(29 days)
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, 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 approved PTA Balloon Catheter family of products. 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 Chocolate PTA Balloon Catheter. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.
The document discusses performance data, but it is entirely focused on bench testing for a physical medical device (a catheter), not an AI or software-based medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth, experts, and sample sizes for training/test sets are not applicable to this submission.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Device Type: The device is a "Chocolate PTA Balloon Catheter," which is a physical angioplasty catheter. It's not an AI/ML-driven diagnostic or prognostic tool.
- Performance Data: The performance data described ("Balloon Rated Burst Pressure," "Balloon Inflation and Deflation," "Balloon Fatigue," "Trackability," etc.) are all physical properties and functions of the catheter, evaluated through laboratory bench tests.
- Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, image analysis, diagnostic performance metrics (e.g., sensitivity, specificity, AUC), ground truth determination by experts, test/training sets of patient data, or any other elements relevant to AI/ML device evaluation.
Conclusion:
The provided document describes a traditional medical device (a balloon catheter) and its mechanical performance testing. It does not contain the information requested regarding acceptance criteria, study design, expert involvement, or data characteristics for an AI/ML 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).