(101 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 Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended 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) 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 lumens contained within one tube. The smaller lumen is the balloon inflation/deflation 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) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.
This document describes the Biotronik Passeo-35 Peripheral Dilatation Catheter (K142379) and its substantial equivalence to a predicate device (K082933). The submission primarily focuses on non-clinical performance testing for additional device size configurations and material changes.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comprehensive list of non-clinical tests performed on the Passeo-35 Peripheral Dilatation Catheter. The "Test Conditions / Specifications" column often implicitly or explicitly states the acceptance criteria, while the "Summary Results" column indicates whether these criteria were met.
Due to the length, a complete table is not feasible here. Instead, a representative sample of acceptance criteria and results is provided.
| Test Name | Acceptance Criteria (or implicit in description) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity | No cytotoxic effects of the test article on L929 cells. | "Growth analyses of cells cultured with test article extract showed no cytotoxic effects of the test article." |
| Sensitization | No reactions identified as sensitization. | "No reactions were identified as sensitization." |
| Irritation / Intracutaneous reactivity | No signs of irritation for polar and non-polar extracts. | "There were no signs of irritation of the polar and non-polar test article extracts injected intracutaneously into rabbits." |
| Acute systemic toxicity | No compound-related mortalities, no significant body weight loss, clinically normal animals, no gross pathology. | "There were no compound related mortalities, no significant body weight loss was recorded and all animals appeared clinically normal. At necropsy no evidence of gross pathology of organs was found. The test article was considered to have no acute toxic characteristics." |
| Pyrogenicity | No single animal showed a temperature increase higher or equal to 0.5°C above its initial temperature. | "No single animal showed a temperature increase higher or equal to 0.5°C above its initial temperature. The test article is considered to be non-pyrogenic." |
| Hemocompatibility | No significant changes in cell counts, TAT complex generation identical to reference, no evidence of hemolysis. | "There were no significant changes in the cell counts and the coagulation system activation value measured as TAT complex generation of the test article was identical in comparison with the reference. There was no evidence of hemolysis." |
| GC-MS / FT-IR | No differences in detected substances / >99% correlation to predicate materials. | "GC/MS fingerprint analysis... yielded no differences in the type of detected substances... Materials had greater than 99% correlation according to FT-IR analysis." |
| Non-Clinical Performance Testing | ||
| Visual and Dimensional Inspection | All inspectional acceptance criteria (e.g., no defects, correct printing, correct marker positioning, specified dimensions) met. | "Inspectional acceptance criteria were met." |
| Crossing Profile | Acceptance criteria for crossing profile met; within specs of predicate. | "Acceptance criteria for crossing profile were met. Crossing profile is within specs of predicate." |
| Simulated Use / Balloon Prep, Deployment, Retraction | Acceptance criteria met; performs similar to predicate in simulated use. | "Acceptance criteria for balloon prep, deployment and retraction were met. Test shows device performs similar to predicate in a simulated use environment." |
| Deflated Balloon Profile | Withdrawal force less than minimal tensile; deflated balloon diameter less than max crossing profile. | "Acceptance criteria were met: withdrawal force is less than minimal tensile and deflated balloon diameter is less than max crossing profile." |
| Trackability | Acceptance criteria for comparison to the predicate met. | "Acceptance criteria for comparison to the predicate were met." |
| Pushability | Comparable or better (greater) than the existing Passeo-35 range. | "Acceptance criteria for comparison to predicate devices were met." |
| Torqueability / Torque Strength | Qualitative assessment showed rotation transfers to distal tip; all balloons passed inflation test. | "Qualitative assessment showed rotation transfers to distal tip on average between 10 and 16 rotations and all balloons passed inflation test. Device meets torqueability and torque strength acceptance criteria." |
| Pullback and Reintroduction test | Pullback and reintroduction comparable or better than comparator product; product specifications met for 1st and 2nd pullback force; safe retrieval after burst. | "Pullback and reintroduction was comparable or better than comparator product. Product specifications were met for 1st and 2nd pullback force values. Balloon can be safely retrieved after burst." |
| Balloon Inflation / Deflation Time | Deflation time according to specifications within instructions for use. | "Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use." |
| Flexibility and kink test | No kink, function not compromised at 20mm radius, guidewire movable, successful inflation/deflation. | "No kink occurred nor was the function of the device compromised at the clinically relevant radius of 20 mm. The guide wire was movable during testing and it was possible to inflate and to deflate the balloon to and from NP." |
| Particulate Evaluation | Number of particulates released either the same as (p-value >0.05) or less than (p-value 0.05) or were less than the comparator device (p-value |
§ 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).