Search Results
Found 2 results
510(k) Data Aggregation
(25 days)
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral
Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.
The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo 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 Xeo Catheter towards and through the lesion(s) to be dilated.
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. The dilatation 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 guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.
The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. 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. The dilatation 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 guide wire lumen.
The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.
Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
The provided FDA 510(k) clearance letter (K250706) is for BIOTRONIK's peripheral and coronary dilatation catheters. This document describes several devices: Passeo-35 Xeo, Passeo-18, Passeo-14, Oscar Peripheral Multifunctional Catheter System, Pantera LEO PTCA Catheter, and Pantera Pro PTCA Catheter.
It's important to note that this 510(k) Summary does not describe an AI/ML powered device. Instead, it focuses on the physical and performance characteristics of medical devices (catheters). Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and details about training data, are not applicable to this type of submission.
The "performance testing" mentioned throughout the document refers to bench testing and engineering assessments to ensure the physical device meets its design specifications and performs safely and effectively. It does not involve AI model performance evaluation with clinical data.
Here's an attempt to answer the applicable parts of your request based on the provided text, with clear indications where the information is not present or not relevant to an AI/ML device:
Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for these devices are implicitly derived from the design specifications and are demonstrated through performance (bench) testing. The study proving these devices meet the acceptance criteria is a series of performance (bench) tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes technological characteristics and states that "All necessary performance testing was conducted... to ensure that the devices conform to the design specification." The "Subject Devices" column in the tables explicitly states "Identical" for most characteristics, meaning they meet the same specifications as the predicate devices. The only explicit change mentioned is that "Components will be brought into compliance with ISO 80369-7:2021" for Luer connectors and manifolds. The full set of specific performance acceptance criteria values (e.g., specific burst pressure thresholds, flexibility requirements, etc.) are not explicitly detailed in this summary but are indirectly stated as being met for "consistent performance during its intended use."
Here's a summary derived from the comparison tables, focusing on the acceptance of "identical" characteristics:
| Acceptance Criteria Category | Specific Criteria (from Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended User | Physicians competent in PTA procedures | Identical |
| Method of Placement | Standard percutaneous access to site over a guide wire, with fluoroscopic visualization | Identical |
| Sterilization | EO gas, SAL 10⁻⁶ | Identical |
| Shelf Life | 3 years | Identical |
| Radiopaque Markers | Presence, material, number, length, and spacing as specified for each device type | Identical |
| Usable Length | Specified lengths (e.g., 90, 130, 170 cm for Passeo-35 Xeo) | Identical |
| Introducer Sheath Compatibility | Specified F sizes and balloon diameter/length compatibility | Identical |
| Crossing Profile | Maximum inches/mm as specified | Identical |
| Guide Wire Compatibility | Specified guide wire diameter (e.g., 0.035" for Passeo-35 Xeo) | Identical |
| Shaft Outer Diameter | Specified F size | Identical |
| Balloon Diameter | Specified range of diameters (e.g., 3.0-12.0 mm for Passeo-35 Xeo) | Identical |
| Balloon Length | Specified range of lengths (e.g., 20-250 mm for Passeo-35 Xeo) | Identical |
| Balloon Wrapping | Specified folds (e.g., 3-5 folds for Passeo-35 Xeo) | Identical |
| Balloon Nominal Pressure | Specified atm | Identical |
| Balloon RBP (Rated Burst Pressure) | Specified atm, often varying by balloon diameter/length | Identical |
| Guiding Catheter Compatibility (PTCA catheters) | Minimum F size/ID | Identical |
| Distal Outer Shaft/Balloon Coating (PTCA catheters) | Hydrophilic/Hydrophobic coating as specified | Identical |
| Luer Connectors and Manifolds | Previously Luer lock connectors (L2) | Will be brought into compliance with ISO 80369-7:2021 (This is the only explicitly noted difference/update) |
Overall Performance Conclusion: "The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not introduce new issues of safety or effectiveness when compared to the predicate device."
2. Sample size used for the test set and the data provenance
The document specifies "performance testing" or "bench testing," which refers to laboratory-based evaluations of the physical device. It does not mention a test set with patient data or any sample size related to clinical data. The provenance is not applicable as this concerns physical device characteristics, not data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is not based on expert-labeled ground truth for an AI/ML algorithm but on physical measurements and engineering tests of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation is not based on expert consensus or adjudication of clinical cases for an AI/ML algorithm.
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 applicable as the device is a physical medical instrument (catheter), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these devices is the established engineering specifications, material properties, and performance benchmarks that the predicate devices have successfully met. These are verified through various physical and mechanical bench tests (e.g., burst pressure, flexibility, lubricity, dimensional accuracy, etc.). The document indicates these tests confirm the new devices' conformity to these specifications.
8. The sample size for the training set
This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training or a training set with ground truth.
Ask a specific question about this device
(59 days)
Passeo-14 Peripheral Dilatation Catheter
The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.
The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic in lower limb arteries. 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 guide wire lumen.
The dilatation catheter has a hydrophobic silicone coating on the outer surface of the proximal shaft and a hydrophilic polymeric based coating on the outer surface of the distal shaft, coated over 150 mm length (valid for 1.5 and 2 mm balloon diameter and 20 to 100 mm balloon length) or coated over 75 mm length (valid for 2 mm balloon diameter and 140 to 220 mm balloon length, and 2.5 to 4 mm balloon diameter and 20 to 220 mm balloon lenqth). The balloon has a hydrophilic patchwork coating.
The dilatation catheter is compatible with quide wire and introducer sheath sizes according to the recommendations on the label.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | Adherence to dimensional specs, no defects, printing and coating homogeneity, x-ray marker positioning. | Inspectional acceptance criteria were met. |
| Crossing Profile (system profile) | French size compatibility (measured by passing through a ring-hole gauge). | Acceptance criteria for crossing profile were met. |
| Simulated Use | Safe and reliable preparation, delivery, and retraction without device damage. | Acceptance criteria were met. Test shows device performs similar to reference devices (K083919; K093139; K090849) in a simulated use environment. |
| Deflated Balloon Profile | Deflated profile less than 4F for all sizes. | Acceptance criteria were met. Test shows deflated profile is less than 4F for all sizes. |
| Trackability and Pushability | Performance similar to reference devices in a simulated use environment (frictional force recorded). | Acceptance criteria were met. Test shows device performs similar to reference devices (K083919; K093139) in a simulated use environment. |
| Torqueability | Rotational movement transferred from manifold to distal tip. | Rotational movement was transmitted. Test was passed. |
| Pullback and Reintroduction test | Measured pullback and reintroduction forces within acceptance criteria. | Measured pullback and reintroduction forces met acceptance criteria. |
| Balloon Rated Burst Pressure | 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 Fatigue | Survivability of the balloon for repeat inflation/deflation cycles (90% survival at 20 cycles). | Results demonstrate that 90% of the balloons will survive the 20 inflation cycles with at least 95% confidence. |
| Balloon Compliance Radial | Acceptance criteria met. | Radial compliance meets acceptance criteria. Device performs similar to predicate (K142379). |
| 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 Inflation / Deflation Time | Deflation time according to specifications within IFU. | Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use. |
| Tensile Strength Catheter | Performance specifications met for distal and proximal balloon sections. | Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications. |
| Tip pull test | Acceptance criteria met. | All tested samples met acceptance criteria. |
| Flexibility and kink test | Device will not kink at bend radii appropriate for intended anatomy. | All tested samples passed the test at the clinically relevant radius. |
| Resistance to Kink | Measured mean catheter kink radius well within acceptance criteria. | Measured mean catheter kink radius was well within the acceptance criteria. |
| Torsional bond / Torque Strength | Functionality given after application of torsional load. | Acceptance criteria were met. Test was passed. |
| Visibility / Radiopacity | X-ray visibility (radiopacity) acceptance criteria met. | Acceptance criteria were met. Test was passed. |
| Coating Integrity | Ability of coating to resist damage due to loading, tracking, deployment, and withdrawal. | Passeo-14 coating performs comparable or better than reference devices (K083919; K090849). |
| Adhesive Strength of Catheter Coating | Visual inspection results. | All samples passed visual inspection. |
| Particulate Evaluation | Particle sizes ≤10, 25, and 50µm were below threshold. | Particle sizes ≤10, 25 and 50µm were below threshold. Passeo-14 particle counts were less than reference devices (K090849). |
| Corrosion Resistance (Catheter) | No signs of corrosion visible on tested samples. | No signs of corrosion were visible on the samples tested. The test was passed. |
| Compatibility with Contrast media | No visible damage or deformation after exposure to contrast medium. | No visible damage or deformation. |
| Connector test | Luer lock fittings resistant to air leakage, excessive torque, and stress cracking. | All samples met acceptance criteria. |
| Indelibility and adhesive strength of printing | Printing indelible and readable after exposure to solvents. | All samples tested showed readable printing following exposure to solvent. |
| Visual Inspection (adverse environmental conditions) | Device maintains integrity after exposure to normal transport, storage, and handling conditions. | All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity. |
| Cytotoxicity | No cytotoxic effects (evaluated by percentage of cell growth inhibition compared to control). | Growth analyses of cells cultured with test article extract showed no cytotoxic effects. Test was passed. |
| Sensitization | No allergic skin reaction compared to the control group. | Test animals showed no allergic skin reaction compared to the control group. Test was passed. |
| Irritation / Intracutaneous reactivity | No signs of irritation. | There were no signs of irritation. Test was passed. |
| Acute systemic toxicity | No signs of acute systemic toxicity. | The test was passed as there were no signs of acute systemic toxicity. |
| Pyrogenicity | No temperature increase above baseline temperature. | None of the animals showed a temperature increase above its baseline temperature. Test was passed. |
| Hemolysis | No hemolytic effect. | The test article showed no hemolytic effect. The test was passed. |
| In vitro hemocompatibility assay | No statistically significant difference between test article and control in blood parameters. | There was no statistically significant difference observed between test article and control. Test was passed. |
| Inactivated partial thromboplastin time assay | No effect on clotting time. | The test article did not have an effect on the clotting time. Test was passed. |
| Lee and White coagulation test | Average coagulation time within accepted range. | The test was passed as the average coagulation time was within the accepted range. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Complement activation assay (C3a and SC5b-9) | No induction of complement activation of C3 or C5 proteins. | The test was passed as the test article did not induce complement activation of C3 or C5 proteins in human plasma. |
| In vivo thromboresistance | Equivalent performance compared to the control article (predicate device). | The test article showed equivalent performance compared to the control article (predicate device; K142379). Test was passed. |
| Bacterial reverse mutation assay (AMES test) | No toxic or mutagenic effects identified in tester strains. | No toxic or mutagenic effects were identified in tester strains. Test was passed. |
| Mouse lymphoma assay | Mutant frequencies of test article extracts did not exceed GEF of concurrent negative control. | The mutant frequencies of the test article extracts did not exceed the GEF of their concurrent negative control. Test was passed. |
| In Vivo Mouse Micronucleus Assay | No statistically significant increase in micronucleated polychromatic erythrocytes. | There was no statistically significant increase in the percentage of micronucleated polychromatic erythrocytes. The test was passed. |
| Correction factor and bioburden | Device meets specifications for CFU/device. | Determine bioburden correction factor. Device meets specifications for CFU/device. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Bacterial endotoxin test (Pyrogen test) | Device endotoxin levels met acceptance criteria. | Bacterial endotoxin test results met acceptance criteria. |
| Validation of the Sterilization Success | SAL of 1x10^-6 achieved. | Testing confirmed SAL of 10^-6. The device performs similar to predicate (K142379). |
| Residual gas analysis: EO and ECH | Device meets acceptance criteria for EO and ECH residuals. | Device meets acceptance criteria. The device performs similar to predicate (K142379). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It generally refers to "all sizes," "all tested samples," or implies replicate testing (e.g., "90% of the balloons will survive the 20 inflation cycles"). The data provenance for these non-clinical tests is internal to the manufacturer (BIOTRONIK) and is retrospective, as the tests were conducted to secure prior market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance and safety is established through engineering and biological testing against predefined specifications and regulatory standards, not through expert consensus on diagnostic interpretations.
4. Adjudication method
Not applicable, as this is a physical medical device. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., medical imaging AI).
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
No MRMC comparative effectiveness study was done. This is a medical device clearance for a physical non-diagnostic product, not an AI-assisted diagnostic tool. No clinical data was submitted, and the determination of substantial equivalence did not rely on clinical data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. There is no algorithm or AI component mentioned.
7. The type of ground truth used
The "ground truth" for the non-clinical tests detailed in the document is based on pre-defined engineering specifications, international standards (ISO-10993), and FDA guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). For biocompatibility, it relies on established biological endpoints and observable reactions in in-vitro and in-vivo models.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Ask a specific question about this device
Page 1 of 1