K Number

Device Name

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Manufacturer

CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL

Date Cleared

2016-07-21

(293 days)

Product Code

DYB

Regulation Number

870.1340

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142829

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components (sheath, dilator, needle, catheter) and their physical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on non-clinical engineering tests and literature review, not data-driven performance metrics typical of AI/ML devices.

Therapeutic

No
The device is used for percutaneous transjugular liver access, essentially as an introducer and delivery system for diagnostic and interventional procedures, not to treat a condition itself.

Diagnostic

The device is intended for percutaneous transjugular liver access during diagnostic and interventional procedures, meaning it facilitates diagnostic procedures rather than performing them itself.

SaMD (Software as a Medical Device)

The device description clearly details physical components made of materials like PTFE and stainless steel, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure." This describes a surgical/interventional procedure performed directly on the patient's body.
Device Description: The description details the physical components of the device (sheath, dilator, needle, guiding catheter) which are used for accessing and navigating within the body.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis of specimens.

The GORE® TIPS Set is a medical device used for a surgical procedure, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DYB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

transjugular liver

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.

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.

Cook® Medical Flexor® Check-Flo II® Introducer Set, K142829, Cook® Medical Needle Catheter Combination

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

Regulation Number and Section

§ 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).

Summary

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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.

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

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 Hickey
Regulatory Affairs Specialist
Creganna Medical
Parkmore West
Galway, Ireland
Tel: + 91 783438
Email: Regulatory@creganna.com
Email: Orla.Hickey@creganna.com

Intended Use

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

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.

| | GORE® TIPS Set
GORE® TIPS Sheath
GORE® TIPS Needle | Cook® Medical Flexor® Check-Flo II®
Introducer Set
(component of the Haskal Transjugular
Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter
Combination |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Creganna Medical | Cook® Medical | Cook® Medical |
| CE Mark | In progress | Yes | Yes |
| FDA
Clearance/Approval | N/A | Yes
K142829 The Flexor® Check-Flo II®
Introducer
Haskal Transjugular Intrahepatic Portal Access
Set (possible pre-amendment device) | Yes
(possible pre-amendment device) |
| Clinical Comparison | | | |
| Principle of
Operation | To achieve the intended use of the GORE®
TIPS Set, first access to the jugular vein using
standard access techniques
The Introducer sheath and dilator are inserted
over the guidewire, advanced, and positioned
in the hepatic vein and the dilator is removed.
The needle and guide catheter is inserted into
the introducer sheath and the Needle is used
to puncture the hepatic vein, liver
parenchyma and the portal vein. | To achieve the intended use of the Flexor
Check-Flo II Introducer, access to the target
vein should be gained using standard access
techniques.
The Introducer sheath and dilator are
inserted over the guidewire, advanced, and
positioned as required, the dilator is
removed. | The needle and guide catheter are
inserted into the introducer sheath and
the Needle is used to puncture the
hepatic vein, liver parenchyma and the
portal vein. |
| Intended Use | The GORE® TIPS Set, GORE® TIPS Sheath and
GORE® TIPS Needle, are intended to be used
together for percutaneous transjugular liver | Introducers are intended for the introduction
of balloons, closed and non-tapered end | Needles are used to puncture where a
native opening is not present. |
| | GORE® TIPS Set | Cook® Medical Flexor® Check-Flo II®
Introducer Set
(component of the Haskal Transjugular
Intrahepatic Portal Access Set) | Cook® Medical Needle Catheter
Combination |
| | GORE® TIPS Sheath
GORE® TIPS Needle | | |
| | procedures in patients undergoing a
Transjugular Intrahepatic Portosystemic Shunt
(TIPS) procedure. | catheters or other diagnostic an
interventional devices.