(283 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is described as a mask intended to protect against transfer of microorganisms and fluids, not to treat a disease or condition.
No
The intended use of the device is to protect the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids. It does not perform any diagnostic function.
No
The device description clearly states it is a physical mask constructed of non-woven materials with a malleable nosepiece and either ties or earloops. The performance studies also focus on physical properties like filtration efficiency, breathability, and liquid resistance, which are characteristic of hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the masks (layers of non-woven material, nosepiece, ties/earloops). This aligns with a protective barrier device.
- Performance Studies: The performance studies focus on characteristics like bacterial filtration efficiency, breathability, particulate filtration efficiency, fluid resistance, flame spread resistance, and biocompatibility (cytotoxicity, sensitization, irritation). These are all relevant to the protective function of a mask, not to diagnosing a condition or analyzing a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of those functions.
N/A
Intended Use / Indications for Use
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) 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 with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided nonsterile.
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)
The following tests were performed:
- ASTM F2101: To demonstrate adequate bacterial filtration efficiency. Result: Pass (at least 95% efficiency).
- EN 14683: 2019 +AC Annex C: To demonstrate acceptable breathability. Result: Pass (at most 5.0 mm H2O/cm2).
- ASTM F2299: To demonstrate adequate particulate filtration efficiency. Result: Pass (at least 95% efficiency).
- ASTM F1862: To demonstrate adequate resistance to liquids. Result: Pass (passing at 80 mmHg conditions).
- 16 CFR 1610: To evaluate flame spread resistance. Result: Pass (Class 1).
- ASTM F2100-19: To evaluate mask performance. Result: Pass (Level 1).
- ISO 10993-5: To evaluate the cytotoxic potential of the mask. Result: Pass (non-cytotoxic).
- ISO 10993-10 Sensitization: To evaluate the sensitization potential of the mask. Result: Pass (not a sensitizer).
- ISO 10993-10 Irritation: To evaluate the irritation potential of the mask. Result: Pass (not an irritant).
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
June 21, 2024
Owens & Minor (O&M) Halyard, Inc. Angela Bunn Sr. Director, Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232807
Trade/Device Name: Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 17, 2024 Received: May 17, 2024
Dear Angela Bunn:
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.
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"
1
(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 OS 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 G
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232807
Device Name
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
Indications for Use (Describe)
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) 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 with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.
| 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)
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4
K232807 510(k) Summary
| Date Summary was
| Prepared | June 21, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| Primary Contact for this | |
| 510(k) Submission | Angela L. Bunn, RAC |
| Tel: 470-347-7147 | |
| Email: angela.bunn@owens-minor.com | |
| Marketed Common Name | Surgical Mask and Procedure Mask |
| Device Submission Trade | |
| Name and Description | Fluidshield * 1 Procedure Mask with SO SOFT* Lining and SO |
| SOFT* Earloops (25869); | |
| Fluidshield * 1 Surgical Mask with SO SOFT* Lining (28802) | |
| Device Common Name | Surgical Mask and Procedure Mask |
| Device Product Code and | |
| Classification Name | FXX Class II, 21 CFR §878.4040 Surgical Apparel |
| Predicate Device | KC 100 Fluidshield* Surgical Masks and Procedure Masks |
| (K110455) | |
| Subject Device Description | The subject device(s) are ASTM Level 1 (blue in color) Surgical |
| and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and | |
| the Fluidshield* 1 Surgical Mask are a three-layer mask, | |
| constructed of non-woven materials. The Surgical Masks | |
| (28802) are provided with ties while the Procedure Masks | |
| (25869) are provided with earloops. A malleable nosepiece is | |
| placed within the bindings to conform with the wearer's nose. | |
| The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 | |
| Surgical Mask are single use, disposable devices, provided | |
| nonsterile. |
5
| Indications for Use | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO
SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO
SOFT* Lining (28802) 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 with SO SOFT* Lining
and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with
SO SOFT* Lining (28802) are single use, disposable device(s),
provided non-sterile. | | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Technological Characteristics Comparison Table | | | |
| | Subject Device | Predicate Device
(K110455)
KC 100 Surgical and
Procedure Masks | Comparison |
| FDA Product Code | 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 | Fluidshield * 1 Procedure
Mask with SO SOFT* Lining
and SO SOFT* Earloops
(25869);
Fluidshield * 1 Surgical
Mask with SO SOFT* Lining
(28802) | KC100 Surgical Mask
KC100 Procedure Mask | Similar |
| Intended Use | Fluidshield* 1 Procedure
Mask with SO SOFT* Lining
and SO SOFT Earloops
(25869); Fluidshield* 1
Surgical Mask with SO
SOFT* Lining (28802) 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.
Fluidshield* 1 Procedure
Mask with SO SOFT* Lining
and SO SOFT Earloops
(25869); Fluidshield* 1
Surgical Mask with SO
SOFT* Lining (28802) are
single use, disposable
device(s), provided non- | The Kimberly-Clark,
KC100 Face 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
Kimberly-Clark, KC100
face mask(s) is a single
use, disposable devices,
provided non-sterile. | Same |
| | sterile. | | |
| Materials of Construction for Surgical Masks (28802) | | | |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Media Filter | Meltblown polypropylene | Meltblown
polypropylene | Same |
| Inner Layer | Polyethylene polyester | Polyethylene polyester | Same |
| Bindings | Polyester polypropylene | Spunbond
polypropylene, Polyester
spunlace | Same |
| Ties (Surgical) | Spunbond polypropylene | Polyester spunlace | Different |
| Nose Wire | Aluminum | Aluminum | Same |
| Materials of Construction for Procedure Masks (25869) | | | |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Media Filter | Meltblown polypropylene | Meltblown
polypropylene | Same |
| Inner Layer | Polyethylene polyester | Polyethylene polyester | Same |
| Bindings | Polyester spunlace | Polyester spunlace | Same |
| Earloops (Procedure) | Polyester lycra | Polyester lycra | Same |
| Nose Wire | Aluminum | Aluminum | Same |
| Design Attributes for Surgical Masks (28802) | | | |
| # of Layers | 3-layer | 3-layer | Same |
| Style | Pleated | Pleated | Same |
| Color | Blue | Blue | Same |
| Ties (Surgical) | Yes | Yes | Same |
| Nose Wire | Enclosed | Enclosed | Same |
| Design Attributes for Procedure Masks (25869) | | | |
| # of Layers | 3-layer | 3-layer | Same |
| Style | Pleated | Pleated | Same |
| Color | Blue | Blue | Same |
| Earloops (Procedure) | Yes | Yes | Same |
| Performance Data/Product Claims for Surgical Masks (28802) | | | |
| Fluid Resistance
Level | ASTM F2100:19 Level 1 | ASTM F2100 Level 1 | Same |
| EN 14683 | Type IIR | No | Different |
| Single Use Device | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Performance Data/Product Claims for Procedure Masks (25869) | | | |
| Fluid Resistance
Level | ASTM F2100:19 Level 1 | ASTM F2100:07 Level 1 | Similar |
| EN 14683 | Type IIR | No | Different |
| Single Use Device | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
6
7
8
Summary of Performance Testing:
| Test | Purpose | Criteria | Result | |
|---|---|---|---|---|
| 28802 | 25869 | |||
| ASTM F2101 | To demonstrate adequate | |||
| bacterial filtration | ||||
| efficiency | Under the conditions of the | |||
| study, at least 95% efficiency | Pass | Pass | ||
| EN 14683: | ||||
| 2019 +AC | ||||
| Annex C | To demonstrate acceptable | |||
| breathability | Under the conditions of the | |||
| study, at most 5.0 mm H2O/cm2 | Pass | Pass | ||
| ASTM F2299 | To demonstrate adequate | |||
| particulate filtration | ||||
| efficiency | Under the conditions of the | |||
| study, at least 95% efficiency | Pass | Pass | ||
| ASTM F1862 | To demonstrate adequate | |||
| resistance to liquids | Under the conditions of the | |||
| study, passing at 80 mmHg | ||||
| conditions | Pass | Pass | ||
| 16 CFR 1610 | To evaluate flame spread | |||
| resistance | Class 1 under the conditions of | |||
| the testing | Pass | Pass | ||
| ASTM | ||||
| F2100-19 | To evaluate mask | |||
| performance | Level 1 under the conditions of | |||
| the evaluation | Pass | Pass | ||
| ISO 10993-5 | To evaluate the cytotoxic | |||
| potential of the mask | Under the conditions of the | |||
| study, non-cytotoxic | Pass | Pass | ||
| ISO 10993-10 | ||||
| Sensitization | To evaluate the | |||
| sensitization potential of | ||||
| the mask | Under the conditions of the | |||
| study, not a sensitizer | Pass | Pass | ||
| ISO 10993-10 | ||||
| Irritation | To evaluate the irritation | |||
| potential of the mask | Under the conditions of the | |||
| study, not an irritant | Pass | Pass |
Summary of Clinical Testing
No clinical testing was performed in support of this submission.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Fluidshield * 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (25869); Fluidshield * 1 Surgical Mask with SO SOFT* Lining (28802) are as safe, as effective and perform as well as or better than the legally marketed predicate device KC100 Face Masks (K110455).