(112 days)
Not Found
No
The document describes a standard surgical mask and does not mention any AI or ML components or functionalities.
No.
The device is a surgical mask intended for protection from transfer of microorganisms and fluids, not for treating any specific condition or disease.
No
Explanation: The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical surgical mask made of non-woven materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is 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 test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, shape, nosepiece). This aligns with a physical barrier device, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Expanded Chamber Surgical Mask 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 potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are the subject of this submission are provided with a visor (39124). These masks are single use, disposable devices, provided non-sterile.
The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devices as cleared under K143287.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject devices are ASTM F2100 Level 2 (blue and white in color) Surgical Masks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) are a four- layer mask, constructed of well-known non-woven materials used in facial protection. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. When compared to a pleated/flat mask, the subject devices have a "duckbill" shape, which expands the volume of the chamber created when the mask is worn.
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)
Performance testing of the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining was evaluated, and the results showed that acceptance criteria were met.
- Face Mask Performance Test: ASTM F2100, Acceptance Criteria: ASTM Level 2, Result: Pass
- Bacterial Filtration Efficiency Test: ASTM F2101, Acceptance Criteria: >=98%, Result: Pass
- Particulate Filtration Efficiency Test: ASTM F2299, Acceptance Criteria: >=98%, Result: Pass
- Differential Pressure Test: EN 14683, Acceptance Criteria:
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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.
January 8, 2024
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232894
Trade/Device Name: HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 15, 2023 Received: September 18, 2023
Dear Anureet Singh:
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) K232894
Device Name
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
Indications for Use (Describe)
The Expanded Chamber Surgical Mask 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 potential exposure to blood and body fluids. This is a 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
510(k) Summary – K232894
| Date of Summary | January 8, 2024 |
|---|---|
| 510(k) Submitter | O&M Halyard, Inc. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 23116 | |
| Phone: 804-723-7000/800-488-8850 | |
| Fax: 804-723-7100 | |
| Primary Contact for this | |
| 510(k) Submission | Anureet Singh |
| Regulatory Affairs Manager | |
| Marketed Common Name | Surgical Mask |
| Device Submission Trade | |
| Name and Description | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* |
| Lining (39123), | |
| HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO | |
| SOFT* Lining and Visor (39124) | |
| Device Product Code, | |
| Class and Classification | |
| Name | FXX |
| II | |
| Surgical Mask (21 CFR 878.4040) | |
| Predicate Device | FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287) |
| Subject Device | |
| Description | The subject devices are ASTM F2100 Level 2 (blue and white in color) Surgical |
| Masks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with | |
| SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with | |
| Expanded Chamber with SO SOFT* Lining and Visor (39124) are a four- layer mask, | |
| constructed of well-known non-woven materials used in facial protection. A malleable | |
| nosepiece is placed within the bindings for comfort and individualized fit around the | |
| wearer's nose. When compared to a pleated/flat mask, the subject devices have a | |
| "duckbill" shape, which expands the volume of the chamber created when the mask is | |
| worn. | |
| Indications for Use | The Expanded Chamber Surgical Mask 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 potential exposure to blood and body fluids. This is a single | |
| use, disposable device(s), provided non-sterile. |
The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are the
subject of this submission are provided with a visor (39124). These masks are single
use, disposable devices, provided non-sterile.
The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded
Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask
with Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devices
as cleared under K143287. |
5
| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | Comparison | |
| HALYARD* FLUIDSHIELD* | ||||
| 2 | ||||
| Surgical Mask with | ||||
| Expanded Chamber | ||||
| with SO SOFT* Lining | ||||
| (39123) | HALYARD* FLUIDSHIELD* | |||
| 2 | ||||
| Surgical Mask with | ||||
| Expanded Chamber | ||||
| with SO SOFT* Lining | ||||
| and Visor | ||||
| (39124) | FLUIDSHIELD Surgical | |||
| Mask with Expanded | ||||
| Chamber (K143287) | ||||
| FDA Product | ||||
| Code | FXX | FXX | FXX | Same |
| FDA | ||||
| Classification | Class II | Class II | Class II | Same |
| Regulation | ||||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Surgical Mask | Same |
| Device | ||||
| Trade | ||||
| Name | HALYARD* FLUIDSHIELD* | |||
| 2 | ||||
| Surgical Mask with | ||||
| Expanded Chamber | ||||
| with SO SOFT* Lining | ||||
| (39123) | HALYARD* FLUIDSHIELD* | |||
| 2 | ||||
| Surgical Mask with | ||||
| Expanded Chamber | ||||
| with SO SOFT* Lining | ||||
| and Visor | ||||
| (39124) | FLUIDSHIELD Surgical | |||
| Mask with Expanded | ||||
| Chamber | Same | |||
| Indications | ||||
| for Use | The Expanded Chamber | |||
| Surgical Mask 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 | ||||
| potential exposure to | ||||
| blood and body fluids. | ||||
| This is a single use, | ||||
| disposable device(s), | ||||
| provided non-sterile | The Expanded Chamber | |||
| Surgical Mask 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 | ||||
| potential exposure to | ||||
| blood and body fluids. | ||||
| This is a single use, | ||||
| disposable device(s), | ||||
| provided non-sterile | The Expanded | |||
| Chamber Surgical | ||||
| Face Mask 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 | ||||
| potential exposure to | ||||
| blood and body fluids. | ||||
| This is a single use, | ||||
| disposable device(s), | ||||
| provided non-sterile. | Same |
6
| Design Attributes | ||||
|---|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | Comparison | |
| HALYARD* FLUIDSHIELD* 2 | ||||
| Surgical Mask with | HALYARD* | |||
| FLUIDSHIELD* 2 | FLUIDSHIELD Surgical | |||
| Mask with Expanded | ||||
| Expanded Chamber with | ||||
| SO SOFT* Lining (39123) | Surgical Mask with | |||
| Expanded Chamber | ||||
| with SO SOFT* Lining | Chamber (K143287) | |||
| and Visor | ||||
| (39124) | ||||
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle Layer 1 | Spunbond | |||
| polypropylene | Spunbond | |||
| polypropylene | Spunbond | |||
| polypropylene | Same | |||
| Middle Layer 2 | Meltblown polypropylene | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner Layer | Polyethylene/polyester | Polyethylene/polyester | Polyethylene/polyester | Same |
| Bindings | Spunbond polypropylene | Spunbond polypropylene | Spunbond polypropylene | Same |
| Ties | Polyester spunlace | Polyester spunlace | Polyester spunlace | Same |
| Visor | Polyester | Polyester | Same | |
| Nose wire | Polyethylene coated galvanized | |||
| steel | Polyethylene coated | |||
| galvanized steel | Polyethylene coated | |||
| galvanized steel | Same | |||
| Number of | ||||
| Layers | 4 | 4 | 4 | Same |
| Color | Blue print | Blue print | Blue print | Same |
| Style | Duckbill with ties | Duckbill with ties | Duckbill with ties | Same |
| ASTM Level | 2 | 2 | 2 | Same |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf Life | 5-year | 5-year | 5-year | Same |
Summary of Non-Clinical Performance Testing:
Performance testing of the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining was evaluated, and the results showed that acceptance criteria were met.
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM Level 2 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥98% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥98% | Pass |
| Differential Pressure | EN 14683 |