(109 days)
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
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.
The provided FDA 510(k) clearance letter and associated summary pertain to a medical device, the GORE® Tri-Lobe Balloon Catheter, not an AI/ML-driven software device. Therefore, the information typically requested for AI/ML device acceptance criteria and study design (such as confidence intervals for performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment) is not applicable or present in this document.
The document describes the device's technical characteristics, indications for use, and summaries of performance testing and clinical data to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the relevant information provided, structured to highlight what is and isn't applicable to your request:
Acceptance Criteria and Device Performance (Not Applicable as per AI/ML context)
While the document details performance testing, it doesn't present a table of quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI/ML device (e.g., Sensitivity, Specificity thresholds). Instead, safety and effectiveness are demonstrated through various tests and clinical observations.
Table 1. Technological Characteristics (This is a comparison of intended balloon diameters and inflation volumes, not performance metrics like accuracy or sensitivity for an AI/ML device.)
| 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 |
Key observations for performance (qualitative as per the document):
- Clinical Outcomes (Day 0 Adverse Events): Among the 44 subjects with known GORE® Tri-Lobe Balloon Catheter use in the Aortic Arch substudy:
- Zero (0) Adverse Events of Aortic Rupture, Aortic Dissection, Balloon Related Mortality, and Type III Endoleak.
- One (1) reported Type I Endoleak at Day 0.
- Conclusion: The device is deemed "substantially equivalent" to its predicate based on bench, pre-clinical, and clinical testing. The changes did not raise new concerns related to safety or effectiveness.
Study Details (Interpreted for a medical device rather than AI/ML)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set (Clinical Data): 77 total subjects were treated for lesions of the aortic arch in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial (G130120). Of these, 44 subjects (57.1%) had known use of the GORE® Tri-Lobe Balloon Catheter during the index procedure.
- Data Provenance: The study was a "prospective, non-randomized, multicenter study." The country of origin is not explicitly stated but implied to be related to FDA clearance (likely US-based).
- Retrospective/Prospective: Prospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as this is a medical device study, not an AI/ML performance evaluation requiring expert labeling for ground truth. Clinical outcomes and observations from medical professionals involved in the trial serve as the "ground truth" for device safety and performance here.
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Adjudication Method for the Test Set:
- Not applicable in the context of AI/ML ground truth adjudication. Clinical adverse events and outcomes were reported and presumably reviewed as part of the clinical trial protocol.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This document describes the performance of a physical medical device.
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If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Not applicable as this is not an algorithm. The device's performance is inherently linked to its use by medical professionals in a clinical setting ("human-in-the-loop" in a very different sense).
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The Type of Ground Truth Used:
- Clinical Outcomes/Events: The "ground truth" for the device's safety and effectiveness was established through direct observation of clinical adverse events (e.g., Aortic Rupture, Aortic Dissection, Type I Endoleak) and the device's ability to facilitate dilatation of endoprostheses during the clinical trial. Bench and In Vivo Animal Testing also contributed to this "ground truth" indirectly by demonstrating physical properties and performance.
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The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary, the provided document is a 510(k) clearance letter for a physical medical device. As such, the standard criteria and study designs relevant to AI/ML device performance evaluation (e.g., sensitivity, specificity, expert adjudication, MRMC studies, training/test sets) are not found within this content.
§ 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).