(295 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device is a surgical face mask explicitly designed for protection and infection control, not for treating or rehabilitating a disease or injury.
No
This device is a surgical face mask, indicated for protective covering and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines the physical components and materials of a surgical face mask, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Function: The PM Excellence SEQUR 100 Surgical Face Mask is a physical barrier worn on the face to protect against the transmission of microorganisms, body fluids, and particulate materials. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's a "protective nose and mouth covering" for infection control and medical procedures. This aligns with the function of a personal protective equipment (PPE) device, not an IVD.
- Device Description: The description details the materials and construction of a physical mask, not components for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility) related to its barrier function, not diagnostic accuracy or analytical performance.
Therefore, based on the provided information, the PM Excellence SEQUR 100 Surgical Face Mask is a medical device, but it falls under the category of personal protective equipment (PPE) and is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
FXX
Device Description
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers and patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the respective 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)
Performance Test Results:
- Fluid Resistance Performance: 31 out of 32 pass at 160 mmHg (Acceptance criteria: 29 out of 32 pass at 160 mmHg) - Pass
- Particle Filtration Efficiency: From 98.98% to 99.06% (Acceptance criteria: ≥ 98%) - Pass
- Bacterial Filtration Efficiency: From 99.85% to 99.96% (Acceptance criteria: ≥ 98%) - Pass
- Differential Pressure (Delta-P) Test: 5.0 to 5.3 mmH2O/cm² (Acceptance criteria:
§ 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.
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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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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
4
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 Device | |
| K220520 (PM Excellence | ||
| SEQUR 100 Surgical Face | ||
| Mask) | Primary Predicate Device | |
| K101000 Wellmien Surgical | ||
| Mask | ||
| Applicant | PM Excellence, LLC | Wellmien (Suzhou) Import and |
| Export Trading Co., Ltd | ||
| Classification | ||
| Regulation | 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: Nonwoven | |
| Spunbond hydrophobic | ||
| Polypropylene Light Blue 35 gsm $\pm$ 2 gsm | ||
| Middle layer: Nonwoven Melt-blown polypropylene filter white 30 gsm $\pm$ 2 gsm | ||
| Inner layer: Nonwoven Spunbond | ||
| Polypropylene white 30 gsm $\pm$ 2 gsm | ||
| Nose wire: Polyethylene coated steel wire | ||
| Earloops: Polyester Elastic Non-Latex | Outer facing layer: Spunbond | |
| Polypropylene Light Blue 33 gsm $\pm$ 2 gsm | ||
| Middle layer: Melt-blown polypropylene filter white 33 gsm $\pm$ 2 gsm | ||
| Inner facing layer: Spunbond | ||
| Polypropylene white 25 gsm $\pm$ 2 gsm | ||
| Nose wire: Polyethylene coated steel wire | ||
| Ear 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 | ||
|---|---|---|
| Performance | ||
| Testing | Subject Device (PM Excellence | |
| SEQUR 100 Surgical Face | ||
| Mask) | Primary Predicate Device | |
| (K101000) | ||
| Fluid | ||
| Resistance | ||
| Performance | 31 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg |
| Particle | ||
| Filtration | ||
| Efficiency | From 98.98% to 99.06% | 99.8% |
| Bacterial | ||
| Filtration | ||
| Efficiency | From 99.85% to 99.96% | 99.9% |
| Differential | ||
| Pressure (Delta | ||
| P) | 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
7
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 |