(115 days)
The Finesse Injectable™ PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Finesse InjectableTM PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter for peripheral indications. The device features a semi-compliant balloon combined with a low-profile tip. The catheter is compatible with 0.014" (0.36 mm) guidewires and has a hydrophilic coating over its distal coaxial segment to facilitate advancement of the catheter to the treatment site. The Finesse Injectable™ PTA Balloon Dilatation Catheter has a working length of 150 cm, and is available with balloon working lengths of 20, 40, 60, 100, and 225 mm. There are two radiopaque marker bands located within the balloon working length (one proximal and one distal). These radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter's balloon segment. There is one additional radiopaque marker located distal of the exit holes to aid in locating their position relative to a guiding sheath distal tip. The catheter construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the guidewire and injection of fluids via the catheter's exit holes that are positioned proximal to the balloon. The proximal portion of the catheter comprises a hub that includes an extension tube with a female luer-lock port connected to a balloon inflation/deflation lumen, and a stopcock with female luer-lock port for fluid/contrast injection attached to the side port of a Touhy-Borst adapter that is in communication with the guidewire lumen.
The Finesse™ Injectable PTA Balloon Dilatation Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for each test. However, it states that "Results from all tests were acceptable" and that the data "demonstrate that the Finesse Injectable™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices."
Based on the information provided, a table of acceptance criteria and reported device performance would look like this:
| Performance Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Testing | Demonstrates sterility suitable for a medical device | Acceptable |
| Package Integrity | Maintain package integrity | Acceptable |
| Crossing Profile | Within acceptable limits for PTA catheters | Acceptable |
| Balloon Outer Diameter | Within specification for marketed balloon sizes | Acceptable |
| Tip/Lesion Entry Profile | Suitable for navigating peripheral vasculature | Acceptable |
| Tip ID | Within specification | Acceptable |
| Catheter Useable Length | Within specification (150 cm) | Acceptable |
| Injection Exit Hole Dimensions and Locations | Within specification | Acceptable |
| Marker Band Position | Accurately placed for fluoroscopic guidance | Acceptable |
| Balloon Burst Strength | Withstands specified pressure without bursting | Acceptable |
| Balloon Compliance | Meets specified compliance characteristics | Acceptable |
| Balloon Working Length | Within specification for marketed balloon lengths | Acceptable |
| Inflation/Deflation Time | Meets specified inflation/deflation times | Acceptable |
| Balloon Fatigue | Withstands repeated inflation/deflation cycles | Acceptable |
| Catheter Bond Tensile Strength | Meets specified tensile strength | Acceptable |
| Kink Resistance | Resists kinking during use | Acceptable |
| Balloon Preparation, Deployment, and Retraction | Demonstrates proper function | Acceptable |
| Introducer Sheath Compatibility | Compatible with specified introducer sheaths | Acceptable |
| Torque Tolerance | Withstands specified torque | Acceptable |
| Radiopacity | Sufficient for fluoroscopic visibility | Acceptable |
| Infusion Rate | Meets specified infusion rate | Acceptable |
| Catheter Body Burst Pressure | Withstands specified burst pressure | Acceptable |
| Guidewire Compatibility | Compatible with specified guidewire diameters | Acceptable |
| Coating Integrity | Maintains integrity during use | Acceptable |
| Particulate Generation | Meets acceptable limits for particulate generation | Acceptable |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Bacterial Endotoxin) | Meets ISO 10993-1 requirements | Met all requirements |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned under "Performance Data." It refers to "Design verification and validation" and "the following tests were conducted," implying a series of laboratory and bench tests.
- Sample size: Not specified.
- Data provenance: The performance data is generated through "Design verification and validation" testing. This typically implies prospective, internal laboratory testing conducted by the manufacturer (Summa Therapeutics, LLC). There is no indication of country of origin for the data or if it was retrospective.
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. The study is a device performance evaluation (bench testing and biocompatibility), not a clinical study involving the establishment of ground truth by experts for diagnostic or treatment effectiveness.
4. Adjudication method for the test set:
This information is not applicable, as it is a device performance study and not a study requiring expert adjudication of clinical outcomes or images.
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. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was conducted.
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 not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of this device performance study. The "ground truth" for this device's evaluation is defined by engineering specifications, material standards, and established test methodologies for evaluating the physical and mechanical properties of balloon catheters and their biological safety.
8. The sample size for the training set:
This information is not applicable. This is a device performance study, not a machine learning or AI algorithm development that would involve training sets.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device submission.
§ 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).