Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard surgical face mask and its performance characteristics, with no mention of AI or ML technology.

Therapeutic

No.
The device is a surgical face mask intended to protect against transfer of microorganisms and fluids, not to provide therapy or treatment for a disease or condition.

Diagnostic

No
The device is a surgical face mask, which is a barrier intended to prevent the transfer of microorganisms, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (nonwoven materials, nosepiece, ties, optional visor) and performance studies related to material properties and physical barriers, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Intended Use: The intended use of this device is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material by being worn on the face. It's a barrier device.
Lack of Diagnostic Function: The description and performance studies focus on the physical properties of the mask (filtration, fluid resistance, flammability, biocompatibility) and its ability to act as a barrier. There is no mention of it being used to analyze samples or provide diagnostic information.

Therefore, based on the provided information, this surgical face mask is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Expanded Chamber Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The product is a face mask utilizing an expanded chamber design consisting of nonwoven spunbond, nonwoven meltblown, and nonwoven inside layer material, nosepiece, and nonwoven ties and may be produced with or without a visor.

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

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Characteristic, Level II per ASTM F2100	Applicable Testing and/or Referenced Standard (Method)	FLUIDSHIELD Surgical Mask with Expanded Chamber
Differential Pressure mm H2O/cm²	MIL-M-36954C	Met Acceptance Criteria
PFE- Particulate Filtration	ASTM F2299	Met Acceptance Criteria
BFE-Bacterial Filtration	ASTM F2101	Met Acceptance Criteria
Flammability	16 CFR Part 1610	Met Acceptance Criteria
Fluid Resistance, synthetic blood	ASTM F1862	Met Acceptance Criteria
Biocompatibility (Mask and Visor)	ISO 10993	Met Acceptance Criteria

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111402

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2015

Halyard Health, Inc. Mr. Roberto F. Refeca Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004

Re: K143287

Trade/Device Name: FLUIDSHIELD* Surgical Mask with Expanded Chamber Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: February 24, 2015 Received: February 25, 2015

Dear Mr. Refeca.

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 (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. 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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Page 2 - Mr. Refeca

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143287

Device Name

FLUIDSHIELD* Surgical Mask with Expanded Chamber

Indications for Use (Describe)

The Expanded Chamber Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

39123 Expanded Chamber Surgical Face Masks w/o Visor 39124 Expanded Chamber Surgical Face Mask with Visor

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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| 510K Owner/
Application | Halyard Health, Inc.
5405 Windward Parkway
Alpharetta, GA 30004 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Roberto F. Refeca
Associate Director, Regulatory Affairs
Tel: 470.448.5586
Fax: 678.254.0104
Roberto.refeca@hyh.com |
| Date Prepared | 03-24-2015 |
| Trade Name | FLUIDSHIELD* Surgical Mask with Expanded Chamber |
| Common Name | Surgical mask |
| Classification
Name | Surgical mask |
| Review Panel | General and Plastic Surgery |
| Device
Classification
and Product
Code | Class II per 21 CFR §878.4040
Product Code - FXX |

Continued on next page

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The Halyard FLUIDSHIELD Surgical Mask with Expanded Chamber, the Predicate Device subject of this submission, is substantially equivalent to the Kimberly-Clark Level 2 face masks originally cleared in K111402.

| Component | Predicate Device KC200 & 300 Surgical
Mask (K111402) | | FLUIDSHIELD* Surgical Mask with
Expanded Chamber (Proposed Device) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KC200 | KC300 | |
| Intended
Use | The Kimberly-Clark, KC200 and KC300 Face
Mask(s) 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 of the wearer
to blood and body fluids. The Kimberly-Clark,
KC200 and KC300 face mask(s) is a single
use, disposable device(s), provided non-sterile.
Same | | Same:

Continued on next page

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Continued on next page

6

| Device
Description | The product is a face mask utilizing an expanded chamber design consisting
of nonwoven spunbond, nonwoven meltblown, and nonwoven inside layer
material, nosepiece, and nonwoven ties and may be produced with or without
a visor. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Expanded Chamber Surgical Face Mask is intended to be worn to protect
both the patient and healthcare personnel from transfer of microorganisms,
body fluids and particulate material. These face masks are intended for use in
infection control practices to reduce the potential exposure to blood and body
fluids. This is a single use, disposable device(s), provided non-sterile. |
| Model
Numbers | 39123 Expanded Chamber Surgical Face Mask (w/o Visor)
39124 Expanded Chamber Surgical Face Mask (with Visor) |
| Technological
Characteristics | There FLUIDSHIELD* Surgical Mask with Expanded Chamber is
substantially equivalent to the current ASTM F2100-11 Level 2 Surgical
Mask (K111402), the product conforms with ASTM 2100-11 and the
Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notification
510K Submissions, issued March 5, 2004. |
| | Continued on next page |

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| Performance
Characteristic,
Level II per
ASTM F2100 | Applicable
Testing and/or
Referenced
Standard
(Method) | FLUIDSHIELD
Surgical Mask
with Expanded
Chamber |
|--------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------|
| Differential
Pressure mm
H2O/cm² | MIL-M-36954C | Met Acceptance
Criteria |
| PFE- Particulate
Filtration | ASTM F2299 | Met Acceptance
Criteria |
| BFE-Bacterial
Filtration | ASTM F2101 | Met Acceptance
Criteria |
| Flammability | 16 CFR Part 1610 | Met Acceptance
Criteria |
| Fluid Resistance,
synthetic
blood | ASTM F1862 | Met Acceptance
Criteria |
| Biocompatibility
(Mask and Visor) | ISO 10993 | Met Acceptance
Criteria |