(152 days)
The 039 Medical Surgical Face Mask 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The 039 Medical Surgical Face Mask is single use, four- layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in blue. The 039 Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
This document describes the regulatory submission for the "039 Medical Surgical Face Mask," a Class II medical device, seeking clearance under a 510(k) premarket notification. The purpose of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605).
The core of the submission relies on non-clinical performance testing to meet established acceptance criteria, which are primarily based on ASTM F2100-2019 standards for medical face masks.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria for Level 2 Barrier | Reported Device Performance (039 Medical Surgical Face Mask) |
|---|---|---|---|
| Section 6.1 Bacterial Filtration Efficiency ASTM F2101 | Measure bacterial Filtration efficiency | >98% (87 of 96 pass) | 99.9% (96 of 96 passed) |
| Section 6.1 Differential Pressure (mm H$_{2}$O/cm$^{2}$) EN14683:2019+AC:2019 Annex C | Determine breathability of a mask | <6.0 (87 of 96 pass) | Average <3.8 (96 of 96 passed) |
| Section 6.1 Sub-micron Particulate Filtration Efficiency ASTM F2299/F2299M-03 | Measure initial particle filtration efficiency | ≥98% (87 of 96 pass) | >99% (96 of 96 passed) |
| Section 6.1 Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017 | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 120 mmHg (Visual inspection, 87 of 96 pass) | None seen in 91 of 96 samples |
| Section 6.2 Flame spread 16CFR Part 1610-2008 | Response of materials to heat and flame | Class 1 (87 of 96 pass) | 96 of 96 passed (Class 1) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For the non-clinical performance testing (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Flammability), three separate non-consecutive lots of 32 samples each were tested. This means a total of 96 samples were tested for each performance criterion.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is a premarket notification for a new device, the testing would inherently be prospective and conducted specifically to support the submission. The manufacturer, AOK Tooling Limited, is located in Shen Zhen, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This submission pertains to the performance characteristics of a physical medical device (face mask). The "ground truth" for these tests is established by standardized laboratory testing methodologies (e.g., ASTM and EN standards) and the physical measurements and observations derived from these tests.
- Therefore, the concept of "experts" establishing ground truth in the sense of human interpretation of medical images or diagnoses (as would be relevant for an AI/CAD device) is not directly applicable here. The experts involved would be the laboratory technicians and engineers who conduct these standardized tests, ensuring adherence to the test protocols and accurate data collection. Their qualifications would typically include training in laboratory procedures, relevant instrumentation, and quality control. The document does not specify the number or specific qualifications of these laboratory personnel.
4. Adjudication Method for the Test Set:
- The testing involves objective measurements and observations based on standardized protocols, not subjective human interpretation requiring adjudication. For example, bacterial filtration efficiency is a measured percentage, and synthetic blood penetration is a visual inspection for the presence of fluid.
- Therefore, an "adjudication method" in the context of resolving discrepancies in expert opinions (like 2+1 or 3+1 for medical image interpretations) is not applicable to this type of device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation. This submission is for a physical medical device (face mask) that does not involve human readers interpreting data assisted by AI.
- The study focuses on the physical and performance characteristics of the mask itself, demonstrating its standalone efficacy in barrier protection, breathability, etc., against predefined objective criteria.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance evaluation was done. The described non-clinical testing assesses the intrinsic performance of the medical face mask (the device itself) against objective physical and performance standards. It measures properties like filtration efficiency, breathability, fluid resistance, and flammability. These tests evaluate the device's technical specifications and capabilities without human intervention or interpretation of diagnostic output.
7. The Type of Ground Truth Used:
- The ground truth used for evaluating the device's performance is based on standardized, objective physical and material performance measurements as defined by:
- ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F2100-2019 (Standard Specification for Performance of Materials Used in Medical Face Masks), ASTM F2101 (Bacterial Filtration Efficiency), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), and ASTM F1862/F1862M-2017 (Resistance to Penetration by Synthetic Blood).
- EN (European Norm) standard: EN14683:2019+AC:2019 Annex C (Differential Pressure).
- CFR (Code of Federal Regulations): 16CFR Part 1610-2008 (Flame spread).
- These standards specify the methodology and expected outcomes for each test, providing the objective "ground truth" for the device's performance.
8. The Sample Size for the Training Set:
- This is a submission for a physical medical device (face mask). The concept of a "training set" is typically associated with machine learning or AI models, where data is used to train an algorithm.
- Since this is not an AI/ML device, there is no training set in the conventional sense. The device's design and manufacturing processes are informed by engineering principles and material science, rather than data-driven training.
9. How the Ground Truth for the Training Set Was Established:
- As there is no training set for this type of device, this question is not applicable.
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November 23, 2021
AOK Tooling Limited % Paul Dryden Consultant AOK Tooling Limited % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K211956
Trade/Device Name: 039 Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 19, 2021 Received: October 22, 2021
Dear Paul Dryden:
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 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, 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)
K211956
Device Name
039 Medical Surgical Face Mask
Indications for Use (Describe)
The 039 Medical Surgical Face Mask 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
XX_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Page 1 of 5
Date Prepared:
21-Nov-2021
AOK Tooling Limited # 101 And 1Building, 2Building, 3Building, 4Building, 5Building NO. 8 Of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District Shen Zhen, China 518122 Tel - +852-0-23101703
| Sponsor Contact: | Francis NithyananthanProject Director |
|---|---|
| Submission Correspondent: | Paul DrydenProMedic Consulting LLC |
| Proprietary or Trade Name: | 039 Medical Surgical Face Mask |
| Common/Usual Name: | Mask, Surgical |
| Classification Name: | Product Code - FXX – Mask, Surgical |
| Predicate Devices: | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. -K202605 |
| Device Description: | The 039 Medical Surgical Face Mask is single use, four-layer folded masks with ear loops, or straps to tie behindthe user's head, and a nose piece. The ear loops are heldin place over the users' mouth and nose by two elasticear loops welded to the facemask. The elastic ear loopsare not made with natural rubber latex. The nose piece inthe layers of facemask is to allow the user to fit thefacemask around their nose, which is made of malleablepolyethylene wire. The surgical face masks will beprovided in blue. The 039 Surgical Face Mask is soldnon-sterile and are intended to be single use, disposabledevices. |
| Principle of Operation: | A surgical mask covers the user's nose and mouth andprovides a physical barrier to fluids and particulatematerials. |
| Indications for Use: | The 039 Medical Surgical Face Mask are intended to beworn to protect both the patient and healthcare personnelfrom transfer of microorganisms, body fluids andparticulate material. These face masks are intended foruse in infection control practices to reduce the potentialexposure to blood and body fluids. This is a single use,disposable device(s), provided non-sterile. |
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510(k) Summary Page 2 of 5
| Description | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. | AOK Tooling Ltd. | |
| 510(k) Number | K202605 | K211956 | |
| Model Name | Standard Procedure Mask, Standard Surgical Mask | 039 Medical Surgical Face Mask | |
| Classification | Class II DeviceFXX21 CFR878.4040 | Class II DeviceFXX21 CFR878.4040 | Identical |
| Intended use /Indications for Use | The device is intended to be worn to protect both thepatient and healthcare personnel from transfer ofmicroorganisms, body fluids and particulate material.These face masks are intended for use in infectioncontrol practices to reduce the potential exposure toblood and body fluids. This is a single use, disposabledevice, provided non-sterile. | The 039 Medical Surgical Face Mask are intendedto be worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids and particulatematerial. These face masks are intended for use ininfection control practices to reduce the potentialexposure to blood and body fluids. This is a singleuse, disposable device(s), provided non-sterile. | Identical |
| Mask Style | Flat pleated | Folded | The mask style isdifferent, butperformance is similar tothe predicate* |
| Materials | |||
| Cover Fabric(s) | Spunbonded nonwoven and Melt blown nonwovenfabric | Non-woven polypropylene; Melt blown non-woven polypropylene filter | The difference does notimpact deviceperformance* |
| Nose Piece | Plastic | Silicone | The difference does notimpact deviceperformance* |
| Ear Loops / Tie-on | Polyester and spandex andSpunbonded nonwoven | Spandex | Identical |
| Color | Blue | Blue and White | Similar |
| Design | Ear loop and tie-on | Ear loop and tie-on | Identical |
| Dimension (Width /Length) Flat even thoughsubject device is folded | 175×95 mm | Small - 208x111 mmMedium - 226x124 mmLarge - 250x138 mmXlarge - 262x144 mm | The size difference doesnot impact deviceperformance* |
| OTC Use | Yes | Yes | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| ASTM 2100 Level | Level 2 | Level 2 | Identical |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Identical |
| Particulate efficiency level | ≥98% | ≥98% | Identical |
| Bacterial filtration level | ≥98% | ≥98% | Identical |
| Differential pressure | <6.0 mm H2O/cm2 | <6.0 mm H2O/cm2 | Identical |
| Flammability | Class I | Class I | Identical |
| Biocompatibility Tested | CytotoxicitySensitizationIrritation | CytotoxicitySensitizationIrritation | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
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510(k) Summary Page 3 of 5
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510(k) Summary Page 4 of 5
Indications for Use -
The indications for use are identical for the proposed device when compared to the predicate -
Discussion - Each device is indicated to cover a user's nose and mouth and provides a physical barrier to fluids and particulate materials.
Technology and construction -
The design, fabrication, shape, size, etc. are equivalent to the predicate - Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605.
Discussion - This mask is not a flat-pleated style and covers a larger surface area of the user's face. However, the difference in mask style of flat pleated vs. folded should not impact the substantial equivalence of the subject device to the predicate. Our testing demonstrated that the subject device has similar performance to the predicate.
Environment of Use -
The environments of use are identical to predicate - Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605.
Discussion - The environments of use are the same.
Patient Population -
The patient population of the proposed device and predicate - Jiangsu Medplus Nonwoven Manufacturer Co., Ltd. - K202605.
Discussion - The identified patient population is equivalent to the predicate.
Non-Clinical Testing Summary -
Performance testing was performed following ASTM F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Masks with reference to Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510k] Submission (2004). Three separate non-consecutive lots of 32 samples each were tested.
| Test Methodology | Purpose | Acceptance Criteria forLevel 2 Barrier | Results |
|---|---|---|---|
| Section 6.1 BacterialFiltration EfficiencyASTM F2101 | Measure bacterialfiltration efficiency | >98%87 of 96 pass | 99.9%96 of 96 passed |
| Section 6.1 DifferentialPressure (mm $H_2O/cm^2$ )EN14683:2019+AC:2019Annex C | Determinebreathability of a mask | <6.087 of 96 pass | Average <3.896 of 96 passed |
| Section 6.1 Sub-micronParticulate FiltrationEfficiency ASTMF2299/F2299M-03 | Measure initial particlefiltration efficiency | ≥98%87 of 96 pass | >99%96 of 96 passed |
| Section 6.1 Resistance toPenetration by SyntheticBlood ASTM F1862/F1862M-2017 | Evaluate the resistanceto penetration byimpact of small volumeof synthetic blood | 120 mmHgVisual inspection87 of 96 pass | None seen in91 of 96 samples |
| Section 6.2 Flame spread16CFR Part 1610-2008 | Response of materialsto heat and flame | Class 187 of 96 | 96 of 96 passed |
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510(k) Summary Page 5 of 5
Bench testing -
We performed the following tests: Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. Discussion - The results were similar.
Biocompatibility -
Both devices are considered Surface Contact, Intact Skin, Limited Duration of Use. Discussion - The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the 039 Medical Surgical Face Mask device is as safe, as effective, and performs as well as or better than the legally marketed device in K202605.
§ 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.