(295 days)
The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.
PM Excellence SEQUR 100 Surgical Face Mask (light blue) for single use only, are pleated 3-ply masks that consist of the following materials: hydrophobic nonwoven PP (polypropylene) spunbond 35 gsm, 17.5cm, light blue (outer layer); nonwoven PP (poly propylene) spunbond 30gsm, 19.5cm, white (inner layer); and nonwoven PP (polypropylene) meltblown 30gsm, 17.5cm, white (middle filter layer). The PM Excellence SEQUR 100 Surgical Face Mask Light Blue also utilizes soft, latex-free elastic earloops and malleable wire nose piece.
This document describes the performance testing for the PM Excellence SEQUR 100 Surgical Face Mask. This is a medical device, and the testing outlined is to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the a set of standardized performance tests that surgical masks must pass, and the results of those tests for the new device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | 31 out of 32 pass at 160 mmHg | Pass |
| Differential Pressure (EN 14683: 2019 Annex C) | < 6.0 mmH2O/cm² | 5.0 to 5.3 mmH2O/cm² | Pass |
| Particle Filtration Efficiency (ASTM F2299) | ≥ 98% | From 98.98% to 99.06% | Pass |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | From 99.85% to 99.96% | Pass |
| Flammability (16 CFR Part 1610) | Class I | Class 1 | Pass |
| Biocompatibility: Cytotoxicity (ISO 10993) | Pass | Non-cytotoxic | Pass |
| Biocompatibility: Maximization Sensitization (ISO 10993-10) | Pass | Non-sensitizing | Pass |
| Biocompatibility: Intracutaneous Study (ISO 10993-23) | Pass | Non-irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states sample sizes for some tests:
- Fluid Resistance (ASTM F1862): The acceptance criteria and reported performance refer to "32" samples (e.g., "31 out of 32 pass"). This indicates a sample size of 32 for this specific test.
- Other Tests: For Bacterial Filtration Efficiency, Particle Filtration Efficiency, Differential Pressure, and Flammability, specific sample sizes are not explicitly stated in the provided text, but it's implied that sufficient samples were tested to generate the reported percentages and values.
Data Provenance: The data is presumed to be prospective bench testing conducted specifically for this 510(k) submission to demonstrate the performance of the PM Excellence SEQUR 100 Surgical Face Mask. The tests were performed following recognized consensus standards (e.g., ASTM, EN, ISO). The country of origin for the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable in this context. The "ground truth" for a surgical mask's performance is established by objective, standardized laboratory measurements and test procedures defined by recognized consensus standards (e.g., ASTM, ISO, EN). It does not involve human expert consensus or interpretation in the way, for example, a diagnostic AI would require radiologist consensus for image labeling.
4. Adjudication Method for the Test Set
This section is not applicable. As stated above, the performance of a surgical mask is determined by objective physical and chemical tests, not by human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A MRMC study is relevant for diagnostic AI or imaging systems where human readers interpret medical images. This document describes the physical and filtration performance of a surgical face mask, which is a personal protective equipment device. Such studies are not applicable or required for this type of device.
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 AI system. It is a physical product (surgical face mask).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements performed in a laboratory setting according to internationally recognized consensus standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration, EN 14683 for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 for biocompatibility). These standards define the test methods and the metrics for performance.
8. The Sample Size for the Training Set
This concept is not applicable. "Training set" refers to data used to train machine learning algorithms. This submission is for a physical medical device (surgical face mask), not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical device.
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December 15, 2022
PM Excellence LLC Nina Bektic-Marrero Managing Director 2864 Wilson Avenue Bellmore, New York 11710
Re: K220520
Trade/Device Name: PM Excellence SEQUR 100 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 12, 2022 Received: December 13, 2022
Dear Nina Bektic-Marrero:
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
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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 mediation-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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220520
Device Name
PM Excellence SEQUR 100 Surgical Face Mask
Indications for Use (Describe)
The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.
| Type of Use (Select one or both, as applicable) | Drug Use, Compounded with FDA-bulk Substance(s)Drug Use, Compounded with FDA-approved Drug(s) | Drug Use, Compounded with FDA-bulk Substance(s) | Drug Use, Compounded with FDA-approved Drug(s) | ||
|---|---|---|---|---|---|
| Drug Use, Compounded with FDA-bulk Substance(s) | |||||
| Drug Use, Compounded with FDA-approved Drug(s) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K220520 Page 1 of 6
510[k] Summary
This Summary of 510(k) pre-market notification was prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: May 28,2022
1. Submitter Identification:
Name: PM Excellence, LLC Address: 2864 Wilson Avenue, Bellmore, NY 11710 Official Correspondent: Nina Bektic-Marrero Title: Managing Director E-mail: nina@mypmexcellence.com Telephone: +1(917) 640-7980
2. Regulatory Information:
Name of Device: Surgical Mask (single use only) Proprietary Name: PM Excellence SEQUR 100 Surgical Face Mask Panel: General Hospital Regulatory Class: Class II Classification Regulation Name: 21CFR 878.4040. Surgical Apparel Product Code: FXX Classification Name: Mask, Surgical Submission type: Traditional 510(k)
3. Primary Predicate Device Information:
Primary Predicate Device Manufacturer: Wellmien (Suzhou) Import and Export Trading Co., Ltd. Device: Surgical Face Mask 510(k) No.: K101000
Device Description: 4.
PM Excellence SEQUR 100 Surgical Face Mask (light blue) for single use only, are pleated 3ply masks that consist of the following materials: hydrophobic nonwoven PP (polypropylene) spunbond 35 gsm, 17.5cm, light blue (outer layer); nonwoven PP (poly propylene) spunbond 30gsm, 19.5cm, white (inner layer); and nonwoven PP (polypropylene) meltblown 30gsm, 17.5cm, white (middle filter layer). The PM Excellence SEQUR 100 Surgical Face Mask Light Blue also utilizes soft, latex-free elastic earloops and malleable wire nose piece. All the materials
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used in the construction of the PM Excellence SEQUR 100 Surgical Face Mask (light blue) are substantially equivalent to those used in currently marketed devices, including the primary predicate device K101000
5. Intended Use
The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.
6. Comparison to Primary Predicate Device:
PM Excellence SEQUR 100 Surgical Face Mask Light Blue for single use only, is compared with its primary predicate device: K101000, Surgical Face Mask by Wellmien (Suzhou) Import and Export Trading Co.. Ltd. The design, dimensions, material, and performance of both devices are very similar, and the two products are substantially equivalent in safety and effectiveness.
The only difference between the primary predicate device and the subject device is that the three layers of Polypropylene materials have very similar but not the same gsm (grams per square meter). It is important however to note that this difference does not raise any concerns regarding the safety and effectiveness of the subject device as evidenced by the test results for biocompatibility and performance.
| i. Comparison to the Primary Predicate Device | ||
|---|---|---|
| Description | Subject DeviceK220520 (PM ExcellenceSEQUR 100 Surgical FaceMask) | Primary Predicate DeviceK101000 Wellmien SurgicalMask |
| Applicant | PM Excellence, LLC | Wellmien (Suzhou) Import andExport Trading Co., Ltd |
| ClassificationRegulation | 21CFR 878.4040 | 21CRF 878.4040 |
| Classification,Product Code | Class II,FXX | Class II,FXX |
| Common name | Surgical Face Mask | Surgical Face Mask |
| Indication for use | The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate Materials. | The 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(s), provided non-sterile. |
| Model | Earloops, Flat Pleated, 3 layers | Earloops, Flat Pleated, 3 layers |
| Material | Outer layer: NonwovenSpunbond hydrophobicPolypropylene Light Blue 35 gsm $\pm$ 2 gsmMiddle layer: Nonwoven Melt-blown polypropylene filter white 30 gsm $\pm$ 2 gsmInner layer: Nonwoven SpunbondPolypropylene white 30 gsm $\pm$ 2 gsmNose wire: Polyethylene coated steel wireEarloops: Polyester Elastic Non-Latex | Outer facing layer: SpunbondPolypropylene Light Blue 33 gsm $\pm$ 2 gsmMiddle layer: Melt-blown polypropylene filter white 33 gsm $\pm$ 2 gsmInner facing layer: SpunbondPolypropylene white 25 gsm $\pm$ 2 gsmNose wire: Polyethylene coated steel wireEar loops: Polyester |
| Color | Light Blue | Blue |
| Dimension (Width) | 17.5cm $\pm$ 0.2cm | 17.5cm $\pm$ 0.2cm |
| Dimension (Length) | 9.5 $\pm$ 0.2cm | 9.5 $\pm$ 0.2cm |
| Earloop Length | 16.0 cm $\pm$ 0.5 cm | 16.0 cm $\pm$ 0.5 cm |
| Nose Wire Length | 11.0 cm $\pm$ 0.5 cm | 11.0 cm $\pm$ 0.5 cm |
| OTC use | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Usage | Single use, disposable | Single use, disposable |
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| i. Comparison of Device Performance | ||
|---|---|---|
| PerformanceTesting | Subject Device (PM ExcellenceSEQUR 100 Surgical FaceMask) | Primary Predicate Device(K101000) |
| FluidResistancePerformance | 31 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg |
| ParticleFiltrationEfficiency | From 98.98% to 99.06% | 99.8% |
| BacterialFiltrationEfficiency | From 99.85% to 99.96% | 99.9% |
| DifferentialPressure (DeltaP) | 5.0 to 5.3 mmH2O/cm² | 3.7-4.0 mmH2O/cm² |
| Flammability | Class I | Class I |
| Biocompatibility | The subject device is non-cytotoxic, non- sensitizing and non-irritating. | Biocompatible. Under the condition of this study the device is non-cytotoxic, non-sensitizing and non-irritating. |
ii. Discussion of non-clinical tests performed to determine substantial equivalence
The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the respective
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consensus standards. Test results met all relevant requirements in the test standards and are comparable to the primary predicate device.
- Bacterial filtration efficiency (BFE): ASTM F2101 (1)
- Differential Pressure (Delta P) EN 14683:2019 Annex C (2)
- Latex particle challenge (PFE): ASTM F2299-03 (3)
- Flammability: 16CFR 1610 (4)
- Biocompatibility: ISO10993 (5)
- Fluid Resistance Synthetic Blood Penetration: Resistant Test: ASTM F1862 (6)
More detail comparison of the design, technical, and performance characteristics to the primary predicate device are summarized in Section 11: Executive Summary and Primary Predicate Comparison.
- Discussion of Clinical Tests Performed 7.
Not applicable
8. Conclusions
The PM Excellence SEQUR 100 Surgical Face Mask Light Blue for single use only have the same intended use, technological characteristics and performance effectiveness as the primary predicate device K101000. Furthermore, bench testing contained in this submission demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. PM Excellence SEOUR 100 Surgical Face Mask for single use only are substantially equivalent to the primary predicate device K101000.
i.Compliance with Recognized Standards
PM Excellence, LLC hereby certifies that testinghas beenconducted in accordance with and has met the acceptance criteria specified in the table below, prior to the product being marketed.
| Test Method | Description | Acceptance Criteria |
|---|---|---|
| ASTM F1862 | Resistance to Penetration by Synthetic Blood Level 3 160mmHg | 29 out of 32 pass at 160 mmHg |
| EN 14683: 2019 Annex C | Differential Pressure | < 6.0mmH2O/cm² |
| ASTM F2299 | Sub-Micron Particulate | ≥ 98% |
| BFE | Bacterial Filtration Efficiency | ≥ 98% |
| 16 CFR Part 1610 | Flammability | Class I |
| ISO 10993 | Cytotoxicity | Pass |
| ISO 10993-10 | Maximization Sensitization | Pass |
| ISO 10993-23 | Intracutaneous Study | Pass |
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ii.Performance Data
The proposed devices were 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.
| Item | Proposed device | Acceptance criteria | Result |
|---|---|---|---|
| Fluid ResistancePerformance | 31 out of 32 pass at 160mmHg | 29 out of 32 pass at 160mmHg | Pass |
| Particulate FiltrationEfficiency | From 98.98% to 99.06% | ≥ 98% | Pass |
| Bacterial FiltrationEfficiency | From 99.85% to 99.96% | ≥ 98% | Pass |
| Differential Pressure(Delta-P) Test | 5.0 to 5.3 mmH2O/cm² | < 6.0mmH2O/cm² | Pass |
| Flammability Testing | Class 1 | Class 1 | Pass |
iii.Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and effective, and performs as well as or better than the legally marketed primary predicate device K101000, Surgical Face Mask
§ 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.