(162 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended for infection control and protection from transfer of microorganisms, not for treating a disease or condition.
No
The intended use of the Banyan USA Surgical Mask Level 3 is for protection against transfer of microorganisms, body fluids, and particulate materials, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layered surgical mask made of various materials (polypropylene spunbond, melt-blown, thermal-bonded) with ear loops and a nosepiece. The performance studies are based on physical testing of the mask's filtration, fluid resistance, and flammability, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate materials. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of a face mask. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This mask does not perform any such analysis.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are not the types of studies conducted for IVD devices, which would involve evaluating analytical and clinical performance related to detecting specific substances or conditions in samples.
In summary, the Banyan USA Surgical Mask Level 3 is a personal protective equipment (PPE) device designed to provide a physical barrier, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
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)
Non-Clinical Tests:
The Banyan USA Surgical Mask Level 3 has been tested in accordance with the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks.
Test Results:
- Fluid Resistance (ASTM F1862): Pass at 160 mmHg (96/96) from 32 Samples from 3 non-consecutive lots.
- Particulate Filtration Efficiency (ASTM F2299): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 98.69%.
- Bacterial Filtration Efficiency (ASTM F2101): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 99.22%.
- Differential Pressure (Delta P) (EN 14683:2019): Pass (96/96) 32 Samples each from 3 non-consecutive lots, Average 3.82 mm H20/cm2.
- Flammability (CFR 16 1610): Class 1 Pass (96/96) 32 Samples each from 3 non-consecutive lots.
Biocompatibility Testing (ISO 10993-I):
- Cytotoxicity (ISO 10993-5): Device is non-cytotoxic. Result: Pass.
- Irritation (ISO 10993-10): Device is non-irritating. Result: Pass.
- Sensitization (ISO 10993-10): Device is non-sensitizing. Result: Pass.
Clinical Tests: NA
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
September 22, 2021
Banyan USA LLC % Timothy Kania Consultant MDI Consultants Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K211097
Trade/Device Name: Banyan USA Surgical Mask Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2021 Received: August 17, 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
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,
For Clarence W. Murray, III, PhD 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) K211097
Device Name Banyan USA Surgical Mask Level 3
Indications for Use (Describe)
The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is 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)
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3
510(k) SUMMARY
The assigned 510(k) number is: K211097
1. Submitter's Identification:
Manufacturer: Banyan USA, LLC Address: 390 Oser Avenue Hauppauge, NY 11788
Contact: Mr. Ricardo Ryan Title: VP of Operations Phone Number: 631-456-5447 Email: rryan@banyanppe.com
Date Summary Prepared: March 31, 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): | Banyan USA Surgical Mask Level 3 |
|---|---|
| Model Number: | M3WH |
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:
3-ply EcoGuard B with Earloop K202096 EcoGuard Inc.
4. Device Description:
The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
4
5. Indications for Use:
The Banyan USA Surgical Mask Level 3 is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| Item | Proposed Device: | Predicate Device: | Comparison |
|---|---|---|---|
| 510(k) Number | K211097 | K202096 | - |
| Manufacturer | Banyan USA, LLC | EcoGuard Inc. | - |
| Product Name | Banyan USA Surgical Mask Level 3 | 3-ply EcoGuard B with Earloop | Different |
| Model Number | M3WH | ECO01 | Different |
| Classification | Class II Device Product Code: FXX Regulation Number: 21 CFR 848.4040 | Class II Device Product Code: FXX Regulation Number: 21 CFR 848.4040 | Same |
| Intended Use/Indications for Use | The Banyan USA Surgical Mask Level 3 are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These surgical masks are single use and disposable. Provided non-sterile. | The following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These surgical masks are single use, disposable devices provided non-sterile. | Same |
| Material | |||
| Outer Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Similar |
| Middle Layer | Melt blown polypropylene | Melt blown polypropylene | Similar |
| Inner Facing Layer | Thermal bonded polypropylene (22 GSM Thermal Bond White Material) | Spunbond polypropylene | Different |
| Nose Piece | Polyethylene Nose Wire | Malleable Polyethylene Wire | Different |
| Table 2: Comparison to Predicate Device | |
|---|---|
5
| Ear Loops | White Knitted Nylon Elastic | Polyester Nylon/Spandex | Different |
|---|---|---|---|
| Mask Style | Flat Pleated | Flat Pleated | Similar |
| Color | White | ||
| Colorant: None | |||
| CAS#: None | Blue | ||
| Colorant: Pigment Blue 15:3 | |||
| CAS#: 147-18-8 | Different | ||
| Design Features | |||
| Specification and | |||
| Dimensions | $6.9 \pm \frac{1}{4}"$ | ||
| $3.7 \pm \frac{1}{4}"$ | $17.5cm \pm 2.0cm$ | ||
| (~6.9 ±0.4") | |||
| $9.5cm \pm 2.0cm$ | |||
| (~3.7 ±0.4") | Similar | ||
| OTC Use | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 | |||
| Level | Level 3 | Level 3 | Same |
| Non-Clinical | |||
| Testing | ASTM F1862 | ||
| ASTM F2299 | |||
| ASTM F2101 | |||
| EN 14683 | |||
| 16 CFR 1610 | ASTM F1862 | ||
| ASTM F2299 | |||
| ASTM F2101 | |||
| MIL-M-36954C | |||
| 16 CFR 1610 | Same | ||
| Biocompatibility | |||
| Testing | Cytotoxicity | ||
| Irritation | |||
| Sensitization | Cytotoxicity | ||
| Irritation | |||
| Sensitization | Same |
Summary of Non-Clinical Tests: 7.
The Banyan USA Surgical Mask Level 3 has been tested in accordance with the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks. See Table 3 below for a summary of the non-clinical test results.
| Test | Purpose | Acceptance Criteria per
ASTM F2100-11 Level 3
(AQL = 4.0%) | Proposed Device Test Result:
Banyan USA Surgical Mask | |
|------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------|---------|
| | | | ASTM F2100-11 Level 3 | Average |
| Fluid Resistance
Performance
(ASTM F1862) | Determine
synthetic blood
penetration
resistance | 160 mmHg | Pass at 160 mmHg (96/96)
32 Samples from 3 non-
consecutive lots | N/A |
| Particulate
Filtration Efficiency
(ASTM F2299) | Determine
bacterial
filtration
efficiency | ≥ 98% | Pass (96/96) 32 Samples
each from 3 non-
consecutive lots | 98.69% |
Table 3: Summary of Non-Clinical Testing
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| Bacterial Filtration
Efficiency
(ASTM F2101) | Determine
submicron
particulate
filtration
efficiency | $\geq$ 98 % | Pass (96/96) 32 Samples
each from 3 non-
consecutive lots | 99.22% |
|-----------------------------------------------------|---------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------|--------------------|
| Differential
Pressure (Delta P)
EN 14683:2019 | Determine
breathing
resistance or
differential
pressure |