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510(k) Data Aggregation
(96 days)
The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.
The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.
The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.
The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.
This document describes the Pirouette 014 PTA Catheter, a medical device for balloon dilation of arteries. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. Instead, it describes a conventional medical device (a catheter) and its non-clinical performance testing.
Therefore, I cannot fulfill the request as it pertains to an AI/ML powered device, an acceptance criteria table, or a study demonstrating AI performance.
The information given is about:
- Device Name: Pirouette 014
- Device Type: Percutaneous Transluminal Angioplasty (PTA) Catheter
- Intended Use: Balloon dilation of the iliac, femoral, popliteal, infra-popliteal, and renal arteries.
- Predicate Device: Pirouette 018 OTW PTA Catheter (K151153) and Bantam α PTA Catheter (K093139)
- Performance Data: Non-clinical bench tests, biocompatibility tests, sterilization, shelf-life, and packaging validation were conducted. No clinical studies were performed. The results from these tests "showed that the Pirouette 014 met the pre-determined acceptance criteria," but the specific acceptance criteria or the reported performance values are not detailed in a quantitative table.
To answer your prompt for an AI/ML powered device, I would need a different type of document specifically detailing the performance of an AI/ML algorithm.
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(59 days)
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.
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