(33 days)
The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter. The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.
The provided text is a 510(k) premarket notification for the BIOTRONIK Passeo-35 PTA Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a more comprehensive clinical trial report.
Therefore, the input does not contain the specific information required to complete the detailed table and answer all questions related to acceptance criteria, study design, and performance. The document primarily describes the device, its intended use, and identifies predicate devices.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. 510(k) submissions typically rely on design verification and validation testing (bench and/or animal studies) to demonstrate that a new device performs as intended and is as safe and effective as a predicate device. Specific acceptance criteria and quantitative performance results for a clinical study with human subjects, in the format requested, are not included.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. There is no mention of a clinical "test set" with human subjects for the Passeo-35, nor details on data provenance. The submission focuses on device characteristics and substantial equivalence to predicates.
3. 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):
This information is not available in the provided document. "Ground truth" establishment by experts is a concept typically associated with studies involving diagnostic accuracy or image interpretation, which is not the focus of this device (a PTA catheter).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided document. Adjudication methods are relevant for studies where expert consensus is needed for outcome assessment, which, again, is not detailed here.
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:
This information is not available in the provided document. An MRMC study is not relevant for a PTA catheter, nor is AI assistance mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. A "standalone algorithm" is not applicable to an interventional medical device like a PTA catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document. As a physical device for dilatation, the concept of "ground truth" for the device's performance often relates to physical and mechanical properties (e.g., balloon diameter at pressure, burst strength, trackability), verified through engineering and bench testing, rather than clinical "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical trial.
8. The sample size for the training set:
This information is not available in the provided document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described here.
9. How the ground truth for the training set was established:
This information is not available in the provided document for the reasons stated above.
Summary based on available information:
The document describes the BIOTRONIK Passeo-35 PTA Catheter as a device for dilating stenotic segments in peripheral vessels (renal, iliac, femoral, popliteal, infrapopliteal arteries) and for treating obstructive lesions in arteriovenous dialysis fistulae.
The device's safety and effectiveness are established through demonstration of substantial equivalence to predicate devices:
The submission implies that the device meets its intended performance through its design, materials, and manufacturing, consistent with the cleared predicate devices. Specific clinical acceptance criteria and results from human studies are not detailed in this 510(k) summary. The FDA's clearance (K082933) indicates that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.
§ 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).