(179 days)
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.
The provided text describes the 510(k) premarket notification for the GORE Tri-Lumen Catheter (TLC), primarily focusing on its substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and the performance data gathered. However, the document does not present "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format typically used for AI/ML device evaluations, which would involve metrics like sensitivity, specificity, or AUC against a ground truth.
Instead, the performance data section (page 8) focuses on engineering and biocompatibility testing for a medical catheter, confirming its functionality and safety characteristics by comparing it to established standards (BS EN ISO 10555-1:2013) and a predicate device. The information provided is for a physical medical device, not an AI/ML algorithm.
Therefore, many of the specific questions regarding acceptance criteria for AI models, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or cannot be answered from the provided text for an AI/ML device.
Here's an attempt to extract relevant information and note the absence of others based on your request, understanding that the device is a physical catheter, not an AI solution:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (catheter) and not an AI/ML algorithm, the "acceptance criteria" are based on engineering performance tests and biocompatibility, demonstrating that the device meets general requirements for intravascular catheters and is substantially equivalent to a predicate. The document doesn't provide specific quantitative acceptance criteria or reported performance values in a table format that are directly comparable, but lists the types of tests performed.
| Acceptance Criteria Category (based on ISO 10555-1:2013 general requirements & equivalency) | Reported Device Performance (as described) |
|---|---|
| Guidewire Compatibility | Verified by testing |
| Catheter Tip Bond Strength | Verified by testing |
| Radiopacity | Verified by testing (Radiopaque Tip) |
| Device Dimensions | Verified by testing |
| Device Trackability | Verified by testing |
| Device Pushability | Verified by testing |
| Device Flushability | Verified by testing |
| Biocompatibility | Biocompatible per ISO 10993-1 |
| Design Verification | Performed |
| Design Validation | Performed |
| Sterilization Validation | Performed (Ethylene Oxide method) |
| Packaging Integrity | Performed |
| Product Shelf-Life | Performed |
| Introducer Sheath Compatibility | Performed (Compatible with ≥ 12 Fr catheters) |
| Device Torqueability | Performed |
| Surface Integrity | Performed |
| Clinical Performance (safety and effectiveness) | Performed safely and effectively with no procedural or device related events in an Early Feasibility Study |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The clinical "test set" (referred to as an Early Feasibility Study) involved 13 patients.
- Data Provenance: The study was an "Early Feasibility Study to evaluate the initial safety of an investigational aortic stent graft," which used the GORE Tri-Lumen Catheter as an accessory device. The document does not specify the country of origin of the data, but W.L. Gore & Associates, Inc. is a U.S.-based company, suggesting the study likely took place in the US or a region with similar regulatory standards. The study appears to be prospective as it involved treating patients with an investigational device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For a physical catheter, "ground truth" as understood in AI/ML is not relevant. The assessment of the catheter's performance in the clinical study would have been conducted by the medical professionals involved in the procedures. The document states the "intended user" includes "Physicians trained in and/or familiar with endovascular procedures and similar devices," which may include "vascular surgeons, interventional radiologists, and interventional cardiologists." No specific number or qualifications for establishing ground truth are provided, as clinical observation and reporting of events served as the outcome assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML device requiring interpretative output to be adjudicated against a ground truth, no such adjudication method is mentioned or relevant. The clinical study assessed the catheter's safe and effective performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, so no MRMC comparative effectiveness study was performed, and thus no effect size related to AI assistance can be reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical performance, the "ground truth" was based on outcomes data and observational reports during the Early Feasibility Study. Specifically, it states, "The GORE® Tri-Lumen Catheter performed this task safely and effectively with no procedural or device related events reported as a result of using the catheter." This indicates safety and efficacy were assessed through direct observation of procedural success and lack of adverse events.
8. The sample size for the training set
Not applicable for a physical medical device. There is no concept of a "training set" for AI/ML in this context. The device's design and manufacturing are based on engineering principles and validated through the performance tests mentioned.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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October 5, 2018
W.L. Gore and Associates Inc. Michael Ivey Regulatory Affairs 1505 N. Fourth St. Flagstaff, Arizona 86005
Re: K180919
Trade/Device Name: GORE Tri-Lumen Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 4, 2018 Received: September 5, 2018
Dear Michael Ivey:
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/cdrl/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.
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
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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 medical devices and radiation-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,
Michael John -S 2018.10.05 09:40:44 -04'00'
Bram D. Zuckerman, M.D. for 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) K180919
Device Name GORE® Tri-Lumen Catheter
Indications for Use (Describe)
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
| 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
510(k) Number: K180919
Device Name: GORE® Tri-Lumen Catheter
Intended Use / Indication for Use:
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
510(k) Owner:
W. L. Gore & Associates, Inc. Medical Products Division 1505 North Fourth Street Flagstaff, Arizona 86004 - U.S.A.
Regulatory Contact:
Michael Ivey W. L. Gore & Associates, Inc 3450 Kiltie Lane Flagstaff, AZ 86005
Phone: 928-864-3790 Fax: 928-864-4303 E-Mail: mivey@wlgore.com
| Trade or Proprietary Name: | GORE® Tri-Lumen Catheter |
|---|---|
| Common/Usual/Classification Name: | Catheter, Percutaneous |
| Product Classification: | Class II |
| Product Code: | DQY |
| Regulation Number: | 21CFR 870.1250 |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 2017233 |
| Predicate Device: | K072618, Twin-Pass Dual Access Catheter,Vascular Solutions, Inc.(this device has not been the subject of a design-related recall) |
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Device Description
The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.
Indications for Use
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple quidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
Summary of Similarities and Differences in Technological Characteristics between Applicant and Predicate Devices
A side-by-side comparison of the subject device to the predicate devices is provided in the table below.
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| Device | GORE® Tri-Lumen Catheter (TLC)(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter(PREDICATE DEVICE) |
|---|---|---|
| Manufacturer | W. L. Gore & Associates Inc. | Vascular Solutions, Inc. |
| 510(k) Number | TBD | K072618 |
| Product Code | DQY | DQY |
| Product Class | II | II |
| Intended use(Clinical) | Access Peripheral and Aortic Vasculature toFacilitate Guidewire Placement | Access Peripheral, Aortic, and Coronary Vasculature to FacilitateGuidewire Placement |
| Intended User(Clinical) | Physicians trained in and/or familiar withendovascular procedures and similar devices.This group of physicians may include vascularsurgeons, interventional radiologists, andinterventional cardiologists from variousregions worldwide. | Physicians trained in and/or familiar with endovascularprocedures and similar devices. This group of physicians mayinclude vascular surgeons, interventional radiologists, andinterventional cardiologists from various regions worldwide. |
| OperatingPrinciple(Clinical) | The GORE® Tri-Lumen Catheter (TLC) is amulti-lumen catheter designed to minimizeentanglement of guidewires while facilitatingthrough and through access duringcardiovascular procedures that require the useof multiple guidewires with fewer snaringmaneuvers. | The Twin-Pass Dual-Access Catheter is a single use devicedesigned for use in the arterial vasculature to provide support formultiple 0-014"/0.36mm guidewires during interventionalprocedures. |
| Device | GORE® Tri-Lumen Catheter (TLC)(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter(PREDICATE DEVICE) |
| UseEnvironment(Clinical) | Intended for use in an operating room, catheterlab, or procedural suite which would havebright lighting and ambient sounds. Personalprotective equipment, which are typical for thesterile theatre (including gowns, gloves, capsand eye protection) will be used. In addition,the operating room is equipped withfluoroscopy equipment, which requires the userto wear lead apron during use. The device isprovided sterile and is intended for one time(single) use. Duration of use is less than 24hours. Normal disposal via hospital biologicalwaste means. | Intended for use in an operating room, catheter lab, or proceduralsuite which would have bright lighting and ambient sounds.Personal protective equipment, which are typical for the steriletheatre (including gowns, gloves, caps and eye protection) will beused. In addition, the operating room is equipped withfluoroscopy equipment, which requires the user to wear leadapron during use. The device is provided sterile and is intendedfor one time (single) use. Duration of use is less than 24 hours.Normal disposal via hospital biological waste means. |
| Indication foruse(Clinical) | Indicated for use in endovascular procedures tofacilitate guidewire delivery and management. | Indicated for use in conjunction with steerable guidewires inorder to access discrete regions of the coronary and peripheralarterial vasculature, to facilitate placement of guidewires andother interventional devices during twoguidewire procedures. |
| Catheter Shaft(Technical) | Tri-Lumen Design | Dual-Lumen Design |
| GuidewireCompatibility(Technical) | Central Lumen: one 0.035" or two 0.018"guidewiresAxillary Lumen: one 0.014" or one 0.018"guidewire | Each lumen can accommodate a single 0.014" guidewire |
| Overall Length(Technical) | 140 cm | 135 -140 cm |
| Profile(Technical) | 7.5 Fr | 3.5 Fr |
| CatheterCompatibility(Technical) | ≥ 12 Fr | ≥ 6 Fr |
| Device | GORE® Tri-Lumen Catheter (TLC)(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter(PREDICATE DEVICE) |
| Radiopacity(Technical) | Radiopaque Tip | Radiopaque Marker Bands |
| User Interface(Technical) | Single Central Lumen TubeDual Axillary Lumen Extension Tubes | Single Port with Separate Rapid Exchange Port |
| VisualComparison(Technical) | Image: Trailing EndImage: Leading End | Image: Trailing EndImage: Leading End |
| Materials ofConstruction(Biological) | Grilamid/Pebax | Pebax / Polycarbonate |
| Part of bodyinteracted with:(Biological) | Iliac artery, aorta, brachial artery | Iliac artery, aorta, coronary artery |
| Biocompatibility(Biological) | Biocompatible perISO 10993-1 | Biocompatible perISO 10993-1 |
| SterilizationMethod(Biological) | Ethylene Oxide | Ethylene Oxide |
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Performance Data
The GORE® Tri-Lumen Catheter is substantially equivalent to the specified predicate device based on testing of the applicant device functionality, technological characteristics, and indication for use. The device design of the GORE® Tri-Lumen Catheter has been verified by testing to the catheter requirements outlined in BS EN ISO 10555-1:2013 "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements". These tests included:
- . Guidewire Compatibility
- . Catheter Tip Bond Strength
- Radiopacity ●
- . Device Dimensions
- Device Trackability ●
- Device Pushability ●
- Device Flushability .
Based on the comparisons and information provided in this premarket notification, W.L. Gore & Associates concludes that the GORE® Tri-Lumen Catheter is substantially equivalent to the identified predicate device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling and performance. The following tests/evaluations were performed to confirm the equivalency, safety, and effectiveness of the device:
- Biocompatibility .
- Design Verification .
- Design Validation ●
- Sterilization Validation ●
- Packaging Integrity ●
- Product Shelf-Life .
- Introducer Sheath compatibility .
- Device Torqueability ●
- Surface Integrity ●
Animal Data
No Animal Studies were performed as part of this 510(k) Submission.
Clinical Data
No formal clinical study was conducted to specifically evaluate the performance of the GORE® Tri-Lumen Catheter; however, the catheter was used as an accessory device during an Early Feasibility Study to evaluate the initial safety of an investigational aortic stent graft. As part of that early feasibility study, 13 patients were treated with an investigational device that required the use and management of multiple through-and-through guidewires. In each case, a GORE® Tri-Lumen Catheter was used to establish the through-and-through access of the 0.014" and 0.035" guidewires from the brachial artery to the common femoral artery. The GORE® Tri-Lumen Catheter performed this task safely and effectively with no procedural or device related events reported as a result of using the catheter.
Conclusion
W.L. Gore & Associates concludes that the subject GORE® Tri-Lumen Catheter is substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).