(184 days)
The Aero Chrome* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Select Breathable Performance Surgical Gown has a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Select Breathable Performance Surgical Gown in the non-critical zone also has the same Spunbond/Film/Spunbond/Meltblown/Spunbond fabric (SFSMS) that provides ASTM 1671 liquid barrier protection. The Aero Chrome* Select Breathable Performance Surgical Gown is single use, disposable medical device that will be provided in a variety of sizes and sterile and non-sterile packaging configurations.
The provided text describes a medical device, the Aero Chrome* Select Breathable Performance Surgical Gown, and its equivalence to a predicate device. The information details various performance tests and their results, which serve as criteria for establishing substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Reference & Test Method) | Reported Device Performance | Meets Requirement |
|---|---|---|
| 16 CFR 1610 (Flammability for Clothing Textiles) | Flammability | Pass |
| ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Cytotoxicity) | Cytotoxicity | Pass (non-cytotoxic) |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Skin Irritation Study) | Irritation | Pass (negligible irritant) |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Sensitization Test) | Sensitization | Pass (non-sensitizing) |
| ISO 10993-7:2008 (Ethylene Oxide sterilization residuals) | EO residuals | Pass |
| ISO 11810-1 (2005) (Laser Ignition Resistance) | Laser resistance | Pass |
| AAMI PB70:2012 Level 4 (Liquid Barrier Performance in Critical Zone) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| AAMI PB70:2012 Level 1 (Liquid Barrier Performance in non-critical raglan sleeve to shoulder seams) | Water resistance | Pass |
| ASTM F1671 (Liquid Barrier Performance in Non-Critical Zone fabric on the back of gown) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| ASTM D5034 (2009) (Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens) | Tensile Strength | Pass |
| WSP 20.5 (2008) (Abrasion Resistance and Surface Bonding of SMS Laminates) | Abrasion resistance | Pass |
| ASTM-1670-08 (2008) (Synthetic Blood Penetration - fabric only in critical and non-critical zone) | Resistance to penetration | Pass |
| D3776 (2009) (Mass Per Area (Basis Weight) of Materials) | Fabric basis weight | Pass |
| WSP 70.4 (2008) (Water Vapor Transmission Rate Through Nonwovens and Plastic Films) | Water Vapor Transmission | Pass |
| STM-00197 (2010) (Degree Peel Strength of Laminated Nonwovens - Raw Materials) | Peel Strength | Pass |
| INDA WSP 160.1 (2009) (Resistance to Linting Dry Particle Generation) | Particulate | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns, or material samples tested per batch). It only lists the tests performed and that the product "met the predetermined specifications."
The data provenance is industrial testing data, generated by Halyard Health, Inc. or its designated testing facilities, to demonstrate compliance with relevant industrial standards and regulations (e.g., AAMI, ISO, ASTM, CFR). The testing appears to be prospective in nature as it is being conducted to demonstrate the performance of a new device.
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 information is not applicable. The device is a surgical gown, and its performance is evaluated against objective, standardized physical and biological parameters, not subjective expert assessment as would be the case for an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for this type of device and testing. The tests involve quantifiable measurements according to established methods, not subjective interpretations requiring 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:
This is not applicable. MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This device is a surgical gown.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable, as this is a physical medical device (surgical gown), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is defined by the established industry standards and regulatory requirements for surgical apparel. These standards specify objective, measurable performance criteria (e.g., liquid barrier effectiveness, flammability, biocompatibility).
8. The sample size for the training set:
This is not applicable. This is not a machine learning or AI device that requires a training set. The device's performance is tested against predetermined physical and biological standards.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this type of device. The ground truth for evaluating the device is based on established scientific and regulatory standards.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Halyard Health, Inc. David M. Lee, JD Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K162930
Trade/Device Name: Aero Chrome* Select Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: March 15, 2017 Received: March 17, 2017
Dear David M. Lee:
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.
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.
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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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |||
|---|---|---|---|
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 | ||
| Indications for Use | Expiration Date: January 31, 2017 | ||
| See PRA Statement below. | |||
| 510(k) Number (if known) | K162930 | ||
| Device Name | Aero Chrome* Select Breathable Performance Surgical Gown | ||
| Indications for Use (Describe) | |||
| The Aero Chrome* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications. | |||
| Type of Use (Select one or both, as applicable) | |||
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |||
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health andHuman Services Food andDrug AdministrationOffice of Chief InformationOfficer PaperworkReduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |||
| FORM FDA 3881 (8/14) | Page 1 of 1 | EFPSC Publishing Services (301) 443-6740 |
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510(k) Summary
| Date Summarywas Prepared: | April 14, 2017 |
|---|---|
| 510(k)Submitter: | David M. Lee, JDAssociate Director of Regulatory AffairsHALYARD HEALTH5405 Windward ParkwayAlpharetta, GA 30004470 448 5182David.lee@hyh.com |
| Primary Contactfor this 510(k)Submission: | David M. Lee, JDAssociate Director of Regulatory Affairs,HALYARD HEALTH5405 Windward ParkwayAlpharetta, GA 30004470 448 5182David.lee@hyh.com |
| Device TradeName: | Aero Chrome* Select Breathable Performance Surgical Gown(hereinafter described as "Aero Chrome* Select") |
| Device CommonNames | Surgical Gown |
| Regulation: | 878.4040 |
| Device ProductCodes andClassificationNames: | FYAClass IISurgical Apparel |
| Predicate Device | The Aero Chrome* Select Breathable Performance SurgicalGown under submission is substantially equivalent to thepredicate device, the Aero Chrome* Breathable PerformanceSurgical Gown (K153255). |
| DeviceDescription: | The Aero Chrome* Select Breathable Performance SurgicalGown has a Spunbond/Film/Spunbond/Meltblown/Spunbonddesign (SFSMS) that provides AAMI Level 4 liquid barrierprotection in the critical zones of the gown. The back of theAero Chrome* Select Breathable Performance SurgicalGown in the non-critical zone also has the sameSpunbond/Film/Spunbond/Meltblown/Spunbond fabric (SFSMS)that provides ASTM 1671 liquid barrier protection. The AeroChrome* Select Breathable Performance Surgical Gown issingle use, disposable medical device that will be provided in a |
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variety of sizes and sterile and non-sterile packaging configurations.
- The Aero Chrome* Select Breathable Performance Surgical Gowns Intended Use: are sterile, single-use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
Product Codes and Descriptions
STERILE CODES
| PRODUCT STOCK CODE | DESCRIPTION | SIZE |
|---|---|---|
| 44699 | Aero Chrome* SelectBreathable PerformanceSurgical Gown | Large |
| 44706 | Aero Chrome* SelectBreathable PerformanceSurgical Gown | X Large |
| 44707 | Aero Chrome* SelectBreathable PerformanceSurgical Gown | XX Large |
NON-STERILE CODES
| PRODUCT STOCK CODE | DESCRIPTION | SIZE |
|---|---|---|
| 44696NS | Aero Chrome* SelectBreathable PerformanceSurgical Gown | Large |
| 44697NS | Aero Chrome* SelectBreathable PerformanceSurgical Gown | X Large |
| 44698NS | Aero Chrome* SelectBreathable PerformanceSurgical Gown | XX Large |
Summary of Non-Clinical Testing
| Standard or Reference | Test Method | DataGenerated | MeetsRequirement |
|---|---|---|---|
| Standard for the Flammability for ClothingTextiles | 16 CFR 1610 | Flammability | Pass |
| Standard or Reference | Test Method | DataGenerated | MeetsRequirement |
| ISO 10993-5:2009 Biological Evaluation ofMedical Devices-Part 5: | Cytotoxicity | Cytotoxicity | Pass, under theconditions of thestudy non-cytotoxic |
| ISO 10993-10:2010 Biological Evaluation ofMedical Devices-Part 10 | Skin IrritationStudy | Irritation | Pass, under theconditions of thestudy anegligible irritant |
| ISO 10993-10:2010 Biological Evaluation ofMedical Devices-Part 10 | Sensitization Test | Sensitization | Pass, under theconditions of thestudy non-sensitizing |
| ISO 10993-7:2008, Ethylene Oxidesterilization residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laserresistance | Pass |
| AAMI Liquid Barrier Performance in CriticalZone(body, sleeves, and ties) | AAMI PB70:2012Level 4 | Resistance toPenetration byBlood-BornePathogensUsing Phi-X174Bacteriophage | Pass |
| AAMI Liquid Barrier Performance Level 1 innon-critical raglan sleeve to shoulder seams | AAMI PB70:2012Level 1 | Waterresistance | Pass |
| Liquid Barrier Performance in Non-CriticalZone fabric on the back of gown | ASTM F1671 | Resistance toPenetration byBlood-BornePathogensUsing Phi-X174Bacteriophage | Pass |
| Grab Tensile, Peak Stretch, and PeakEnergy - Nonwovens | ASTM D5034(2009) | TensileStrength | Pass |
| Abrasion Resistance and Surface Bonding ofSMS Laminates | WSP 20.5 (2008) | Abrasionresistance | Pass |
| Synthetic Blood Penetration(fabric only in critical and non-critical zone) | ASTM-1670-08(2008) | Resistance topenetration | Pass |
| Mass Per Area ( Basis Weight ) of Materials | D3776 (2009) | Fabric basisweight | Pass |
| Water Vapor Transmission Rate ThroughNonwovens and Plastic Films | WSP70.4 (2008) | Water VaporTransmission | Pass |
| Degree Peel Strength of LaminatedNonwovens - Raw Materials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1(2009) | Particulate | Pass |
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Test results established that the product met the predetermined specifications.
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Substantial Equivalence Table
| Attribute | Predicate Device: K153255Aero Chrome* BreathablePerformance Surgical Gown (AAMILiquid Barrier Level 4) | Device under submission: AeroChrome* Select BreathablePerformance Surgical Gown(AAMI Liquid Barrier Level 4) |
|---|---|---|
| Indicationsfor Use | The Aero Chrome* BreathablePerformance Surgical Gowns aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect both thepatient and the healthcare worker fromthe transfer of microorganisms, bodyfluids, and particulate matter. The AeroChrome* Breathable PerformanceSurgical Gowns meet the Level 4requirements of the AAMI PB70:2012Liquid Barrier classifications.The Aero Chrome* BreathablePerformance Surgical Gowns are alsosold as bulk non-sterile, single useitems, to repackager/relabelerestablishments for further packagingand Ethylene Oxide (EtO) sterilization | The Aero Chrome* Select BreathablePerformance Surgical Gowns aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect both thepatient and the healthcare worker from thetransfer of microorganisms, body fluids,and particulate matter. The AeroChrome* Select BreathablePerformance Surgical Gowns meet theLevel 4 requirements of the AAMIPB70:2012 Liquid Barrier classifications. |
| Howsupplied | Sterile (10-6) or bulk non-sterile | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| SAL | 10-6 | Same |
| Gown color | Gray | Same |
| Gown sizes | Small, Large, X-Large, XX-Large,XXX-Large, L X-Long, XXL X- Long | Large, X-Large, and XX-Large |
| ConstructionOverview | The Aero Chrome* surgical gownsunder submission are manufacturedfrom a moisture-vapor breathable,repellent, non-woven fabric using apolymer blend of polypropylene andpolyethylene. The front body andsleeve fabric is a three-layer filmlaminate. This fabric is an SFSMSdesign Spunbond/Film/Spunbond-Meltblown-Spunbond that is adhesivelybonded together. The Aero Chrome*surgical gowns in the critical zone meetAAMI-4 liquid barrier requirements,while back of gown in the non-criticalzone is composed of a breathable SMSfabric with an AAMI level 1 liquidbarrier protection. | Same, except the fabric on the back ofthe gown in the non-critical zone is madewith the same Spunbond/Film/Spunbond-Meltblown-Spunbond fabric (SFSMS) asused on the front of the gown in thecritical zone. This fabric on the back ofthe gown in the non-critical zone meetsASTM F1671.Overall finished gown dimensions are notchanging from the predicate device. |
| Not madewith NaturalRubberLatex | Yes | Same |
| Attribute | Predicate Device: Aero Chrome* Performance Surgical Gown | Device under submission in this 510(k): Aero Chrome Select Breathable Performance Surgical Gowns (AAMI Liquid Barrier Level 4) |
| Performance Testing in Critical Zone | ANSI/AAMI PB70: 2012 Level 4 Liquid Barrier Requirements - Pass | Same |
| WSP 70.4 (STM-00164)-Water Vapor Transmission Rate - Pass | Same | |
| WSP 160.1 (STM-00353) Test Method for Resistance to Linting: Dry Particle Generation with a Modified Gelbo Flex Unit -Pass | Same | |
| ASTM D 5034 - 2009 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) - Pass | Same | |
| ASTM F1670:2008 for fabric in critical zone-Pass | Same | |
| STM- 00149 (WSP 20.5 2008), Abrasion Resistance Test - Pass | Same | |
| Biocompatibility per ISO 10993 – Pass, the device under the conditions of the study is non-cytotoxic, non-irritant, and non-sensitizing. | Same, device under the conditions of the study was non-cytotoxic, non-irritant, and non-sensitizing. | |
| 16 CFR, Chapter II--Consumer Product Safety Commission Part 1610 -Standard for The Flammability of Clothing Textiles Class I - Pass | Same | |
| Laser Ignition Resistance/ ISO 11810- Pass | Same | |
| Performance Testing on fabric in Non-Critical Zone on back of gown | AAMI level 1-Pass |
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Performance Testing
Conclusion The performance testing submitted for the Aero Chrome* Select Breathable Performance Surgical Gown demonstrates substantial equivalence to the predicate Aero Chrome* Breathable Performance Surgical Gown (K153255) in intended use, design, materials, performance, and biocompatibility attributes. Based on the comparisons to the predicate device, the subject device described in this 510(k) Summary, Aero Chrome* Select Breathable Performance Surgical Gown, does not raise any different questions or new issues of safety and effectiveness.
*Registered Trademark or Trademark of Halyard Health, Inc., or its affiliates.
§ 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.