GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

{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 an image of three stylized human profiles facing to the right, with a design that resembles an eagle or bird in flight above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 21, 2016 Creganna Medical Ms. Orla Connaughton Director of Regulatory Affairs Parkmore West Galway, Ireland Re: K152913 Trade/Device Name: GORE TIPS Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 14, 2016 Received: June 17, 2016 Dear Ms. Connaughton: 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) K152913 Device Name GORE TIPS Set #### Indications for Use (Describe) The GORE TIPS Set, GORE TIPS Sheath and GORE TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> </span> </span> </span> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> </span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Both words are in blue. #### 510(k) Summary #### General Information | Date: | 21 July 2016 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification: | Class II, 21 CFR 870.1340, Catheter Introducer | | Trade Name: | GORE® TIPS SET | | Common Name: | Catheter Introducer | | Model Numbers: | 142097-01, 142098-01, 142099-01 | | Submitter: | Creganna Medical,<br>Parkmore West,<br>Galway, Ireland | | Regulatory Contact: | Orla Hickey<br>Regulatory Affairs Specialist<br>Creganna Medical<br>Parkmore West<br>Galway, Ireland<br>Tel: + 91 783438<br>Email: Regulatory@creganna.com<br>Email: Orla.Hickey@creganna.com | #### Intended Use The GORE® TIPS Set, GORE® TIPS Sheath and GORE® TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. #### Predicate Device - . Cook® Medical Flexor® Check-Flo II® Introducer Set, K142829 (component of the Haskal Transjugular Intrahepatic Portal Access Set) - . Cook® Medical Needle Catheter Combination {4}------------------------------------------------ #### Device Description The GORE® TIPS Set consists of the GORE® TIPS Sheath and the GORE® TIPS Needle, which may be supplied together or individually. #### GORE® TIPS Sheath: Transjugular Liver Access Introducer Sheath and Dilator: The GORE® TIPS Sheath consists of a flexible introducer sheath with a hemostatic valve and a dilator. The introducer sheath includes an inner PTFE layer, a stainless steel coil and an outer jacket. The dilator has a tapered leading end and provides dilatation of the access vessel. The dilator hub has a direction indicator to allow identification of the leading end curvature direction. The dilator hub may be locked into place in the hub of the introducer sheath to prevent the dilator backing out of the sheath. #### GORE® TIPS Needle: Transjugular Liver Access Needle and Guiding Catheter: The GORE® TIPS Needle consists of a stainless steel hollow shaft and a guiding catheter. The needle handle has a direction indicator to allow identification of the leading end curvature direction. The guiding catheter has a tapered leading end and provides protection around the sharp needle tip during vascular access. A white needle status band printed on the trailing end of the needle shaft ensures correct positioning of the guiding catheter around the needle shaft when covering the sharp needle tip. The guiding catheter hub has a direction indicator that identifies the leading end curvature direction. The set is supplied as a single use sterile device. #### Materials The Creganna Medical GORE® TIPS Set is comprised of materials that are commonly used in medical device applications, including implantable medical devices. The biological safety tests performed in accordance with ISO 10993-1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing) for external communicating devices, circulating blood, limited duration demonstrate that the device is biocompatible for its intended use. The tests performed to demonstrate the biocompatibility of the device were: - l Cytotoxicity - . Sensitization - . Intracutaneous Reactivity/Irritation {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the text "CREGANNA MEDICAL" in blue font. The word "CREGANNA" is on the top line and is larger than the word "MEDICAL" which is on the second line. The text appears to be a logo or brand name. - I Acute Systemic Toxicity - I Material Mediated Pyrogenicity - . Hemocompatibility - 트 Complement Activation Assay - 트 Thromboresistance #### Summary of the Technological Characteristics of GORE TIPS Set compared to the Predicate Device The GORE® TIPS Set and the equivalent commercialized predicate devices Cook® Medical Flexor® Check Flo® Introducer Set and Cook® Medical Needle Catheter Combination were evaluated for substantial equivalence in accordance with 510(k) "Substantial Equivalence" Decision-Making Process, as outlined in ODE Guidance Document No. K86-3, "Guidance on the CDRH Premarket Notification Review Program". The critical predictors of device safety and performance are compared utilizing clinical, technical and biological criteria. In summary, no significant difference in clinical, technical and biological parameters was identified between the GORE® TIPS Set and the Cook® Medical Flexor® Check Flo® Introducer Set and Cook® Medical Needle Catheter Combination. In fact, the clinical use of these devices is the same; they are used in the same locations within the body and have similar clinical performance criteria. These devices have similar designs and principles of operations and the materials that are used meet the same biological standards. Based on this and the design and engineering data provided, the GORE® TIPS Set has been shown to be substantially equivalent to the commercialized Cook® Medical Flexor® Check Flo® Introducer Set and Cook® Medical Needle Catheter Combination devices. {6}------------------------------------------------ | | GORE® TIPS Set<br>GORE® TIPS Sheath<br>GORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®<br>Introducer Set<br>(component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter<br>Combination | |--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Creganna Medical | Cook® Medical | Cook® Medical | | CE Mark | In progress | Yes | Yes | | FDA<br>Clearance/Approval | N/A | Yes<br>K142829 The Flexor® Check-Flo II®<br>Introducer<br>Haskal Transjugular Intrahepatic Portal Access<br>Set (possible pre-amendment device) | Yes<br>(possible pre-amendment device) | | Clinical Comparison | | | | | Principle of<br>Operation | To achieve the intended use of the GORE®<br>TIPS Set, first access to the jugular vein using<br>standard access techniques<br>The Introducer sheath and dilator are inserted<br>over the guidewire, advanced, and positioned<br>in the hepatic vein and the dilator is removed.<br>The needle and guide catheter is inserted into<br>the introducer sheath and the Needle is used<br>to puncture the hepatic vein, liver<br>parenchyma and the portal vein. | To achieve the intended use of the Flexor<br>Check-Flo II Introducer, access to the target<br>vein should be gained using standard access<br>techniques.<br>The Introducer sheath and dilator are<br>inserted over the guidewire, advanced, and<br>positioned as required, the dilator is<br>removed. | The needle and guide catheter are<br>inserted into the introducer sheath and<br>the Needle is used to puncture the<br>hepatic vein, liver parenchyma and the<br>portal vein. | | Intended Use | The GORE® TIPS Set, GORE® TIPS Sheath and<br>GORE® TIPS Needle, are intended to be used<br>together for percutaneous transjugular liver | Introducers are intended for the introduction<br>of balloons, closed and non-tapered end | Needles are used to puncture where a<br>native opening is not present. | | | GORE® TIPS Set | Cook® Medical Flexor® Check-Flo II®<br>Introducer Set<br>(component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter<br>Combination | | | GORE® TIPS Sheath<br>GORE® TIPS Needle | | | | | procedures in patients undergoing a<br>Transjugular Intrahepatic Portosystemic Shunt<br>(TIPS) procedure. | catheters or other diagnostic an<br>interventional devices.<br><br>The Haskal Transjugular Intrahepatic Portal<br>Access Set is intended for transjugular liver<br>access in diagnostic and interventional<br>procedures. | In this case, the Needle is used to<br>puncture the hepatic vein, liver<br>parenchyma and the portal vein. | | Contraindications | There are no known contraindications for<br>these devices. | None known. | Unknown. | | Single Use | Yes | Yes | Yes | | Supplied Sterile | Yes | Yes | Yes | | Technical and Biological Comparison | | | | | Device Description | The GORE® TIPS Set consists of the GORE®<br>TIPS Sheath and the GORE® TIPS Needle,<br>which may be supplied together or<br>individually.<br>The GORE® TIPS Sheath consists of an<br>introducer sheath with a hemostatic valve and<br>a dilator.<br>The GORE® TIPS Needle consists of a stainless<br>steel hollow shaft with a Needle tip and a<br>guiding catheter. | The Flexor® Check-Flo II® Introducer consists<br>of an introducer sheath with a hemostatic<br>valve and a dilator. | The Needle Catheter Combination<br>consists of a stainless steel hollow shaft<br>with a Needle tip and a guiding catheter. | | | GORE® TIPS Set<br>GORE® TIPS Sheath<br>GORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®<br>Introducer Set<br>(component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter<br>Combination | | Introducer Sheath<br>Compatibility | 10Fr | 10Fr | N/A | | Introducer Sheath<br>Working Length (cm) | Introducer Sheath: 40cm<br>Dilator: 47cm | Introducer Sheath: 38.5cm<br>Dilator - not referenced | N/A | | Introducer Sheath<br>Curve angle | 35° | N/A | N/A | | Sheath composition | PTFE Liner<br>SS Coil<br>Pt/IR markerband<br>Pebax 6333 Jacket<br>Grilamid hub<br>Hemostasis seal | Liner<br>Coil<br>Radiopaque markerband<br>Nylon Jacket<br>Polymer hub<br>Hemostasis seal | N/A | | Dilator ID /<br>Guidewire<br>Compatibility | ≤ 0.035" | ≤ 0.035" | N/A | | Dilator material | HDPE Extrusion | Polymer Extrusion | N/A | | | GORE® TIPS Set | Cook® Medical Flexor® Check-Flo II® | Cook® Medical Needle Catheter | | | GORE® TIPS Sheath | Introducer Set | Combination | | | | (component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | | | | GORE® TIPS Needle | | | | | HDPE Hub | Polymer Hub | | | Needle Gauge | 16Ga | N/A | 16Ga | | Needle Working<br>Length (cm) | Needle: 56cm<br>Needle Guide: 49cm | N/A | Needle: 50.5cm<br>Needle Guide 45.5cm | | Needle Curve angle | 35° | N/A | N/A | | | | | | | Needle Material | 304 Stainless Steel<br>Grilamid Hub | N/A | Stainless Steel Hypotube<br>Stainless steel hub | | Needle Guide ID /<br>Guidewire<br>Compatibility | ≤ 0.035" | N/A | N/A | | Needle Guide<br>Material | MDPE Extrusion<br>HDPE Hub | N/A | Polymer Extrusion<br>SS Hub | | ISO 10555-1 | Needle, Needle guide and Dilator meet<br>requirements | Meets requirements | Meets requirements | | ISO 11070 | Introducer Sheath meets requirements | Meets requirements | N/A | | | GORE® TIPS Set | Cook® Medical Flexor® Check-Flo II® | Cook® Medical Needle Catheter | | | GORE® TIPS Sheath | Introducer Set | Combination | | | GORE® TIPS Needle | (component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | | | ISO 9626 | Needle Meets requirements | N/A | Meets requirements | | Biocompatibility<br>ISO 10993-1 | Meets ISO requirements for externally<br>communicating, circulating blood, limited<br>contact (<24 hours) | Meets Requirements | Meets Requirements | | Shelf-Life | 1 years | 3 years | 3 years | | Packaging / Shipping<br>ISO 11607-1, ISO<br>11607-2, ASTM<br>D4169 | Meets Requirements | Meets Requirements | Meets Requirements | | Clinical,<br>Technological,<br>Biological<br>Equivalence | Yes | Yes | Yes | | Justification for<br>Equivalence | | Designed and manufactured using the same<br>or similar standards. | Designed and manufactured using the<br>same or similar standards. | | | | Manufactured using the same or similar<br>materials used in the same anatomical<br>location | Manufactured using the same or similar<br>materials used in the same anatomical<br>location | | | | Technological characteristics such as size are<br>similar. | Technological characteristics such as size are<br>similar. | | | GORE® TIPS Set<br>GORE® TIPS Sheath<br>GORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®<br>Introducer Set<br>(component of the Haskal Transjugular<br>Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter<br>Combination | | | - | Similar biological characteristics. | Similar biological characteristics. | | | - | Similar clinical performance, patient<br>populations, intended use and principle of<br>operation. | Similar clinical performance, patient<br>populations, intended use and principle<br>of operation. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the words "CREGANNA MEDICAL" in a blue serif font. The word "CREGANNA" is in a larger font size and is placed above the word "MEDICAL". The word "MEDICAL" is in a smaller font size and is placed below the word "CREGANNA". {11}------------------------------------------------ # CREGA Parkmore West Galway, Ireland Tel: +353 91 757 801 Fax: +353 91 757 850 www.creganna.com Table 5-1 Substantial Equivalence Comparison Table of Proposed Device and Predicate Device {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for "CREGANNA MEDICAL". The text is in a blue serif font. The word "CREGANNA" is on the top line, and the word "MEDICAL" is on the bottom line. #### Non Clinical Information The determination of substantial equivalence is also based on an assessment of non-clinical engineering tests, as listed in Table 5-2 and Table 5-3. | Design Verification Tests | | |----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Sheath and Dilator | Needle and Needle Guide | | Sheath Length | Needle Length | | Sheath Size Diameter | Needle Size Diameter(s) | | Introducer Sheath Curvature | Needle Curvature | | Dilator Working Length | Needle Tip Geometry | | Dilator ID | Needle Guide Length | | Dilator Shaft OD and Tip Geometry | Needle Guide Outer Diameter (OD) | | Dilator Curvature | Needle Guide Inner Diameter (ID) | | Flushing port tubing and 3 Way Stopcock | Needle Guide Curvature | | Sheath Hub Seal | Needle Hub Directional Indicator | | Dilator Directional Indicator | Needle Guide Hub Directional Indicator | | Introducer Sheath Directional Indicator | Needle Puncture Force | | Sheath Kink Resistance | Needle Puncture Force | | Valve Hemostasis | Bond Strengths of Assembled Components,<br>Needle Hub and Needle Guide Hub | | System Leak (Pressure Integrity) | System Leak (Pressure Integrity) | | Bonds Strength of Assembled Components,<br>Dilator Hub Sheath Hubs and Introducer Sheath<br>Shaft. | Needle Shaft Marker | | Sheath/Dilator Interface | Needle and Needle Guide Directional Indicator | | Visual Appearance | Visual Appearance | Table 5-2: List of Design Verification Tests {13}------------------------------------------------ | Design Validation Tests | | |----------------------------------------------------------------------------|-------------------------------------------------------------------------| | Sheath and Dilator | Needle and Needle Guide | | Distinguishable feature between the Dilator and<br>Needle Guide Components | Needle Guide Curvature | | Sheath Deliverability (Push, Track, and<br>Withdrawal) | Needle and Needle Guide Deliverability (Push,<br>Track, and Withdrawal) | | Dilator Shaft and Tip Deliverability (Push, Track,<br>and Withdrawal) | Needle Kink Resistance (Fatigue Resistance) | | Radiopacity | Needle Pushability / Column Strength | | Flush Port Tubing and 3 Way Stopcock | Needle Shaft Markers | | Sheath/Dilator Interface. | Needle and Needle Guide Radiopacity | | VIATORR® Device Compatibility | Needle Echogenic Performance | | Compatibility with Ancillary Devices and Fluids. | Needle / Needle Guide Interface | | Transjugular Liver Access Set (TLAS) Needle<br>Compatibility. | Guidewire Compatibility | | VIATORR® Access Sleeve - Black Mark Alignment | Introducer compatibility | | VIATORR® Loading Tool - Bottoms out distal to<br>the flush port | Needle Guide Hub Interface | | Ergonomic Sheath Hub | Needle Hub Interface | | Ergonomic Dilator Hub | Needle and Needle Guide Hub Ergonomics | | Stackable and Storable in Use Environment | Stackable and Storable in Use Environment | | Labeling Information | Labeling Information | Table 5-3: List of Design Validation Tests The test results demonstrate that the GORE® TIPS Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device. #### Clinical Information Clinical studies were not deemed necessary for the Gore® TIPS Set since bench testing and a clinical literature review were sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device. #### Summary of Substantial Equivalence Creganna Medical believes the GORE® TIPS Set is substantially equivalent to the predicate device based on the nonclinical and clinical literature review as discussed above. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products, and demonstrate that the device is substantial equivalent and performs as well as the predicate device.