(30 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable surgical mask, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a face mask intended for protection and infection control, not for treatment.
No
The device is a surgical face mask, intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device description clearly outlines physical components (layers of fabric, head ties/ear loops, nosepiece) and the performance studies are based on physical properties and testing of these materials, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "Disposable Surgical Face Mask" intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. Its function is external and protective.
The provided information focuses on the physical properties and performance of the mask as a barrier, not on any diagnostic capabilities.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Benchtop performance testing:
- Level 3 Fluid Resistance (ASTM F1862): 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. Acceptance criteria: AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg.
- Particulate Filtration Efficiency (ASTM F2299): 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. Acceptance criteria: ≥ 98%.
- Bacterial Filtration Efficiency (ASTM F2101): 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. Acceptance criteria: ≥ 98%.
- Differential Pressure (ASTM F2100/EN 14683:2019): Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at
§ 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 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
1
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
2
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.
4
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 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 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. | Same |
| Materials | | | |
| Inner Facing Layer | Polyethylene/Polyester
Nonwoven | Spun-bond polypropylene | Similar (see
conclusion) |
| Middle Layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| Outer Facing Layer | Polyethylene/Polyester
Nonwoven | Spun-bond polypropylene | Similar (see
conclusion) |
| Nose piece | Galvanized wire coated with
polyethylene | Galvanized wire coated
with polyethylene | Same |
| Ear loop | Spandex and Nylon - Not
made from natural rubber
latex | Spandex/nylon | Same |
| Head ties- Tie On | Polyethylene/Polyester nonwoven | N/A | Predicate
offers only ear
loops |
| Ear Band | Polyethylene/Polyester
Nonwoven | N/A | Predicate
offers only ear
loop |
| 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 Fluid
Resistance
Performance
ASTM F1862 | 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 | AQL 4%, single
sampling plan, 29
out of 32 Pass at
160mmHg | Pass at 160 mmHg
(Level 3 Fluid
Resistance) | Pass |
| Particulate
Filtration
Efficiency
ASTM F2299 | 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 | ≥ 98% | Pass at ≥99% | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | 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 | ≥ 98% | Pass at ≥99% | Pass |
| Differential
Pressure
ASTM
F2100/EN
14683:2019 | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at