(179 days)
The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral balloon catheters designed for Percutaneous Transluminal Angioplasty (PTA). These three PTA balloon dilatation catheters have been bundled in one 510(k) submission due to the similar/equivalent construction and identical material of the products. As summarized by the comparison between the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters in Table 1, the devices only differ in guidewire compatibility, balloon diameter, and balloon length. The devices are offered with catheter working lengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" for the Polux device, 0.018" for the Minerva device and 0.035" for the Atropos device. The balloon diameters range from 1.5 mm to 10.0 mm, with balloon working lengths ranging from 5 mm to 200 mm. The balloon material is made of a semi-compliant Pebax material and offered in diameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter depending on the pressure delivered. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
This document describes the BrosMed Medical Co., Ltd. Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters and their substantial equivalence to predicate devices. It does not contain information about an AI/ML device. Therefore, I cannot provide a response based on the request's specific requirements concerning AI/ML performance.
However, I can extract the acceptance criteria and study information related to the device performance of these balloon catheters, as presented in the provided text.
Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)
The document primarily focuses on demonstrating the substantial equivalence of the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters to existing predicate devices (NanoCross Elite, Sterling, Mustang Balloon Dilatation Catheters). The "Performance Data" section summarizes the testing conducted to ensure the device's suitability for its intended use.
Here's a table based on the provided text, outlining the types of performance tests conducted and the general outcome:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In vitro Performance Tests | |
| Dimensional Verification | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Preparation, Deployment, Retraction | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Rated Burst Pressure | Test results met all acceptance criteria and were similar to predicate devices. (Rated Burst Pressure 14atm, as per Table 1). |
| Balloon Fatigue | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Compliance | Test results met all acceptance criteria and were similar to predicate devices. (Semi-compliant balloon characteristic, as per Table 1). |
| Balloon Inflation and Deflation Time | Test results met all acceptance criteria and were similar to predicate devices. |
| Catheter Bond Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Tip Pull Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Flexibility and Kinking | Test results met all acceptance criteria and were similar to predicate devices. |
| Torque Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Radiopacity | Test results met all acceptance criteria and were similar to predicate devices. (The balloon has radiopaque markers for positioning, as described in the device description). |
| Coating Integrity | Test results met all acceptance criteria and were similar to predicate devices. |
| Particulate Evaluation | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Burst (in stents) | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Fatigue (in stent) | Test results met all acceptance criteria and were similar to predicate devices. |
| Biocompatibility Tests | |
| Cytotoxicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Sensitization | Test results met all acceptance criteria and were similar to predicate devices. |
| Hemocompatibility | Test results met all acceptance criteria and were similar to predicate devices. |
| Pyrogenicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Acute Systemic Toxicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Intracutaneous Reactivity | Test results met all acceptance criteria and were similar to predicate devices. |
| Genotoxicity (Bacterial Mutagenicity) | Test results met all acceptance criteria and were similar to predicate devices. |
| Genotoxicity (In vitro Mouse Lymphoma) | Test results met all acceptance criteria and were similar to predicate devices. |
Missing Information (Relevant to AI/ML, but not present in the document):
- Sample size used for the test set and data provenance: Not applicable as this is not an AI/ML device or study. The document states "test results met all acceptance criteria" but does not detail sample sizes for the various performance and biocompatibility tests.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images) is not relevant here. The "ground truth" for these tests would be established by industry standards, engineering specifications, or biological assay controls.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: For this type of medical device, the "ground truth" for performance evaluations typically refers to established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for medical devices, FDA guidance documents). For biocompatibility, it's based on established biological assays and toxicology principles.
- Sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study per the Document:
The document describes a 510(k) submission for PTA balloon dilatation catheters. The study conducted was a series of "in vitro performance tests" and "biocompatibility tests". These tests were designed to evaluate the physical characteristics, functional performance, and biological safety of the Polux, Minerva, and Atropos catheters. The overall conclusion is that the "test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." The intent was to demonstrate substantial equivalence to legally marketed predicate devices, not to benchmark the performance of an AI model.
§ 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).