(269 days)
The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) 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 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece. The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.
The provided text describes a 510(k) premarket notification for two medical masks, HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) and HALYARD* Level 1 Procedure Mask (48388). This document is a regulatory filing demonstrating "substantial equivalence" to a legally marketed predicate device, the Kimberly-Clark KC100 Face Masks (K110455).
The information provided does not pertain to an AI/ML-driven device or a comparative effectiveness study involving human readers with and without AI assistance. Instead, it details the performance characteristics and safety of physical medical masks based on standardized non-clinical tests. Therefore, many of the requested criteria regarding AI device studies cannot be answered from this document.
However, I can extract information related to the acceptance criteria and the non-clinical study performed for these masks.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Technological Characteristics Comparison Table" and a "Summary of Non-Clinical Testing." These tables effectively outline the acceptance criteria (as defined by the predicate device's performance and relevant ASTM/ISO standards) and the results for the subject devices.
| Test / Characteristic | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| FDA Product Code | FXX | FXX |
| FDA Classification | Class II | Class II |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Common Name | Surgical Mask | Surgical Mask |
| Indications for Use | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. |
| Over-the-Counter / Prescription | OTC | OTC |
| Number of Layers | 3 | 3 |
| Color | Yellow, blue, green, white, lavender | Yellow |
| Style | Pleated with earloops | Pleated with earloops |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene |
| Middle Layer | Meltblown polypropylene | Meltblown polypropylene |
| Inner Layer | Polyethylene/polyester | Subject 25867: Polyethylene/polyester; Subject 48388: Spunbond polypropylene |
| Bindings | Spunbond polypropylene or polyester spunlace | Subject 25867: Polyester spunlace; Subject 48388: Spunbond polypropylene |
| Earloop | Polyester/lycra | Polyester/lycra |
| Nose wire | Aluminum or polyethylene coated steel | Polyethylene coated steel |
| Mask Dimension Length | 6.875" ± 0.125" | 6.875" ± 0.125" |
| Mask Dimension Width (Flat) | 3.625" +/- 0.125" | 3.625" +/- 0.125" |
| ASTM F2100 Level | 1 | 1 |
| EN 14683 | Not explicitly stated for predicate in comparison table, but test result provided for subject. | Yes (Pass for breathability, < 5.0 mm H₂O/cm²) |
| Single Use | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Fluid Resistance (ASTM F1862) | 80 mmHg | 80 mmHg (Pass) |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | ≥ 95% (Pass) |
| Differential pressure | < 5.0 mmH₂O/cm² | < 5.0 mmH₂O/cm² (Pass) |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | ≥ 95% (Pass) |
| Flame Resistance (16 CFR 1610) | Class 1 | Class 1 (Pass) |
| ISO 10993-5 (Cytotoxicity) | Under conditions of testing, not cytotoxic | Under conditions of testing, not cytotoxic (Pass) |
| ISO 10993-10 (Sensitization) | Under conditions of testing, not a sensitizer | Under conditions of testing, not a sensitizer (Pass) |
| ISO 10993-10 (Irritation) | Under conditions of testing, not an irritant | Under conditions of testing, not an irritant (Pass) |
2. Sample size used for the test set and the data provenance:
The document refers to non-clinical tests (e.g., ASTM F2101, ASTM F1862). For these types of standardized tests, samples are drawn from production lots. The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from the manufacturer's own testing as part of their regulatory submission, likely conducted in certified labs. There is no mention of country of origin of the data beyond the manufacturer's location (Mechanicsville, Virginia, USA). The studies are not retrospective or prospective in the sense of clinical imaging studies; they are laboratory-based performance and safety evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to this type of device and study. The "ground truth" for mask performance and safety is established by adherence to recognized international standards (e.g., ASTM, ISO, CFR), not by expert consensus on complex imaging data. The tests are objective measurements of physical and biological properties.
4. Adjudication method for the test set:
Not applicable. There is no subjective interpretation requiring adjudication. Results are based on objective pass/fail criteria defined by the standards.
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 not an AI/ML-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-driven device.
7. The type of ground truth used:
The "ground truth" for the performance claims of these medical masks is established through adherence to recognized performance standards and regulations (e.g., ASTM F2101, ASTM F1862, 16 CFR 1610, ISO 10993 series). This involves objective measurements obtained in laboratory settings.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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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 7, 2024
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232806
Trade/Device Name: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2024 Received: April 26, 2024
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.
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"
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(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 medical devices and radiation-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 DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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
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Indications for Use
510(k) Number (if known) K232806
Device Name
HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388)
Indications for Use (Describe)
The HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388) 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 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| Restricted Use (Part 21 CFR 801.2 Labeling) |
| Over-The-Counter Use (21 CFR 801.2 Labeling) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary — K232806
| Date of Summary | June 06, 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 and Procedure Mask |
| Device Submission TradeName and Description | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So SoftEarloops (25867)HALYARD* Level 1 Procedure Mask (48388) |
| Device Product Code,Class andClassification Name | FXXIISurgical Mask (21 CFR 878.4040) |
| Predicate Device | K110455Kimberly-Clark KC100 Face MasksFXX Surgical MaskSurgical Apparel (21 CFR 878.4040) |
| Subject Device Description | The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks.The ASTM F2100 Level 1 Procedure Mask family of products are a three-layermask, constructed of well-known non-woven materials used in facialprotection. The Procedure Masks are provided with earloops and a malleablenosepiece.The ASTM F2100 Level 1 Procedure Masks that are the subject of thissubmission are not provided with a fog-free foam or visor. These masks aresingle use, disposable devices, provided non-sterile. |
| Indications for Use | The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So SoftEarloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended tobe worn to protect both the patient and healthcare personnel from transfer ofmicroorganisms, body fluids, and particulate material. These face masks areintended for use in infection control practices to reduce the potential exposureof the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD*Level 1 Procedure Mask (48388) are single use, disposable device(s), providednon-sterile. |
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| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject DeviceHALYARDFLUIDSHIELD 1Procedure Mask with SoSoft Lining and So SoftEarloops (25867) | Subject DeviceHALYARD* Level 1Procedure Mask(48388) | Predicate DeviceKC100 Face Masks(K110455) | Comparison | |
| 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 |
| Device TradeName | HALYARD* FLUIDSHIELD* 1Procedure Mask with SoSoft Lining and So SoftEarloops (25867) | HALYARD* Level 1Procedure Mask(48388) | KC100 ProcedureMask | Different |
| Indications forUse | The HALYARD*FLUIDSHIELD* 1Procedure Mask with SoSoft Lining and So SoftEarloops (25867) isintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure of the wearer toblood and body fluids. TheHALYARD* FLUIDSHIELD* 1Procedure Mask with SoSoft Lining and So SoftEarloops (25867) is a singleuse, disposable device,provided non- sterile. | The HALYARD* Level 1Procedure Mask(48388) is intended tobe worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce the potentialexposure of thewearer to blood andbody fluids. TheHALYARD* Level 1Procedure Mask(48388) is a single use,disposable device,providednon-sterile. | The Kimberly-ClarkKC100 Face Mask(s) isintended to be wornto protect both thepatient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce the potentialexposure of thewearer to blood andbody fluids. TheKimberly-Clark KC100face mask(s) is a singleuse, disposabledevice(s), providednon-sterile. | SameThe devicetrade namesare different |
| Over-the-Counter /Prescription | OTC | OTC | OTC | Same |
| Design Attributes | ||||
| Number ofLayers | 3 | 3 | 3 | Same |
| Color | Yellow | Yellow | Yellow, blue, green,white, lavender | Same |
| Style | Pleated with earloops | Pleated with earloops | Pleated with earloops | Same |
| Outer Layer | Spunbond polypropylene | Spunbondpolypropylene | Spunbondpolypropylene | Same |
| Middle Layer | Meltblown polypropylene | Meltblownpolypropylene | Meltblownpolypropylene | Same |
| Inner Layer | Polyethylene/polyester | Spunbondpolypropylene | Polyethylene/polyester | Different |
| Bindings | Polyester spunlace | Spunbondpolypropylene | Spunbondpolypropylene orpolyester spunlace | Same |
| Earloop | Polyester/lycra | Polyester/lycra | Polyester/lycra | Same |
| Nose wire | Polyethylene coated steel | Polyethylene coatedsteel | Aluminum orpolyethylene coatedsteel | Same |
| MaskDimensionLength | 6.875" ± 0.125" | 6.875" ± 0.125" | 6.875" ± 0.125" | Same |
| MaskDimensionWidth (Flat) | 3.625" +/- 0.125" | 3.625" +/- 0.125" | 3.625" +/- 0.125" | Same |
| Performance Data/Product Claims | ||||
| ASTM F2100Level | 1 | 1 | 1 | Same |
| EN 14683 | Yes | Yes | No | Different |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Fluid ResistanceASTM F1862 | 80 mmHg | 80 mmHg | 80 mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Differentialpressure | < 5.0 mmH₂O/cm² | < 5.0 mmH₂O/cm² | < 5 mmH₂O/cm² | Same |
| BacterialFiltrationEfficiencyASTM F2101 | $\ge 95%$ | $\ge 95%$ | $\ge 95%$ | Same |
| FlameResistance16 CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
| ISO 10993-5 | Under the conditions of thetesting, not cytotoxic | Under the conditions ofthe testing, notcytotoxic | Under the conditionsof the testing, notcytotoxic | Same |
| ISO 10993-10 | Under the conditions of thetesting, not a sensitizer andnot an irritant | Under the conditions ofthe testing, not asensitizer and not anirritant | Under the conditionsof the testing, not asensitizer and not anirritant | Same |
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HALYARD* FLUIDSHIELD* 1 Procedure Mask (25867); HALYARD* Level 1 Procedure Mask (48388) Premarket Notification 510(k) K232806
O&M Halyard, Inc.
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HALYARD* FLUIDSHIELD* 1 Procedure Mask (25867); HALYARD* Level 1 Procedure Mask (48388) Premarket Notification 510(k) K232806
Summary of Non-Clinical Testing:
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| ASTM F2101 | To demonstrate adequatebacterial filtration efficiency | Under the conditions of the study,at least 95% efficiency | Pass |
| EN 14683:2019+AC Annex C | To demonstrate acceptablebreathability | Under the conditions of the study,at most 5.0 mm H₂O/cm² | Pass |
| ASTM F2299 | To demonstrate adequateparticulate filtration efficiency | Under the conditions of the study,at least 95% efficiency | Pass |
| ASTM F1862 | To demonstrate adequateresistance to liquids | Under the conditions of the study,passing at 80 mmHg conditions | Pass |
| 16 CFR 1610 | To evaluate flame spreadresistance | Class 1 under the conditions ofthe testing | Pass |
| ASTM F2100-19 | To evaluate mask performance | Level 1 under the conditions ofthe evaluation | Pass |
| ISO 10993-5 | To evaluate the cytotoxicpotential of the mask | Under the conditions of the study,non-cytotoxic | Pass |
| ISO 10993-10 Sensitization | To evaluate the sensitizationpotential of the mask | Under the conditions of the study,not a sensitizer | Pass |
| ISO 10993-10 Irritation | To evaluate the irritationpotential of the mask | Under the conditions of the study,not an irritant | Pass |
Summary of Clinical Testing
No clinical testing was performed in support of this submission.
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Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the HALYARD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are as safe, as effective and perform as well as or better than the legally marketed predicate device KC100 Face Masks (K110455).
§ 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.