(329 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a surgical mask, with no mention of AI or ML.
No.
Surgical masks are protective barriers designed to prevent the transfer of microorganisms, bodily fluids, and particulate material, not to treat a medical condition or disease.
No
This device is described as a surgical mask intended to protect against the transfer of microorganisms, bodily fluids, and particulate material. It is a barrier device, not one that performs a diagnostic function.
No
The device description clearly outlines a physical product (surgical mask) made of nonwoven polypropylene with ear loops and a nose piece. The performance studies also focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for "use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material." This describes a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers of nonwoven polypropylene, ear loops, nose piece). This is consistent with a personal protective equipment (PPE) device, not a diagnostic device.
- Performance Studies and Key Metrics: The performance studies and key metrics (fluid resistance, filtration efficiency, differential pressure, flammability, biocompatibility) are all related to the physical barrier and safety properties of the mask. IVD performance studies would typically involve metrics like sensitivity, specificity, accuracy, etc., related to detecting or measuring substances in biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
This device is a surgical mask, which falls under the category of personal protective equipment (PPE) and is regulated as a medical device, but not as an IVD.
N/A
Intended Use / Indications for Use
Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The 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. The 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. The 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. The mask is provided non-sterile and intended to be a single use, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing: Sovereign America Surgical Mask 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 passed all acceptance criteria in the consensus standards as set forth in the Tables 2 and 3 below.
Key Results:
Performance Testing Results (ASTM F2100 Level 1):
- Fluid Resistance (ASTM F1862): 29 out of 32 passed at 80 mmHg
- Bacterial Filtration Efficiency (ASTM F2101): 99.1 - 99.8%
- Particulate Filtration Efficiency (ASTM F2299): 99.55 - 99.91 %
- Differential Pressure (EN 14683/MIL-M-36954C): 2.5 - 3.3 mm H2O/cm²
- Flammability (16 CFR 1610): Class 1
Biocompatibility Testing Results:
- Cytotoxicity (MEM Elution) (ISO 10993-5:2009): Pass (Non-Cytotoxic)
- Intracutaneous Reactivity (ISO 10993-10:2010): Pass (Non-Irritating)
- Kligman Maximization Sensitization (ISO 10993-10:2010): Pass (Non-Sensitizing)
Key Metrics
- Fluid Resistance (ASTM F1862): 29 out of 32 passed at 80 mmHg
- Bacterial Filtration Efficiency (ASTM F2101): 99.1 - 99.8%
- Particulate Filtration Efficiency (ASTM F2299): 99.55 - 99.91 %
- Differential Pressure (EN 14683/MIL-M-36954C): 2.5 - 3.3 mm H2O/cm²
- Flammability (16 CFR 1610): Class 1
- Cytotoxicity (MEM Elution) (ISO 10993-5:2009): Non-Cytotoxic
- Intracutaneous Reactivity (ISO 10993-10:2010): Non-Irritating
- Kligman Maximization Sensitization (ISO 10993-10:2010): Non-Sensitizing
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
March 19, 2021
Homtex, Inc. Jeremy Wootten President and CFO 2125 2nd Avenue SW Cullman, Alabama 35055
Re: K201095
Trade/Device Name: Sovereign America Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 11, 2021 Received: February 26, 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.
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,
Ryan Ortega, Ph.D. Acting 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) K201095
Device Name
Sovereign America Surgical Mask, Model: 2000SM1
Indications for Use (Describe)
Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 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. Above the shield is the text "SOVEREIGN AMERICA" in a bold, sans-serif font. Below the text is an image of the American flag and the words "MADE IN USA".
510(K) SUMMARY
This 510(K) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Preparation Date:
March 17, 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
3. Proposed Device:
| Trade Name: | Sovereign America Surgical Mask, Model 2000SM1 |
|---|---|
| Common Name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Classification: | Class II |
| Product Code: | FXX |
4. Predicate Device:
| 510(k) Number: | K153409 |
|---|---|
| Trade Name: | Protect U Guard Earloop Mask and Tie-On |
| Common Name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product Code: | FXX |
4
5. Device Description:
The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The 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. The 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. The 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. The mask is provided non-sterile and intended to be a single use, disposable device.
Intended Use: 6.
Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.
Comparison to Predicate Device: 7.
| Item | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Homtex, Inc. | Protect U Guard, LLC | |
| Product Code | FXX | FXX | Same |
| Classification and | |||
| Regulation | Class II | ||
| 21 CFR878.4040 | Class II | ||
| 21 CFR878.4040 | Same | ||
| Intend use | The Sovereign American | ||
| Surgical Mask is intended for | |||
| use by healthcare personnel to | |||
| protect both patients and | |||
| healthcare personnel against | |||
| the transfer of | |||
| microorganisms, bodily fluids | |||
| and particulate material. This | |||
| is a single use, disposable | |||
| device, provided non-sterile. | The Protect U Guard Earloop | ||
| Mask and Tie-On Mask is | |||
| intended for use by | |||
| healthcare workers during | |||
| procedures to protect both | |||
| patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, bodily fluids | |||
| and airborne particles. This | |||
| device is single use and | |||
| provided non-sterile. | Similar |
Table 1: General Comparison
5
| Model Style | | Flat-pleated
earloops | Flat pleated
Earloops or tie-on | Same |
|------------------------------------------------------|--------------|---------------------------------------|---------------------------------------|---------|
| Material | Outer layer | Spunbond nonwoven
polypropylene | Spunbound polypropylene | Same |
| | Middle layer | Melt-blown nonwoven
polypropylene | Meltblown polypropylene | Same |
| | Inner layer | Spunbond nonwoven
polypropylene | Spunbound polypropylene | Same |
| | Nose Piece | Polypropylene coated
aluminum wire | Aluminum strip | Similar |
| | Ear loops | Polyester spandex elastic | Urethane elastic fiber | Similar |
| Color | | Blue | Blue, White, or Green | Similar |
| Dimension (Width) | | 17.5 cm | 17.7 cm | Similar |
| Dimension (Length) | | 9.5 cm | 9.5 cm | Same |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| Latex | | Not Made with Natural
Rubber Latex | Not Made with Natural
Rubber Latex | Same |
| Performance (ASTM F2100 Level 1) | | | | |
| Fluid Resistance
(ASTM F1862) | | 29 out of 32 passed at 80 mmHg | 29 out of 32 passed at 80 mmHg | Same |
| Bacterial Filtration
Efficiency
(ASTM F2101) | | 99.1 - 99.8% | 99.17% | Similar |
| Particulate Filtration
Efficiency
(ASTM F2299) | | 99.55 - 99.91 % | 99.18% | Similar |
| Differential Pressure
(EN 14683/MIL-M-
36954C) | | 2.5 - 3.3 mm H2O/cm² | 3.79 mm H2O/cm² | Similar |
| Flammability
(16 CFR 1610) | | Class 1 | Class 1 | Same |
| Biocompatibility | | | | |
| Cytotoxicity
(MEM Elution)
ISO 10993-5:2009 | | Non-Cytotoxic | Non-Cytotoxic | Same |
| Intracutaneous
Reactivity
ISO 10993-10:2010 | | Non-Irritating | Non-Irritating | Same |
6
Non-Clinical Testing: 8.
Sovereign America Surgical Mask 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 passed all acceptance criteria in the consensus standards as set forth in the Tables 2 and 3 below.
Table 2: Performance Testing
| Testing Standards | Acceptance Criteria
ASTM F2100 Level 1 | Sovereign America
Surgical Mask
(K201095) | Predicate Device
(K153409) |
|------------------------------------------------------|-------------------------------------------|-------------------------------------------------|-----------------------------------|
| Fluid Resistance
(ASTM F1862) | 29 out of 32 passed at
80 mmHg | 29 out of 32 passed at
80 mmHg | 29 out of 32 passed
at 80 mmHg |
| Bacterial Filtration
Efficiency
(ASTM F2101) | ≥ 95% | 99.1 - 99.8% | 99.17% |
| Particulate Filtration
Efficiency
(ASTM F2299) | ≥ 95% | 99.55 - 99.91 % | 99.18% |
| Differential Pressure
(EN 14683/
MIL-M-36954C) |