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510(k) Data Aggregation
(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) comparator device. | "The number of particulates released by the Passeo-35 LE were either the same as (p-value >0.05) or were less than the comparator device (p-value <0.05)." |
| X-ray Visibility | Markers visible with contrast values approximately equivalent to a 10mm thick aluminum plate (based on predicate). | "The markers are unchanged from the predicate and the predicate (K082933) results show that markers are visible with contrast values approximately equivalent to a 10mm thick aluminum plate." |
| Corrosion Resistance | No signs of corrosion visible on tested samples. | "No signs of corrosion were visible on the samples tested." |
| Compatibility with Contrast media | No visible damage or deformation after 1-hour in contrast solution; balloon inflation to RBP possible. | "No visible damage or deformation after 1-hour in contrast solution. Balloon inflation to RBP was possible after contrast exposure." |
| Balloon Compliance Radial | All balloon diameters within tolerance and radial compliance meets acceptance criteria. | "All balloon diameters are within tolerance and radial compliance meets acceptance criteria." |
| Balloon Compliance Axial | Difference between balloon length at RBP and NP within specification. | "The difference between balloon length at RBP and NP is within specification." |
| Balloon RBP | Balloons met acceptance criteria for lower 99.9% quantile at 95% confidence interval for all sizes. | "Balloons met acceptance criteria for lower 99.9% quantile at 95% confidence interval for all sizes." |
| Balloon Rated Fatigue Testing | 90% of balloons survive the test with at least 95% confidence. | "Results demonstrate that 90% of the balloons will survive the test with at least 95% confidence." |
| Tensile Strength of the Entire Catheter | Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications. | "Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications." |
| Tip pull test | All tested samples met acceptance criteria for mean tensile strength. | "All tested samples met acceptance criteria for mean tensile strength." |
| Resistance to Kink | Measured mean catheter kink radius well within acceptance criteria. | "Measured mean catheter kink radius was well within the acceptance criteria." |
| Adhesive Strength of Catheter hydrophobic Coating | No delamination or residual particles observed on tape or catheter; all samples passed. | "No delamination or residual particles were observed on the tape or the catheter. All samples tested passed." |
| Connector Test | Connector meets acceptance criteria and complies with ISO 594-2. | "Connector meets acceptance criteria and complies with ISO 594-2." |
| Indelibility and adhesive strength of printing | All samples showed readable printing following exposure to solvent. | "All samples tested showed readable printing following exposure to solvent." |
| Post-Dilatation Test | All samples withstood 10 inflation/deflation cycles within the stent without bursting. | "All samples withstood 10 inflation/deflation cycles within the stent without bursting." |
| Visual Inspection of packaging after exposure to adverse environmental conditions | All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity. | "All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of devices or tests) for each specific non-clinical test. It generally refers to "test article," "samples," or "all sizes." For example, for "Balloon RBP," it mentions "all sizes," implying multiple devices were tested across the range of diameters and lengths.
- Test Set: No specific number for a single "test set" is provided across all tests. Each test likely utilized a relevant number of samples appropriate for the specific test's statistical requirements, though these numbers are not detailed.
- Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a laboratory or simulated environment (e.g., "anatomical model," "Crossover model," "polymer tube"). There is no mention of country of origin, but given it's a submission to the FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's reasonable to infer the testing was conducted either internally by the manufacturer or by a contracted lab, adhering to international standards (e.g., ISO, ASTM, DIN EN ISO, USP). The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate the performance of the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The studies are non-clinical, mechanical, and biocompatibility tests. They do not involve expert interpretation or human assessment of image data or clinical outcomes that would require a "ground truth" established by experts in the sense of a medical device intended for diagnostic or prognostic purposes.
4. Adjudication Method for the Test Set
This information is not applicable as there is no expert human reading involved in these non-clinical tests. The results are typically quantitative measurements or qualitative observations by trained technicians or automated systems according to defined protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This information is not applicable. The device is a physical medical device (catheter), not a software algorithm or AI that would have "standalone performance."
7. Type of Ground Truth Used
The concept of "ground truth" as typically used for AI/software in medicine (e.g., pathology, clinical outcomes) is not directly applicable here. For these non-clinical tests, "ground truth" would correspond to:
- Engineering specifications and standards: e.g., ISO, ASTM, DIN EN ISO, USP standards that define acceptable performance ranges and test methodologies.
- Predicate device performance: The performance of the previously cleared Passeo-35 (K082933) serves as a benchmark or "ground truth" for demonstrating substantial equivalence for many parameters.
- Material properties: Established properties of materials (e.g., for biocompatibility tests).
- Defined physical measurements: e.g., specified balloon diameters, lengths, pressures.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical device undergoing non-clinical validation studies, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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