(184 days)
Not Found
No
The device is a surgical gown and the summary focuses on material properties and barrier performance, with no mention of AI/ML.
No.
The device is a surgical gown, intended for protection against microorganisms, body fluids, and particulate matter, not for treating or curing a disease or condition.
No
This device is a surgical gown, which is a protective barrier for healthcare professionals, not a diagnostic tool used to identify medical conditions.
No
The device description clearly states it is a "single use, disposable medical device" made of fabric with a specific layered design (SFSMS). The performance studies listed are all related to the physical properties and barrier performance of the fabric, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting healthcare professionals and patients from the transfer of microorganisms, body fluids, and particulate matter. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the material composition and barrier properties of the gown.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies listed evaluate the physical properties and barrier performance of the gown (flammability, cytotoxicity, irritation, barrier levels, tensile strength, etc.), not diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Surgical gowns, while medical devices, do not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
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.
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 professionals
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)
Non-Clinical Testing:
- Standard for the Flammability for Clothing Textiles (16 CFR 1610): Flammability - Pass
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Cytotoxicity - Pass, under the conditions of the study non-cytotoxic
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Skin Irritation Study - Pass, under the conditions of the study a negligible irritant
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Sensitization Test - Pass, under the conditions of the study non-sensitizing
- ISO 10993-7:2008, Ethylene Oxide sterilization residuals: EO residuals - Pass
- Laser Ignition Resistance (ISO 11810-1 (2005)): Laser resistance - Pass
- AAMI Liquid Barrier Performance in Critical Zone (body, sleeves, and ties) (AAMI PB70:2012 Level 4): Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage - Pass
- AAMI Liquid Barrier Performance Level 1 in non-critical raglan sleeve to shoulder seams (AAMI PB70:2012 Level 1): Water resistance - Pass
- Liquid Barrier Performance in Non-Critical Zone fabric on the back of gown (ASTM F1671): Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage - Pass
- Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens (ASTM D5034 (2009)): Tensile Strength - Pass
- Abrasion Resistance and Surface Bonding of SMS Laminates (WSP 20.5 (2008)): Abrasion resistance - Pass
- Synthetic Blood Penetration (fabric only in critical and non-critical zone) (ASTM-1670-08 (2008)): Resistance to penetration - Pass
- Mass Per Area (Basis Weight) of Materials (D3776 (2009)): Fabric basis weight - Pass
- Water Vapor Transmission Rate Through Nonwovens and Plastic Films (WSP 70.4 (2008)): Water Vapor Transmission - Pass
- Degree Peel Strength of Laminated Nonwovens - Raw Materials (STM-00197(2010)): Peel Strength - Pass
- Resistance to Linting Dry Particle Generation (INDA WSP 160.1 (2009)): Particulate - Pass
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.
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
§ 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/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.
1
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
2
| 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 and | |||
| Human Services Food and | |||
| Drug Administration | |||
| Office of Chief Information | |||
| Officer Paperwork | |||
| Reduction Act (PRA) Staff | |||
| PRAStaff@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 | EF | |
| PSC Publishing Services (301) 443-6740 |
3
510(k) Summary
| Date Summary
| was Prepared: | April 14, 2017 |
|---|---|
| 510(k) | |
| Submitter: | David M. Lee, JD |
| Associate Director of Regulatory Affairs | |
| HALYARD HEALTH | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| 470 448 5182 | |
| David.lee@hyh.com | |
| Primary Contact | |
| for this 510(k) | |
| Submission: | David M. Lee, JD |
| Associate Director of Regulatory Affairs, | |
| HALYARD HEALTH | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| 470 448 5182 | |
| David.lee@hyh.com | |
| Device Trade | |
| Name: | Aero Chrome* Select Breathable Performance Surgical Gown |
| (hereinafter described as "Aero Chrome* Select") | |
| Device Common | |
| Names | Surgical Gown |
| Regulation: | 878.4040 |
| Device Product | |
| Codes and | |
| Classification | |
| Names: | FYA |
| Class II | |
| Surgical Apparel | |
| Predicate Device | The Aero Chrome* Select Breathable Performance Surgical |
| Gown under submission is substantially equivalent to the | |
| predicate device, the Aero Chrome* Breathable Performance | |
| Surgical Gown (K153255). | |
| Device | |
| Description: | 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 |
4
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* Select | |
| Breathable Performance | ||
| Surgical Gown | Large | |
| 44706 | Aero Chrome* Select | |
| Breathable Performance | ||
| Surgical Gown | X Large | |
| 44707 | Aero Chrome* Select | |
| Breathable Performance | ||
| Surgical Gown | XX Large |
NON-STERILE CODES
| PRODUCT STOCK CODE | DESCRIPTION | SIZE |
|---|---|---|
| 44696NS | Aero Chrome* Select | |
| Breathable Performance | ||
| Surgical Gown | Large | |
| 44697NS | Aero Chrome* Select | |
| Breathable Performance | ||
| Surgical Gown | X Large | |
| 44698NS | Aero Chrome* Select | |
| Breathable Performance | ||
| Surgical Gown | XX Large |
Summary of Non-Clinical Testing
| Standard or Reference | Test Method | Data
Generated | Meets
Requirement |
|--------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Standard for the Flammability for Clothing
Textiles | 16 CFR 1610 | Flammability | Pass |
| Standard or Reference | Test Method | Data
Generated | Meets
Requirement |
| ISO 10993-5:2009 Biological Evaluation of
Medical Devices-Part 5: | Cytotoxicity | Cytotoxicity | Pass, under the
conditions of the
study non-
cytotoxic |
| ISO 10993-10:2010 Biological Evaluation of
Medical Devices-Part 10 | Skin Irritation
Study | Irritation | Pass, under the
conditions of the
study a
negligible irritant |
| ISO 10993-10:2010 Biological Evaluation of
Medical Devices-Part 10 | Sensitization Test | Sensitization | Pass, under the
conditions of the
study non-
sensitizing |
| ISO 10993-7:2008, Ethylene Oxide
sterilization residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser
resistance | Pass |
| AAMI Liquid Barrier Performance in Critical
Zone
(body, sleeves, and ties) | AAMI PB70:2012
Level 4 | Resistance to
Penetration by
Blood-Borne
Pathogens
Using Phi-X174
Bacteriophage | Pass |
| AAMI Liquid Barrier Performance Level 1 in
non-critical raglan sleeve to shoulder seams | AAMI PB70:2012
Level 1 | Water
resistance | Pass |
| Liquid Barrier Performance in Non-Critical
Zone fabric on the back of gown | ASTM F1671 | Resistance to
Penetration by
Blood-Borne
Pathogens
Using Phi-X174
Bacteriophage | Pass |
| Grab Tensile, Peak Stretch, and Peak
Energy - Nonwovens | ASTM D5034
(2009) | Tensile
Strength | Pass |
| Abrasion Resistance and Surface Bonding of
SMS Laminates | WSP 20.5 (2008) | Abrasion
resistance | Pass |
| Synthetic Blood Penetration
(fabric only in critical and non-critical zone) | ASTM-1670-08
(2008) | Resistance to
penetration | Pass |
| Mass Per Area ( Basis Weight ) of Materials | D3776 (2009) | Fabric basis
weight | Pass |
| Water Vapor Transmission Rate Through
Nonwovens and Plastic Films | WSP
70.4 (2008) | Water Vapor
Transmission | Pass |
| Degree Peel Strength of Laminated
Nonwovens - Raw Materials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1
(2009) | Particulate | Pass |
5
Test results established that the product met the predetermined specifications.
6
Substantial Equivalence Table
| Attribute | Predicate Device: K153255
Aero Chrome* Breathable
Performance Surgical Gown (AAMI
Liquid Barrier Level 4) | Device under submission: Aero
Chrome* Select Breathable
Performance Surgical Gown
(AAMI Liquid Barrier Level 4) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Aero Chrome* 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* Breathable Performance
Surgical Gowns meet the Level 4
requirements of the AAMI PB70:2012
Liquid Barrier classifications.
The Aero Chrome* Breathable
Performance Surgical Gowns are also
sold as bulk non-sterile, single use
items, to repackager/relabeler
establishments for further packaging
and Ethylene Oxide (EtO) sterilization | 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. |
| How
supplied | Sterile (10-6) or bulk non-sterile | Same |
| Sterilization
Method | 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 |
| Construction
Overview | The Aero Chrome* surgical gowns
under submission are manufactured
from a moisture-vapor breathable,
repellent, non-woven fabric using a
polymer blend of polypropylene and
polyethylene. The front body and
sleeve fabric is a three-layer film
laminate. This fabric is an SFSMS
design Spunbond/Film/Spunbond-
Meltblown-Spunbond that is adhesively
bonded together. The Aero Chrome*
surgical gowns in the critical zone meet
AAMI-4 liquid barrier requirements,
while back of gown in the non-critical
zone is composed of a breathable SMS
fabric with an AAMI level 1 liquid
barrier protection. | Same, except the fabric on the back of
the gown in the non-critical zone is made
with the same Spunbond/Film/Spunbond-
Meltblown-Spunbond fabric (SFSMS) as
used on the front of the gown in the
critical zone. This fabric on the back of
the gown in the non-critical zone meets
ASTM F1671.
Overall finished gown dimensions are not
changing from the predicate device. |
| Not made
with Natural
Rubber
Latex | 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 |
7
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.