(28 days)
The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.
The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.
The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.
Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.
The provided text is a 510(k) Premarket Notification for Cordis PTA Balloon Catheters, and it does not include information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI/ML performance study would.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on non-clinical design verification tests and analyses. This approach is typical for 510(k) submissions where the new device is very similar to an already approved one.
Therefore, many of the requested points related to acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable or discoverable in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no explicit table of acceptance criteria and reported device performance in the context of a clinical performance study with defined metrics (e.g., sensitivity, specificity, accuracy).
Instead, the "performance" demonstrated is that the modified devices are "virtually identical" to their original cleared devices, with changes limited to non-clinical aspects like hub material and design configuration for user preference. The regulatory "acceptance criteria" here are implicitly that these minor design changes do not negatively impact the safety and effectiveness, and the device continues to meet the safety and performance of its predicate.
- Acceptance Criteria (Implicit): The modified devices demonstrate biocompatibility, and their non-clinical performance (e.g., inflation/deflation, tracking over a guidewire, radiopacity) is equivalent to the predicate devices, and the changes do not introduce new safety concerns.
- Reported Device Performance: "Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible."
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not applicable. This submission relies on non-clinical design verification tests, not a clinical test set with patient data.
- Data Provenance: Not applicable, as there are no patient data. The "data" are from non-clinical laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth as typically understood for clinical performance studies (e.g., diagnosis, lesion identification) is not established here.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. There is no clinical test set requiring adjudication.
5. 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:
- MRMC Study: No. This is a medical device (balloon catheter), not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Ground Truth: For biocompatibility, the "ground truth" is adherence to ISO 10993-Part 1 standards. For functional performance, the "ground truth" is equivalence in non-clinical bench testing to the predicate device. This is a technical (engineering/materials) ground truth, not a clinical ground truth.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component, so no training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).