(123 days)
The Velguard Surgical Face Mask is intended to be worn to protect 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 nonsterile.
The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Velguard Surgical Face Mask:
The document is an FDA 510(k) summary for the Velguard Surgical Face Mask (K210761). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a comprehensive clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Predicate K182515 Performance or Standard) | Reported Device Performance (Velguard Surgical Face Mask K210761) | Comparison / Outcome |
|---|---|---|---|
| Performance Testing (ASTM F2100-19 Level 3) | Subject device exceeded predicate device in one performance test. ASTM F2100-19 uses a different test method for measuring Delta-P (H2O/cm2). | ||
| Fluid Resistance (ASTM F1862) | 32/32 passed at 120 mmHg | Three lots passed at 160mm Hg | Similar; subject device exceeded fluid resistance of the predicate device. |
| Particulate Filtration Efficiency (ASTM F2299) | Pass at 99.7% @ 0.1 micron | Three lots passed at ≥98% @ 0.1 micron | Similar; both devices meet ASTM F2299. |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass at 99.9% | Three lots passed at ≥98% | Similar; both devices meet ASTM F2101. |
| Differential Pressure (EN 14683:2019, Annex C and ASTM F2100-19) | 4.0 mmH2O/cm2 (MIL-M-36954C) | Three lots passed at <5 Delta-P (mmH2O/cm2) | Similar; subject device utilized ASTM F2100-19 test methods. The value of <5 mmH2O/cm2 is the acceptance criteria for ASTM F2100 Level 3. |
| Flammability (16 CFR 1610) | Class 1 | Three lots passed – Class 1 | Same. |
| Biocompatibility (ISO 10993-1, -5, -10) | Non-cytotoxic, non-irritant, non-sensitizer | Non-cytotoxic, non-irritant, non-sensitizer | Same. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Non-clinical tests were conducted on 32 samples per lot, across three non-consecutive lots.
- Data Provenance: The document implies the data is prospective as it refers to tests conducted on the newly manufactured device. There is no explicit mention of the country of origin for the data generation, but the sponsor information indicates the manufacturer is in Tirupur, Tamil Nadu, India.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (510(k) for a surgical mask) relies on standardized laboratory testing rather than expert interpretation of images or clinical data for ground truth establishment. Therefore, there are no "experts" in the sense of clinical specialists like radiologists establishing ground truth in this context. The "ground truth" is established by the results of the specific physical, chemical, and biological tests performed according to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective, standardized laboratory results against pre-defined thresholds from consensus standards. There is no human interpretation or adjudication process for test results like one would find in a clinical study involving subjective assessments.
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
Not applicable. This is for a physical medical device (surgical face mask), not an AI/software device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established through adherence to recognized consensus standards for performance and biocompatibility (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series). These standards define the methodologies and acceptance criteria for evaluating the physical, chemical, and biological properties of surgical masks.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
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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 in blue. Underneath the FDA logo is the text "ADMINISTRATION".
August 3, 2021
Esstee Exports Health Care Division % Amy Fowler Regulatory Counsel Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, Minnesota 55391
Re: K210761
Trade/Device Name: Velguard Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX
Dear Amy Fowler:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 16, 2021. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, Clarence. Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
For Clarence W. Murray III, Ph.D. 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
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services - USA and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 16, 2021
Estee Exports Health Care Division % Amy Fowler Regulatory Counsel Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, Minnesota 55391
Re: K210761
Trade/Device Name: Velguard Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 11, 2021 Received: June 14, 2021
Dear Amy Fowler:
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K210761
Device Name Velguard Surgical Face Mask
Indications for Use (Describe)
The Velguard Surgical Face Mask is intended to be worn to protect 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 nonsterile.
| 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) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for Esstee Health Care Division. The logo features the word "esstee" in green, with a needle and thread forming the "l" in "Health Care". Below the word "esstee" is a red line, and below that is the text "Health Care Division".
| 510(k) Summary | |
|---|---|
| Velguard Surgical Face Mask (K210761) | |
| Sponsor Information: | Esstee Exports Health Care Division8/3176 A3 & A4, Jothipuram, 2nd Street,Pandian Nagar, PN Road,Tirupur, Tamil Nadu, India 641602 |
| Sponsor Contact:Zachary WilsonLacote Supply, Inc.880 N Ventura Ave, Ste GOak View, CA 93022Em: zwilson@lacotesupply.comPh: 805-365-1348 | |
| Contact Person: | Amy FowlerRegulatory CounselPathmaker FDA Law, PLLC901 Twelve Oaks Center DriveSuite 936Wayzata, Minnesota 55391Em: fowler@pathmakerlaw.comPh: 612-356-9653 |
| Date of Summary Preparation: | June 11, 2021 |
| Proprietary Name: | Velguard Surgical Face Mask, Model Number VG3MCB |
| Common Name: | Surgical Mask |
| Device Classification: | Class II |
| Classification Name: | Surgical Apparel |
| Regulation Medical Specialty: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulatory Class: | Class II |
| Predicate Device: | Surgical Face Mask (K182515) - Model Ear Loop(no known design-related recalls) |
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Image /page/5/Picture/1 description: The image shows the logo for Esstee Health Care Division. The logo features the word "esstee" in green letters, with a red line running through the first "s" and under the entire word. A needle and thread are incorporated into the logo, with the needle forming the "l" in "esstee" and the red thread looping through the needle's eye. Below the word "esstee" is the phrase "Health Care Division" in smaller, black letters.
| Device Description: | The Velguard Surgical Face Mask is a single use, three pleated,flat-folded rectangular masks with ear loops and adjustable nosewire. The Surgical Masks are manufactured with three layers, theinner and outer layers are made of spun-bond polypropylene, andthe middle layer is made of melt blown polypropylene filter. Theinner spun-bond polypropylene layer uses no colorant. The outerspun-bond polypropylene layer uses a blue colorant. The earloops are held in place over the users' mouth and nose by twoelastic ear loops welded to the facemask. The elastic ear loops arenot made with natural rubber latex. The nose piece in the layersof facemask is to allow the user to fit the facemask around theirnose, which is made of malleable polyethylene coated zinc wire.The surgical face masks are sold non-sterile and are intended tobe single use, disposable devices. |
|---|---|
| Intended Use/Indications forUse: | The Velguard Surgical Face Mask is intended to be worn toprotect both the patient and healthcare personnel from transferof microorganisms, body fluids and particulate material. Theseface masks are intended for use in infection control practices toreduce the potential exposure to blood and body fluids. This is a |
| Item(s) | Subject Device (K210761)Velguard Surgical Face Mask | Predicate Device (K182515)Surgical Face Mask | Comparison |
|---|---|---|---|
| Intended Use /Indications for Use | The Velguard Surgical FaceMask is intended to be wornto protect both the patientand healthcare personnelfrom transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This isa single use, disposabledevice, provided non-sterile. | The Surgical Face Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile | Same, minordifferences tocorrect grammar. |
| Type of Use | Over-The-Counter Use (21CFR 801 Subpart C) | Over-The-Counter Use (21CFR 801 Subpart C) | Same |
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylenefilter | Melt blown polypropylenefilter | Same |
| Item(s) | Subject Device (K210761)Velguard Surgical Face Mask | Predicate Device (K182515)Surgical Face Mask | Comparison |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable polyethylenecoated zinc wire | Malleable polyethylene wire | Similar, both nosepieces usemalleablepolyethylene. Thesubject device nosepiece is enclosedwithin the layers. |
| Ear loops | Polyester spandex blend | Spandex | Similar, both usespandex forelasticity. |
| Color(s) | Blue & White | Yellow | Different, thedifference incolorants does notraise concerns ofsafety oreffectiveness.Biocompatibilitytestingdemonstrated thesubject device wasnon-cytotoxic,non-irritating, andnon-sensitizing. |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Length | 17.5cm ±0.5cm | 17.5cm±0.2cm | Similar |
| Width | 9.5cm ±0.3cm | 9.5cm±0.2cm | Similar |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| PerformanceTesting | Level 3 - ASTMF2100-19 | Level 2 - ASTMF2100-11 | Different, subjectdevices exceededpredicate device inone performancetest. ASTM F2100-19 uses differenttest method formeasuring Delta-P(H2O/cm2). |
| Item(s) | Subject Device (K210761)Velguard Surgical Face Mask | Predicate Device (K182515)Surgical Face Mask | Comparison |
| Fluid ResistancePerformance | Three lots passed at 160mmHg - ASTM F1862 | 32/32 passed at 120 mmHg -ASTM F1862 | Similar,subject deviceexceeded fluidresistance of thepredicate device. |
| ParticulateFiltrationEfficiency | Three lots passed at ≥98% @0.1 micron - ASTM F2299 | pass at 99.7% - ASTM F2299 | Similar, bothdevices meet ASTMF2299. |
| BacterialFiltrationEfficiency | Three lots passed at ≥98% –ASTM F2101 | pass at 99.9% - ASTM F2101 | Similar, bothdevices meet ASTMF2101. |
| DifferentialPressure | Three lots passed at <5Delta-P (mmH2O/cm2) – EN14683:2019, Annex Cand ASTM F2100-19 | 4.0mmH2O/cm2 - MIL-M-36954C | Similar, subjectdevice utilizedASTMF2100-19 testmethods (FRRecognitionNumber 6-425). |
| Flammability | Three lots passed – Class 116 CFR 1610 | Class 1 16 CFR 1610 | Same |
| Biocompatibility | Under the conditions of thestudy the device was foundnon-cytotoxic;Under the conditions of thestudy the device was foundnot an irritant;Under the conditions of thestudy the device was foundnot a sensitizer. | Under the conditions of thestudy the device was foundnon-cytotoxic;Under the conditions of thestudy the device was foundnot an irritant;Under the conditions of thestudy the device was foundnot a sensitizer. | Same |
single use, disposable device, provided non-sterile.
Comparison of Subject and Predicate Devices:
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Image /page/6/Picture/1 description: The image shows a logo for "essee Health Care Division". The word "essee" is written in green, with a red line going through the bottom of the word. A needle and thread are placed between the two "s" letters, with the thread being red. The words "Health Care Division" are written in a smaller font below the word "essee".
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Image /page/7/Picture/1 description: The image shows the logo for Esstee Health Care Division. The logo features the word "esstee" in green, with a needle and thread design above it. The words "Health Care Division" are written in smaller font below the main logo. The thread is red and the needle is black.
Differences in technological characteristics do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing:
Non-clinical tests were conducted on 32 samples per lot, three non-consecutive lots. The tests were in accordance with the recommendations included in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004 and the following FDA recognized consensus standards:
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Image /page/8/Picture/1 description: The image shows a logo for "essee Health Care Division". The word "essee" is written in green, with a red line going through the bottom of the word. Above the word is a red line that looks like a thread going through a needle. Below the word is the text "Health Care Division".
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to Penetration bySynthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
|---|---|
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Used inMedical Face Masks to Penetration by Particulates Using Latex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of MedicalFace Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| EN 14683 | Standard Test Method for Differential Pressure |
| 16 CFR Part 1610 | Standard for the Flammability of Clothing |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ofmedical devices |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization |
Summary of Clinical Performance Test:
No clinical study is included in this submission.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device K210761 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.
§ 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.