(293 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical mask, with no mention of AI or ML technologies.
No.
This device is a face mask intended for infection control to protect against microorganisms, body fluids, and particulate matter, not to treat or cure a disease or condition.
No
The device is described as a procedure/surgical mask intended to protect against transfer of microorganisms, body fluids, and particulate material, which are infection control practices, not diagnostic functions.
No
The device description clearly states it is a physical mask constructed of non-woven materials with a malleable nosepiece and ties or earloops. It is a tangible, disposable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, ties/earloops, nosepiece, optional visor). This aligns with a personal protective equipment (PPE) device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are designed to perform tests on biological samples.
- Performance Studies and Metrics: The performance studies and key metrics (filtration efficiency, fluid resistance, flammability, biocompatibility) are all related to the physical barrier and safety properties of the mask, not diagnostic accuracy or performance.
In summary, the FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are classified as medical devices, specifically personal protective equipment (PPE), intended for infection control by providing a physical barrier. They do not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) 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 of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings.
The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device(s) met all design specifications similar to the predicate device(s).
Tests performed:
- Face Mask Performance (ASTM F2100 Level 1) - Pass
- Bacterial Filtration Efficiency (ASTM F2101) - ≥95% - Pass
- Particulate Filtration Efficiency (ASTM F2299) - ≥95% - Pass
- Differential Pressure (EN 14683) -
§ 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.
0
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2024
Owens & Minor (O&M) Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232824
Trade/Device Name: FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2024
Dear Caitlin Senter:
Received: May 31, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232824
Device Name
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
Indications for Use (Describe)
The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) 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 of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803)
FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, and it features the letters "OM" in a bold, red font, with the words "Owens & Minor" in a smaller, gray font to the right. The second logo is for Halyard, and it features a blue circle with a white and green design inside, followed by the word "HALYARD" in a bold, blue font.
510(k) Summary (K232824)
| Date Summary
| was Prepared | June 28, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 231161 | |
| Primary Contact for | |
| this 510(k) Submission | Caitlin Senter, MS, RAC |
| Tel: 678-221-7330 | |
| Email: caitlin.senter@owens-minor.com | |
| Marketed Common Name | Procedure Mask and Surgical Mask |
| Device Submission Trade | |
| Name and Description | Procedure Mask |
| FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining | |
| and SO SOFT* Earloops, White (41802) |
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining
and SO SOFT* Earloops, White, Wrap Around Visor (41803)
Surgical Mask
FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White,
(41805) |
| Device Common Name | Procedure Mask and Surgical Mask |
| Device Product Code
and Classification Name | FXX Class II, 21 CFR §878.4040 Surgical Apparel |
| Predicate Device | Kimberly-Clark KC100 Face Masks (K110455) |
| Subject Device
Description | The subject device(s) are ASTM F2100 Level 1 (white in color)
Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure
Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products
are a three-layer mask, constructed of well-known non-woven
materials used in facial protection. The Surgical Masks are
provided with ties while the Procedure Mask(s) are provided with
earloops. A malleable nosepiece is placed within the bindings.
The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1
Surgical Mask(s) family will be provided in designs with and
without a protective visor. The FLUIDSHIELD* 1 Procedure
Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single
use, disposable devices, provided non-sterile. |
| Indications for Use | The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1
Surgical Mask(s) 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 of the wearer to blood and body fluids. | |
| The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 | |
| Surgical Mask(s) are single use, disposable device(s), provided | |
| non-sterile. | |
5
Image /page/5/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, which features the letters "OM" in a bold, maroon color, with the words "Owens & Minor" in a smaller, gray font to the right. The second logo is for Halyard, which features a green and blue symbol resembling a stylized mountain or upward-pointing arrow, followed by the word "HALYARD" in a bold, dark blue font.
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| (K110455) | |||
| Kimberly-Clark KC100 | |||
| Face Masks | Comparison | ||
| FDA Product Code | FLUIDSHIELD* 1 Procedure | ||
| Mask(s) and FLUIDSHIELD* | |||
| 1 Surgical Mask(s) | |||
| FXX | FXX | Same | |
| FDA Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Same |
| Device Trade Name | Procedure Mask(s) | Similar | |
| FLUIDSHIELD* 1 Fog-Free | |||
| Procedure Mask with SO | |||
| SOFT* Lining and SO SOFT* | |||
| Earloops, White (41802) | KC100 Procedure Mask, | ||
| Lavender, Blue, Yellow, | |||
| Green, White | |||
| FLUIDSHIELD* 1 Fog-Free | |||
| Procedure Mask with SO | |||
| SOFT* Lining and SO SOFT* | |||
| Earloops, White, Wrap | |||
| Around Visor (41803) | KC100 Procedure Mask | ||
| with visor, Lavender, Blue, | |||
| Yellow, Green, White | The predicate | ||
| device was | |||
| cleared with a | |||
| multitude of | |||
| colors while | |||
| the subject | |||
| device is | |||
| offered in | |||
| white only. | |||
| Surgical Mask(s) | KC100 Procedure Mask | ||
| with fog-free strip, | |||
| Lavender, Blue, Yellow, | |||
| Green, White | |||
| FLUIDSHIELD* 1 Surgical | |||
| Mask with SO SOFT* Lining, | |||
| White, (41805) | |||
| Intended Use | The FLUIDSHIELD* 1 | ||
| Procedure Mask(s) and | |||
| FLUIDSHIELD* 1 Surgical | |||
| Mask(s) 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 | The Kimberly-Clark KC100 | ||
| Face Mask(s) is 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 | Same |
6
Image /page/6/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, featuring a stylized maroon "OM" symbol with horizontal lines, followed by the company name in gray text. To the right is the Halyard logo, which includes a green and white upward-pointing arrow within a dark blue circle, accompanied by the company name in bold, dark blue letters.
| | infection control practices
to reduce the potential
exposure of the wearer to
blood and body fluids. The
FLUIDSHIELD* 1 Procedure
Mask(s) and FLUIDSHIELD*
1 Surgical Mask(s) are single
use, disposable device(s),
provided non-sterile. | potential exposure of the
wearer to blood and body
fluids. The Kimberly-Clark
KC100 face mask(s) is a
single use, disposable
device(s), provided non-
sterile. | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Design Attributes | | | |
| # of Layers | 3-layer | 3-layer | Same |
| Color | White | White | Same |
| Earloops (Procedure) | Yes | Yes | Same |
| Ties (Surgical) | Yes | Yes | Same |
| Visor | Some Designs | Some Designs | Same |
| Performance Data/Product Claims | | | |
| Fluid Resistance Level | 1 | 1 | Same |
| Single Use Device | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
Summary of Non-Clinical Performance Testing:
Non-clinical tests were conducted to verify that the proposed device(s) met all design specifications similar to the predicate device(s).
| Table: | |
|---|---|
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM F2100 Level 1 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥95% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥95% | Pass |
| Differential Pressure | EN 14683 | ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
7
Image /page/7/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard Health. The Owens & Minor logo is on the left and features the company's initials in a bold, red font, with the full name in a smaller, gray font to the right. The Halyard Health logo is on the right and features a stylized green and blue symbol next to the company's name in a bold, blue font.
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
-
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
Summary of Clinical Performance Testing:
N/A
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803), and FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) are as safe, as effective, and perform as well as or better than the legally marketed KC100 Face Masks (K110455).