(208 days)
The IFM Surgical Mask Model SM3 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.
The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This device is not made with natural rubber latex.
The document is a 510(k) Premarket Notification for the IFM Surgical Mask Model SM3. It asserts the substantial equivalence of the subject device to a predicate device, the 3M™ High Fluid-Resistant Procedure Mask (K191355, Model Number 1840).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally aligned with ASTM F2100 Level 3 performance standards, which are demonstrated through specific test methods.
| Test Parameter / Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (IFM Surgical Mask Model SM3) | Predicate Device Performance (3M™ High Fluid-Resistant Procedure Mask, Model 1840) | Comparison |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% as per ASTM F2101 | ≥98% as per ASTM F2101 | Equal to predicate (meets or exceeds) |
| Particulate Filtration Efficiency (PFE) | ≥98% @ 0.1 micron as per ASTM F2299 | ≥98% @ 0.1 micron as per ASTM F2299 | Equal to predicate (meets or exceeds) |
| Fluid Resistance | 160 mm Hg as per ASTM F1862 | 160 mm Hg as per ASTM F1862 | Equal to predicate (meets or exceeds) |
| Differential Pressure (Delta-P) | < 5 mmH₂O/cm² as per EN 14683:2019, Annex C and ASTM F2100-19 | < 5 mmH₂O/cm² as per MIL-M36954C | Equal to predicate (meets or exceeds the standard for breathability) |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) | Equal to predicate (meets or exceeds) |
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizer (ISO 10993-1, 10993-5, 10993-10) | Non-cytotoxic, non-irritant, non-sensitizer (ISO 10993-1, 10993-5, 10993-10) | Equal to predicate (meets criteria for biological safety) |
2. Sample size used for the test set and the data provenance:
- Particulate Filtration Efficiency (PFE): "Three lots passed"
- Fluid Resistance: "Three lots passed"
- Bacterial Filtration Efficiency (BFE): "Three lots passed"
- Differential Pressure: "Three lots passed"
- Flammability: "Three lots Passed."
- Biocompatibility: The text states "Under the conditions of the study the device was found..." for cytotoxicity, irritation, and sensitization, implying a test was conducted.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided document. The studies were non-clinical, meaning they were laboratory-based tests rather than human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies are non-clinical performance tests, not studies requiring expert interpretation of results, ground truth, or adjudication. The "ground truth" for these tests is the quantitative measurement against established standards (e.g., specific filtration percentages, pressure differentials).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the studies are non-clinical performance tests.
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 is not applicable. The device is a surgical mask, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a surgical mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical performance tests is the established industry or regulatory standard (e.g., ASTM F2100 Level 3 requirements for BFE, PFE, fluid resistance, differential pressure, flammability, and ISO 10993 series for biocompatibility). The tests measure the device's physical and biological properties against these pre-defined benchmarks.
8. The sample size for the training set:
This is not applicable as the device is a physical product (surgical mask) and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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March 2, 2021
Fssc, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K202214
Trade/Device Name: IFM Surgical Mask Model SM3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: February 3, 2021 Received: February 17, 2021
Dear Prithul 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.
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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 (OS) 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 Ryan Ortega, PhD Acting 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) K202214
Device Name IFM Surgical Mask
Indications for Use (Describe)
The IFM Surgical Mask Model SM3 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.
| 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) |
_ | 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
K202214
IFM Surgical Mask Model SM3
| Sponsor Information: | FSSC, LLC3300 West Clark St.Rensselaer, IN 47978 |
|---|---|
| Sponsor Contact:Clayton GeyerOperations EngineerPhone Number: 219-863-8316Email: clayton@ifmasks.com | |
| Contact Person: | Amy FowlerRegulatory CounselPathmaker FDA Law, PLLC528 Hennepin Ave., Suite 503Minneapolis, MN 55403 |
| Date of Summary: | March 1, 2021 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Proprietary Names: | IFM |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
| Predicate Device: | 3M™ High Fluid-Resistant Procedure Mask (K191355) – ModelNumber 1840 |
| Intended Use: | The IFM Surgical Mask Model SM3 is intended to be worn toprotect both the patient and healthcare personnel from transferof microorganisms, body fluids, and particulate material. Theseface masks are intended for use in infection control practices toreduce potential exposure to blood and body fluids. The facemask is single use, disposable device, provided non-sterile. |
| Device Description: | The IFM Surgical Mask Model SM3 is composed of four-layersand is flat-pleated. The mask materials consist of an outer coverweb (polypropylene spunbond, white), insertion layer(polypropylene, melt-blown, white), filter web (polypropylenemelt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the |
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mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This device is not made with natural rubber latex.
| Available Model Numbers | SM3 | IFM Surgical Mask |
|---|---|---|
| ------------------------- | ----- | ------------------- |
Comparison of Subject and Predicate Devices:
| Item(s) | Subject Device(K202214)IFM Surgical Mask ModelSM3ASTM F2100 Level 3 | Predicate Device(K191355)1840 3M™ High Fluid-Resistant Procedure MaskASTM F2100 Level 3 | Comparison |
|---|---|---|---|
| Intended Use /Indications for Use | The IFM Surgical MaskModel SM3 is intended tobe worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reducepotential exposure toblood and body fluids.The face mask is singleuse, disposable device,provided non-sterile. | The 3M™ High Fluid-Resistant Surgical Maskand 3M™ High Fluid-Resistant Procedure Maskis intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reducepotential exposure toblood and body fluids.The face mask is singleuse, disposable device,provided non-sterile.1840 - 3M™ High Fluid-Resistant ProcedureMask1 | Same |
| Type of Use | Over-The-Counter Use(21 CFR 801 Subpart C) | Over-The-Counter Use(21 CFR 801 Subpart C) | Same |
| Outer layer | Polypropylene Spunbond,white | Polypropylene Spunbond,green | Similar |
| Item(s) | Subject Device(K202214)IFM Surgical Mask ModelSM3ASTM F2100 Level 3 | Predicate Device(K191355)1840 3M™ High Fluid-Resistant Procedure MaskASTM F2100 Level 3 | Comparison |
| Insertion | Polypropylene Spunbond,white | Polypropylene Spunbond,white | Same |
| Middle layer | PolypropyleneMeltblown, white | PolypropyleneMeltblown, white | Same |
| Inner layer | PolypropyleneMeltblown, white | Polypropylene Thermal-bonded, white | Similar |
| Nose Piece | Polyethylene Strip | Polyethylene CoatedSteel Wire | Similar |
| Edge wrap | Polypropylene Spunbond,white | Polypropylene Spunbond,white or PolyethyleneTerephthalate, white | Similar |
| Ear Loops | Spandex Elastic Cord | Spandex elastic cord(polyurethane core withpolyethyleneterephthalate /nyloncover) | Similar |
| Colors | White | Green (Outer) | Different. Subjectdevice does not havecolorant. |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Item(s) | Subject Device(K202214)IFM Surgical Mask ModelSM3ASTM F2100 Level 3 | Predicate Device(K191355)1840 3M™ High Fluid-Resistant Procedure MaskASTM F2100 Level 3 | Comparison |
| Length | 6.63" ± 0.2" | 6.9" ± 0.2" | Similar |
| Width | 3.5" ± 0.3" | 3.5" ± 0.3" | Same |
| Particulate FiltrationEfficiency (PFE) | Three lots passed at≥98% @0.1 micronASTM F2299 | 32/32 Passed at ≥98% @0.1 micronASTM F2299 | Similar |
| Fluid Resistance | Three lots passed at160mm HgASTM F1862 | 32/32 Passed at 160mmHgASTM F1862 | Same |
| Bacterial FiltrationEfficiency (BFE) | Three lots passed at≥98% ASTM F2101 | 31/32 Passed at ≥98%ASTM F2101 | Same |
| Differential Pressure | Three lots passed at <5Delta-P (mmH₂O/cm²)EN 14683:2019, Annex Cand ASTM F2100-19 | 32/32 Passed at <5mmH2O/cm² MIL-M36954C | Similar |
| Flammability | Three lots Passed. - Class1 16 CFR1610 | 5/5 Passed ≥3 Secondsburn time - Class 1 16 CFR1610 | Similar |
| Biocompatibility | Under the conditions ofthe study the device wasfound non-cytotoxic; | Under the conditions ofthe study the device wasfound non-cytotoxic; | Same |
| Under the conditions ofthe study the device wasfound not an irritant; | Under the conditions ofthe study the device wasfound not an irritant; | ||
| Under the conditions ofthe study the device wasfound not a sensitizer; | Under the conditions ofthe study the device wasfound not a sensitizer; |
1 The predicate device has four cleared model numbers. The subject device is only being compared to model 1840 3M™ High Fluid-Resistant Procedure Mask
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Performance Testing (non-clinical)
The following non-clinical performance testing standards have been met for the IFM Surgical Mask Model SM3:
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical FaceMasks |
|---|---|
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to Penetration bySynthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Usedin Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) ofMedical Face Mask Materials, Using a Biological Aerosol of Staphylococcusaureus |
| 16 CFR Part 1610 | Standard for the Flammability of Clothing |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing withina risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityof medical devices |
| ISO 10993-10 | Biological evaluation of medical devices — Part 10: Tests for irritation and skinsensitization |
Performance Testing (clinical)
No Clinical performance testing conducted.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.