(226 days)
The disposable surgical face masks are 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 provided non-sterile.
The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
The provided text describes the acceptance criteria and performance study for a Surgical Mask - Level 3 & Procedure Mask - Level 3. This is a medical device (PPE), not an AI/software device, so the requested information regarding AI-specific studies (experts establishing ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this submission.
Here is the information directly relevant to the acceptance criteria and study for this physical device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 (K202607)
| Item | Acceptance Criteria | Reported Device Performance (Subject Device) | Predicate Device Performance | Result |
|---|---|---|---|---|
| Level 3 Fluid Resistance (ASTM F1862) | 29 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.67-99.80% | ≥99% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.6 - 99.9% | ≥99% | Pass |
| Differential Pressure (ASTM F2100) | < 6.0 mmH₂0/cm² | 4.8-5.0 mmH₂0/cm² | Avg. 3.6 mmH₂0/cm² | Pass |
| Class 1 Flammability (16 CFR 1610) | < 3.5 second burn time | Did not ignite or Ignited but Extinguished | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Under the conditions of the study the device is non-cytotoxic | Non-cytotoxic | Pass |
| Skin Sensitization (ISO 10993-10) | Non-sensitizing | Under the conditions of the study the device is non-sensitizing | Non-sensitizing | Pass |
| Skin Irritation (ISO 10993-10) | Non-irritating | Under the conditions of the study the device is non-irritating | Non-irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The sample size is explicitly stated for the Level 3 Fluid Resistance test: 32 samples (32 Out of 32 pass). For the other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly provided in the summary, but the results are reported as meeting the criteria, implying sufficient samples were tested according to the respective standards.
Data Provenance: The data comes from non-clinical benchtop performance testing and biocompatibility testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying testing conducted to U.S. and international standards (ASTM, ISO). The testing is implicitly prospective, as it's conducted to demonstrate meeting the criteria for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is a physical medical device (surgical mask), not an AI/software device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device is established through standardized laboratory testing protocols of its physical properties and biological compatibility.
4. Adjudication Method for the Test Set
Not Applicable. As this is a physical device tested against established engineering and biological standards, "adjudication" in the sense of expert review for ambiguous cases is not relevant. The results are quantitative measurements against defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are typically performed for AI or diagnostic devices where human reader performance is a key metric. This is a physical protective device. The study performed was non-clinical benchtop testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device. There is no algorithm to assess.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements from standardized laboratory tests according to recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, ASTM F2100, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the test methods and the performance criteria for surgical masks.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no ground truth to establish for it.
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April 23, 2021
String King Lacrosse, LLC % Thomas Frasca President 19100 S Vermont Ave. Gardena, CA, 90248 USA
Re: K202607
Trade/Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 9, 2020 Received: September 9, 2020
Dear Thomas Frasca:
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 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, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202607
Device Name Surgical Mask - Level 3 & Procedure Mask - Level 3
Indications for Use (Describe)
The disposable surgical face masks are 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 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 - K202607
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- SUBMITTER String King Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA. 90248 USA Tel: +1.508.654.1988 Fax: N/A Contact Person: Thomas Frasca
April 22, 2021
| II. DEVICE | |
|---|---|
| Name of Device: | Surgical Mask – Level 3 & Procedure Mask – Level 3 |
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR § 878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FXX |
PREDICATE DEVICE |||.
Date Prepared:
| Predicate Manufacturer: | DemeTECH Corporation |
|---|---|
| Predicate Trade Name: | DemeMASK |
| Predicate 510(k): | K201479 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
V. INDICATIONS FOR USE
The disposable surgical face masks are 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 provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence in Table 1 below.
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| Device | Proposed Device -Surgical Mask - Level 3& Procedure Mask -Level 3 (K202607) | Predicate Device -DemeMASK(K201479) | Result |
|---|---|---|---|
| Manufacturer | StringKing | DemeTECH Corporation | N/A |
| 510K Number | K202607 | K201479 | N/A |
| Product CommonName | SURGICAL FACE MASK | SURGICAL FACE MASK | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Identical |
| Intended Use | The disposable surgical facemasks are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single-use, disposabledevice provided non-sterile. | The Disposable SurgicalFace Masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice provided non-sterile. | Identical |
| Model | 3 Ply, Ear Loops, Flat-PleatedStyle | 3 Ply, Ear Loops or Tie-On | No tie-onoption forsubject device |
| Materials | |||
| Outer FacingLayer | Spun-Bond Polypropylene(same material as inner layer) | Spunbond Polypropylene | Same |
| Middle Layer | Melt-blown Polypropylene | Melt Blown PolypropyleneFilter | Same |
| Inner Facing Layer | Spun-Bond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | LDPE cover and galvanized wirecore | Single Galvanize Wire, CoatedBy PE | Same |
| Ear Loops | Nylon, Spandex, Polyester | not made with natural rubber latex | Same |
| Color | Blue | White | Different, performance supported by biocompatibility and performance test data |
| Dimension (Width) | 9.5 cm ± 0.5 cm | 9.5 cm ± 1.0 cm | Similar |
| Dimension (Length) | 17.5 cm ± 1 cm | 17.5 cm ± 1.0 cm | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 3 | Same, see Table 2 |
| Biocompatibility ISO 10993-5 and ISO 10993-10 | Non-cytotoxic, nonsensitizing, and nonirritating | Non-cytotoxic, nonsensitizing, and nonirritating | Same, see Table 3 |
Table 1 – Comparison of Technological Characteristics
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VII. NON-CLINICAL 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 along with the acceptance criteria and the predicate device's reported results.
| Item | Proposed Device -Surgical Mask - Level 3 &Procedure Mask - Level 3 | Predicate Device -DemeMASK (K201479) | Acceptance Criteria | SubjectDeviceResult |
|---|---|---|---|---|
| Level 3 FluidResistancePerformanceASTM F1862 | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at160 mm Hg | 29 Out of 32 pass at 160 mmHg | Pass |
| ParticulateFiltrationEfficiencyASTM F2299 | 99.67-99.80% | ≥99% | ≥ 98% | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | 99.6 - 99.9% | ≥99% | ≥ 98% | Pass |
| DifferentialPressureASTM F2100 | 4.8-5.0 mmH₂0/cm² | Avg. 3.6 mmH₂0/cm² | < 6.0 mmH₂0/cm² | Pass |
| Class 1Flammability16 CFR 1610 | Did not ignite or Ignited butExtinguished | Class 1 | < 3.5 second burn time | Pass |
Table 2 - Benchtop Performance Testing
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.
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| Standards | Proposed Device -Surgical Mask - Level 3 &Procedure Mask - Level 3 | Predicate Device -DemeMASK (K201479) | Result |
|---|---|---|---|
| Cytotoxicity -ISO 10993-5 | Under the conditions of thestudy the device is non-cytotoxic | Under the conditions of thestudy the device is non-cytotoxic | Pass |
| SkinSensitization -ISO 10993-10 | Under the conditions of thestudy the device is non-sensitizing | Under the conditions of thestudy the device is non-sensitizing | Pass |
| Skin Irritation -ISO 10993-10 | Under the conditions of thestudy the device is non-irritating | Under the conditions of thestudy the device is non-irritating | Pass |
Table 3 - Biocompatibility Testing
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive 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 non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device (K201479), manufactured by DemeTECH Corporation.
§ 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.