(252 days)
The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons 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.
Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
The provided text does not describe an AI/ML device but rather a surgical mask (Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons). Therefore, the information requested for AI/ML devices, such as sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable and cannot be extracted.
However, I can provide the acceptance criteria and the reported device performance for the surgical masks based on the provided text, as these are relevant to non-AI/ML medical devices.
1. A table of acceptance criteria and the reported device performance (for the Surgical Mask):
| Test Standards | ASTM Level 2 Requirements (Acceptance Criteria) | Subject Device (K201421) Reported Performance |
|---|---|---|
| ASTM F2101- Bacterial Filtration Efficiency (BFE) | ≥98% | >99% |
| ASTM F2299- Particulate Filtration Efficiency (PFE) | ≥98% | >99% |
| Mil-M-36954C, EN14683 - Differential Pressure (Breathability) | <6.0 mm H2O/cm² | ≤4.9 mm H2O/cm² |
| ASTM F1862- Fluid Resistance | 120 mmHg | Passed at 120 mmHg (30 out of 32 test articles passed) |
| 16 CFR 1610- Flammability | Class I No Flame Spread | Class I |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions specific test standards for surgical masks. While it indicates that 32 test articles were used for the ASTM F1862 Fluid Resistance test, it does not explicitly state the sample sizes for the other tests, nor does it specify the data provenance (e.g., country of origin or whether the tests were retrospective or prospective). The tests are non-clinical, meaning they are performed on the device itself, not on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a surgical mask and not an AI/ML device requiring expert interpretation for ground truth establishment. The testing involves standardized laboratory procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is a surgical mask and not an AI/ML device requiring adjudication of human expert interpretations.
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 device is a surgical mask and not an AI/ML device.
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 surgical mask and not an AI/ML device. The performance reported is that of the device itself under specified test conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the surgical mask, the "ground truth" is established by objective measurements and adherence to international and national standard test methods for material performance, such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, and flammability. These are laboratory-based, quantitative assessments, not subjective interpretations by experts or clinical outcomes data.
8. The sample size for the training set
This information is not applicable as the device is a surgical mask and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a surgical mask and not an AI/ML device that requires a training set and associated ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2021
Dukal Corporation Megan Quevedo Ouality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K201421
Trade/Device Name: Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 28, 2021 Received: February 4, 2021
Dear Megan Quevedo:
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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542 of the Act); 21 CFR 1000-1050.
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 (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-
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 CAPT Elizabeth Claverie, M.S. 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) K201421
Device Name
Dukal Corporation Level 2 Surgical Mask with Ear Loops Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
Indications for Use (Describe)
The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons 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 posure 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
K201421
In accordance with the requirements set forth in Title 21 CFR §807.92 Prepared on Feb 5, 2021
| 1. | Submitter: | Dukal Corporation2 Fleetwood CourtRonkonkoma NY 11779Phone: 631-656-3800Fax: 631-656-3810FDA Registration Number: 2435946 |
|---|---|---|
| 2. | Regulatory Affairs Contact: | Megan QuevedoQuality and Regulatory Affairs Engineer2 Fleetwood CourtRonkonkoma NY 11779Telephone Number: 631-656-3800 ext. 133Fax Number: 631-656-3810 |
| 3. | Name of Device: | Dukal Corporation Level 2 Surgical Mask with EarLoopsDukal Corporation Level 2 Surgical Mask with EarLoops and Face ShieldDukal Corporation Level 2 Surgical Mask withAdjustable Tie Ons |
| Trade Name: | Dukal Corporation Level 2 Surgical Mask with EarLoopsDukal Corporation Level 2 Surgical Mask with EarLoops and Face ShieldDukal Corporation Level 2 Surgical Mask withAdjustable Tie Ons | |
| Common/Classification Name:Regulation Number:Device Class:Regulation Name:Product Code: | Surgical Mask21 CFR §878.4040Class IISurgical ApparelFXX | |
| 4. | Predicate Device: | San-M Package Co., LTD Level 2 Face Mask Models:EL20000, EL 20010, TO 20000, and TO 20010510(K) number: K160269Cleared: 9/6/2016 |
| 5. | Device Description: | Face Masks intended to be worn to protect both the patientand healthcare personnel from transfer of microorganisms |
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body fluids, and particulate material.
Indications for Use: The Dukal Corporation Level 2 Surgical Mask with Ear Loops, 6. Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons 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.
7. Comparison of technological characteristics between the predicate and subject devices
| Element ofComparison | Predicate Device | Subject Device | Remark |
|---|---|---|---|
| San-M Package Co., LTD Level 2 FaceMask Models: EL 20000, EL 20010, TO20000, and TO20010 (K160269) | Dukal Corporation Level 2 SurgicalMask with Ear Loops, DukalCorporation Level 2 Surgical Maskwith Ear Loops and Face Shield, andDukal Corporation Level 2 SurgicalMask with Adjustable Tie Ons(K201421) | ||
| IndicationsFor Use | The surgical face masks are intended to beworn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids, andparticulate material. These face masks areintended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. This is a single-use, disposable device,provided non-sterile. | The Dukal Corporation Level 2 SurgicalMask with Ear Loops, DukalCorporation Level 2 Surgical Maskwith Ear Loops and Face Shield, andDukal Corporation Level 2 SurgicalMask with Adjustable Tie Ons areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulate material.These face masks are intended for usein infection control practices toreduce the potential exposure toblood and body fluids. This is a single-use, disposable device,provided non-sterile. | Same |
| MaterialComposition | • Outer material: Polypropylene• Inner material: Polypropylene• Filter Media:Polypropylene SpunbondPolypropylene Meltblown• Nose Clamp:Polyethylene coated steel wire• Ear loops: | • Outer and Inner Material: PurePolypropylene (Spunbond)• Filter Material:Polypropylene (Meltblown)• Nose Piece Material:Malleable aluminum wire• Ear loop Material:Spandex elastic, polyester | Similar |
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| Polyester, polyurethane• Side tapes: Polyester spunbond (ear loops mask only)• Tie tapes: Polypropylene spunbond or polyester spunbond | • Tie on Material:Pure Polypropylene(Spunbond) | ||||
|---|---|---|---|---|---|
| Dimensions | Length: 90 ± 3 mm;Width:175 ± 5 mm | Length: 90 ± 3 mm;Width:180 ± 5 mm | 9.5 x 17.5cm | Similar | |
| Mask Style | Flat-pleated | Similar | |||
| DesignFeatures | Visor option: polyester | Fluid Shield option: Polyethylene (PE) | Similar | ||
| Sterility | Non-Sterile | Non-Sterile | Similar | ||
| Use | Single Use; Disposable | Single Use; Disposable | Similar | ||
| Biocompatibility | 10993-5-Cytotoxicity | Under the conditions of the studies, the device did not show toxicity to L929 cells. | Under the conditions of the study, the device was non-cytotoxic. | Similar | |
| 10993-10-Irritation | Under the conditions of the study, the device was non-irritating. | Under the conditions of the study, the device was non-irritating. | Similar | ||
| 10993-10-Sensitization | Under the conditions of the study, the device was non-sensitizing. | Under the conditions of the study, the device was non-sensitizing. | Similar |
| Test Standards | Subject Device (K201421)(conforms to ASTM F2100-19Level 2 requirements) | Predicate Device (K160269)(conforms to ASTM F2100-11Level 2 requirements) | Comparison |
|---|---|---|---|
| ASTM F2101- BacterialFiltration Efficiency (BFE) | >99% | >98% | Similar |
| ASTM F2299- ParticulateFiltration Efficiency | >99% | 99.6% | Similar |
| Mil-M-36954C orEN14683- DifferentialPressure | ≤4.9 mmH2O/cm2 | Pass at 1.6 mmH2O/cm2 | Similar |
| ASTM F1862- FluidResistance | Pass at 120mmHg (30 out of 32test articles passed) | Pass at 120 mmHg | Similar |
| 16 CFR 1610-Flammability | Class I | Class I | Similar |
8. Non-clinical test results
The subject surgical masks were tested and found conformance with following standards:
- ASTM F1862/1862M-17, Standard Test Method for Resistance of Medical Face Masks to Penetration by . Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- . ASTM F2101-14, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ISO 22609:2004, Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
- MIL-M-36954C Section 4.4.1.2, Military Specification, Mask, Surgical, Disposable ●
- EN 14683: 2014 Annex B and C, Medical Face Masks-Requirements and Test Methods
- AS4381:2015, Single-Use Face Masks for Use in Health Care
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- 16 CFR 1610, Standard for the Flammability of Clothing Textiles ●
- ASTM F2299/F2299M-03, Standard Test Method for Determining the Initial Efficiency of Materials Used ● in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- . ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
| Test Standards | ASTM Level 2 Requirements | Subject Device (K201421) | Remark |
|---|---|---|---|
| ASTM F2101- BacterialFiltration Efficiency(BFE) | ≥98% | >99% | Meets requirement |
| ASTM F2299-Particulate FiltrationEfficiency | ≥98% | >99% | Meets requirement |
| Mil-M-36954C,EN14683-Differential Pressure | <6.0 mm H2O/cm2 | ≤4.9 mmH2O/cm2 | Meets requirement |
| ASTM F1862- FluidResistance | 120 mmHg | Passed at 120mmHg (30 outof 32 test articles passed) | Meets requirement |
| 16 CFR 1610-Flammability | Class INo Flame Spread | Class I | Meets requirement |
Performance Summary for Non-Clinical Testing:
9. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201421, the Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under 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.