(351 days)
The DEFEND Ear-Loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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 DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user). The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection.
The provided document describes the K201127 submission for DEFEND Ear-loop Face Masks, a Class II surgical mask. The information focuses on non-clinical performance testing against ASTM F2100 standards to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Methodology | Purpose | Acceptance Criteria (AQL = 4.0%) | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862 | Determine synthetic blood penetration resistance | 29/32 pass at 160 mmHg | 32/32 Pass per lot at 160 mmHg |
| ASTM F2101 | Determine the bacterial filtration efficiency | ≥ 98% | 32/32 Pass per lot, Average = 99.8% |
| ASTM F2299 | Determine sub-micron particulate filtration efficiency | ≥ 98% | 32/32 Pass per lot, Average = 99.7% |
| MIL-M-36954C or EN 14683 Annex C | Determine breathing resistance or differential pressure | < 6.0 mm H2O/cm² | 32/32 Pass per lot, 3.4 - 4.0 mm H20/cm² |
| 16 CFR Part 1610 | Determine flammability or flame spread | Class 1 | Class 1 |
| ISO 10993-5 (Cytotoxicity) | Biocompatibility | Non-cytotoxic | Non-cytotoxic |
| ISO 10993-10 (Irritation) | Biocompatibility | Non-irritating | Non-irritating |
| ISO 10993-10 (Sensitization) | Biocompatibility | Non-sensitizing | Non-sensitizing |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests (ASTM F1862, F2101, F2299, MIL-M-36954C/EN 14683): "32/32 Pass per lot" is mentioned for these tests. This implies that 32 samples were tested per lot, and all passed. The document does not specify how many "lots" were tested.
- Sample Size for biocompatibility tests (ISO 10993-5, 10993-10): The sample size for these specific tests is not explicitly stated in the provided text, but the results indicate that the tests were performed "Under the conditions of the study".
- Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. Food & Drug Administration (FDA), suggesting the data was generated for the purpose of meeting U.S. regulatory requirements. The studies are retrospective in the context of the submission, as the tests have already been conducted and the results are being reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to a device like a surgical face mask that relies on objective, standardized physical and material property tests. The "ground truth" for these tests is defined by the ASTM, MIL, EN, and CFR standards themselves, which specify measurable criteria and methodologies. Expert interpretation in the traditional sense (e.g., radiologists reviewing images) is not involved in establishing the "ground truth" for physical performance or biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical endpoints where there might be disagreement among evaluators of subjective data (e.g., medical image interpretation). For objective physical and material property tests, the outcome is determined by adherence to the standardized test procedure and measurement against defined thresholds.
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. This device is a surgical face mask, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or an AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on objective, standardized measurements against established criteria defined by international and national standards:
- ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials.
- ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates.
- MIL-M-36954C or EN 14683 Annex C: Standards for measuring differential pressure (breathing resistance).
- 16 CFR Part 1610: Standard for the flammability of clothing textiles.
- ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
The "ground truth" is therefore the metrological result of these tests compared to the numerical thresholds specified in the respective standards.
8. The sample size for the training set
This is not applicable. This document describes the testing of a physical medical device (face mask), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The tests are for product verification against established standards.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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April 14, 2021
Young Dental Manufacturing Co. 1, LLC Jose Espino, Official Correspondent 13705 Shoreline Court East Earth City, Missouri 63045
Re: K201127
Trade/Device Name: DEFEND Ear-loop Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 8, 2021
Dear Jose Espino:
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 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
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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).
Sincerelv.
Ryan Ortega -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201127
Device Name DEFEND Ear-loop Face Masks
Indications for Use (Describe)
DEFEND Ear-loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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.
Level 3 Model: MK-7300
| 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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Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks
510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.93, 510(k) summary is provided.
DATE: April 2, 2021
510(k) NUMBER: K201127
. SUBMITTER
Young Dental Manufacturing Co 1, LLC. 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com
ll. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Jose Espino 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com
= 510(K) PREPARER
Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 314-372-8054 Email: bprange@younginnovations.com
IV. DEVICE
Brand Name of Device: DEFEND Ear-Loop Face Masks Common or Usual Name: Surgical Mask Classification Name: Mask, Surqical Regulation: 21 CFR 872.4040 Device Classification: Class: II
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Product Code: FXX
V. PREDICATE DEVICE
Trade Name: Surgical Masks (Ear loop and Tie-on) Common Name: Surgical Mask 510(k) Number: K160269 (Decision Date: September 6, 2016) Manufacturer: San-M Package Co., LTD.
VI. DEVICE DESCRIPTION
The DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user).
The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection.
The DEFEND Ear-Loop Face Masks will be available in ASTM Level 3 in blue. Table 1 lists the Model number of the masks that will be available.
| Table 1. DEFEND Ear-Loop Face Masks Model Number | ||
|---|---|---|
| Model Number | ASTM Level | Color |
| MK-7300 | Level 3 | Blue |
Table 1, DEEEND Ear-Loop Eace Masks Model Number
VII. INDICATIONS FOR USE
The DEFEND Ear-Loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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.
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Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks
VIII. SUBSTANTIAL EQUIVALENCE (SE) COMPARISON
| Product Comparison - Similarities and Differences | ||||
|---|---|---|---|---|
| Characteristic | Proposed Device | San-M Package Co.,LTD., Surgical FaceMasks (Ear loopsand Tie-on) | Results | |
| Manufacturer | Young Innovations | San-M Package Co.,Ltd. | ||
| 510(k) Number | K201127 | K160269 | ||
| Class | Class II | Class II | Same | |
| Regulation Number | 21 CFR 872.4040 | 21 CFR 872.4040 | Same | |
| Intended Use / Indications forUse | The DEFEND Ear-Loop Face Masks areintended to be wornto protect both thepatient andhealthcareprofessional fromtransfer ofmicroorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single use,disposable device,provided non-sterile. | The surgical facemasks are intendedto be worn toprotect both thepatient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single-use,disposable device,provided non-sterile. | Same | |
| Product Code | FXX | FXX | Same | |
| Use | OTC | OTC | Same | |
| Length of Main body | 175 mm ± 5 mm | 175 mm ± 5 mm or180 mm ± 5 mm | Same | |
| Width of Main body | 95 mm ± 5 mm | 90 mm ± 5 mm | Similar | |
| Mask Style | Flat-pleated | Flat-Pleated | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Colors | Blue | White or Blue | Similar | |
| Outer Material | SpunbondPolypropylene | Polypropylene | Polypropylene | Same |
| Filter Material | MeltblownPolypropyleneFluid ResistantPolypropylene Film-Blue | Polypropylene | PolypropylenespunbondPolypropylenemeltblown | Same |
| Inner Material | SpunbondPolypropylene | Polyethylene | Polyethylene | Similar |
| Ear loops | Polyester | Polyester | Polyester,polyurethane | Same |
| Nose piece | Steel wire | Polyethylene coatedsteel wire | Similar | |
| Performance Testing (ASTMF2100-11) | ||||
| Fluid Resistance(ASTM F1862) | Level 3 (@ 160mmHg) | Pass @ 160 mmHg | Pass at 160 mmHg | Same |
| ParticulateFiltrationEfficiency(ASTM F2299) | Level 3 (≥ 98%) | Pass @ 99.5% | Pass at 99.7% | Same |
| BacterialFiltrationEfficiency(ASTM F2101) | Level 3 (≥ 98%) | Pass @ > 99% | Pass at > 99% | Same |
| DifferentialPressure (EN14683:2019,Annex C andMIL-M-36954C) | Level 3 (< 6.0) | Pass @ 3.4-4.0 | Pass at 2.5mmH2O/cm² | Same |
| Flammability(16 CFR 1610) | Level 3 (Class1) | Class 1 | Class 1 | Same |
| CytotoxicityISO 10993-5 | Under the conditionsof the study, thesubject device wasnon-cytotoxic. | Under the conditionsof the study thesubject device wasnon-cytotoxic. | Same | |
| IrritationISO 10993-10 | Under the conditionsof the study, thesubject device wasnon-irritating. | Under the conditionsof the study, thesubject device wasnon-irritating. | Same | |
| SensitizationISO 10993-10 | Under the conditionsof the study, thesubject device was | Under the conditionsof the study, thesubject device was | Same |
Table 2. Device Comparison (Similarities and Differences)
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Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks
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As indicated in Table 2, all relevant comparison items are very similar, and do not exhibit any changes that would impact intended use or the user experience.
IX. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
The DEFEND Ear-Loop Face Masks have been tested according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. This includes performance testing according to ASTM F2100. See Table 3 for a testing summary.
| Methodology | Purpose | AcceptanceCriteria (AQL =4.0%) | Results |
|---|---|---|---|
| ASTM F1862 | Determine syntheticblood penetrationresistance | 29/32 pass at 160mmHg | 32/32 Pass per lot at160 mmHg |
| ASTM F2101 | Determine thebacterial filtrationefficiency | ≥ 98% | 32/32 Pass per lot,Average = 99.8% |
| ASTM F2299 | Determine sub-micron particulatefiltration efficiency | ≥ 98% | 32/32 Pass per lot,Average = 99.7% |
| MIL-M-36954C orEN 14683 AnnexC | Determine breathingresistance ordifferential pressure | < 6.0 mm H2O/cm2 | 32/32 Pass per lot, 3.4- 4.0 mm H20/cm2 |
| 16 CFR Part 1610 | Determineflammability orflame spread | Class 1 | Class 1 |
Table 3. Summary of ASTM F2100 Testing
All results of testing met ASTM F2100 acceptance criteria.
X. Summary of Clinical Testing
No clinical study is included in this submission
XI. CONCLUSIONS
The conclusions drawn from nonclinical tests demonstrate that the 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.