(62 days)
The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The hydrophilic coated Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire. The catheter shaft is hydrophilic coated.
This document describes the application for a 510(k) premarket notification for the "Chocolate™ PTCA Balloon Catheter." It is a medical device application, not an AI/ML device, and therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not applicable. The document outlines the device's indications for use, description, and the performance testing conducted to demonstrate substantial equivalence to predicate devices.
Not Applicable: The provided document describes a medical device, specifically a PTCA balloon catheter, and not an AI/ML-based device. Therefore, the questions related to AI/ML acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not relevant to this submission.
Summary of Device and Testing (as provided in the document):
Device Name: Chocolate™ PTCA Balloon Catheter
Intended Use / Indications:
The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Device Description:
The hydrophilic coated Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi-compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire. The catheter shaft is hydrophilic coated.
Technological Characteristics/Performance Testing/Substantial Equivalence:
The subject device has classification information, indication for use, fundamental design features, mechanism of action, materials, and principle of operation identical to the predicate device. The device specifications are all similar and within the range of the predicate devices. Testing requirements for this device were based upon the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).
The following tests were performed:
- Dimensional Verification
- Balloon Preparation, Deployment & Retraction
- Flexibility & Kink
- Balloon Rated Burst Pressure (RBP)
- Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation
- Catheter Bond Strength
- Tip Pull Test
- Torque Strength
- Radiopacity
- Particulate Evaluation
- Biocompatibility Testing
Conclusion:
No new questions of safety or effectiveness were identified during device testing; therefore, the hydrophilic coated Chocolate PTCA Balloon Catheter is considered substantially equivalent to the predicate devices.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.