(165 days)
The Surgical 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 single use, disposable device, provided non-sterile.
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria for ASTM Level 2 | Reported Device Performance (Surgical Mask - K203064 Level 2) | Acceptance Criteria for ASTM Level 3 | Reported Device Performance (Surgical Mask - K203064 Level 3) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | Pass @ 120 mmHg | Pass @ 120 mmHg | Pass @ 160 mmHg | Pass @ 160 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 99.8% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 99.8% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ >99% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ >99% |
| Differential Pressure (EN 14683:2019 Annex C) | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 5.1mm H₂O/cm² | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 5.1mm H₂O/cm² |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO10993-1, -5, -10) | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document for the performance tests. The document only mentions that the device "meets the requirements" or "Passed" these tests. For Biocompatibility testing, the document states "No cytotoxicity or cell lysis was noted" and "No evidence of sensitization or irritation was observed," implying a sufficient number of samples were tested to reach these conclusions, but the exact number isn't given.
- Data Provenance: Not specified. The tests are referred to as "Non-Clinical Performance Testing," suggesting they were conducted in a laboratory setting, not on human subjects. There's no mention of country of origin for the data or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical mask, and the evaluation relies on technical performance standards (ASTM, EN, CFR, ISO) rather than expert interpretation of images or clinical outcomes. The "ground truth" is defined by the passing criteria of the specified standards.
4. Adjudication method for the test set:
- Not applicable. The "ground truth" is determined by meeting the objective pass/fail criteria of the specified technical standards, not through expert 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:
- No MRMC study was done. This is a surgical mask, not an AI-powered diagnostic device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (surgical mask), not an algorithm or AI system. The performance tests are for the physical properties of the mask.
7. The type of ground truth used:
- Objective Technical Standards/Specifications: The ground truth for this device's performance is established by its ability to meet the quantitative and qualitative criteria defined by recognized standards such as ASTM F1862-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR Part 1610, and ISO 10993 series for biocompatibility.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
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March 23, 2021
Plastikon Industries % Mary Gallup RA Consultant Hantel Technologies, Inc 3496 Breakwater Ct Hayward, California 94545
Re: K203064
Trade/Device Name: Surgical Mask, ASTM Level 2 or Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 12, 2021 Received: February 17, 2021
Dear Mary Gallup:
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.
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) K203064
Device Name Surgical Mask, ASTM Level 2 or Level 3
Indications for Use (Describe)
The Surgical 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 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 - K203064
| Device Name: | Surgical Mask, ASTM Level 2 or Level 3 |
|---|---|
| Sponsor Information: | Plastikon Industries688 Sandoval WayHayward, CA 94545 |
| Contact person: | Paul GutwaldTitle: Chief Operating OfficerPhone Number: (510) 400-1010Fax Number: (510) 400-1141e-mail: pgutwald@plastikon.com |
| Date of Summary: | 03/15/2021 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Proprietary Name: | Surgical Mask - ASTM Level 2 or Level 3 |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per (21 CFR §878.4040) |
| Predicate Device: | San-M Package Co, K160269 Surgical Mask |
| Intended Use: | The Surgical Mask is intended to be worn to protect both thepatient and healthcare personnel from transfer ofmicroorganisms, 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. |
Available Model Numbers
PLASMA Surgical-1 Surgical Mask
Device Description:
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
The device is not made from Natural Rubber Latex.
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Technological Characteristics:
The Surgical Mask is compared with the predicate device. The results are shown below in the Technological Characteristics Comparison Table:
| Items(S) | Surgical Mask (K203064)Subject Device | Predicate Device (K160269)San-M Package Co.Surgical Face Masks | Comparison | |||
|---|---|---|---|---|---|---|
| Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | ||
| Intended Use/Indications forUse | The surgical mask is intendedto be worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Thisface mask is intended for usein infection control practices toreduce potential exposure toblood and body fluids. This isa single-use, disposabledevice, provided non-sterile. | The surgical face masks areintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce potential exposure toblood and body fluids. This isa single-use, disposabledevice, provided non-sterile. | Same | |||
| Materials | ||||||
| Outer Material | Polypropylene Spunbond,White | Polypropylene | Same | |||
| Filter Web(Middle) | Polypropylene Meltblown,white | 1. Polypropylenespunbond2. Polypropylenemeltblown | Same | |||
| Inner Material | Polypropylene Spunbond,white | Polypropylene | Same | |||
| Nose Clamp | Polyethylene Coated SteelWire | Polyethylene coated steel wire | Same | |||
| Ear Loops / TieTapes | Elastic Laminate –No Tie Tapes | Ear loops: Polyester,polyurethaneSide tapes:Polyester spunbond (ear loopsmask only)Tie tapes:Polypropylene spunbond orpolyester spunbond | Same – Thesubject deviceis an ear looptypeattachment.The ear loopmaterials hasbeen tested forbiocompatibilityand does notdoes not affectthe deviceperformance. | |||
| Design Features | ||||||
| Colors | White (Outer) | Colors: white or blueVisor option: polyester | DifferentThe subjectdevice does not |
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| Style | Flat - Pleated | Flat - Pleated | come in any other colors. The color of the device does not affect the device performance or Biocompatibility as demonstrated by the test results. |
|---|---|---|---|
| Multiple Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions | |||
| Length | $95 \pm 19mm$ | $90 \pm 3mm$ | Same |
| Width | $175 \pm 19mm$ | $175 \pm 5mm$ | Same |
| Performance Testing (ASTM F2100) | Subject DeviceLevel 2 Level 3 | Predicate DeviceLevel 1 Level 2 Level 3 | Comparison |
|---|---|---|---|
| ---------------------------------- | ----------------------------------- | --------------------------------------------- | ------------ |
| FluidResistanceASTM F1862-17 | Pass @120mmHg | Pass @160mmHg | Pass @80mmHg | Pass @120mmHg | Pass @160mmHg | Same |
|---|---|---|---|---|---|---|
| ParticulateFiltrationEfficiency(PFE)ASTM F2299 | Pass @99.8% | Pass @99.8% | Pass @99.6% | Pass @99.6% | Pass@99.7% | DifferentThe subjectdevice hasslightly higheror improvedparticulateefficiency. Thisdoes notincrease riskassociatedwith the use ofthe device |
| BacterialFiltrationEfficiency(BFE)ASTM F2101-19 | Pass @>99% | Pass @>99% | Pass @>98% | Pass @>98% | Pass @>98% | DifferentThe subjectdevice hasslightly higheror improvedBFE. Thisdoes notincrease riskassociatedwith the use of |
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| DifferentialPressureEN 14683:2019Annex C | Pass @5.1mmH₂0/cm² | Pass @5.1mmH₂0/cm² | Pass @2.0mmH₂0/cm² | Pass @1.0mmH₂0/cm² | Pass @2.5 mmH₂0/cm² | the deviceDifferentThe subjectdevice hashigherdifferentialpressure, andcontinues tomeet thestandard forASTMclassificationfor 2 and 3.This does notincrease riskassociatedwith the use ofthe device |
|---|---|---|---|---|---|---|
| Flammability16 CFR Part1610 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | ||||||
| Test | Subject Device | Predicate Device | Comparison | |||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same | |||
| Irritation | Non-irritating | Non-irritating | Same | |||
| Sensitization | Non-sensitizing | Non-sensitizing | Same |
Non-Clinical Performance Testing
The surgical mask has been tested according to ASTM 2100-19 -- Standard Specification for Performance of materials used in Medical Face Masks, and meets the requirements to be designated as ASTM Level 2 or Level 3, and have met the requirements for biocompatibility.
| Standard | Performance Characteristics, Level 2, 3 | Surgical Mask |
|---|---|---|
| ASTM F1862-17 | Resistance to Penetration by SyntheticBlood | Passed |
| ASTM F2299 | Particulate Filtration Efficiency (PFE) | Passed |
| ASTM F2101-19 | Bacterial Filtration Efficiency (BFE) | Passed |
| EN 14683:2019Annex C | Differential Pressure | Passed |
| 16 CFR Part 1610 | Flammability of Clothing Textiles | Passed |
| ISO10993-1 | Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within ARisk Management Process | Met the requirements |
| ISO10993-5 | Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity | No cyctotoxicity orcell lysis was noted. |
| ISO10993-10 | Biological Evaluation of Medical DevicesPart 10: Tests for Irritation andSensitization, 1ed | No evidence ofsensitization orirritation wasobserved |
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Clinical Performance
No Clinical study is included in this submission. The device as designed does not posed any new or additional risks to user or patient.
Summary of Test Results:
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed device identified as the predicate device, K160269.
§ 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.