The GORE Tri-Lobe Balloon Catheter is a dual lumen catheter with a low pressure compliant balloon attached to the distal end of the catheter. The balloon is a tri-lobe design to allow for limited blood flow when used to touch up an endoprosthesis. The catheter is designed to be used with a 0.035" guidewire. Two 304 stainless steel markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The GORE Tri-Lobe Balloon Catheter is provided sterile for single-use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the GORE Tri-Lobe Balloon Catheter, focusing on acceptance criteria and supporting studies:

This 510(k) summary is for a medical device (GORE Tri-Lobe Balloon Catheter) seeking market clearance by demonstrating substantial equivalence to predicate devices, not for a software algorithm. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML or diagnostic software (like sensitivity, specificity, MRMC studies, training/test set details, ground truth establishment) are not applicable.

The "acceptance criteria" for this type of device primarily revolve around meeting safety and performance specifications through mechanical/physical testing and demonstrating manufacturing quality, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a balloon catheter), the 'acceptance criteria' are related to the physical performance and integrity of the device. The document states that "All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements," implying that the device successfully passed pre-defined performance benchmarks. However, the specific quantitative acceptance criteria (e.g., burst pressure minimum, inflation/deflation times, guidewire compatibility) are not detailed in this summary.

Acceptance Criteria Category (Implied)	Reported Device Performance	Comments
Device Integrity/Performance	Met specified requirements	Specific quantitative criteria (e.g., burst pressure, fatigue life, inflation/deflation characteristics, guidewire compatibility, marker visibility) are not explicitly detailed in this summary. The statement indicates successful completion of internal testing against W.L. Gore & Associates' established specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. Device integrity testing typically involves a statistically relevant sample size of the manufactured devices for each test (e.g., burst testing, fatigue testing). The specific number of catheters tested for "device integrity" is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The data provenance would be from internal lab testing conducted by W. L. Gore & Associates, Inc. (developer and manufacturer). It is retrospective in the sense that the testing was performed on completed devices before submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is simply the physical properties or behavior of the device under test, measured by calibrated equipment and assessed against engineering specifications. No human experts are establishing a "ground truth" in this context in the way they would for medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert annotation for diagnostic ground truth. This is not relevant for physical device integrity testing. The "adjudication" would involve engineering review and quality control processes to ensure test results are valid and meet specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or software algorithms where human interpretation is involved. This device is a catheter, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a form of "standalone" performance was inherently evaluated through the device integrity testing. The catheter's physical performance (e.g., balloon inflation, pressure resistance, guidewire tracking) was assessed independently of human interaction during these lab tests, against engineering specifications. It's not an "algorithm" in the AI sense, but the device's functional performance was evaluated in isolation.

7. Type of Ground Truth Used

The "ground truth" for device integrity testing is based on engineering specifications and validated test methods. This includes:
- Physical measurements: Dimensions, material properties.
- Functional performance standards: Burst pressure limits, inflation/deflation characteristics, fatigue life, guidewire compatibility, bond strength, tensile strength, marker visibility.
- These standards are often derived from industry benchmarks, regulatory guidance, and internal risk assessments.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a "training set" of data. The manufacturing process is refined through development and iterative testing, but not in the sense of an algorithm training on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense for this device. For the manufacturing process and device design, the "ground truth" (i.e., optimal design and manufacturing parameters) would be established through:
- Engineering design principles
- Material science knowledge
- Pre-clinical testing (benchtop, ex-vivo, in-vivo animal studies)
- Quality control processes
- Regulatory requirements and standards.

Summary of the Study

The study performed was focused on "device integrity testing." This involved a series of laboratory tests designed to ensure the physical and functional aspects of the GORE Tri-Lobe Balloon Catheter met its design specifications and would perform adequately for its intended use. The summary states that "All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements," indicating successful completion of these tests. This type of testing is standard for demonstrating the safety and effectiveness of physical medical devices like catheters to support a 510(k) submission for substantial equivalence. The predicate devices (ANCURE® Iliac Balloon Catheter, Equalizer™ Balloon Catheter, LDOB Occlusion Balloon Catheter) also served as benchmarks for establishing equivalence in features, materials, and intended use.

Summary

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MAY - 5 2004

510(k) Premarket Notification

510(k) Summary of Substantial Equivalence

K033670

GORE Tri-Lobe Balloon Catheter

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Proprietary Name:	GORE Tri-Lobe Balloon Catheter
Common Name:	balloon catheter
Classification Name:	catheter, angioplasty, peripheral, transluminal,percutaneous catheter
Device Classification:	Class II
Product Classification and Code:	870.1250, DQY
Classification Panel:	Cardiovascular Devices
Establishment Registration Number:	2025240
Contact Person:	Brandon HansenRegulatory AffairsMedical Products DivisionWL Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86002-0500Telephone: (928) 864-3784Facsimile: (928) 864-4144E-mail: bhansen@wlgore.com

Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

Device Description

Image /page/0/Picture/9 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a stylized design with the word "GORE" in bold letters. The word "Confidential" is written in a simple, sans-serif font. The image appears to be a stamp or watermark, indicating that the document is confidential.

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Indication for Use

The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Substantially Equivalent Devices

In W. L. Gore & Associates Inc.'s opinion, the GORE Tri-Lobe Balloon Catheter is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

ANCURE® Iliac Balloon Catheter (Guidant Cardiac & Vascular Surgery . (C&VS), Menlo Park, CA) - K003495
Equalizer™ Balloon Catheter (Boston Scientific Corporation, Natick, MA) -. K021721
LDOB Occlusion Balloon Catheter (COOK INCORPORATED, . Bloomington, IN) - K002286

Labeling, packaging and sterilization of the GORE Tri-Lobe Balloon Catheter is substantially equivalent to that of the predicate devices listed above.

Summary of Studies

W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE Tri-Lobe Balloon Catheter will perform adequately when used according to the intended use. All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements.

Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the W. L. Gore & Associates, Inc.'s GORE Tri-Lobe Balloon Catheter through this 510(k) Premarket Notification.

Image /page/1/Picture/14 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a stylized design with the word "GORE" in bold letters. The word "Confidential" is written in a simple, sans-serif font. The image appears to be a document header or watermark indicating the confidential nature of the document.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird, which is likely an eagle, with its wings spread. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

W. L. Gore and Associates, Inc. c/o Mr. Brandon Hansen Regulatory Affairs 3450 West Kiltie Lanc Flagstaff, AZ 86001

K033670 Rc:

Trade Name: Tri-Lobe Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Codc: DQY Dated: November 21, 2003 Received: November 24, 2003

Dear Mr. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to togens actment date of the Medical Device Amendments, or to commence prox to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is classified (600 a00 r0) als. Existing major regulations affecting your device can may be subject to basil adon't regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Brandon Hansen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dr is issuates or wor device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any redital statutes and regations and ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements,01); good manufacturing practice requirements as set CFK Part 807), labering (21 CFRT art 801), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neviole (seting your device as described in your Section 510(k) This letter will anow you to begin mailwang your device of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrise 101 ) 594-4646. Also, please note the regulation entitled, Comaci the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misorallums by reference to premanter to premainter the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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):_____________________________________________________________________________________________________________________________________________________

Device Name: GORE Tri-Lobe Balloon Catheter Catheter Cather Cather

Indications For Use:

The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K033670

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Regulation Number and Section

§ 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).