(224 days)
The OPN NC PTCA Dilatation Catheter is intended 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 is also indicated for post deployment expansion of balloon expandable coronary stents.
The OPN NC PTCA Dilatation Catheter is a sterile, single use, rapid exchange catheter with a distal non-compliant double layer balloon attached to a flexible distal polymer shaft. The balloon is made from Polyamide and is available in diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5mm and in balloon lengths of 10, 15 and 20mm.
The distal polymer shaft consists of a two coaxial lumens, with one lumen for inflation and the other to enable the use of a quide wire for positioning the catheter. The catheter is compatible with a 0.014" guidewire, which enters at the distal tip of the catheter and exists at the RX port.
The proximal portion of the catheter is formed from a hypotube containing the inflation lumen. At the proximal end, a hub with luer connector is attached to the hypotube, allowing connection to an inflation device. Radiopaque balloon marker bands enable accurate positioning of the device. Shaft markers for brachial and femoral techniques are also in place.
The OPN NC comes in a single useable length of 147cm. The device nominal pressure is 10 atm and the rated burst pressure is 35 atm.
The provided text describes a 510(k) premarket notification for the OPN NC PTCA Dilatation Catheter, demonstrating its substantial equivalence to a predicate device (NC Euphora Rapid Exchange Balloon Dilatation Catheter).
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a tabulated format with corresponding "reported device performance" against numerical targets. Instead, it states that "The in vitro bench tests demonstrated that the OPN NC PTCA Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device." This implies that the acceptance criteria were based on established engineering and performance standards for PTCA dilatation catheters, and the device successfully met these standards.
Based on the "NON-CLINICAL TESTING/PERFORMANCE DATA" section, the following tests were performed, and the implicit acceptance criterion for all of them was that the device performs as intended and similarly to the predicate device, demonstrating substantially equivalent safety and effectiveness/performance.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Dimensional Verification (e.g., balloon diameters, lengths) | Met all acceptance criteria; performed similarly to predicate. Specifically, balloon diameters: 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, and 4.5mm. Balloon lengths: 10, 15, and 20mm. Useable length: 147cm. |
| Simulated Use | Met all acceptance criteria; performed similarly to predicate. |
| Compliance (of balloon) | Met all acceptance criteria; performed similarly to predicate. |
| Coating Integrity | Met all acceptance criteria; performed similarly to predicate. |
| Particulate | Met all acceptance criteria; performed similarly to predicate. |
| Inflation/Deflation (characteristics and time) | Met all acceptance criteria; performed similarly to predicate. Nominal pressure: 10 atm. Rated burst pressure: 35 atm. |
| Corrosion | Met all acceptance criteria; performed similarly to predicate. |
| Abrasion/Puncture Resistance | Met all acceptance criteria; performed similarly to predicate. |
| Lubricity/Pinch Testing | Met all acceptance criteria; performed similarly to predicate. |
| Flex/Kink | Met all acceptance criteria; performed similarly to predicate. |
| Torque | Met all acceptance criteria; performed similarly to predicate. |
| Tensile Strength | Met all acceptance criteria; performed similarly to predicate. |
| Rated Burst Pressure | Met all acceptance criteria; performed similarly to predicate. Reported as 35 atm. |
| In-Stent Rated Burst Pressure | Met all acceptance criteria; performed similarly to predicate. |
| Balloon Fatigue | Met all acceptance criteria; performed similarly to predicate. |
| In-Stent Balloon Fatigue | Met all acceptance criteria; performed similarly to predicate. |
| Radiopacity | Met all acceptance criteria; performed similarly to predicate. Achieved with 2 Platinum/Iridium markers. |
The biocompatibility tests also showed the device to be biocompatible, which is a key acceptance criterion for medical devices.
Study Details for Acceptance Criteria Proof:
-
Sample size used for the test set and data provenance:
- The document does not specify the exact sample sizes (number of devices or components) used for each non-clinical bench test.
- The data provenance is from non-clinical laboratory testing (bench tests). No geographical origin for the testing lab is explicitly stated, but the applicant is based in Switzerland. The data is retrospective in the sense that it's reported from completed tests for regulatory submission.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This question is not applicable as the study described is a non-clinical, bench testing study. Ground truth, in the context of expert consensus, multi-reader studies, or pathology, is typical for clinical performance studies or diagnostic device evaluations. For bench testing, "ground truth" is established by defined physical and engineering specifications and validated test methods.
-
Adjudication method for the test set:
- This question is not applicable as the described study is non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when multiple readers evaluate images or patient data.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The described study is non-clinical bench testing comparing the device's physical and performance characteristics to a predicate device. MRMC studies are relevant for evaluating the impact of AI-assisted diagnostic devices on human performance.
-
Effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as no MRMC or AI-assisted study was performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a medical catheter, not an AI algorithm.
-
The type of ground truth used:
- For the non-clinical testing, the "ground truth" is based on engineering specifications, material science principles, established performance standards, and validated test methods. The device's performance is compared against these predetermined criteria and the known performance of the predicate device to establish substantial equivalence.
-
The sample size for the training set:
- This question is not applicable as the device is a physical medical catheter, not a machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
§ 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.