(115 days)
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for post deployment expansion of balloon expandable stents.
The Euphora™ RX Balloon Dilatation catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
The document provided is a 510(k) premarket notification for the Euphora™ Rapid Exchange Balloon Dilatation Catheter. It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Based on the provided text, the device discussed is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is a physical medical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study design referencing AI/ML performance (e.g., sample size for test set, data provenance, ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable.
However, I can extract information related to the performance criteria and the non-clinical studies conducted for this conventional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful completion of the "Design Verification in-vitro testing" and "Biocompatibility testing" in accordance with relevant guidance documents and standards. The reported device performance is that it met all these requirements.
| Acceptance Criteria Category | Specific Tests Performed (as per FDA Guidance and ISO) | Reported Device Performance |
|---|---|---|
| Design Verification (In-Vitro) | Effective length | Met requirements |
| Catheter Profile | Met requirements | |
| System Pressure Capability & System Pressure Capability (in Stent) | Met requirements | |
| Balloon Fatigue & Balloon Fatigue (in Stent) | Met requirements | |
| Balloon Compliance | Met requirements | |
| Balloon Inflation and Deflation Time | Met requirements | |
| Catheter Bond Strength | Met requirements | |
| Coating Integrity | Met requirements | |
| Coating Particulate Evaluation | Met requirements | |
| Flexibility and Kink | Met requirements | |
| Torque Strength | Met requirements | |
| Biocompatibility Testing | Cytotoxicity Study (ISO MEM Elution) | Met requirements |
| ISO Maximisation Sensitisation Study | Met requirements | |
| ISO Acute Intracutaneous Reactivity | Met requirements | |
| ISO Acute Systemic Toxicity | Met requirements | |
| USP Material Mediated Pyrogen Study in Rabbits | Met requirements | |
| In Vivo Thromboresistance Study | Met requirements | |
| ASTM In-vitro Haemolysis | Met requirements | |
| ASTM Partial Thromboplastin Time (PTT) Coagulation Testing | Met requirements | |
| C3a Complement Activation Assay Study | Met requirements | |
| Sc5b-9 Complement Activation Assay Study | Met requirements | |
| USP Physicochemical Tests | Met requirements | |
| Sterilization Validation | EtO Sterilization in accordance with ISO11135 and EN556 to achieve SAL of 10⁻⁶ | Validated |
| Pre-Clinical Study | Evaluation of Radiopacity attribute (non-GLP in-vivo) | Met requirements |
The overall conclusion is that "The Euphora™ RX Balloon Dilatation Catheter met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Euphora™ RX Balloon Dilatation Catheter is substantially equivalent in terms of safety and effectiveness to the predicate device."
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/ML system.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- 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 consensus, pathology, outcomes data, etc): Not applicable (for clinical endpoints, as no clinical study was conducted). For bench testing, the "ground truth" would be the engineering specifications and established standards the device had to meet.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.