(63 days)
The High Fluid-Resistant Surgical and Procedure 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
The provided document is a 510(k) premarket notification for a High Fluid-Resistant Surgical and Procedure Mask, which is a Class II medical device. The study described focuses on benchtop performance testing and biocompatibility testing rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI, human readers, and ground truth establishment in a clinical context is not applicable.
Here's the summary of the acceptance criteria and the study performance for the device itself, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Type 3 mask, as per ASTM F2100. The acceptance criteria and performance data are primarily drawn from Table 2 and Table 3.
| Test Item | Acceptance Criteria (ASTM Level 3 Mask Standard) | Reported Device Performance (High Fluid-Resistant Surgical and Procedure Mask ASTM Level 3) | Result |
|---|---|---|---|
| Benchtop Performance Testing | |||
| ASTM F1862/ISO 22609 Fluid Resistance | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| ASTM F2299 Particulate Filtration Efficiency | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Bacterial Filtration Efficiency (BFE) ASTM F2101 | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Differential Pressure ASTM F2100/EN 14683:2019 | < 6.0 mmH2O/cm2 | Three non-sequential lots of 32 (total of 96) passed at <6mmH20/cm2: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 31/32 pass | Pass |
| Class 1 Flammability 16 CFR 1610 | Class 1 < 3.5 second burn time | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610: Lot 1: Class 1, IBE, Lot 2: Class 1, IBE, Lot 3: Class 1, IBE | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non-Sensitizing | Non-Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Non-Irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Benchtop Tests: For each of the benchtop performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), three non-sequential lots were tested. Each lot consisted of 32 samples, resulting in a total of 96 samples (3 lots * 32 samples/lot) for each specific test.
- Sample Size for Biocompatibility Tests: The document states that Biocompatibility testing was performed, but does not explicitly provide the sample size for these specific tests (Cytotoxicity, Skin Sensitization, Skin Irritation). These are typically laboratory-based tests on material extracts.
- Data Provenance: The document does not specify the country of origin of the data for these tests. The tests are benchtop performance and biocompatibility studies, not clinical studies, so the "retrospective or prospective" designation as it typically applies to patient data is less relevant here. These are laboratory-executed tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the document describes the testing of a physical medical device (a surgical mask) through benchtop performance and biocompatibility tests, not the evaluation of an AI algorithm or a clinical study requiring human expert review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are relevant to studies involving human interpretation or clinical data, not the physical testing of a mask.
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
This information is not applicable as the document concerns the premarket notification of a surgical mask, which is a passive device. It does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical surgical mask, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective, standardized laboratory test methods (ASTM and ISO standards) for physical and biological properties. For example:
- Fluid Resistance: Measured resistance to synthetic blood penetration at a specific pressure.
- Filtration Efficiency: Measured percentage of particulates/bacteria filtered.
- Differential Pressure: Measured breathability.
- Flammability: Measured burn time.
- Biocompatibility: Measured cellular response (cytotoxicity), and skin reactions (sensitization, irritation) to material extracts.
8. The Sample Size for the Training Set
This information is not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. Device specifications and manufacturing processes are developed based on engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and the requirements outlined in relevant ASTM and ISO standards for surgical masks.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 14, 2022
America's Supply Chains % Prithul Bom, MBA, MS, RAC (US, EU), CSQE Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114
Re: K222749
Trade/Device Name: High Fluid-Resistant Surgical and Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 31, 2022 Received: November 1, 2022
Dear Ms. Bom:
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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222749
Device Name
High Fluid-Resistant Surgical and Procedure Mask
Indications for Use (Describe)
The High Fluid-Resistant Surgical and Procedure 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 intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is a 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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Image /page/3/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the text "America's" in a bold, blue font, with the "A" being significantly larger than the rest of the letters. Below "America's" is the text "Supply Chains" in a smaller, sans-serif font. Above the text is a circular emblem containing a stylized image of a building with columns, suggesting a government or institutional connection.
510(k) Summary
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92:
I. SUBMITTER
America's Supply Chains 7555 Warren Pkwy, Unit 486 Frisco, TX 75034 USA
Contact Person:
Paul Park Tel: (617) 800-3602 Email: americasupplychains@gmail.com Date Prepared: September 06, 2022
II. DEVICE
Name of Device: High Fluid-Resistant Surgical and Procedure Mask Common or Usual Name: Surgical Mask Classification Name: Surgical Apparel Regulatory Class: Class II (21 CFR §878.4040) Regulation Medical Specialty: General & Plastic Surgery 510k Review Panel: General Hospital FXX Product Code:
III. PREDICATE DEVICE
Predicate Manufacturer: Predicate Trade Name:
Predicate 510(k):
3M Health Care 3MTM High Fluid- Resistant Procedure Mask Model Number 1840 K191355
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Image /page/4/Picture/0 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold, dark blue font, with the word "Supply Chains" in a smaller font underneath. Above the text is an oval shape containing a small building with columns and a red roof.
IV. DEVICE DESCRIPTION
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose.
This device is not made from natural rubber latex.
V. INDICATIONS FOR USE
The High Fluid-Resistant Surgical and Procedure 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
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Image /page/5/Picture/1 description: The image contains the logo for "America's Supply Chains". The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is an oval shape containing a building with columns and a red roof. The building is blue and white.
| Description | Subject DeviceHigh Fluid-ResistantSurgical and ProcedureMask ASTM Level 3 | Predicate Device (K191355)1840 3M™ HighFluid-Resistant ProcedureMask ASTM Level 3 | Comparison |
|---|---|---|---|
| Intended Use/Indicationsfor Use | The High fluid-ResistantSurgical and Procedure Maskis intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. This face mask isintended for use in infectioncontrol practices to reducepotential exposure to bloodand body fluids. This is asingle use, disposable device,provided non-sterile. | 3M™ High Fluid- ResistantProcedure Mask is intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material.These face masks are intendedfor use in infection controlpractices to reduce potentialexposure to blood and bodyfluids. This is a single use,disposable device, providednon-sterile. | Same |
| Materials | |||
| Outer CoverWeb | Polypropylene Spunbond,white | Polypropylene Spunbond,green | Similar(Subjectdevice doesnot havecolorant) |
| Insertion | Polypropylene Spunbond,white | Polypropylene Spunbond,white | Same |
| Filter Web(Middle) | Polypropylene Meltblown,white | Polypropylene Meltblown,white | Same |
| Inner CoverWeb | PolypropyleneThermalbonded, white | PolypropyleneThermalbonded, white | Same |
| Nose Piece | Polyethylene Coated SteelWire | Polyethylene Coated SteelWire | Same |
| Ear Loops | Spandex elastic cord | Spandex elastic cord | Same |
| Style | Flat - Pleated | Flat - Pleated | Same |
| MultipleLayers | 4-Ply | 4-Ply | Same |
| Colors | White (Outer) | Green (Outer) | Different(Subjectdevice doesnot havecolorant) |
| Dimension(Width) | $3.5" \pm 0.3"$ | $3.5" \pm 0.3"$ | Same |
| Dimension(Length) | $6.9" \pm 0.2"$ | $6.9" \pm 0.2"$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100Level | Level 3 | Level 3 | Same |
[Table 1: Comparison of Predicate Devices]
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Image /page/6/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem containing a stylized image of a building with a red roof and blue columns. The overall design is clean and professional, suggesting a company involved in logistics or supply chain management.
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Image /page/7/Picture/0 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem with a building with columns inside of it. The building is blue and white, and the roof is red.
VII. PERFORMANCE DATA
The subject 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. A summary of the benchtop performance testing results is provided below in Table 2.
| Item | Proposed DeviceHigh Fluid-ResistantSurgical and ProcedureMaskASTM Level 3 | ASTM Level 3MaskStandardAcceptanceCriteria | PredicateDevice(K191355)3MTM HighFluid-ResistantProcedureMaskASTM Level 3 | Result |
|---|---|---|---|---|
| ASTMF1862/ISO22609FluidResistance | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at 160mmHgLot 1: 32 /32 passLot 2: 32 /32 passLot 3: 32 /32 pass | AQL 4%,single samplingplan, 29 out of32 Pass at160mmHg | 32/32 Passed at160mm Hg | Pass |
| ASTM F2299ParticulateFiltrationEfficiency | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98%Lot 1: 32/32 passLot 2: 32/32 passLot 3: 32/32 pass | ≥ 98% | 32/32 Passed at≥98% @ 0.1micron | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at ≥98%Lot 1: 32/32 passLot 2: 32/32 passLot 3: 32/32 pass | ≥ 98% | 31/32 Passed at≥98% | Pass |
| DifferentialPressureASTM | Three non-sequential lotsof 32 (total of 96) passedat <6mmH20/cm2 | AQL 4%,singlesampling plan, | 32/32 Passed at<5mmH20/cm2MIL-M36954C | Pass |
[Table 2: Benchtop Performance Testing]
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Image /page/8/Picture/1 description: The image shows the logo for "America's Supply Chains." The word "America's" is in large, bold, dark blue letters, with the apostrophe represented by a stylized "S." Below "America's" is the phrase "Supply Chains" in smaller, dark blue letters. Above the text is a small, oval-shaped graphic with a red roof and blue columns, suggesting a building or institution.
| F2100/EN14683:2019 | MIL-M36954CLot 1: 32/32 passLot 2: 32/32 passLot 3: 31/32 pass | < 6.0mmH2O/cm2 | ||
|---|---|---|---|---|
| Class 1Flammability16 CFR 1610 | Three non-sequential lotsof 32 (total of 96, AQL4.0) passed Class 116 CFR 1610Lot 1: Class 1, IBELot 2: Class 1, IBELot 3: Class 1, IBE | Class 1< 3.5 secondburn time | 5/5 Passed $\geq$ 3Seconds burntime | Pass |
Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
[Table 3: Biocompatibility Testing]
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
[Table 4: Summary of Non-Clinical Performance Testing]
The following standards have been used to evaluate the High Fluid-Resistant Surgical and Procedure Mask:
| ASTM | Standard Test Method for Evaluating the Bacterial Filtration Efficiency(BFE) of Medical Face Mask Materials, Using a Biological Aerosol ofStaphylococcus aureus |
|---|---|
| F2101-19/EN14683:2019 | |
| ASTM | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volumeat a Known Velocity) |
| F1862/F1862M-17 |
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Image /page/9/Picture/1 description: The image shows the logo for "America's Supply Chains". The word "America's" is in a large, bold font, with the "A" in dark blue and the "S" in black. Below "America's" is the phrase "Supply Chains" in a smaller, sans-serif font. Above the text is a small oval containing a red roof and blue columns, resembling a government building.
| AMERICA'SSUPPLY CHAINS | Surgical Mask 510(k) Submission |
|---|---|
| ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration by ParticulatesUsing Latex Spheres |
| ASTM F2100/EN14683:2019ANNEX C | Standard Test Method for Differential PressureStandard Specification for Performance of Materials Used in MedicalFace Masks |
| 16 CFR Part 1610EN 14683:2019ANNEX C | Standard for Flammability |
| ISO 10993-5 | ISO 10993-5 Third edition 2009-06-01Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | ISO 10993-10 Third Edition 2010-08-01Biological evaluation of medical devices - Part 10: Tests for irritationand skin sensitization |
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The conclusions drawn from the performance data demonstrate that the subject device is as safe, effective, and performs as well as or better than the legally marketed device K191355, 3M™ High Fluid- Resistant Procedure Mask manufactured by 3M Health Care.
§ 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.