(226 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the masks are for protection against microorganisms, body fluids, and particulate material in infection control, not for treating or rehabilitating a disease or injury.
No
The device is a surgical face mask, which acts as a barrier to protect against the transfer of microorganisms and body fluids. It does not diagnose any medical conditions.
No
The device description clearly outlines a physical product (surgical masks made of polypropylene with ear loops and a nose piece) and the performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability. There is no mention of software as the primary or sole component.
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 masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, which are consistent with a barrier device.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on barrier properties like fluid resistance, particulate filtration, bacterial filtration, and breathability. These are relevant to the protective function of a mask, not a diagnostic function.
- Predicate Device: The predicate device is also a surgical face mask, further indicating the device's classification as a protective barrier.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The following Liberty 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
These are single use, disposable device(s) provided non-sterile.
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
Product codes
FXX
Device Description
The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Two models will be sold:
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
The models are identical except for labeling.
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
Adults
Intended User / Care Setting
Over-The-Counter Use
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)
Non-clinical testing was performed for Fluid Resistance Performance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta-P MIL-M-36954C), and Flammability (16CFR 1610). Biocompatibility testing was also conducted for Cytotoxicity, Irritation, and Sensitization.
Fluid Resistance Performance ASTM F1862:
LM Surgical Mask Level 3, LM0787: 95 out of 96 samples passed from 3 nonconsecutive lots at 160mm Hg.
LM Surgical Mask Level 2, LM0786: 96 out of 96 samples passed from 3 nonconsecutive lots at 160mm Hg.
Acceptance Criteria: 29 out of 32 pass at 160mmHg. Result: Similar & Acceptable.
Particulate Filtration Efficiency ASTM F2299:
LM Surgical Mask Level 3, LM0787: 96 out of 96 passed from 3 nonconsecutive lots at an average of 99.09%.
LM Surgical Mask Level 2, LM0786: 96 out of 96 passed from 3 nonconsecutive lots at an average of 98.42%.
Acceptance Criteria: ≥ 98%. Result: Similar & Acceptable.
Bacterial Filtration Efficiency ASTM F2101:
LM Surgical Mask Level 3, LM0787: 96 out of 96 passed from 3 nonconsecutive lots at an average of 99.60%.
LM Surgical Mask Level 2, LM0786: 96 out of 96 passed from 3 nonconsecutive lots at an average of 99.59%.
Acceptance Criteria: ≥ 98%. Result: Similar & Acceptable.
Differential Pressure (Delta-P) MIL-M-36954C:
LM Surgical Mask Level 3, LM0787: 4.80mmH2O/cm^2.
LM Surgical Mask Level 2, LM0786: 5.20mmH2O/cm^2.
Acceptance Criteria:
§ 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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
December 16, 2021
Liberty Mask LLC % Timothy Kania Consultant mdi Consultants 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K211378
Trade/Device Name: LM Surgical Mask Level 3, LM Surgical Mask Level 2 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 3, 2021 Received: May 4, 2021
Dear Timothy Kania:
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
542 of the Act); 21 CFR 1000-1050.
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-
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211378
Device Name LM Surgical Mask Level 2 LM Surgical Mask Level 3
Indications for Use (Describe)
The following Liberty 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
These are single use, disposable device(s) provided non-sterile.
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
The assigned 510(k) number is: K211378
1. Submitter's Identification:
Manufacturer: Liberty Mask, LLC Address: 1819 Firman Drive, Suite 101 Plano, Texas 75081
Contact: Mr. Will Kincaid Title: Operations Manager Phone Number: 214-915-2133 Email: willk@Libertymask.com
Date Summary Prepared: April 15, 2021
Official Correspondent: Mr. Tim Kania mdi Consultants, Inc. Phone Number: (732)-796-4565 Email: tim@mdiconsultants.com
2. Name of the Device:
| Device Name(s): | LM Surgical Mask Level 3, LM Surgical Mask Level 2 |
|---|---|
| Model Number: | LM0787, LM0786 |
Common Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX
3. Information for the 510(k) Cleared Device (Predicate Device):
Predicate Device:
Disposable Surgical Face Mask Ear Loop and Tie-On K153496 Xiantao Rayxin Medical Products
4. Device Description:
The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
4
Two models will be sold:
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
The models are identical except for labeling.
5. Indications for Use:
The following Liberty 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
These are single use, disposable device(s) provided non-sterile.
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| Device | Proposed device | Predicate device | Result | |
|---|---|---|---|---|
| 510(k) Holder | Liberty Mask, LLC | Xiantao Rayxin Medical Products | -- | |
| 510(k) | ||||
| Number | K211378 | K153496 | -- | |
| Name | LM Surgical Mask Level 2 | |||
| Model #: LM0786 | ||||
| LM Surgical Mask Level 3 | ||||
| Model #: LM0787 | Disposable Surgical Face Mask | |||
| Ear Loop and Tie-On | -- | |||
| Classification | Class II Device, FXX (21 CFR | |||
| 878.4040) | Class II Device, FXX (21 CFR | |||
| 878.4040) | Same | |||
| Intended use | The following Liberty 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 masks are | ||||
| intended for use in infection control | ||||
| practices to reduce the potential | ||||
| exposure to blood and body fluids. | ||||
| These are single use, disposable | ||||
| device(s) provided non-sterile. | ||||
| LM Surgical Mask Level 2 | 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(s), provided non- | ||||
| sterile | Same | |||
| Model #: LM0786 | ||||
| LM Surgical Mask Level 3 | ||||
| Model #: LM0787 | ||||
| Flat- Pleated | ||||
| Mask style | Flat - Pleated | Same | ||
| Design | Ear loop | Ear loop, Tie-On | Same | |
| Layers | Three | Three | Same | |
| Color | White | |||
| Standridge White 20790 | ||||
| CAS#13463-67-7 | Blue | Different | ||
| but | ||||
| mitigated | ||||
| through | ||||
| biocompati | ||||
| bility | ||||
| testing | ||||
| Target | ||||
| population | Adults | Adults | Same | |
| Dimension | ||||
| (Length) | 17.0 cm +/- 4mm | 17.5 cm | Different | |
| Dimension | ||||
| (Width) | 9.0 cm +/- 4mm | 9.5 cm | ||
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single use, disposable | Single use, disposable | Same | |
| Anatomical | ||||
| site | Nose and mouth | Nose and mouth | Same | |
| Environment | ||||
| of use | OTC | OTC | Same | |
| Material | ||||
| Outer facing | ||||
| layer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Middle layer | Melt blown polypropylene Filter | Melt blown polypropylene Filter | Same | |
| Inner facing | ||||
| layer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Ear Loops | Spandex Elastic Cord. (Polyurethane | |||
| terephthalate/nylon cover) | Polyester | Different | ||
| but | ||||
| mitigated | ||||
| through | ||||
| biocompati | ||||
| bility | ||||
| testing | ||||
| Nose piece | Polypropylene Coated Steel Wire | Malleable aluminum wire | Different | |
| but | ||||
| mitigated | ||||
| through | ||||
| biocompati | ||||
| bility | ||||
| testing | ||||
| ASTM F2100 | ||||
| Level | Level 2 & 3 | Level 2 | bility | |
| testing | ||||
| Different. | ||||
| No new | ||||
| issues of | ||||
| safety or | ||||
| effectivenes | ||||
| s and higher | ||||
| protection | ||||
| provided by | ||||
| Proposed | ||||
| Device | ||||
| Performance Testing Results | ||||
| Performance | ||||
| tests | Subject device | Predicate device | Acceptance | |
| Criteria | Result | |||
| Fluid | ||||
| Resistance | ||||
| Performance | ||||
| ASTM F1862 | LM Surgical Mask Level 3, LM0787: | |||
| 95 out of 96 samples passed from 3 | ||||
| nonconsecutive lots at 160mm Hg | ||||
| LM Surgical Mask Level 2, LM0786: | ||||
| 96 out of 96 samples passed from 3 | ||||
| nonconsecutive lots at 160mm Hg | 32 out of 32 Pass | |||
| at | ||||
| 160mm Hg | 29 out of 32 pass | |||
| at 160mmHg | Similar & | |||
| Acceptable | ||||
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM F2299 | LM Surgical Mask Level 3, LM0787: | |||
| 96 out of 96 passed from 3 | ||||
| nonconsecutive lots at an average of | ||||
| 99.09% | ||||
| LM Surgical Mask Level 2, LM0786: | ||||
| 96 out of 96 passed from 3 | ||||
| nonconsecutive lots at an average of | ||||
| 98.42% | 99.67% | ≥ 98% | Similar & | |
| Acceptable | ||||
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM F2101 | LM Surgical Mask Level 3, LM0787: | |||
| 96 out of 96 passed from 3 | ||||
| nonconsecutive lots at an average of | ||||
| 99.60% | ||||
| LM Surgical Mask Level 2, LM0786: | ||||
| 96 out of 96 passed from 3 | ||||
| nonconsecutive lots at an average of | ||||
| 99.59% | 99.95% | ≥ 98% | Similar & | |
| Acceptable | ||||
| Differential | ||||
| Pressure | ||||
| (Delta-P) | ||||
| MIL-M- | ||||
| 36954C | LM Surgical Mask Level 3, LM0787: | |||
| $4.80mmH2O/cm^2$ | ||||
| LM Surgical Mask Level 2, LM0786: | ||||
| $5.20mmH2O/cm^2$ | $5.62mmH2O/cm^2$ | $ |