |
|---|---|---|---|---|---|---|
| Manufacturer | Homtex, Inc. | - | San-M Package Co., Ltd. | - | - | |
| 510(k) number | K211066 | - | K160269 | - | - | |
| Device CommonName | Surgical Mask | - | Surgical Mask | - | Same | |
| Classification | Class II Device, FXX(21 CFR878.4040) | - | Class II Device, FXX(21 CFR878.4040) | - | Same | |
| Intend use | The Sovereign AmericanSurgical Mask is intended foruse by adult patients andhealthcare personnel to protectagainst the transfer ofmicroorganisms, bodily fluidsand particulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposureto blood and body fluids. This isa single use, disposable device,provided non-sterile. | The surgical face masks areintended to be worn toprotectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids, andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | Similar | |||
| Model Style | Flat-pleated; ear loops | Flat-pleated; ear loops | Same | |||
| Material | Outer layer | Spunbond nonwovenpolypropylene | Polypropylene | Similar | ||
| Middle layer | Melt-blown nonwovenpolypropylene | Two layers - Spunbondpolypropylene and Meltblownpolypropylene | Similar | |||
| Inner layer | Spunbond nonwovenpolypropylene | Polypropylene | Similar | |||
| Nose Piece | Polypropylene coated aluminumwire | Polyethylene coated steel wire | Similar | |||
| Ear loop | Polyester spandex elastic | Polyester, polyurethane withpolyester spunbond side tapes | Different | |||
| Color | Blue | White or blue | Similar | |||
| Dimension (Width) | 175 mm | 175 ± 5 mm | 180 ± 5 mm | Similar | ||
| Dimension (Length) | 95 mm | 90 ± 3 mm | 90 ± 3 mm | Similar | ||
| OTC use | Yes | Yes | Same | |||
| Sterility | Non-Sterile | Non-Sterile | Same | |||
| Use | Single Use, Disposable | Single Use, Disposable | Same | |||
| Latex | Not Made with Natural RubberLatex | Unknown | Unknown | |||
| Performance (ASTM F2100) | ||||||
| ASTM F2100 Level | Level 2 | Level 3 | Level 2 | Level 3 | Same | |
| Fluid Resistance(ASTM F1862) | 32/32 passedat 120 mm Hg | 31/32 passed at160 mm Hg | Passed at 120mm Hg | Passed at 160mm Hg | Same | |
| Bacterial FiltrationEfficiency(ASTM F2101) | Passed at99.1 - 99.9% | Passed at99.1 - 99.9% | Passed at >98% | Passed at >99% | Simliar | |
| Particulate FiltrationEfficiency(ASTM F2299) | Passed at99.55 - 99.91% | Passed at99.55 - 99.91% | Passed at 99.6% | Passed at 99.7% | Similar | |
| Differential Pressure(EN 14683/MIL-M-36954C) | Passed at2.5 - 3.3 mmH2O/cm² | Passed at2.5 - 3.3 mmH2O/cm² | Passed at 1.6mm H2O/cm² | Passed at 2.5mm H2O/cm² | Similar | |
| Flammability(16 CFR 1610) | Passed as Class 1 | Passed as Class 1 | Same | |||
| Biocompatibility | ||||||
| Cytotoxicity(MEM Elution)ISO 10993-5:2009 | Non-Cytotoxic | Non-Cytotoxic | Same | |||
| IntracutaneousReactivityISO 10993-10:2010 | Non-Irritating | Non-Irritating | Same | |||
| KligmanMaximizationSensitizationISO 10993-10:2010 | Non-Sensitizing | Non-Sensitizing | Same |
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Non-Clinical Testing: 8.
Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, has been tested in conformity with the recognized consensus standards outlined in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions issued on March 5, 2004 and in ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks, including performance tests for 1) fluid resistance; 2) bacterial filtration efficiency; 3) particulate filtration efficiency; 4) differential pressure; and 5) flammability as well as biocompatibility tests. The performance testing and biocompatibility testing results showed that Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, passed all acceptance criteria in the consensus standards as set forth in Tables 2, 3, and 4 below.
| Table 2: Performance Testing - Sovereign America Surgical Mask Model 2000SM2 | ||||
|---|---|---|---|---|
| Testing Standards | Acceptance CriteriaASTM F2100 Level 2 | Sovereign AmericaSurgical MaskModel 2000SM2 | PredicateDevice(K160269) | Result |
| Fluid Resistance(ASTM F1862) | 29/32 pass at 120mm Hg | 32/32 pass at 120mm Hg | Pass at 120mm Hg | Meets orexceedsacceptancecriteria |
| Bacterial FiltrationEfficiency(ASTM F2101) | ≥ 98% | 99.1 - 99.9% | ≥ 98% | Meets orexceedsacceptancecriteria |
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| Particulate FiltrationEfficiency(ASTM F2299) | ≥ 98% | 99.55 - 99.91 % | 99.6% | Meets orexceedsacceptancecriteria |
|---|---|---|---|---|
| Differential Pressure(EN 14683/MIL-M-36954C) | < 6.0 mm H2O/cm² | 2.5 - 3.3 mmH2O/cm² | 2.5 mmH2O/cm² | Meets orexceedsacceptancecriteria |
| Flammability(16 CFR 1610) | Class 1 | Class 1 | Class 1 | Meets orexceedsacceptancecriteria |
Table 3: Performance Testing - Sovereign America Surgical Mask Model 2000SM3
| Testing Standards | Acceptance CriteriaASTM F2100 Level 3 | SovereignAmerica SurgicalMaskModel 2000SM3 | PredicateDevice(K160269) | Result |
|---|---|---|---|---|
| Fluid Resistance(ASTM F1862) | 29/32 pass at 160mm Hg | 31/32 pass at160 mm Hg | Pass at 160mm Hg | Meets orexceedsacceptancecriteria |
| Bacterial FiltrationEfficiency(ASTM F2101) | ≥ 98% | 99.1 - 99.9% | ≥ 99% | Meets orexceedsacceptancecriteria |
| Particulate FiltrationEfficiency(ASTM F2299) | ≥ 98% | 99.55 - 99.91 % | 99.7% | Meets orexceedsacceptancecriteria |
| Differential Pressure(EN 14683/MIL-M-36954C) | < 6.0 mm H₂O/cm² | 2.5 - 3.3 mmH₂O/cm² | 1.6 mmH₂O/cm² | Meets orexceedsacceptancecriteria |
| Flammability(16 CFR 1610) | Class 1 | Class 1 | Class 1 | Meets orexceedsacceptancecriteria |
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Table 4: Biocompatibility Testing - Sovereign America Surgical Mask Model 2000SM2 and 2000SM3
| Testing Items | Standards | Results | Result |
|---|---|---|---|
| Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Pass (Non-Cytotoxic) | Meets or exceedsacceptance criteria |
| Intracutaneous Reactivity | ISO 10993-10:2010 | Pass (Non-Irritating) | Meets or exceedsacceptance criteria |
| Kligman MaximizationSensitization | ISO 10993-10:2010 | Pass (Non-Sensitizing) | Meets or exceedsacceptance criteria |
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and performs as well as or better than the legally marketed predicate device, K160269.
§ 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.