(109 days)
Not Found
No.
The device description outlines a purely mechanical catheter with no mention of computational, processing, or AI capabilities. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
Yes.
The device is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels, which is a therapeutic intervention.
No
The intended use of the GORE® Tri-Lobe Balloon Catheter is to assist in the dilatation of self-expanding endoprostheses, which is a therapeutic function, not diagnostic.
No
The device description clearly describes a physical, catheter-based product with multiple lumens, balloons, radiopaque markers, and guidewire access. The performance studies also focus on physical attributes like balloon burst, inflation/deflation time, pushability, and in-vivo animal testing, all pointing to a hardware device. There is no mention of software components.
No
The device is a balloon catheter intended for mechanical dilatation of endoprostheses in blood vessels, not for providing information through in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
Product codes
DQY
Device Description
The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen.
The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large diameter vessels, aortic arch, Descending Thoracic Aorta (DTA), ascending aorta, porcine aortic arch
Indicated Patient Age Range
Mean (Std Dev) 70.8 (10.75) years. Range (41, 89) years.
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)
The GORE® Tri-Lobe Balloon Catheter was evaluated through:
- Bench testing: Balloon Burst, Recommended Inflation Volume (RIV) Determination, Pushability, Trackability, and Kink Resistance, Torque, Balloon Inflate / Deflate Time, Balloon Fatigue, Simulated Use, Aortic Blood Flow.
- In Vivo Animal Testing: Conducted in the porcine aortic arch to support use in the ascending aorta.
- Clinical use: An accessory device in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial (G130120), a prospective, non-randomized, multicenter study. 77 subjects were treated for lesions of the aortic arch. 44 subjects (57.1%) had known use of the GORE® Tri-Lobe Balloon Catheter during the index procedure, used in the ascending aorta and/or aortic arch.
- Key results: Zero (0) Day 0 Adverse Events of Aortic Rupture, Aortic Dissection, Balloon Related Mortality, and Type III Endoleak in the 44 subjects with known GORE® Tri-Lobe Balloon Catheter use. One (1) reported Type I Endoleak at Day 0. The clinical data supports the ability to use the GORE® Tri-Lobe Balloon Catheter in ascending aorta and aortic arch.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Adverse Events:
- Aortic Rupture: 0
- Aortic Dissection: 0
- Balloon Related Mortality: 0
- Type III Endoleak: 0
- Type I Endoleak: 1
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - GORE® Tri-Lobe Balloon Catheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 2, 2025
W. L. Gore & Associates, Inc.
Erika Grecco
Regulatory Affairs Associate
1505 N. Fourth Street
Flagstaff, Arizona 86004
Re: K250410
Trade/Device Name: GORE® Tri-Lobe Balloon Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: April 30, 2025
Received: May 1, 2025
Dear Erika Grecco:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K250410 - Erika Grecco Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250410 - Erika Grecco Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carmen G. Johnson -S
Carmen Gacchina Johnson, PhD
Assistant Director
DHT2B: Division of Circulatory Support, Structural and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250410
Device Name
GORE® Tri-Lobe Balloon Catheter
Indications for Use (Describe)
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Traditional 510(k) GORE® Tri-Lobe Balloon Catheter
Page 1 of 5
510(K) SUMMARY
510(k) Submitter
W. L. Gore & Associates, Inc.
1505 N. Fourth Street
Flagstaff, AZ 86004
Regulatory Contact: Erika Grecco
Phone: (475) 202-2705
E-mail: egrecco@wlgore.com
Date Prepared
May 30, 2025
Device Names/Classification
Device Name: GORE® Tri-Lobe Balloon Catheter
Classification Name: Percutaneous Catheter
Regulation: 21 CFR 870.1250
Classification: Class II
Product Code: DQY
Predicate Devices
K081799, GORE® Tri-Lobe Balloon Catheter
Device Description
The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen.
The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.
Page 6
Traditional 510(k) GORE® Tri-Lobe Balloon Catheter
Page 2 of 5
Indications for Use
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
The Indication for Use is identical to that of the predicate.
Technological Characteristics
The technological characteristics (materials, design, etc.) compared to the predicate device remain largely unchanged. The only difference, from a technological perspective, between the subject devices and predicate is that the subject devices incorporate changes to the intended balloon diameters and associated recommended inflation volumes, as shown in Table 1 below.
Table 1. Technological Characteristics between predicate and subject devices
| Model Numbers | Predicate Device (K081799) Configuration | Subject Device Configuration |
|---|---|---|
| BCM1634/TBCM1634 | Intended Balloon Diameter: 16mm – 32mm | |
| Recommended Inflation Volume: 4mL-13mL | Same | |
| BCL2645/TBCL2645 | Intended Balloon Diameter: 26mm – 42mm | |
| Recommended Inflation Volume: 12mL-25mL | Intended Balloon Diameter: 26mm – 48mm | |
| Recommended Inflation Volume: 12mL-35mL |
Summary of Performance Testing
The following testing was conducted to evaluate the changes that are the subject of this submission and demonstrate substantial equivalence to the predicate device:
- Balloon Burst
- Recommended Inflation Volume (RIV) Determination
- Pushability, Trackability, and Kink Resistance
- Torque
- Balloon Inflate / Deflate Time
- Balloon Fatigue
- Simulated Use
- Aortic Blood Flow
- Use in the Ascending Aorta
- In Vivo Animal Testing
- Clinical use in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial
In Vivo Animal Testing was completed for the GORE® TAG® Thoracic Branch Endoprosthesis and included validation of the GORE® Tri-Lobe Balloon Catheter in the porcine aortic arch to support the use of the GORE® Tri-Lobe Balloon Catheter in the ascending aorta for the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial. The clinical evidence from this study, in combination with the in vitro and in vivo testing, was provided to support the removal of an IFU warning precluding use in the ascending aorta. The data also supported the recommended increased inflation volume and balloon diameters.
Page 7
Traditional 510(k) GORE® Tri-Lobe Balloon Catheter
Page 3 of 5
Summary of Clinical Data:
The GORE® Tri-Lobe Balloon Catheter was used as an accessory device in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial to assist in the dilatation of the self-expanding GORE® TAG® Thoracic Branch Endoprosthesis. The information that was collected on the use of the GORE® Tri-Lobe Balloon Catheter at the time of the index procedure (Day 0) is summarized below.
The GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial (G130120) was a prospective, non-randomized, multicenter study evaluating the GORE® TAG® Thoracic Branch Endoprosthesis in the treatment of lesions of the Aortic Arch and Descending Thoracic Aorta (DTA). The data provided specifically in support of this 510(k) focused on the Aortic Arch substudy, though the GORE® Tri-Lobe Balloon Catheter was used also for the DTA substudy.
In G130120, 77 subjects were treated for lesions of the aortic arch; please refer to Table 2 for Baseline Demographic Information. Forty four 44 (57.1%) total subjects had known use of the GORE® Tri-Lobe Balloon Catheter during the index procedure; the balloon was used in the ascending aorta and/or aortic arch in these cases. Those 44 subjects with known GORE® Tri-Lobe Balloon Catheter use experienced zero (0) Day 0 Adverse Events of Aortic Rupture, Aortic Dissection, Balloon Related Mortality, and Type III Endoleak. There was one (1) reported Type I Endoleak at Day 0. The clinical data supports the ability to use the GORE® Tri-Lobe Balloon Catheter in ascending aorta and aortic arch.
Table 2. Baseline Demographic Information
| Aneurysm | Dissection | Other Isolated Lesion | All | |
|---|---|---|---|---|
| Number of Enrolled Subjects | 50 | 24 | 3 | 77 |
| Sex | ||||
| Male | 32 (64.0%) | 17 (70.8%) | 2 (66.7%) | 51 (66.2%) |
| Female | 18 (36.0%) | 7 (29.2%) | 1 (33.3%) | 26 (33.8%) |
| Ethnicity | ||||
| Not Hispanic or Latino | 47 (94.0%) | 23 (95.8%) | 3 (100.0%) | 73 (94.8%) |
| Hispanic or Latino | 3 (6.0%) | 1 (4.2%) | 0 (0%) | 4 (5.2%) |
| Unknown | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Race¹ | ||||
| White | 27 (54.0%) | 14 (58.3%) | 3 (100.0%) | 44 (57.1%) |
| Black or African American | 6 (12.0%) | 6 (25.0%) | 0 (0%) | 12 (15.6%) |
| Asian | 16 (32.0%) | 2 (8.3%) | 0 (0%) | 18 (23.4%) |
| American Indian or Alaska Native | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hawaiian or Pacific Islander | 1 (2.0%) | 1 (4.2%) | 0 (0%) | 2 (2.6%) |
| Other | 0 (0%) | 2 (8.3%) | 0 (0%) | 2 (2.6%) |
| Age (yrs) | ||||
| n | 50 | 24 | 3 | 77 |
| Mean (Std Dev) | 74.3 (8.56) | 63.0 (11.31) | 73.7 (9.02) | 70.8 (10.75) |
Page 8
Traditional 510(k) GORE® Tri-Lobe Balloon Catheter
Page 4 of 5
| Aneurysm | Dissection | Other Isolated Lesion | All | |
|---|---|---|---|---|
| Median | 75.0 | 63.0 | 73.0 | 72.0 |
| Range | (50, 89) | (41, 86) | (65, 83) | (41, 89) |
| BMI² | ||||
| n | 49 | 24 | 3 | 76 |
| Mean (Std Dev) | 27.3 (5.94) | 29.9 (4.44) | 23.4 (2.01) | 27.9 (5.57) |
| Median | 25.6 | 29.0 | 24.4 | 26.9 |
| Range | (16.8, 44.4) | (21.7, 40.2) | (21.1, 24.8) | (16.8, 44.4) |
¹More than one option can be selected.
²Site was queried and the weight for one Subject is unavailable.
Additional information on the clinical study can be found in the Summary of Safety and Effectiveness for the GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S015).
Conclusion
The GORE® Tri-Lobe Balloon Catheter is substantially equivalent to the predicate device, as supported by the bench, pre-clinical and clinical testing provided. The removal of the warning against use in the ascending aorta, additional larger balloon diameters/recommended inflation volumes, and other minor changes (e.g., addition of new model numbers, burst testing specification) since the last clearance did not raise new concerns related to safety or effectiveness.