(257 days)
Not Found
No
The device description and performance studies focus on the physical barrier properties and construction of a surgical gown, with no mention of AI or ML technology.
No.
The device is a surgical gown, which is a protective apparel, not a therapeutic device designed to treat or cure a medical condition.
No
Explanation: The device is a surgical gown, which is a protective apparel, not a diagnostic tool. Its intended use is to protect individuals from the transfer of microorganisms, body fluids, and particulate matter.
No
The device description explicitly details the physical construction of a surgical gown made from nonwoven SMS, poly-fabric reinforcement, hook and loop closures, ties, and knitted cuffs. This indicates a physical, hardware-based medical device, not a software-only one.
No, 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 function.
- Device Description: The description focuses on the physical construction and barrier properties of the gown. It does not mention any components or processes related to testing samples outside of the body.
- Regulation: The device is regulated under 21 CFR 878.4040, which is for surgical apparel. IVDs are regulated under different sections of the CFR (typically starting with 866 or 864).
- Performance Studies: The performance studies described are related to barrier performance (liquid barrier, seams, tie attachment), not diagnostic accuracy or analytical performance.
- Lack of IVD Keywords: The document does not contain any keywords typically associated with IVDs, such as "sample," "assay," "reagent," "analyte," "diagnosis," "detection," etc.
In summary, the Medline Level 4 Surgical Gown is a protective medical device, not a device used for diagnosing conditions by testing samples outside of the body.
N/A
Intended Use / Indications for Use
The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a 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 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a Class II medical device regulated under FDA product code FYA, General & Plastic Surgery Panel, and regulation 21 CFR 878.4040. The device description of the Medline Level 4 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993.
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a single-use, sterile, disposable medical device that is provided in a variety of sizes and styles. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) constructed from nonwoven SMS (spubound, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel and on both sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) has been tested according to ANSI/AAMI PB70:2012 and meets AAMI Level 4 barrier level protection for a surgical gown.
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 / healthcare facilities, operating room 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)
Summary of Non-Clinical Testing: The final proposed finished device was tested in accordance with the Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes- August 1993, Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA- December 9, 2015, and ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Testing was performed on the body and sleeve (equivalent design/technology), sleeve seam, and tie attachment to generate the test data shown in the comparison Table 2. Additional performance testing was conducted to further characterize the device.
ISO 10993-5 Cytoxticity
ISO 10993-10 Irritation
ISO 10993-10 Sensitization
ASTM F1929-15 - Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1671 - Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens
ASTM D5034-09 (2013) - Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15 - Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D3776/D3776M-09a - Basis Weight-Mass Per Unit Area (Weight) of Fabric
ASTM D3786/D3786M-13 - Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
16 CFR 1610 - Flammability of Clothing Textiles
ASTM F1929 - Resistance to Dye Penetration Test
ANSI/AAMI/ISO 10993-7:2008(R)2012 - Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals
AATCC 42 - Water Resistance: Impact Penetration Test
ANSI/AAMI PB70:2012 - Liquid Barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The conclusions drawn from the non-clinical tests demonstrate that the Medline Level 4 Surgical Gowns (Sirus, Eclipse and Aurora) are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Kimberly-Clark (Halyard) ULTRA Fluid Barrier Surgical Gown.
Summary of Clinical Testing: Not applicable.
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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2019
Medline Industries, Inc. Pauline Maralit Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K182172
Trade/Device Name: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 26, 2019 Received: March 28, 2019
Dear Pauline Maralit:
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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -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
Indications for Use
510(k) Number (if known) K182172
Device Name
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora),
Indications for Use (Describe)
The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a 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 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
| 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."
3
Image /page/3/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters, and a white abstract star-like shape is behind the text. The star shape has four points, with the top and bottom points being longer than the side points.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
510(k) SUMMARY - K182172
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Submission Contact
Pauline Maralit Regulatory Affairs Specialist Phone: 847-949-2283 Email: pmaralit(@medline.com
Summary Preparation Date August 9, 2018
Type of 510(k) Submission Traditional
Device Name / Classification
| Regulation Name: | Surgical Apparel |
|---|---|
| Regulatory Panel: | General & Plastic Surgery |
| Regulation #: | 21 CFR 878.4040 |
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Gown |
| Proprietary Name: | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), |
| Medline Level 4 Surgical Gown (Aurora). | |
| Product Code: | FYA |
| Classification Panel: | II |
Predicate Device
PREDICATE DEVICE:
- Kimberly Clark (Halyard) ULTRA Fluid Barrier Surgical Gown 트
PREDICATE DEVICE K NUMBER:
4
Image /page/4/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white abstract star-like shape. The background is a solid dark blue. A gray bar is on the right side of the logo.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
- K080795 (Kimberly-Clark Corp./Halyard) ■
Device Description
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a Class II medical device regulated under FDA product code FYA, General & Plastic Surgery Panel, and regulation 21 CFR 878.4040. The device description of the Medline Level 4 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993.
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a single-use, sterile, disposable medical device that is provided in a variety of sizes and styles. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) constructed from nonwoven SMS (spubound, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel and on both sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) has been tested according to ANSI/AAMI PB70:2012 and meets AAMI Level 4 barrier level protection for a surgical gown.
| Item Number | Device Description | Sleeve Style | Size |
|---|---|---|---|
| DYNJP2707 | Aurora Surgical Gown, Poly Reinforced, | Set-in | Large |
| DYNJP2708 | Aurora Surgical Gown, Poly Reinforced, | Set-in | X-Large |
| DYNJP2709 | Aurora Surgical Gown, Poly Reinforced, | Set-in | XX-Large |
| DYNJP2724 | Aurora Surgical Gown, Poly Reinforced, | Set-in | Large, X-Long |
| DYNJP2725 | Aurora Surgical Gown, Poly Reinforced, | Set-in | X-Large, X-Long |
| DYNJP2726 | Aurora Surgical Gown, Poly Reinforced, | Set-in | XX-Large, X-Long |
| DYNJP2807 | Aurora Surgical Gown, Poly Reinforced, | Raglan | Large |
| DYNJP2808 | Aurora Surgical Gown, Poly Reinforced, | Raglan | X-Large |
| DYNJP2809 | Aurora Surgical Gown, Poly Reinforced, | Raglan | XX-Large |
| DYNJP220 | Eclipse Surgical Gown, Poly Reinforced | Set-in | Large |
| DYNJP2202 | Eclipse Surgical Gown, Poly Reinforced | Set-in | X-Large |
| DYNJP2203 | Eclipse Surgical Gown, Poly Reinforced | Set-in | XX-Large |
| DYNJP2204 | Eclipse Surgical Gown, Poly Reinforced | Set-in | Large, X-Long |
| DYNJP2205 | Eclipse Surgical Gown, Poly Reinforced | Set-in | X-Large, X-Long |
| DYNJP2206 | Eclipse Surgical Gown, Poly Reinforced | Set-in | XX-Large, X-Long |
| DYNJP2201S | Sirus Surgical Gown, Poly Reinforced | Set-in | Large |
| DYNJP2202S | Sirus Surgical Gown, Poly Reinforced | Set-in | X-Large |
| DYNJP2203S | Sirus Surgical Gown, Poly Reinforced | Set-in | XX-Large |
Table 1: Device Models
5
Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol placed behind and slightly above the text. The starburst has four points, with the top and bottom points being longer than the side points. There is a gray bar on the right side of the image.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
| DYNJP2204S | Sirus Surgical Gown, Poly Reinforced | Set-in | Large, X-Long |
|---|---|---|---|
| DYNJP2205S | Sirus Surgical Gown, Poly Reinforced | Set-in | X-Large, X-Long |
| DYNJP2206S | Sirus Surgical Gown, Poly Reinforced | Set-in | XX-Large, X-Long |
| DYNJP2219SL | Sirus Surgical Gown, Poly Reinforced | Set-in | XXX-Large, X-Long |
| DYNJP2601 | Sirus Surgical Gown, Poly Reinforced | Raglan | Large |
| DYNJP2602 | Sirus Surgical Gown, Poly Reinforced | Raglan | X-Large |
| DYNJP2603 | Sirus Surgical Gown, Poly Reinforced | Raglan | XX-Large |
Indications for Use
The Medline Level 4 Surgical Gown (Sirus). Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a 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 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Technological Characteristics
The final proposed finished device was tested in accordance with the Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes- August 1993, Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA- December 9, 2015, and ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Testing was performed on the body and sleeve (equivalent design/technology), sleeve seam, and tie attachment to generate the test data shown in the comparison Table 2. Additional performance testing was conducted to further characterize the device.
| Element of Comparison | Subject Device | Predicate Device | Comparison
Analysis | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------|--|
| Product Name | Medline Level 4 Surgical Gown
(Sirus), Medline Level 4 Surgical
Gown (Eclipse), Medline Level 4
Surgical Gown (Aurora) | ULTRA Fluid Barrier Surgical
Gown | Different | |
| 510(k) Reference | K182172 | K080795 | Different | |
| Product Owner | Medline Industries, Inc. | Kimberly-Clark Corp. (Halyard) | Different | |
| Product Code | FYA | FYA | Same | |
| Intended Use | The Medline Level 4 Surgical
Gown is a sterile, single use | The Kimberly-Clark* ULTRA
Surgical Gown and ULTRA Film | Similar | |
| | | | | |
| | surgical apparel intended to be | Reinforced Surgical Gown are | | |
| | worn by healthcare professionals to | sterile, single use surgical gowns | | |
| | help protect both the patient and | intended to protect surgical patients | | |
| | the healthcare worker from the | and operating room personnel from | | |
| | transfer of microorganisms, body | the transfer of | | |
| | fluids, and particulate matter. The | microorganisms, body fluids, and | | |
| | Medline Level 4 Surgical Gown | particulate material. The ULTRA | | |
| | meets the Level 4 requirements of | Surgical Gown meets Level 3 of the | | |
| | ANSI/AAMIPB70:2012 Liquid | AAMI Liquid Barrier | | |
| | barrier performance and | classifications, and the ULTRA | | |
| | classification of protective apparel | Film-Reinforced Surgical Gown | | |
| | and drapes intended for use in | meets Level 4 of the AAMI Liquid | | |
| | healthcare facilities. | Barrier classifications. | | |
| Regulation Number | | | | |
| | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Gown Color | Blue | Blue | | |
| | | | Same | |
| Design Configurations | Neck Closure: Hook and Loop | Hoop & Neck Closures | | |
| | Belt Ties | Tie Waist Closure | | |
| | Knit Cuffs | Cuffs | Similar | |
| | Reinforced Material | Film Reinforcement | | |
| | Raglan or Set-in/Standard Sleeves | Raglan Sleeves | | |
| Material Composition | Nonwoven SMS polypropylene | Nonwoven SMS polypropylene | | |
| | Anti-Static, Repellency | Anti-Static, Repellency | | |
| | Poly-Reinforcement Film | Film Reinforcement | Same | |
| | White Knitted Cuffs | Cuffs | | |
| Prescription vs. OTC | OTC | OTC | Same | |
| | | | | |
| Contact Durations | Surface, Intact,