(68 days)
The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for post-delivery expansion of balloon expandable stents (bare metal and drug-eluting.)
The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The NC Quantum Apex Monorail PTCA Dilatation Catheter is available with balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6 mm to 30 mm.
The provided text describes a 510(k) premarket notification for a medical device, the NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML study components (sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.
Device Acceptance Criteria and Reported Performance (Non-Clinical Testing)
The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable to or within acceptable limits of the predicate. The document lists various non-clinical tests performed. While specific numeric acceptance criteria and reported performance values are not provided in the summary, the successful completion of these tests suggests the device met the pre-defined criteria for substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implied by successful testing for substantial equivalence) |
|---|---|
| Physical and Mechanical Performance | |
| Effective Length | Met requirements comparable to predicate and reference devices. |
| Proximal Shaft Profile | Met requirements comparable to predicate and reference devices. |
| Shaft and Bond Burst Pressure | Met requirements comparable to predicate and reference devices. |
| Catheter Bond Strength | Met requirements comparable to predicate and reference devices. |
| Flexibility and Kink | Met requirements comparable to predicate and reference devices. |
| Balloon Deflation Time | Met requirements comparable to predicate and reference devices. |
| Corrosion Resistance | Met requirements comparable to predicate and reference devices. |
| Torque Strength | Met requirements comparable to predicate and reference devices. |
| Particulate Evaluation | Met requirements comparable to predicate and reference devices. |
| Biocompatibility | |
| Biocompatibility | Met requirements for biological safety. |
Information Regarding AI/ML Study Components (Not applicable to this 510(k))
As this submission is for a physical medical device (PTCA Dilatation Catheter) and not an AI/ML algorithm, the following sections are not relevant and the requested information cannot be found in the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML analysis is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Nature of the Study and Device
The K121667 submission describes a PTCA Dilatation Catheter, which is a physical, invasive medical device used in coronary angioplasty. The "study" referenced in the document is a non-clinical design verification testing program aimed at demonstrating substantial equivalence to an existing predicate device (NC Quantum Apex™ PTCA Dilatation Catheter) and reference devices (Emerge™ PTCA Dilatation Catheter and Quantum™ Maverick™ PTCA Dilatation Catheter).
The document explicitly states: "Design verification testing was performed to demonstrate that the performance of the modified NC Quantum Apex Monorail PTCA Dilatation Catheter remains substantially equivalent to the predicate device." This means the purpose of the testing was to confirm that the minor modifications to the device (related to the hypotube, midshaft component, proximal shaft marks, and removal of accessory kit components) did not negatively impact its safety and effectiveness compared to the already approved devices.
The tests conducted are typical for mechanical and material aspects of a catheter: Effective Length, Proximal Shaft Profile, Shaft and Bond Burst Pressure, Catheter Bond Strength, Flexibility and Kink, Balloon Deflation Time, Corrosion Resistance, Torque Strength, Particulate Evaluation, and Biocompatibility. The successful completion of these tests formed the basis for the FDA's determination of substantial equivalence.
§ 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.