(112 days)
The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece
The provided text is a 510(k) Summary for a medical device (HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family). It describes the device, its intended use, and its performance against pre-defined acceptance criteria through non-clinical testing. It does not involve any clinical studies, expert-based ground truth, or MRMC comparative effectiveness studies as it's a device clearance for a respirator mask, not an AI/software-based medical device.
Therefore, many of the requested elements are "Not Applicable" (NA) for this type of submission.
Here's the information extracted from the text:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Filtration Efficiency | TEB-APR-STP-0059 | Minimum efficiency for each filter of ≥95% (≤5% penetration) | Pass |
| Breathability | TEB-APR-STP-0007 and TEB-APR-STP-0003 | Not exceeding 35mmH2O for TEB-APR-STP-0007, Not exceeding 25 mmH2O for TEB-APR-STP-0003 | Pass |
| Fluid Resistance (120mmHg) | ASTM F1862 | Pass at 120mmHg | Pass |
| Fluid Resistance (160mmHg) | ASTM F1862 | Pass at 160mmHg | Pass |
| Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass |
| Biocompatibility (Non-cytotoxic) | ISO 10993-5 L929 MEM Elution Test | < Grade 2 (mild reactivity), Non-cytotoxic | Pass |
| Biocompatibility (Non-sensitizing) | ISO 10993-10 Guinea Pig Maximization test | No dermal erythemic response, Non-sensitizing | Pass |
| Biocompatibility (Non-irritating) | ISO 10993-23 Intracutaneous Injection Test | Difference between test article and control article overall mean score ≤ 1, Non-irritating | 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 the exact sample sizes used for each non-clinical test (e.g., number of masks tested for filtration efficiency or breathability). The testing is non-clinical bench testing, not involving human subjects or clinical data in the traditional sense. Data provenance is not specified but is typically internal lab testing by the manufacturer or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert-based ground truth from medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert adjudication.
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 physical medical device (respirator mask), not an AI/software-based device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical device (respirator mask), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here refers to established technical standards and test methods (e.g., NIOSH certification requirements for filtration, ASTM F1862 for fluid resistance, ISO 10993 standards for biocompatibility). The device's performance is compared against these objective criteria rather than expert consensus or pathology.
8. The sample size for the training set:
Not applicable. This is for a physical medical device (respirator mask). The concept of a "training set" is not relevant here as there is no algorithm being trained.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a physical respirator mask.
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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.
January 12, 2024
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K233022
Trade/Device Name: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: MSH Dated: January 10, 2024 Received: January 10, 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.
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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 (OS) 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).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director 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
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Indications for Use
510(k) Number (if known) K233022
Device Name
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Fiter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
Indications for Use (Describe)
The HALYARD FLUIDSHIELD N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
| 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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510(k) Summary K233022
| 510(k) Owner: | O & M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 23116Phone: 804-723-7000/800-488-8850Fax: 804-723-7100 |
|---|---|
| Regulatory Contact: | Anureet SinghRegulatory Affairs Manager |
| Date of Summary: | 12 January 2024 |
| Device Trade Name: | HALYARD* FLUIDSHIELD* 3 N95 Particulate Filter Respirator and SurgicalMask with So Soft Lining, Orange, Regular and Small,HALYARD* FLUIDSHIELD* 3 N95 Particulate Filter Respirator and SurgicalMask with Safety Seal and So Soft Lining, Orange, Regular and Small,HALYARD* FLUIDSHIELD* 2 N95 Particulate Filter Respirator and SurgicalMask with So Soft Lining, White, Regular and Small |
| Common Name: | Surgical Respirator |
| Classification Name: | Surgical Respirator (21 CFR 878.4040, Product Code MSH) |
| Predicate Device: | PFR95TM Particulate Filter Respirator and Surgical Mask Regular Size, K974068 |
| Device Description: | Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrierfilm, and an outer facing. It covers the nose and mouth of the wearer and is heldin place with two synthetic elastic headbands, conforming to the curvature of thewearer's nose with a malleable nosepiece |
Device Model Information:
| ModelNumber | Name | Color | Size | ASTMF1862 | IndividuallyPackaged | DispenserQuantity | CaseQuantity |
|---|---|---|---|---|---|---|---|
| 46827 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 |
| 76827 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 |
| 46828 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand Surgical | Orange | Small | 160mmHg | Yes | 35 | 210 |
| Mask with SOSOFT* Lining | |||||||
| 46867 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SafetySeal and SOSOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 |
| 76867 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SafetySeal and SOSOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 |
| 46727 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 |
| 76727 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 |
| 46728 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | Orange | Regular | 160mmHg | Yes | 35 | 210 |
| 46767 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SafetySeal and SOSOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 |
| 76767 | FLUIDSHIELD*3 N95 ParticulateFilter Respiratorand SurgicalMask with SafetySeal and SOSOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 |
| 62355 | FLUIDSHIELD*2 N95 Particulate | White | Small | 120mmHg | No | 50 | 300 |
| Filter Respiratorand SurgicalMask with SOSOFT* Lining | |||||||
| 62126 | FLUIDSHIELD*2 N95 ParticulateFilter Respiratorand SurgicalMask with SOSOFT* Lining | White | Regular | 120mmHg | No | 50 | 300 |
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Note: All devices are provided non-sterile
The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Indication for Use: Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Comparison of Device Technological Characteristics:
| Subject DeviceHALYARD*FLUIDSHIELD* N95Particulate FilterRespirator and SurgicalMask(K233022) | PredicateTecnol PFR95™Particulate FilterRespirator and SurgicalMask (K974068) | ComparisonResult | |
|---|---|---|---|
| Manufacturer | O&M Halyard, Inc. | Tecnol Medical Products, Incorporated | Different |
| Device ModelNumbers | 46827 & 768274682846867 & 7686746727 & 767274672846767 & 767676235562126 | 47119-11047119-210467174673747119-11447119-17447119-21447119-27446817468274683746867 | Similar |
| Common orUsual Name | Surgical Respirator | Surgical Respirator | Same |
| Classification | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product Code | MSH | MSH | Same |
| Indication forUse | The HALYARD*FLUIDSHIELD* N95Particulate Filter Respirator | The PFR95™ ParticulateFilter Respirator andSurgical Masks are intended | Similar |
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| DeviceDescriptionand Materials | and Surgical Mask family isintended for use by operatingroom personnel and otherhealth care workers to protectboth the patients and thehealth care workers fromtransfer of microorganisms,blood and body fluids, andairborne particulate materials. | for use by operating roompersonnel and other healthcare workers to protect boththe patients and the healthcare workers from transfer ofmicroorganisms, blood andbody fluids, and airborneparticulate materials. | |
|---|---|---|---|
| Respirator consisting ofnonwoven inner facing, filtermedia(s), a fluid barrier film,and an outer facing. It coversthe nose and mouth of thewearer and is held in placewith two synthetic elasticheadbands, conforming to thecurvature of the wearer's nosewith a malleable nosepiece. | Respirator consisting ofnonwoven inner facing, filtermedia(s), a fluid barrier film,and an outer facing. It coversthe nose and mouth of thewearer and is held in placewith two synthetic elasticheadbands, conforming tothe curvature of the wearer'snose with a malleablenosepiece. | Same | |
| Method forBonding | Ultrasonic | Ultrasonic | Same |
| Distribution | Non-Sterile and Over-the-Counter | Non-Sterile and Over-the-Counter | Same |
| Single UseDevice | Yes | Yes | Same |
Comparison of Specification Performance and Biocompatibility:
| Subject DeviceHALYARD*FLUIDSHIELD* N95Particulate FilterRespirator and SurgicalMask(K233022) | PredicateTecnol PFR95™Particulate FilterRespirator and SurgicalMask (K974068) | ComparisonResult | |
|---|---|---|---|
| FiltrationEfficiency | NIOSH certified | NIOSH certified | Same |
| Resistance topenetration bysynthetic blood,minimumpressure in mmHg for passresult, 160mmHg(Fluidshield 3models: 46827,76827, 46828,46867, 76867,46727, 76727) | Pass | Standard did not exist | Different |
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| 46728, 46767,76767)ASTM F1862Resistance topenetration bysynthetic blood,minimumpressure in mmHg for passresult, 120mmHg(Fluidshield 2models: 62355,62126)ASTM F1862 | Pass | Standard did not exist | Different |
|---|---|---|---|
| Biocompatibility:Non-sensitizingNon-cytotoxicNon-irritating | Pass | Pass | Same |
| Flame spread,Class I | Pass | Standard did not exist | Different |
| BacterialFiltrationEfficiencyASTM F2101 | PassBFE ≥ 98% | Standard did not exist | Different |
| ParticulateFiltrationEfficiencyASTM F2299 | PassPFE ≥ 98% | Standard did not exist | Different |
Summary of Non-Clinical Performance Testing Performance Testing (Bench):
| PerformanceCharacteristic | Test Method | Acceptance Criteria | Result |
|---|---|---|---|
| FiltrationEfficiency | TEB-APR-STP-0059 | Minimum efficiency foreach filter of ≥95% (≤5%penetration) | Pass |
| Breathability | TEB-APR-STP-0007andTEB-APR-STP-0003 | Not exceeding 35mmH2O forTEB-APR-STP-0007,Not exceeding 25 mmH2O forTEB-APR-STP-0003 | Pass |
| Fluid Resistance | ASTM F1862 | Pass at 120mmHgPass at 160mmHg | Pass |
| Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass |
| Biocompatibility | ISO 10993-5L929 MEM Elution Test | < Grade 2 (mild reactivity)Non-cytotoxic | Pass |
| Biocompatibility | ISO 10993-10Guinea Pig Maximization test | No dermal erythemic responseNon-sensitizing | Pass |
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| Biocompatibility | ISO 10993-23Intracutaneous Injection Test | Difference between test articleand control article overall meanscore $ \leq $ 1Non-irritating | Pass |
|---|---|---|---|
| ------------------ | ----------------------------------------------- | ------------------------------------------------------------------------------------------------------------- | ------ |
Summary of Clinical Performance Testing: Not applicable.
Conclusions: The conclusions drawn from the non-clinical tests demonstrate the subject device, the HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Tecnol PFR95TM Particulate Filter Respirator and Surgical Mask (K974068).
§ 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.