(112 days)
Not Found
No
The device description and performance studies focus on material properties and physical performance, with no mention of AI or ML.
No.
The device functions as a protective barrier (respirator and surgical mask) to prevent the transfer of microorganisms, blood, body fluids, and airborne particulate materials, rather than treating or diagnosing a medical condition.
No
The device is a respirator and surgical mask intended for protection against transfer of microorganisms and particulate materials, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (nonwoven inner facing, filter media, fluid barrier film, outer facing, headbands, malleable nosepiece) and performance testing related to these physical properties (filtration, breathability, fluid resistance, flammability, biocompatibility). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a physical barrier (a mask/respirator) that covers the nose and mouth. It does not involve the analysis of biological samples.
- Performance Studies and Metrics: The performance studies focus on the physical properties of the mask, such as filtration efficiency, breathability, fluid resistance, flammability, and biocompatibility. These are relevant to its function as a barrier and filter, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.
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 fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MSH
Device Description
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.
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
operating room personnel and other health care workers
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)
Summary of Non-Clinical Performance Testing Performance Testing (Bench):
| Performance Characteristic | Test Method | Acceptance Criteria | Result |
|---|---|---|---|
| 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 | ASTM F1862 | Pass at 120mmHg Pass at 160mmHg | Pass |
| Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass |
| Biocompatibility | ISO 10993-5 L929 MEM Elution Test |
§ 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 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.
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 (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).
2
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
3
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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4
510(k) Summary K233022
| 510(k) Owner: | O & M Halyard, Inc.
9120 Lockwood Boulevard
Mechanicsville, VA 23116
Phone: 804-723-7000/800-488-8850
Fax: 804-723-7100 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Anureet Singh
Regulatory Affairs Manager |
| Date of Summary: | 12 January 2024 |
| Device Trade 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 |
| 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 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 |
Device Model Information:
| Model
Number | Name | Color | Size | ASTM
F1862 | Individually
Packaged | Dispenser
Quantity | Case
Quantity |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|--------|---------|---------------|--------------------------|-----------------------|------------------|
| 46827 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 |
| 76827 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 |
| 46828 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical | Orange | Small | 160mmHg | Yes | 35 | 210 |
| | Mask with SO
SOFT* Lining | | | | | | |
| 46867 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with Safety
Seal and SO
SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 |
| 76867 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with Safety
Seal and SO
SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 |
| 46727 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 |
| 76727 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 |
| 46728 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | Orange | Regular | 160mmHg | Yes | 35 | 210 |
| 46767 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with Safety
Seal and SO
SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 |
| 76767 | FLUIDSHIELD*
3 N95 Particulate
Filter Respirator
and Surgical
Mask with Safety
Seal and SO
SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 |
| 62355 | FLUIDSHIELD*
2 N95 Particulate | White | Small | 120mmHg | No | 50 | 300 |
| | Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | | | | | | |
| 62126 | FLUIDSHIELD*
2 N95 Particulate
Filter Respirator
and Surgical
Mask with SO
SOFT* Lining | White | Regular | 120mmHg | No | 50 | 300 |
5
6
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 Device
HALYARD*
FLUIDSHIELD* N95
Particulate Filter
Respirator and Surgical
Mask
(K233022) | Predicate
Tecnol PFR95™
Particulate Filter
Respirator and Surgical
Mask (K974068) | Comparison
Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | O&M Halyard, Inc. | Tecnol Medical Products, Incorporated | Different |
| Device Model
Numbers | 46827 & 76827
46828
46867 & 76867
46727 & 76727
46728
46767 & 76767
62355
62126 | 47119-110
47119-210
46717
46737
47119-114
47119-174
47119-214
47119-274
46817
46827
46837
46867 | Similar |
| Common or
Usual 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 for
Use | The HALYARD*
FLUIDSHIELD* N95
Particulate Filter Respirator | The PFR95™ Particulate
Filter Respirator and
Surgical Masks are intended | Similar |
7
| Device
Description
and Materials | 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. | 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. | 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. | Same |
| Method for
Bonding | Ultrasonic | Ultrasonic | Same |
| Distribution | Non-Sterile and Over-the-
Counter | Non-Sterile and Over-the-
Counter | Same |
| Single Use
Device | Yes | Yes | Same |
Comparison of Specification Performance and Biocompatibility:
| | Subject Device
HALYARD*
FLUIDSHIELD* N95
Particulate Filter
Respirator and Surgical
Mask
(K233022) | Predicate
Tecnol PFR95™
Particulate Filter
Respirator and Surgical
Mask (K974068) | Comparison
Result |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------|
| Filtration
Efficiency | NIOSH certified | NIOSH certified | Same |
| Resistance to
penetration by
synthetic blood,
minimum
pressure in mm
Hg for pass
result, 160mmHg
(Fluidshield 3
models: 46827,
76827, 46828,
46867, 76867,
46727, 76727) | Pass | Standard did not exist | Different |
8
| 46728, 46767,
76767)
ASTM F1862
Resistance to
penetration by
synthetic blood,
minimum
pressure in mm
Hg for pass
result, 120mmHg
(Fluidshield 2
models: 62355,
62126)
| ASTM F1862 | Pass | Standard did not exist | Different |
|---|---|---|---|
| Biocompatibility: | |||
| Non-sensitizing | |||
| Non-cytotoxic | |||
| Non-irritating | Pass | Pass | Same |
| Flame spread, | |||
| Class I | Pass | Standard did not exist | Different |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | Pass | ||
| BFE ≥ 98% | Standard did not exist | Different | |
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2299 | Pass | ||
| PFE ≥ 98% | Standard did not exist | Different |
Summary of Non-Clinical Performance Testing Performance Testing (Bench):
| Performance
| Characteristic | Test Method | Acceptance Criteria | Result |
|---|---|---|---|
| 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 | ASTM F1862 | Pass at 120mmHg | |
| Pass at 160mmHg | Pass | ||
| Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass |
| Biocompatibility | ISO 10993-5 | ||
| L929 MEM Elution Test |