(90 days)
NC Quantum Apex™ 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™ PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).
Not Found
This document is a 510(k) premarket notification for a medical device called the NC Quantum Apex™ PTCA Dilatation Catheter. It is not an AI/ML device, therefore the requested information regarding AI/ML studies is not applicable.
However, I can provide available information regarding the non-clinical testing performed to demonstrate substantial equivalence for this device.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes a range of non-clinical bench tests and biocompatibility tests. While specific acceptance criteria for each test (e.g., a specific numerical threshold for corrosion resistance or burst pressure) are not explicitly stated in this high-level summary, the general acceptance criterion is that the device demonstrates performance equivalent to the predicate device and is safe and effective for its intended use. The reported performance is that the device met these tests, providing reasonable assurance of conformance.
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Bench Testing | Corrosion Resistance, Proximal Shaft Marks, Midshaft Bond Tensile, Proximal Mark Abrasion Resistance, Repeat Inflation, Shaft and Bond Burst Pressure | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing." |
| Biocompatibility and Chemical Characterization Tests | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Pyrogenicity, Mutagenicity, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physicochemical, Latex Assay, Nonvolatile Residue, SEM | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each non-clinical bench test or biocompatibility test. These are typically described in detail in the full test reports submitted to the FDA, but not in the 510(k) summary. The data provenance is from internal Boston Scientific Corporation testing, which is standard for premarket submissions. These are prospective tests conducted on manufactured device samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. This is a medical device for physical intervention, not an AI/ML diagnostic device requiring expert interpretation of outputs for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are bench tests or laboratory assays, not requiring human adjudication in the context of diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/ML device.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established engineering principles, industry standards (e.g., ISO standards for medical devices, USP for physicochemical tests, ASTM for material properties), and regulatory requirements. For example:
- Bench tests: Performance metrics (like burst pressure, tensile strength, corrosion resistance) are compared against predetermined functional specifications derived from the predicate device's performance or engineering requirements.
- Biocompatibility tests: Compliance with standards like ISO 10993 (Biological evaluation of medical devices) is the "ground truth" to ensure the materials are safe for human contact.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
§ 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.