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510(k) Data Aggregation
(176 days)
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm. All materials are identical to GliderXtreme product. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
The provided text describes the 510(k) summary for the TriReme Medical, Inc. Chocolate PTA Balloon Catheter. This device is an angioplasty catheter primarily relying on substantial equivalence to predicate devices, rather than a novel AI/ML algorithm requiring extensive clinical trials for performance validation. Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (like human reader studies, ground truth establishment, training sets) are not applicable in this context.
However, I can extract the relevant performance data and aspects that were used for FDA clearance in this traditional medical device submission.
Here's a breakdown based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (angioplasty catheter), performance is typically demonstrated through bench testing against established standards and comparison to predicate devices, rather than accuracy metrics seen in AI/ML. The provided document lists the tests performed, which serve as the "acceptance criteria" for demonstrating safety and effectiveness.
| Acceptance Criteria (Bench Test Performed) | Reported Device Performance |
|---|---|
| Balloon Rated Burst Pressure | Assumed to meet specified pressure ratings; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Balloon Inflation and Deflation | Assumed to perform as intended; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Balloon Fatigue / CS Fatigue | Assumed to meet durability requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Catheter Body Strength (Bond Strength) | Assumed to meet strength requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Torsional Strength | Assumed to meet strength requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Catheter Diameter, Balloon Profile & Tip Configuration | Assumed to meet specified dimensions and configurations; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Balloon Compliance | Assumed to meet specified compliance chart values; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Trackability, Pushability | Assumed to perform adequately; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Kink Resistance | Assumed to resist kinking during use; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Device Interface Compatibility | Assumed to be compatible with standard accessories; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion) |
| Overall Conclusion | "Performance testing demonstrated that the Chocolate Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test. The "test set" refers to the physical devices undergoing the described in vitro (bench) testing. The data provenance is from bench testing conducted by the manufacturer, TriReme Medical, Inc. There is no mention of human subject data or its origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. For a traditional medical device like a balloon catheter, "ground truth" is established through engineering specifications, material science, and established in vitro testing methodologies, not through expert consensus on medical images or clinical outcomes in the same way an AI device would.
4. Adjudication Method for the Test Set
Not applicable. Bench testing results are typically objectively measured against pre-defined engineering specifications, not subject to human adjudication methods like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study assesses how human performance improves with AI assistance and is not relevant for a standalone physical medical device like this balloon catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its design and manufacturing.
7. The Type of Ground Truth Used
The "ground truth" (or reference standard) for evaluating this device's performance would be:
- Engineering Specifications and Industry Standards: Performance metrics (e.g., burst pressure, inflation/deflation times, material strength, dimensional tolerances) are compared against pre-defined engineering specifications for the device and relevant industry standards for angioplasty catheters.
- Predicate Device Performance: A key aspect of this 510(k) submission is the demonstration of substantial equivalence to predicate devices, meaning its performance should be similar or better than those already cleared.
8. The Sample Size for the Training Set
Not applicable. There is no training set for a physical medical device. This term is used in the context of machine learning, where an algorithm learns from a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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