(162 days)
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.
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.
The provided document is a 510(k) summary for the Banyan USA Surgical Mask Level 3. It details non-clinical laboratory testing performed to demonstrate substantial equivalence to a predicate device, rather than a study with human subjects (clinical study) for an AI/CADe device. Therefore, many of the requested criteria regarding AI device studies are not applicable.
Here's the information that can be extracted and a clear indication of which points are not applicable:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria (ASTM F2100-11 Level 3) | Reported Device Performance (Banyan USA Surgical Mask Level 3) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine synthetic blood penetration resistance | 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Determine bacterial filtration efficiency | ≥ 98% | 98.69% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | ≥ 98% | 99.22% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Determine breathing resistance or differential pressure | < 6.0 mmH2O / cm2 | 3.82 mm H2O/cm2 | Pass |
| Flammability (CFR 16 1610) | Determine flammability | Class 1 | Class 1 Pass | Pass |
| Cytotoxicity (ISO 10993-5) | Assess in vitro cytotoxicity | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Assess irritation | Non-irritating | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Assess skin sensitization | Non-sensitizing | Non-sensitizing | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): 32 samples each from 3 non-consecutive lots (total 96 samples for each test).
- Sample Size for biocompatibility tests (Cytotoxicity, Irritation, Sensitization): Not explicitly stated how many individual mask samples were used for these tests, but the results refer to "the device" as a whole fulfilling the criteria.
- Data Provenance: The document does not specify the country of origin of the data. The tests are laboratory-based, not clinical data.
- Retrospective or Prospective: Not applicable as this is laboratory testing of a physical device, not an AI/CADe study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this device (a surgical mask) is established by standardized laboratory testing methods (e.g., ASTM, EN, ISO, CFR standards), not by human expert consensus or medical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Laboratory test results are objective measurements based on the specified standards, not subjective expert reviews requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document is for a physical surgical mask, not an AI or CADe device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that the mask itself is tested according to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the surgical mask's performance is defined by the acceptance criteria specified in the relevant international and national standards (e.g., ASTM F2100-11 for performance of materials, ISO 10993 for biocompatibility, EN 14683 for differential pressure, 16 CFR 1610 for flammability). These standards set objective thresholds for physical and biological properties.
8. The sample size for the training set
- Not applicable. This is not an AI/CADe device, and therefore does not involve a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/CADe was used or established.
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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
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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
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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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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.
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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 | |
|---|---|
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| Ear Loops | White Knitted Nylon Elastic | Polyester Nylon/Spandex | Different |
|---|---|---|---|
| Mask Style | Flat Pleated | Flat Pleated | Similar |
| Color | WhiteColorant: NoneCAS#: None | BlueColorant: Pigment Blue 15:3CAS#: 147-18-8 | Different |
| Design Features | |||
| Specification andDimensions | $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 F2100Level | Level 3 | Level 3 | Same |
| Non-ClinicalTesting | ASTM F1862ASTM F2299ASTM F2101EN 1468316 CFR 1610 | ASTM F1862ASTM F2299ASTM F2101MIL-M-36954C16 CFR 1610 | Same |
| BiocompatibilityTesting | CytotoxicityIrritationSensitization | CytotoxicityIrritationSensitization | 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 perASTM F2100-11 Level 3(AQL = 4.0%) | Proposed Device Test Result:Banyan USA Surgical Mask | |
|---|---|---|---|---|
| ASTM F2100-11 Level 3 | Average | |||
| Fluid ResistancePerformance(ASTM F1862) | Determinesynthetic bloodpenetrationresistance | 160 mmHg | Pass at 160 mmHg (96/96)32 Samples from 3 non-consecutive lots | N/A |
| ParticulateFiltration Efficiency(ASTM F2299) | Determinebacterialfiltrationefficiency | ≥ 98% | Pass (96/96) 32 Sampleseach from 3 non-consecutive lots | 98.69% |
Table 3: Summary of Non-Clinical Testing
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| Bacterial FiltrationEfficiency(ASTM F2101) | Determinesubmicronparticulatefiltrationefficiency | $\geq$ 98 % | Pass (96/96) 32 Sampleseach from 3 non-consecutive lots | 99.22% |
|---|---|---|---|---|
| DifferentialPressure (Delta P)EN 14683:2019 | Determinebreathingresistance ordifferentialpressure | < 6.0 mmH2O / cm2 | Pass (96/96) 32 Sampleseach from 3 non-consecutive lots | 3.82 mmH20/cm2 |
| FlammabilityCFR 16 1610 | Determineflammability | Class 1 | Class 1 Pass (96/96) 32Samples each from 3 non-consecutive lots | N/A |
Table 4: Summary of Biocompatibility Testing
| BiocompatibilityISO 10993-I Evaluation and testing within a risk management process | ||||
|---|---|---|---|---|
| Test | Test Findings | Result | ||
| CytotoxicityISO 10993-5 Tests for in vitrocytotoxicity of medical devices | Under the conditions of the study, thedevice is non-cytotoxic | Banyan USA SurgicalMask Level 3 :Pass | ||
| IrritationISO 10993-10 Tests for irritation | Under the conditions of the study, thedevice is non-irritating | Banyan USA SurgicalMask Level 3: Pass | ||
| SensitizationISO 10993-10 Tests for skinsensitization | Under the conditions of the study, thedevice is non-sensitizing | Banyan USA SurgicalMask Level 3:Pass |
8. Summary of Clinical Test: NA
9. Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the proposed device, the Banyan USA Surgical Mask Level 3, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202096.
§ 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.