WestTec Procedure Facemask;WestTec Surgical Facemask
Device Facts
| Record ID | K141085 |
|---|---|
| Device Name | WestTec Procedure Facemask;WestTec Surgical Facemask |
| Applicant | Westtec, LLC |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 27, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
WestTec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
Device Story
Single-use, disposable, non-sterile surgical/procedure facemasks; worn by healthcare workers to protect against microorganisms, blood, body fluids, and airborne particulates. Constructed of three layers of nonwoven polypropylene (outer/inner spunbond, middle meltblown filter). Features include malleable nose band (steel wires in polyethylene) and elastic ear loops (latex-free). Surgical model includes comfort band to maintain space between mask and mouth. Used in clinical settings; manually fitted by user over nose and mouth. Provides physical barrier; performance validated against ASTM F2100 Level 2 requirements.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing per ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), MIL-M-36945C (differential pressure), 16 CFR 1610 (flammability), and ISO 10993-5/-10 (biocompatibility).
Technological Characteristics
Three-layer nonwoven polypropylene construction. Middle layer: 100% meltblown polypropylene filter. Nose band: two 0.018" steel wires in polyethylene. Elastic ear loops (non-latex). Dimensions: 175mm x 95mm. Flat pleated style. Non-sterile. Meets ASTM F2100 Level 2 performance classification.
Indications for Use
Indicated for healthcare workers to protect the user and patient against transfer of microorganisms, blood, body fluids, and airborne particulates.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
WestTec, LLC Mr. John Jensen 265 North Main Street Ste. D-115 Kaysville, Utah 84037
Re: K141085
Trade/Device Name: WestTec Procedure Facemask WestTec Surgical Facemask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: February, 2015 Received: February 25, 2015
Dear Mr. Jensen:
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. 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
# Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K141085
#### Device Name WestTec Procedure Facemask WestTec Surgical Facemask
#### Indications for Use (Describe)
West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
| Facemask<br>Name | Model<br>Number | Color |
|------------------|--------------------|---------------|
| Procedure | 10-1318<br>10-1358 | Blue<br>White |
| Surgical | 20-1318<br>20-1358 | Blue<br>White |
| 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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Image /page/3/Picture/0 description: The image shows the logo for WESTTEC, LLC, followed by the text "510(k) Summary K141085". The logo is a geometric design with two interlocking squares, one in gray and the other in orange. The text is in a simple, sans-serif font.
# 510(k) Summary K141085
| Summary Preparation Date: | Original submission; July 2014<br>Revision Submission: February 2015<br>Revision Submission: March 26, 2015 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | John Jensen<br>WestTec LLC.<br>265 North Main Street<br>Ste. D-115<br>Kaysville, Utah 84037<br>Phone: 435-200-4608<br>E-mail: jjensen@westtec.us |
| Device Trade Names: | WestTec Procedure Facemask<br>WestTec Surgical Facemask |
| Device Common Name: | Surgical Mask |
| Classification Name:<br>Device Classification<br>Product Code | Surgical apparel<br>Class II per 21 CFR 878.4040<br>FXX |
#### Predicate Devices:
The WestTec Procedure and Surgical facemasks, the subject of this submission, are substantially equivalent to the Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787).
#### Device Description:
The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.
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Image /page/4/Picture/0 description: The image shows the logo for WESTTECuc, followed by the text "510(k) Summary K141085". The logo is a stylized geometric shape with orange and gray colors. The text is in a smaller font size than the logo.
#### Intended Use:
WestTec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
| Facemask Name | Model Number | Color |
|---------------|--------------|-------|
| Procedure | 10-1318 | Blue |
| Procedure | 10-1358 | White |
| Surgical | 20-1318 | Blue |
| Surgical | 20-1358 | White |
#### Technological Characteristics and Similarities of the Device and the Predicate:
The WestTec Procedure and Surgical facemasks are substantially equivalent to the predicate device, Jingzhou Haixin Green Cross Medical Products (K123787), with regard to the intended use and technological characteristics. The WestTec facemasks and the Jingzhou Haixin Green Cross Medical Products mask use polypropylene coverstock materials of similar size to encase a similar sized polypropylene filter layer. Both facemasks use a malleable nose band to fit the mask to the users face and utilize similar sized ear loops to secure the facemask to the users face. Any technological differences are not expected to affect safety or performance of the device.
| Description | WestTec Masks | Predicate Device (K123787) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | WestTec Procedure and<br>Surgical facemasks are intended<br>to be worn by healthcare<br>workers to protect the user and<br>patient against transfer of<br>microorganisms, blood and<br>body fluids, and airborne<br>particulates. The WestTec<br>Procedure and Surgical<br>facemasks are single use,<br>disposable devices provided<br>non-sterile. | Nose and mouth covering for<br>health care workers and patients<br>to prevent microorganism, body<br>fluid, and particulate aerosol<br>transfer. |
| Layers | Three | Three |
#### Comparison of Intended Use, Design, Material, and Specifications
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Image /page/5/Picture/0 description: The image shows the logo for WESTTEC, LLC, along with the text "510(k) Summary K141085". The logo consists of three overlapping squares in shades of gray, orange, and yellow. The text is written in a serif font, with "WESTTEC" in a larger size than the rest of the text. The "LLC" is written in a smaller font size and is located to the right of "WESTTEC".
| Description | WestTec Masks | Predicate Device (K123787) |
|-------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Materials | Outer Layer is 100% spunbond<br>polypropylene. | Outer Layer is 100% spunbond<br>polypropylene. |
| | Middle Layer is 100%<br>meltblown polypropylene filter<br>media. | Middle Layer is 100%<br>meltblown polypropylene filter<br>media. |
| | Inner Layer is 100% spunbond<br>polypropylene. | Inner Layer is 100% spunbond<br>polypropylene. |
| | Earloops are soft non<br>natural rubber latex,<br>elastic loops. | Earloops are soft non<br>natural rubber latex, elastic<br>loops. |
| | Nose Band is two 0.018"<br>diameter steel wires encased in<br>polyethylene<br>The Surgical Mask includes a | Nose Band is plastic wire |
| Dimensions | 6.875" x 3.75"<br>(175mm x 95mm) | 175mm x 90mm |
| Mask Style | Flat pleated | Flat pleated |
| Design | Ear Loop | Ear Loop |
| Color | Blue, White | White |
# Comparison of Device Performance
The following table compares the results of testing performed on the WestTec masks to the published results of the predicate device. Since both the WestTec and the predicate facemasks are labeled to meet the ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks requirements for Level 2 performance classification, these requirements are also shown in the table.
| Description | WestTec Masks | Predicate Device (K123787) | ASTM F2100 Requirement for Level 2 Classification |
|----------------------------------------------|------------------------------|------------------------------|---------------------------------------------------|
| Fluid Resistance Performance ASTM F1862 | 32 out of 32 pass at 120mmHg | 29 out of 32 pass at 120mmHg | 29 out of 32 pass at 120mmHg |
| Particulate Filtration Efficiency ASTM F2299 | 98.0% | 99.1% | ≥98% |
| Bacterial Filtration Efficiency ASTM F2101 | 99.7% | 99.8% | ≥98% |
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Image /page/6/Picture/0 description: The image shows the logo for WESTTEC, LLC, followed by the text "510(k) Summary K141085". The logo consists of two interlocking squares, one in gray and one in orange. The text is in a simple, sans-serif font.
| Description | WestTec Masks | Predicate Device<br>(K123787) | ASTM F2100 Requirement for Level 2 Classification |
|----------------------------------------------------|--------------------------|-------------------------------|---------------------------------------------------|
| Differential<br>Pressure (Delta P)<br>MIL-M-36954C | 3.3 – 3.6 mmH2O/cm² | 2.6 – 2.9 mmH2O/cm² | <5.0 mmH2O/cm² |
| Flammability<br>16 CFR 1610 | Class 1<br>Non Flammable | Class 1<br>Non Flammable | Class 1 |
| Biocompatibility<br>ISO 10993-5, -10 | Biocompatible | Biocompatible | |
## Discussion of Non-Clinical Tests Performed to Determine Substantial Equivalence
The non-clinical tests listed in the above table were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the following standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to ● Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- . ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency ● (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical Mask, disposable
- 16 CFR Part 1610 Standard For The Flammability Of Clothing Textiles ●
- . ISO 10993-5 & -10 Biological evaluation of medical devices
Test results show the WestTec facemasks met all relevant requirements of the above test standards. The results also indicate the WestTec facemasks have similar results as the predicate and both meet the ASTM F2100 requirements for a Class 2 Performance Level facemask. More details of non-clinical tests are summarized in Tab 18.
## Discussion of Clinical Tests Performed
Not applicable
## Conclusions:
The WestTec facemasks and the predicate facemask are similar in size and are made of similar materials, polypropylene coverstocks to encase a polypropylene filter layer. Both the WestTec facemasks and the predicate facemask have the same intended use. Bench testing detailed in this submission demonstrates the WestTec facemasks and the predicate facemask have similar functional characteristics. The technological characteristics do not raise any new questions of safety or effectiveness. Therefore, the WestTec facemasks are substantially equivalent to the predicate device.
