(19 days)
The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system.
The Maxi DS PTA Balloon Catheters are indicated for dilatation of 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. In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system.
This document is a 510(k) premarket notification for the Cordis Maxi DS PTA Balloon Catheter, seeking to establish substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond biocompatibility and a general statement of substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information:
1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." and focuses on demonstrating substantial equivalence to predicate devices rather than meeting new, specific performance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable, as detailed performance testing data for a specific acceptance criterion is not provided. The substantial equivalence claim is based on the device design and intended use being similar to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a medical device (balloon catheter) submission, not an AI-enabled diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for substantial equivalence is based on comparison to legally marketed predicate devices.
8. The sample size for the training set: Not applicable.
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).