(101 days)
The Passeo-18 peripheral dilatation catheter is indicated to dilate stenoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion.
The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter 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 flushing of the dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.
The dilatation catheter is compatible wire and introducer sheath sizes according to the recommendations on the label.
The provided text describes a 510(k) premarket notification for the BIOTRONIK Passeo-18 Peripheral Dilatation Catheter, specifically detailing the justification for clearance of additional device size configurations and minor design changes. The document focuses on non-clinical performance testing to demonstrate substantial equivalence to a previously cleared predicate device. It explicitly states that no clinical data was submitted or relied upon for this substantial equivalence determination. Therefore, questions related to human reader performance, multi-reader multi-case studies, or ground truth established by experts/pathology/outcomes data are not applicable to this submission.
Here's an analysis of the acceptance criteria and the study as described:
1. A table of acceptance criteria and the reported device performance
| Test Name | Test Conditions / Specifications (Acceptance Criteria implicitly defined) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | ||
| Visual and Dimensional Inspection | The balloon catheter was visually inspected for defects, printing, coating homogeneity, x-ray marker positioning and adherence to dimensional specs. | Inspectional acceptance criteria were met. |
| Crossing Profile (system profile) | The diameter of the device is measured by passing the device through a ring-hole gauge to verify French size compatibility. | Acceptance criteria for crossing profile were met. Crossing profile is within specs of predicate. |
| Simulated Use Testing | ||
| Simulated Use | Testing is conducted to demonstrate that the balloon catheter can be safely and reliably prepared, delivered, and retracted using the recommended techniques and instructions for use, without damage to the device. | Acceptance criteria were met. Test shows device performs similar to predicate in a simulated use environment. |
| Trackability and Pushability | Test recorded frictional force (N) when tracked over a guide wire in arterial model. | Acceptance criteria were met. Test shows device performs similar to predicate in a simulated use environment. |
| Pullback and reintroduction test | With the balloon in an appropriate sheath, the friction to introduce and pullback the device after inflation to RBP is evaluated. | Pullback and reintroduction was comparable or better than comparator product. Device performs similar to predicate. |
| Balloon Inflation / Deflation Time | Inflation and deflation time are measured with the device placed in an anatomical model. Inflation and deflation times were measured for characterization. | Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use. |
| Compatibility with Contrast media | Devices were stored for in contrast medium (ionic and non-ionic) for a specified time, dilated to RBP and then visually inspected. | No visible damage or deformation. Device performs similar to predicate. |
| Mechanical Testing | ||
| Balloon Compliance Radial | Radial compliance is calculated as the balloon diameter at NP and at RBP. | Radial compliance meets acceptance criteria. Device performs similar to predicate. |
| Balloon Compliance Axial | Axial compliance (balloon length at RBP and NP) of the device is measured to verify that it meets product specification. | The difference between balloon length at RBP and NP is within specification. |
| Balloon burst strength | This test determines the balloon Rated Burst Pressure (RBP). The balloon is inflated until burst and pressure at burst is recorded. The burst failure mode is recorded. | Balloons met acceptance criteria for lower 99.9% quantile at 95% confidence interval for all sizes. |
| Balloon Fatigue | The balloons were subjected to repeat inflation/deflation cycles to determine survivability of the balloon. Any loss of pressure, whether due to failure of the balloon, shaft or proximal or distal seals, was reported as a test failure. All failure modes were recorded. | Results demonstrate that 90% of the balloons will survive the test with at least 95% confidence. |
| Tensile Strength Catheter | Following simulated use, a tensile strain is applied along the relevant catheter region until the first sign of fracture. The force (Fmax) at first sign of damage is recorded. | Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications. |
| Resistance to Kink | Test was performed to determine the minimum bending radius of the catheter shaft at proximal and distal locations. | Measured mean catheter kink radius was well within the acceptance criteria. |
| Torsional rigidity | Test was performed to assess the ability to inflate and deflate the balloon following application of a torsional load. | Device meets acceptance criteria. Device performs similar to predicate. |
| Rotatability | Test was performed to evaluate torque response. The proximal end of the device is rotated until the first rotational movement at the distal end is observed. | Device meets acceptance criteria. Device performs similar to predicate. |
| Post-Dilatation Test | In a simulated arterial model, balloon is positioned within a deployed stent and subjected to multiple inflation/deflation cycles. | All samples withstood all inflation/deflation cycles within the stent without bursting. Device performs similar to predicate. |
| Biocompatibility | ||
| Cytotoxicity | L929 cells are incubated with test article extracts and evaluated for percentage of cell growth inhibition and compared to a control sample (control: cells exposed to extraction medium). | Growth analyses of cells cultured with test article extract showed no cytotoxic effects of the test article. |
| Gas Chromatography – Mass Spectrometry (GC/MS) | The old materials are compared to the new materials. The test articles are extracted in different solvents (polar and non-polar, e.g. purified water, isopropyl alcohol and hexane) and the extracts are analyzed by GC-MS fingerprint analysis. | There are no significant differences between old and new materials. |
| Fourier Transform Infrared Spectroscopy (FT-IR) analysis | Fourier Transform Infrared Spectroscopy (FT-IR) was utilized to compare the chemical composition of the new materials and old materials. The resulting FT-IR spectra were compared. | Materials had greater than 99% correlation according to FT-IR analysis. The new materials are similar to the predicate. |
| Sterilization Validation | ||
| Correction factor and bioburden | Test conducted to determine typical device bioburden prior to sterilization. | Determine bioburden correction factor. Device meets specifications for CFU/device. |
| Test for inhibitors and activators, Pyrogen test | Test conducted to determine device endotoxin levels after manufacturing. | Bacterial endotoxin test results met acceptance criteria. |
| Validation of the Sterilization Success | Test was performed according to determine if sterilization parameters are sufficient for a SAL of 1x10-6. | Testing confirmed SAL of 10-6. The device performs similar to predicate. |
| Residual gas analysis: EO and ECH | Test conducted to determine EO and ECH residuals on the device following two sterilization cycles. | Device meets acceptance criteria. The device performs similar to predicate. |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes (N-numbers) for each individual test. It mentions "all sizes" for balloon burst strength and refers to "samples" in other tests. The data provenance is non-clinical bench testing and simulated use environment testing, not clinical data from patients. The location of testing is not explicitly stated, but it would typically be conducted by the manufacturer (BIOTRONIK) or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical device performance study. Ground truth was established through engineering specifications, material science analysis, and physical measurements, not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes. This study focuses on physical and mechanical properties of the device.
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. No clinical studies, and specifically no MRMC studies, were performed or submitted. The submission 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."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/algorithm-based device. It is a physical medical device (catheter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this submission is based on engineering specifications, material standards, and benchmark performance metrics of the predicate device. For example, for "Balloon burst strength," the ground truth is the specified Rated Burst Pressure (RBP) and accepted failure modes. For "Biocompatibility," the ground truth involves established biological safety standards and comparison to the predicate's material composition.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.
§ 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).