(209 days)
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid 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.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
The provided document is a 510(k) Summary for a surgical face mask (MAF Guard). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/algorithm-based medical device.
Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical characteristics and filtration efficacy of the surgical mask based on the provided tables.
Here's the information that can be extracted from the document, focusing on the appropriate acceptance criteria and "study" (non-clinical testing) for a surgical mask:
Device: MAF Guard Surgical Face Mask (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521)
Device Type: Surgical Face Mask
Regulatory Class: Class II
Product Code: FXX
Predicate Device: Non Woven Face Mask (K173062)
The study described is non-clinical performance testing to demonstrate that the MAF Guard surgical face mask meets established consensus standards for surgical masks, aligning with the "Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004."
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Method (Standard) | Purpose | Acceptance Criteria (for Level 3 Surgical Mask) | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood, minimum pressure in mm Hg | Level 3 requirement: 29 out of 32 passed at 160 mm Hg | 32 out of 32 passed at 160 mm Hg for three non-consecutive lots | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Evaluate Sub-micron particulate filtration efficiency at 0.1 micron (%) | Level 3 requirement: ≥ 98% | Mean for three non-consecutive lots = 99.88%, 99.89%, and 98.50% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Evaluate BFE using a biological aerosol of Staphylococcus aureus (%) | Level 3 requirement: ≥ 98% | Mean for three non-consecutive lots = 98.9%, 98.5%, and 98.4% | Pass |
| Differential Pressure (Delta P) (EN 14683) | Evaluate Differential pressure (mm H2O/cm²) | Level 3 requirement: < 6 mm H2O/cm² | Mean for three non-consecutive lots = 2.11, 2.57, and 4.60 mm H2O/cm² | Pass |
| Flammability (16 CFR 1610) | Evaluate flammability | Class 1 | Class 1 for 3 non-consecutive lots of each mask model | Pass |
| Biocompatibility (ISO 10993-5) | Evaluate for Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Biocompatibility (ISO 10993-10) | Evaluate for Sensitization | Non-Sensitizing | Non-Sensitizing | Pass |
| Biocompatibility (ISO 10993-10) | Evaluate for Irritation | Non-Irritating | Non-Irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for performance tests: The performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, and Flammability) were conducted on three non-consecutive lots of the device. For Fluid Resistance, 32 samples were tested per lot. The specific number of samples for other tests (e.g., for efficiency percentages or differential pressure) within each lot is not explicitly stated beyond "mean for three non-consecutive lots."
- Data Provenance: The document does not specify the country of origin where the testing was performed. It is implicitly retrospective as it's a 510(k) submission summarizing completed testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission pertains to physical and performance specifications of a medical device (surgical face mask), not an AI/algorithm-based device requiring expert clinical ground truth evaluation. The ground truth is established by laboratory test methods and international/national standards (e.g., ASTM, EN, ISO).
4. Adjudication Method for the Test Set:
- Not applicable. This is not a clinical study involving human readers or subjective interpretations that would require an adjudication method. The testing relies on objective measurement and adherence to defined technical standards.
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 is not an AI/algorithm-based device, and no MRMC study was performed. The device is a physical surgical face mask.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm-based device. "Standalone performance" in this context refers to the intrinsic performance of the physical mask itself as measured by the specified tests.
7. The Type of Ground Truth Used:
- The ground truth is established by objective laboratory testing methods defined by recognized consensus standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101 for bacterial filtration, EN 14683 for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 for biocompatibility). The acceptance criteria are derived from these standards, specifically aiming for Level 3 performance for surgical masks.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/algorithm-based device.
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December 8, 2021
MAF Clothing Pvt Ltd Unit-3 Thomas Knott Senior Regulatory Advisor Benjamin L. England and Associates, LLC 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061
Re: K211487
Trade/Device Name: MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 11, 2021 Received: November 15, 2021
Dear Thomas Knott:
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.
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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 mediation-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
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Indications for Use
510(k) Number (if known) K211487
Device Name
MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521)
Indications for Use (Describe)
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid 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.
| 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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510(k) SUMMARY
Date of Summary Prepared: November 30, 2021 510(k) Number: K211487
| Submitted By: | Benjamin L. England And Associates, LLC |
|---|---|
| Address: | 810 Landmark DriveSuite 126Glen Burnie, MD 21061 |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@englandlawgroup.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
| On Behalf of: | MAF CLOTHING PVT LTD UNIT-3 |
| Address | Sy. No59/3, 59/4. Rajathadripura, Near K B CrossTiptur Taluk, Tumkur District - 572114.Karnataka, India. |
| Phone: | +91- 9513696166 |
| Fax: | None |
| E-Mail: | faizal@mafclothing.com / kirit@mafclothing.com |
| Contact: | Mr. Kirit Jagani (Business Head) |
1. Regulatory Information
| Proprietary Name: | MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-onmodel SM3P-MB25-2521) |
|---|---|
| Classification Name: | Surgical Face Mask, Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Panel | General Surgery Devices |
| Regulation: | 21 CFR 878.4040 |
2. Predicate Device
| 510(k) Number: | K173062 |
|---|---|
| Device Name: | Non Woven Face Mask (Models: VQN0185W (earloop) andVQN0185B (ties)) |
| Recalls: | A search of the recall database revealed no design-related recalls. |
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3. Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
4. Indications for Use
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid 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.
5. Summary of Comparison and Technological Characteristics
| CLASSIFICATION INFORMATION | |||
|---|---|---|---|
| 510(k) Number | K211487 | K173062 | N/A |
| Manufacturer | MAF Clothing Pvt. Ltd. | V&Q Manufacturing Corporation | N/A |
| ProprietaryName | MAF Guard (Models Ear Loop –SM3P-MB25-2511, Tie-on –SM3P-MB25-2521. | Non Woven Face Mask (Models:VQN0185W (earloop) andVQN0185B (ties)) | N/A |
| CommonName | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II | Class II | Same |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications forUse | MAF Guard is a deviceintended to be worn byoperating room personnelduring surgical procedures toprotect both the surgical patientand the operation roompersonnel from transfer ofmicroorganisms, body fluid andparticulate material. These facemasks are intended for use ininfection control practices toreduce potential exposure toblood and body fluids. The facemask is single use, disposabledevice, provided non-sterile. | Non Woven Face Mask (Models:VQN0185W (ear loop) andVQN0185B (ties)) is intended forsingle use by operating roompersonnel and other generalhealthcare workers to protectboth patients and healthcareworkers against transfer ofmicroorganisms, blood and bodyfluids, and particulate materials. | Similar |
| Model | Three ply, flat pleated with earloops and ties | 3 Ply, Flat-Pleated Style with earloops and ties | Same |
Table 1 - General Comparison
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| MATERIALS | |||
|---|---|---|---|
| Outer Layer | Spunbond Polypropylene | Same | |
| Middle Layer | Melt Blown Polypropylene Filter | Same | |
| Inner Layer | Spunbond Polypropylene | Same | |
| Nose Piece | Steel core wire coated with Polyethylene resin | White aluminum strip covered by PP covering | Different |
| Ear Loops | Polyester Spandex | Urethane elastic fiber | Different |
| Tie strips: | Spunbond polypropylene | Spunbond polypropylene | Same |
| Color | Blue outer layer | Blue | Same |
| Width | 95 ± 3 mm | 95 mm | Same |
| Length | 175 ± 5 mm | 175 mm | Same |
| OTC Use? | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use? | Yes | Yes | Same |
| ASTM F2100 | Level 3 | Level 2 | Different |
| ASTM F1862 Fluid Resistance Performance | 32 out of 32 pass at 160 mm Hg for each of three lots | Pass at 120 mm Hg | Different |
| ASTM F2299 Particulate Filtration Efficiency | Mean for three lots = 99.88%, 99.89%, and 98.50%, respectively | Average 99.74% at 0.1µm | Similar |
| ASTM F2101 Bacterial Filtration Efficiency | Mean for three lots = 98.9%, 98.5%, and 98.4% | Average 99.4% | Similar |
| Differential Pressure (Delta P) | Mean for three lots = 2.11, 2.57, and 4.60 mm H2O/cm² | Average 2.7 mm H2O/cm² | Similar |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility Testing | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Same |
Differences in technological characteristics do not raise different questions of safety and effectiveness.
6. Non-clinical Tests Performed on the Proposed Device
The proposed 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.
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Table 2 - Performance Testing
| TestMethod | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM 2100 | Meetsrequirements forLevel 3 | ||
| Fluid ResistancePerformanceASTM F1862 | To evaluate the resistance topenetration by syntheticblood, minimum pressure inmm Hg | Level 3 requirement: 29 outof 32 passed at 160 mm Hg | Pass32 out of 32passed at 160mm Hgfor three non-consecutive lots |
| ParticulateFiltrationEfficiency ASTMF2299 | To evaluate the Sub-micronparticulate filtrationefficiency at 0.1 micron (%) | Level 3 requirement: ≥ 98% | PassMean for threenon-consecutivelots = 99.88%,99.89%, and98.50% |
| BacterialFiltrationEfficiency ASTMF2101 | To evaluate the BFE of thetest article using a biologicalaerosol of Staphylococcusaureus (%) | Level 3 requirement: ≥ 98% | PassMean for threenon-consecutivelots = 98.9%,98.5%, and98.4% |
| DifferentialPressure (DeltaP) EN 14683 | To evaluate the Differentpressure (mm H2O/cm²) | Level 3 requirement: <6 mm H2O/cm² | PassMean for threenon-consecutivelots = 2.11, 2.57,and 4.60 mmH2O/cm² |
| Flammability16 CFR 1610 | To evaluate the flammability | Class 1 | Pass3 non-consecutive lotsof each maskmodel |
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Table 3 - Biocompatibility Testing
| ltem | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Pass |
| ISO 10993-10 | Non-Sensitizing | Non- Sensitizing | Pass |
| ISO 10993-10 | Non-Irritating | Non-Irritating | Pass |
7. Conclusion
There is no clinical study included in this submission. The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
END OF 510(k) SUMMARY**
§ 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.