(140 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a surgical face mask intended for infection control, not for therapeutic purposes.
No
The device is a surgical face mask intended for protection and infection control, not for diagnosing conditions.
No
The device description clearly outlines a physical, disposable face mask made of polypropylene layers with ear loops and a nose piece. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical construction of the mask and its materials. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's barrier properties (filtration efficiency, fluid resistance, flammability, etc.) and biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to a protective device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or screen for a health issue.
In summary, the Sparta 3-Ply Surgical Disposable Face Mask is a medical device intended for personal protection and infection control, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable 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, non-sterile, disposable device.
Product codes
FXX
Device Description
The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with three layers: Outer Layer: Spunbond polypropylene, Middle Layer: Melt Blown polypropylene, Inner Layer: Spunbond polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Studies:
-
Study Type: Sensitization
-
Test Method / Standard: ISO 10993-10:2013, ISO 10993-12:2021
-
Key Results: Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non-sensitizing.
-
Study Type: Cytotoxicity
-
Test Method / Standard: ISO 10993-5:2009, ISO 10993-12:2021
-
Key Results: Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic.
-
Study Type: Irritation
-
Test Method / Standard: ISO 10993-10:2013, ISO 10993-12:2021
-
Key Results: Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non-irritating.
Performance Testing - Bench:
-
Study Type: Bacterial Filtration Efficiency (BFE)
-
Test Method / Standard: ASTM F2101-19
-
Key Results: 0.999 passing
-
Study Type: Differential Pressure (Delta P)
-
Test Method / Standard: EN 14683:2019
-
Key Results:
§ 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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2022
Sparta East, LLC % Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418
Re: K220378
Trade/Device Name: Sparta 3-Ply Surgical Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 13, 2022 Received: June 17, 2022
Dear Dallas L. Thomas:
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.
1
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 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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220378
Device Name Sparta 3-Ply Surgical Disposable Face Mask
Indications for Use (Describe)
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable 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, non-sterile, disposable device
| 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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3
510(k) Summary
General Information 5.1
5 February 2022 Preparation Date:
Submitter/Holder / Applicant
Ricardo Samayoa
General Manager
Sparta East LLC
8830 NW 102 Street, Medley, FL 33178
Contact Phone#: 305-924-3610
Email: resamayoa@yahoo.com
Primary Submission Contact
Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions 5613 Tiger Way Winter Garden, FL 34787 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com
Regulatory Information 5.2
| Subject Device Name | Sparta 3-Ply Surgical Disposable Face Mask |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Sparta 3-Ply Surgical Disposable Face Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |
4
5.3 Identification of Predicate Device
The predicate device for this submission has been identified as the Disposable Surgical Mask K202463.
Subject Device Description 5.4
The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch.
The device is manufactured with three layers:
Outer Layer: Spunbond polypropylene
Middle Layer: Melt Blown polypropylene
Inner Layer: Spunbond polypropylene
The subject device is provided non-sterile and is a single use, disposable device.
A visual representation of the device can be found in the following figure.
Image /page/4/Figure/12 description: The image shows a light blue surgical mask. The mask has a white border along the top and bottom edges. The ear loops are white and attached to the sides of the mask.
Figure 1: Sparta 3-Ply Surgical Disposable Face Mask Product Image
ર્સ્ટ Subject Device Specification
Design specifications:
- Size/Dimensions: ●
5
| Dimensions-Width | 3.74in (9.5 cm) |
|---|---|
| Dimensions-Length | 6.89in (17.5cm) |
- Materials of subject device are as listed below. ●
| Outer Layer (Blue) | Spunbond polypropylene |
|---|---|
| Middle Layer (White) | Melt blown polypropylene |
| Inner Layer (White) | Spunbond polypropylene |
| Nose Wire | Polypropylene and galvanized steel |
| Ear Band | Spandex |
ર્ડ.6 Indications for Use
Per the current proposed product labeling, the indications for the Sparta 3-Ply Surgical Disposable Face Mask are quoted as follows:
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable 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, non-sterile, disposable device.
Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Disposable Surgical Mask K202463 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use.
5.7 Substantial Equivalence Discussion
Below is a summary table of the Substantial Equivalence between the subject and predicate devices. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that Sparta 3-Ply Surgical Disposable Face Mask is substantially equivalent to the predicate device, Disposable Surgical Mask K202463.
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K220378 4 of 9
Section 5: 510(k) Summary
Sparta 3-Ply Surgical Disposable Face Mask
| Device
Characteristic | Proposed Subject Device:
3-ply disposable face
mask | Primary Predicate Device
3-ply EcoGuard B with
Earloop, 3-ply EcoGuard B
with Tie-On
K202096 | Comparison
Analysis: |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Surgical Disposable Face
Masks | 3-ply EcoGuard B with
Earloop, 3-ply EcoGuard B
with Tie-On | N/A-
Differences do
not impact
safety or
efficacy. |
| Manufacturer | Sparta East, LLC | EcoGuard Inc. | N/A-
Differences do
not impact
safety or
efficacy. |
| FDA Product Code | FXX | FXX | Identical |
| CFR Reference | 878.4040 | 878.4040 | Identical |
| Device Class | II | II | Identical |
| 510(k) reference | TBD | K202096 | N/A-
Differences do
not impact
safety or
efficacy. |
| Implanted Device | No | No | Identical |
| Device
Characteristic | Proposed Subject Device:
3-ply disposable face
mask | Primary Predicate Device
3-ply EcoGuard B with
Earloop, 3-ply EcoGuard B
with Tie-On
K202096 | Comparison
Analysis:
Identical /
Substantially
Equivalent /
Modified /
Cannot Be
Determined /
Not
Applicable |
| Indications for use
statement | The SPARTA Disposable
Surgical Mask is intended to
be worn to protect both
health care practitioners and
patients
from transfer of
microorganisms, body fluids
and particulate material. The
masks are intended for use in
infection control practices to
reduce the
potential exposure to blood
and bodily fluids. This is a
single use, disposable device,
which is provided non-sterile | The Following EcoGuard
Surgical Masks are intended
to be worn to protect both
the patient and healthcare
personnel
from the transfer
ofmicroorganisms, body
fluids, and particulate
material. These surgical
masks are intended for use in
infection control practices to
reduce the potential
exposure to blood and bodily
fluid. These surgical masks
are single use,
disposable devices provided
non-sterile.
3-ply EcoGuard B with
Earloop, Model Number:
ECOOI
3-ply EcoGuard B with Tie-
on, Model Number: ECO02 | Substantially
Equivalent,
minor
wording
differences do
not impact
safety or
efficacy. |
| Device Generic Raw
Materials | Outer Facing Layer:
Spunbond nonwoven
polypropylene
Middle Layer: Melt Blown
nonwoven polypropylene
filter
Inner facing layer: Spunbond
nonwoven polypropylene
Ear loop: Polyester and
Spandex
Nose wire: Polypropylene | Outer Facing Layer:
Spunbond polypropylene
Middle Layer: Melt Blown
polypropylene filter
Inner facing layer: Spunbond
polypropylene
Ear loop: Polyester Nylon and
Spandex
Nose wire: Malleable
Polyethylene wire | Substantially
Equivalent,
minor
wording
differences do
not impact
safety or
efficacy. |
Table 1. Summary Comparison of Characteristics
7
8
| Sparta 3-Ply Surgical Disposable Face Mask | ||
|---|---|---|
| Device
Characteristic | Proposed Subject Device:
3-ply disposable face
mask | Primary Predicate Device
3-ply EcoGuard B with
Earloop, 3-ply EcoGuard B
with Tie-On
K202096 | Comparison
Analysis:
Identical /
Substantially
Equivalent /
Modified /
Cannot Be
Determined /
Not
Applicable |
|----------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Color (outward
facing Layer) | Blue | Blue | Identical |
| Color (middle Layer) | White | Not publically available | Modified -
Minor
differences do
not impact
safety or
efficacy. |
| Color (inward facing
Layer) | White | Not publically available | Modified -
Minor
differences do
not impact
safety or
efficacy. |
| Colorant(s) -ALL
Needed in terms of
Material Name /
Chemical Name | N/A | Not publically available | Modified -
Minor
differences do
not impact
safety or
efficacy. |
| Patient Anatomical
Site for Use of
Device | Nose and Mouth | Nose and Mouth | Identical |
| Mode of Operation | Protective Mask | Protective Mask | Identical |
| Reusable or Single
Use | Single Use | Single Use | Identical |
| Sold Sterile or Non-
Sterile | Non-Sterile | Non-Sterile | Identical |
| Prescription Status | OTC | OTC | Identical |
| Fluid Resistance
Performance ASTM
F1862-13 (how
many passing) | 96 Passed (3 batches of 32) | Not publically available | Substantially
Equivalent |
9
| Sparta 3-Ply Surgical Disposable Face Mask | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -------------------------------------------- | -- |
| Device
Characteristic | Proposed Subject Device:
3-ply disposable face
mask | Primary Predicate Device
3-ply EcoGuard B with
Earloop, 3-ply EcoGuard B
with Tie-On
K202096 | Comparison
Analysis:
Identical /
Substantially
Equivalent /
Modified /
Cannot Be
Determined /
Not
Applicable |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Particulate Filtration
Efficiency ASTM
F2299 % Passing | ≥98% | ≥ 99% | Substantially
Equivalent |
| Bacterial Filtration
Efficiency ASTM
F2101 % Passing | 0.999 | ≥ 98% | Substantially
Equivalent |
| Differential Pressure
(Delta P) EN 14683
Results / Conclusion |