(293 days)
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.
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.
The provided document is a 510(k) premarket notification for the GORE TIPS Set, a medical device used for transjugular liver access. It primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies.
Therefore, the document does NOT contain information regarding:
- A table of acceptance criteria and reported device performance: The document lists design verification and validation tests, but it does not specify acceptance criteria (e.g., quantitative thresholds) for these tests or report specific numerical performance results. It only states that the device "meets the requirements in the applicable standards and specifications."
- Sample sizes used for the test set and data provenance: While non-clinical tests were performed, the sample sizes and the origin of any data (beyond the device manufacturer) are not provided.
- Number of experts and their qualifications for ground truth: No expert involvement is mentioned in establishing ground truth for a test set, as no clinical study was performed.
- Adjudication method for the test set: Not applicable as no clinical test set requiring adjudication was used.
- MRMC comparative effectiveness study: No MRMC study was conducted.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Ground truth, in the sense of clinical outcomes or expert consensus for a diagnostic task, is not applicable here as no clinical study for performance was conducted. The "ground truth" for the non-clinical tests would be the established engineering and material standards.
- Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
- How ground truth for the training set was established: Not applicable.
What the document does describe is an argument for substantial equivalence based on technical principles, materials, intended use, and a review of existing scientific literature and standards, rather than a de novo clinical performance study.
The core of the "proof" is based on:
- Bench Testing (Non-Clinical Information): A series of design verification and validation tests were performed (listed in Table 5-2 and Table 5-3). These tests assess physical characteristics, mechanical properties, and compatibility with other devices. The document states that the "test results demonstrate that the GORE® TIPS Set meets the requirements in the applicable standards and specifications." While specific numerical acceptance criteria and results are not provided, the implication is that the device performed within acceptable limits defined by those standards.
- Biocompatibility Testing: Tests were performed in accordance with ISO 10993-1, demonstrating the device is biocompatible. The specific tests performed are listed (Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, Complement Activation Assay, Thromboresistance). This indicates adherence to established safety standards for biological interaction.
- Comparison to Predicate Devices: The primary argument for substantial equivalence is a detailed comparison (Table 5-1) of the GORE TIPS Set to two legally marketed predicate devices (Cook® Medical Flexor® Check-Flo II® Introducer Set and Cook® Medical Needle Catheter Combination). This comparison covers:
- Clinical Comparison: Principle of operation, intended use, contraindications, single use, supplied sterile. The document states that the clinical use, designs, principles of operation, and materials are "the same" or "similar."
- Technical and Biological Comparison: Device description, introducer sheath compatibility, working length, curve angle, composition, dilator ID/guidewire compatibility, material, needle gauge, working length, curve angle, material, needle guide ID/guidewire compatibility, material, and adherence to various ISO standards (ISO 10555-1, ISO 11070, ISO 9626, ISO 10993-1, ISO 11607-1, etc.).
- Conclusion of Equivalence: The document explicitly states, "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 summary, the "study" proving the device meets criteria is primarily a non-clinical, comparative assessment against established predicate devices and relevant industry standards, rather than a clinical trial with a defined test set, expert ground truth, or statistical performance metrics as typically seen for (e.g., AI/diagnostic) devices.
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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.
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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 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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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,Parkmore West,Galway, Ireland |
| Regulatory Contact: | Orla HickeyRegulatory Affairs SpecialistCreganna MedicalParkmore WestGalway, IrelandTel: + 91 783438Email: Regulatory@creganna.comEmail: 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
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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
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- 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.
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| GORE® TIPS SetGORE® TIPS SheathGORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®Introducer Set(component of the Haskal TransjugularIntrahepatic Portal Access Set) | Cook® Medical Needle CatheterCombination | |
|---|---|---|---|
| Manufacturer | Creganna Medical | Cook® Medical | Cook® Medical |
| CE Mark | In progress | Yes | Yes |
| FDAClearance/Approval | N/A | YesK142829 The Flexor® Check-Flo II®IntroducerHaskal Transjugular Intrahepatic Portal AccessSet (possible pre-amendment device) | Yes(possible pre-amendment device) |
| Clinical Comparison | |||
| Principle ofOperation | To achieve the intended use of the GORE®TIPS Set, first access to the jugular vein usingstandard access techniquesThe Introducer sheath and dilator are insertedover the guidewire, advanced, and positionedin the hepatic vein and the dilator is removed.The needle and guide catheter is inserted intothe introducer sheath and the Needle is usedto puncture the hepatic vein, liverparenchyma and the portal vein. | To achieve the intended use of the FlexorCheck-Flo II Introducer, access to the targetvein should be gained using standard accesstechniques.The Introducer sheath and dilator areinserted over the guidewire, advanced, andpositioned as required, the dilator isremoved. | The needle and guide catheter areinserted into the introducer sheath andthe Needle is used to puncture thehepatic vein, liver parenchyma and theportal vein. |
| Intended Use | The GORE® TIPS Set, GORE® TIPS Sheath andGORE® TIPS Needle, are intended to be usedtogether for percutaneous transjugular liver | Introducers are intended for the introductionof balloons, closed and non-tapered end | Needles are used to puncture where anative opening is not present. |
| GORE® TIPS Set | Cook® Medical Flexor® Check-Flo II®Introducer Set(component of the Haskal TransjugularIntrahepatic Portal Access Set) | Cook® Medical Needle CatheterCombination | |
| GORE® TIPS SheathGORE® TIPS Needle | |||
| procedures in patients undergoing aTransjugular Intrahepatic Portosystemic Shunt(TIPS) procedure. | catheters or other diagnostic aninterventional devices.The Haskal Transjugular Intrahepatic PortalAccess Set is intended for transjugular liveraccess in diagnostic and interventionalprocedures. | In this case, the Needle is used topuncture the hepatic vein, liverparenchyma and the portal vein. | |
| Contraindications | There are no known contraindications forthese 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®TIPS Sheath and the GORE® TIPS Needle,which may be supplied together orindividually.The GORE® TIPS Sheath consists of anintroducer sheath with a hemostatic valve anda dilator.The GORE® TIPS Needle consists of a stainlesssteel hollow shaft with a Needle tip and aguiding catheter. | The Flexor® Check-Flo II® Introducer consistsof an introducer sheath with a hemostaticvalve and a dilator. | The Needle Catheter Combinationconsists of a stainless steel hollow shaftwith a Needle tip and a guiding catheter. |
| GORE® TIPS SetGORE® TIPS SheathGORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®Introducer Set(component of the Haskal TransjugularIntrahepatic Portal Access Set) | Cook® Medical Needle CatheterCombination | |
| Introducer SheathCompatibility | 10Fr | 10Fr | N/A |
| Introducer SheathWorking Length (cm) | Introducer Sheath: 40cmDilator: 47cm | Introducer Sheath: 38.5cmDilator - not referenced | N/A |
| Introducer SheathCurve angle | 35° | N/A | N/A |
| Sheath composition | PTFE LinerSS CoilPt/IR markerbandPebax 6333 JacketGrilamid hubHemostasis seal | LinerCoilRadiopaque markerbandNylon JacketPolymer hubHemostasis seal | N/A |
| Dilator ID /GuidewireCompatibility | ≤ 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 TransjugularIntrahepatic Portal Access Set) | |||
| GORE® TIPS Needle | |||
| HDPE Hub | Polymer Hub | ||
| Needle Gauge | 16Ga | N/A | 16Ga |
| Needle WorkingLength (cm) | Needle: 56cmNeedle Guide: 49cm | N/A | Needle: 50.5cmNeedle Guide 45.5cm |
| Needle Curve angle | 35° | N/A | N/A |
| Needle Material | 304 Stainless SteelGrilamid Hub | N/A | Stainless Steel HypotubeStainless steel hub |
| Needle Guide ID /GuidewireCompatibility | ≤ 0.035" | N/A | N/A |
| Needle GuideMaterial | MDPE ExtrusionHDPE Hub | N/A | Polymer ExtrusionSS Hub |
| ISO 10555-1 | Needle, Needle guide and Dilator meetrequirements | 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 TransjugularIntrahepatic Portal Access Set) | ||
| ISO 9626 | Needle Meets requirements | N/A | Meets requirements |
| BiocompatibilityISO 10993-1 | Meets ISO requirements for externallycommunicating, circulating blood, limitedcontact (<24 hours) | Meets Requirements | Meets Requirements |
| Shelf-Life | 1 years | 3 years | 3 years |
| Packaging / ShippingISO 11607-1, ISO11607-2, ASTMD4169 | Meets Requirements | Meets Requirements | Meets Requirements |
| Clinical,Technological,BiologicalEquivalence | Yes | Yes | Yes |
| Justification forEquivalence | Designed and manufactured using the sameor similar standards. | Designed and manufactured using thesame or similar standards. | |
| Manufactured using the same or similarmaterials used in the same anatomicallocation | Manufactured using the same or similarmaterials used in the same anatomicallocation | ||
| Technological characteristics such as size aresimilar. | Technological characteristics such as size aresimilar. | ||
| GORE® TIPS SetGORE® TIPS SheathGORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®Introducer Set(component of the Haskal TransjugularIntrahepatic Portal Access Set) | Cook® Medical Needle CatheterCombination | |
| - | Similar biological characteristics. | Similar biological characteristics. | |
| - | Similar clinical performance, patientpopulations, intended use and principle ofoperation. | Similar clinical performance, patientpopulations, intended use and principleof operation. |
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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
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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,Needle Hub and Needle Guide Hub |
| System Leak (Pressure Integrity) | System Leak (Pressure Integrity) |
| Bonds Strength of Assembled Components,Dilator Hub Sheath Hubs and Introducer SheathShaft. | Needle Shaft Marker |
| Sheath/Dilator Interface | Needle and Needle Guide Directional Indicator |
| Visual Appearance | Visual Appearance |
Table 5-2: List of Design Verification Tests
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| Design Validation Tests | |
|---|---|
| Sheath and Dilator | Needle and Needle Guide |
| Distinguishable feature between the Dilator andNeedle Guide Components | Needle Guide Curvature |
| Sheath Deliverability (Push, Track, andWithdrawal) | Needle and Needle Guide Deliverability (Push,Track, and Withdrawal) |
| Dilator Shaft and Tip Deliverability (Push, Track,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) NeedleCompatibility. | Guidewire Compatibility |
| VIATORR® Access Sleeve - Black Mark Alignment | Introducer compatibility |
| VIATORR® Loading Tool - Bottoms out distal tothe 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.
§ 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).