(112 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (surgical masks). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It does not typically contain information about AI/ML models, human reader studies, or detailed ground truth methodologies used in the context of advanced diagnostic or imaging AI.
Therefore, many of the requested points related to AI/ML device studies are not applicable to this document.
Here's the information that can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance:
| Purpose | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 | <6.0 mmH2O/cm2 | Pass |
| Fluid Resistance | ASTM F1862 | 120 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility | ISO 10993 | Pass | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Non-irritant | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It describes non-clinical performance testing against established standards (ASTM, EN, ISO). Data provenance (country of origin, retrospective/prospective) is not mentioned as these are laboratory-based material performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are non-clinical material performance tests, not studies requiring expert interpretation of medical data (like radiology images). The ground truth is defined by the technical specifications and outcomes of the standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML or diagnostic study requiring expert adjudication of interpretations.
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 surgical mask, not an AI-assisted diagnostic device. No "human readers" or "AI assistance" are involved in its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is for a surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests is based on the specific methodologies and pass/fail criteria defined by the international and national standards cited (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). The tests objectively measure physical and biological properties against quantifiable benchmarks.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product developed with a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML product.
{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)
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}------------------------------------------------
510(k) Summary – K232894
| Date of Summary | January 8, 2024 |
|---|---|
| 510(k) Submitter | O&M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 23116Phone: 804-723-7000/800-488-8850Fax: 804-723-7100 |
| Primary Contact for this510(k) Submission | Anureet SinghRegulatory Affairs Manager |
| Marketed Common Name | Surgical Mask |
| Device Submission TradeName and Description | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*Lining (39123),HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SOSOFT* Lining and Visor (39124) |
| Device Product Code,Class and ClassificationName | FXXIISurgical Mask (21 CFR 878.4040) |
| Predicate Device | FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287) |
| Subject DeviceDescription | The subject devices are ASTM F2100 Level 2 (blue and white in color) SurgicalMasks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber withSO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask withExpanded 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 malleablenosepiece is placed within the bindings for comfort and individualized fit around thewearer'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 isworn. |
| Indications for Use | The Expanded Chamber Surgical Mask is intended to be worn to protect both thepatient and healthcare personnel from transfer of microorganisms, body fluids, andparticulate material. These face masks are intended for use in infection controlpractices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device(s), provided non-sterile.The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are thesubject of this submission are provided with a visor (39124). These masks are singleuse, disposable devices, provided non-sterile.The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with ExpandedChamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Maskwith Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devicesas cleared under K143287. |
{5}------------------------------------------------
| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | Comparison | |
| HALYARD* FLUIDSHIELD*2Surgical Mask withExpanded Chamberwith SO SOFT* Lining(39123) | HALYARD* FLUIDSHIELD*2Surgical Mask withExpanded Chamberwith SO SOFT* Liningand Visor(39124) | FLUIDSHIELD SurgicalMask with ExpandedChamber (K143287) | ||
| FDA ProductCode | FXX | FXX | FXX | Same |
| FDAClassification | Class II | Class II | Class II | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Surgical Mask | Same |
| DeviceTradeName | HALYARD* FLUIDSHIELD*2Surgical Mask withExpanded Chamberwith SO SOFT* Lining(39123) | HALYARD* FLUIDSHIELD*2Surgical Mask withExpanded Chamberwith SO SOFT* Liningand Visor(39124) | FLUIDSHIELD SurgicalMask with ExpandedChamber | Same |
| Indicationsfor Use | The Expanded ChamberSurgical Mask isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile | The Expanded ChamberSurgical Mask isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile | The ExpandedChamber SurgicalFace Mask is intendedto be worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood 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* 2Surgical Mask with | HALYARD*FLUIDSHIELD* 2 | FLUIDSHIELD SurgicalMask with Expanded | ||
| Expanded Chamber withSO SOFT* Lining (39123) | Surgical Mask withExpanded Chamberwith SO SOFT* Lining | Chamber (K143287) | ||
| and Visor(39124) | ||||
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle Layer 1 | Spunbondpolypropylene | Spunbondpolypropylene | Spunbondpolypropylene | 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 galvanizedsteel | Polyethylene coatedgalvanized steel | Polyethylene coatedgalvanized steel | Same |
| Number ofLayers | 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 | <6.0 mmH2O/cm2 | Pass |
| Fluid Resistance | ASTM F1862 | 120 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility | ISO 10993 | Pass | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Non-irritant | Pass |
Summary of Clinical Performance Testing:
{7}------------------------------------------------
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD2 Surgical Mask with Expanded Chamber with SO SOFT Lining and Visor (39124) are as safe, as effective and performs as well as or better than the legally marketed FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287).
§ 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.