(101 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No
The device is an introducer sheath designed to facilitate the insertion of other endovascular devices, not to directly treat a condition or disease.
No
This device is an introducer sheath, which provides a conduit for the insertion of endovascular devices and is not used to diagnose a medical condition.
No
The device description clearly outlines physical components such as a sheath, valve, dilator, and syringe, and the performance studies focus on bench testing of these physical attributes. There is no mention of software as a component or function of the device.
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 device is for providing a conduit for inserting endovascular devices into the vasculature and minimizing blood loss. This is a direct intervention within the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical device (sheath, valve, dilator, syringe) used for accessing and working within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Product codes
DYB
Device Description
The GORE® DrySeal Flex Introducer Sheath consists of an introducer sheath with the GORE® DrySeal Valve attached, a twist style locking dilator, and a syringe. The introducer sheath is a composite tube which consists of a flat stainless steel wire reinforced hydrophilic coated Pebax® outer tube and PTFE liner with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5 mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel while providing a smooth transition from the guidewire to the introducer sheath leading tip. The dilator is 0.035" guidewire compatible and has a locking mechanism which mates with, and secures to, the DrySeal Valve. The sheath hub is embossed with its French size and a visual marker on the trailing end of the dilator shaft that ensures correct combination of the dilator within the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
A bench study demonstrated the subject device performed as intended and was substantially equivalent to the predicate devices. The testing included:
Critical Dimensions - IDs and Lengths
Compatibility with Devices-Sheath Dimensions
Guidewire Compatibility
Sheath Tip to Dilator Transition
Radiodetectability
Tortuosity
Kink Resistance
Peak Tensile Force - Critical Junctions
Dilator to Valve Locking
Tensile Strength
Dilator Removal Force
System Freedom from Leakage
Lubricity
Particulation
Usability
Shelf life
Biocompatibility Evaluation
Animal study: No animal studies were performed.
Clinical: No clinical evaluations of this product have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
W.L. Gore & Associates, Inc. Mary Townsend Regulatory Affairs Associate 1505 North Fourth Street Flagstaff, Arizona 86004
Re: K160254
Trade/Device Name: Gore DrySeal Flex Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 8, 2016 Received: April 11, 2016
Dear Mary Townsend:
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 yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160254
Device Name GORE® DrySeal Flex Introducer Sheath
Indications for Use (Describe)
The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
| 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) |
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3
510(k) SUMMARY (Per 21CFR807.92)
510(k) Owner:
W.L. Gore & Associates, Inc. Medical Products Division 1505 North Fourth Street Flagstaff, Arizona 86004 – U.S.A.
Regulatory Contact: Mary Townsend W. L. Gore & Associates, Inc 3450 West Kiltie Lane Flagstaff, AZ 86001 Phone: 928-864-4192 928-864-4304 Fax: E-mail: mtownsen@wlgore.com
Date Prepared: January 28, 2016
Device Names/Classification
| Trade Name: | GORE® DrySeal Flex Introducer Sheath |
|---|---|
| 510k Number: | K160254 |
| Product Code: | DYB |
| 21CFR | 870.1340 |
| Classification Panel: | Cardiovascular Devices |
| Device Class: | Class II |
Predicate Devices
K121234 GORE® DrySeal Sheath with hydrophilic coating K093791 GORE® DrySeal Sheath
4
Device Description
The GORE® DrySeal Flex Introducer Sheath consists of an introducer sheath with the GORE® DrySeal Valve attached, a twist style locking dilator, and a syringe. The introducer sheath is a composite tube which consists of a flat stainless steel wire reinforced hydrophilic coated Pebax® outer tube and PTFE liner with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5 mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel while providing a smooth transition from the guidewire to the introducer sheath leading tip. The dilator is 0.035" guidewire compatible and has a locking mechanism which mates with, and secures to, the DrySeal Valve. The sheath hub is embossed with its French size and a visual marker on the trailing end of the dilator shaft that ensures correct combination of the dilator within the sheath.
Indications for Use
The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use
The intended use and indications for the GORE® DrySeal Flex Introducer Sheath device are identical to the predicate GORE® DrySeal Sheath with hydrophilic coating and GORE® DrySeal Sheath. The primary difference between the subject and predicate devices is in the expanded range of French diameters and sheath lengths, the addition of a locking dilator hub to valve mechanism and a coil reinforced, flexible sheath. There are no changes to the hemostatic mechanism of the DrySeal Valve, flush ports, valve fill ports or tubing from the predicate devices.
Performance Data / Predicate Device Comparison
A bench study demonstrated the subject device performed as intended and was substantially equivalent to the predicate devices. The testing included:
Critical Dimensions - IDs and Lengths Compatibility with Devices-Sheath Dimensions Guidewire Compatibility Sheath Tip to Dilator Transition
5
- Radiodetectability Tortuosity Kink Resistance Peak Tensile Force - Critical Junctions Dilator to Valve Locking Tensile Strength Dilator Removal Force System Freedom from Leakage Lubricity Particulation Usability Shelf life Biocompatibility Evaluation
Animal study: No animal studies were performed.
Clinical: No clinical evaluations of this product have been conducted.
Conclusion
W.L. Gore & Associates concludes that the subject GORE® DrySeal Flex Introducer is substantially equivalent to the predicate GORE® DrySeal Sheath GORE® DrySeal Sheath with hydrophilic coating and GORE® DrySeal Sheath in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance.