(127 days)
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.
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.
This document describes the regulatory clearance for the FLUIDSHIELD* Surgical Mask with Expanded Chamber (K143287). The information provided is primarily for regulatory purposes and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics in humans.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The device is evaluated against the ASTM F2100-11 Level 2 Surgical Mask standard. The acceptance criteria are implicitly defined by this standard, and the device reports meeting these.
| Performance Characteristic, Level II per ASTM F2100 | Applicable Testing and/or Referenced Standard (Method) | Acceptance Criteria (Implicit from ASTM F2100 Level 2, not explicitly detailed here) | Reported Device Performance (FLUIDSHIELD Surgical Mask with Expanded Chamber) |
|---|---|---|---|
| Differential Pressure mm H2O/cm² | MIL-M-36954C | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
| PFE - Particulate Filtration | ASTM F2299 | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
| BFE - Bacterial Filtration | ASTM F2101 | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
| Flammability | 16 CFR Part 1610 | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
| Fluid Resistance, synthetic blood | ASTM F1862 | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
| Biocompatibility (Mask and Visor) | ISO 10993 | (Not explicitly detailed, but implied by Level 2) | Met Acceptance Criteria |
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on sample sizes for the performance tests (e.g., how many masks were tested for BFE or PFE). The data provenance is also not mentioned, as these are likely laboratory tests conducted for regulatory compliance by the manufacturer.
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)
This is not applicable as the document describes physical and biological performance testing of a surgical mask, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to established industry performance standards (ASTM F2100-11).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance testing of surgical masks against standards does not typically involve adjudication methods like those used in clinical studies with human readers.
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 document is for a physical medical device (surgical mask), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (surgical mask), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for evaluating the device's performance is adherence to established industry performance standards (ASTM F2100-11 for Level 2 surgical masks) and other relevant standards (MIL-M-36954C, ASTM F2299, ASTM F2101, 16 CFR Part 1610, ASTM F1862, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic.
8. The sample size for the training set
Not applicable. This document describes the regulation of a physical product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This document describes the regulation of a physical product, not a machine learning model.
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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 ParkwayAlpharetta, GA 30004 |
|---|---|
| Contact Person | Roberto F. RefecaAssociate Director, Regulatory AffairsTel: 470.448.5586Fax: 678.254.0104Roberto.refeca@hyh.com |
| Date Prepared | 03-24-2015 |
| Trade Name | FLUIDSHIELD* Surgical Mask with Expanded Chamber |
| Common Name | Surgical mask |
| ClassificationName | Surgical mask |
| Review Panel | General and Plastic Surgery |
| DeviceClassificationand ProductCode | Class II per 21 CFR §878.4040Product Code - FXX |
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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 SurgicalMask (K111402) | FLUIDSHIELD* Surgical Mask withExpanded Chamber (Proposed Device) | |
|---|---|---|---|
| KC200 | KC300 | ||
| IntendedUse | The Kimberly-Clark, KC200 and KC300 FaceMask(s) is intended to be worn to protect boththe patient and healthcare personnel fromtransfer of microorganisms, body fluids, andparticulate material. These face masks areintended for use in infection control practicesto reduce the potential exposure of the wearerto blood and body fluids. The Kimberly-Clark,KC200 and KC300 face mask(s) is a singleuse, disposable device(s), provided non-sterile.Same | Same:The Expanded Chamber Surgical FaceMask is intended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids. Thisis a single use, disposable device(s),provided non-sterile. | |
| MaskDesign | Flat Pleated | Expanded Chamber (Duckbill) | |
| Sterile | Non Sterile | Non Sterile | |
| Single Use | Yes | Yes | |
| Outer Facing | Polyester Cellulose(Blue/Orange Print) | OrangePolypropyleneSpunbond | Top Half: Blue PolypropyleneSpunbond (w Print)Bottom Half: White PolypropyleneSpunbond |
| SpunbondMiddleLayer | Polypropylene Spunbond | Polypropylene Spunbond | |
| MeltblownMiddleLayer | Polypropylene Meltblown | Polypropylene Meltblown | |
| Inner FacingLayer | Polyester Cellulose | Polyethylene/Polyester | |
| Component | Predicate Device KC200 & 300 (K111402) | FLUIDSHIELD* Surgical Maskwith Expanded Chamber(Proposed Device) | |
| KC200 | KC300 | ||
| Top andBottomBinding | Polyester Spunlace or Polypropylene Spunbond | Polypropylene Spunbond | |
| Ties | Polyester Spunlace | Polyester Spunlace orPolypropylene Spunbond | |
| Branding | Kimberly-Clark, Markem Ink, Blue | Halyard Branding (Colorant notused, embossed logo) | |
| Style | Flat-pleated | Expanded Chamber | |
| Offered withVisor | Yes | Yes | |
| ProductPerformanceSpecifications | Meets ASTM F2100-11, ASTMF1862-07, ASTM F2101-07,ASTM F2299-03, MIL-M369454C16 CFR 1610 (PSC CS-191-53)ASTM Level 2 Performance(KC200) | Meets ASTMF2100-11,ASTM F1862-07, ASTMF2101-07,ASTM F2299-03, MIL-M369454C16 CFR 1610(PSC CS-191-53)ASTM Level 3Performance(KC300) | Meets ASTM F2100-11, ASTMF1862-07, ASTM F2101-07,ASTM F2299-03, MIL-M369454C16 CFR 1610 (PSC CS-191-53)ASTM Level 2 Performance(KC200) |
| Biocompatibility | Biocompatible, Non-cytotoxic, Non-sensitizing,Non-irritating | Biocompatible, Non-cytotoxic,Non-sensitizing, Non-irritating | |
| DimensionsWidth(Cheek toCheek) | 6.5" ± 0.75" | 6.5" ± 0.75" | 7.5" ± 0.11" |
| DimensionsLength(Nose toChin) | 4" ± 0.75" | 4" ± 0.75" | 8.3" ± 0.4" |
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| DeviceDescription | The product is a face mask utilizing an expanded chamber design consistingof nonwoven spunbond, nonwoven meltblown, and nonwoven inside layermaterial, nosepiece, and nonwoven ties and may be produced with or withouta visor. |
|---|---|
| Intended Use | The Expanded Chamber Surgical Face Mask is intended to be worn to protectboth the patient and healthcare personnel from transfer of microorganisms,body fluids and particulate material. These face masks are intended for use ininfection control practices to reduce the potential exposure to blood and bodyfluids. This is a single use, disposable device(s), provided non-sterile. |
| ModelNumbers | 39123 Expanded Chamber Surgical Face Mask (w/o Visor)39124 Expanded Chamber Surgical Face Mask (with Visor) |
| TechnologicalCharacteristics | There FLUIDSHIELD* Surgical Mask with Expanded Chamber issubstantially equivalent to the current ASTM F2100-11 Level 2 SurgicalMask (K111402), the product conforms with ASTM 2100-11 and theGuidance for Industry and FDA Staff: Surgical Masks-Premarket Notification510K Submissions, issued March 5, 2004. |
| Continued on next page |
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| PerformanceCharacteristic,Level II perASTM F2100 | ApplicableTesting and/orReferencedStandard(Method) | FLUIDSHIELDSurgical Maskwith ExpandedChamber |
|---|---|---|
| DifferentialPressure mmH2O/cm² | MIL-M-36954C | Met AcceptanceCriteria |
| PFE- ParticulateFiltration | ASTM F2299 | Met AcceptanceCriteria |
| BFE-BacterialFiltration | ASTM F2101 | Met AcceptanceCriteria |
| Flammability | 16 CFR Part 1610 | Met AcceptanceCriteria |
| Fluid Resistance,syntheticblood | ASTM F1862 | Met AcceptanceCriteria |
| Biocompatibility(Mask and Visor) | ISO 10993 | Met AcceptanceCriteria |
§ 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.