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510(k) Data Aggregation
(41 days)
The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Ultraverse® 035 PTA Dilatation Catheter is a semi-compliant balloon catheter consisting of an over the wire (OTW) catheter with an angioplasty balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter also includes a radiopaque, atraumatic tip. GeoAlign™ Marker Bands are designated on the catheter shaft by 1cm increment bands. Each 10cm increment is labeled with the distance from the distal balloon tip. Thicker bands denote the midway point (5cm) between the labeled distances. GeoAlign™ Marker Bands are designed to be used as a location reference tool. GeoAlign™ Marker Bands are also designed to be used as a guide to assist with geographic alignment when used with an adjunctive therapy that utilizes the same GeoAlign™ Marker Bands. The aforementioned design elements of the GeoAlign " Marker Bands facilitate increased procedure efficiency and minimize fluoroscopy exposure. The Ultraverse® 035 PTA Dilatation Catheter is compatible with .035" guidewires. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and should be removed prior to use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. A rewrapping tool is also provided on the catheter shaft. These products are not made with natural rubber latex.
The provided text describes a medical device, the Ultraverse® 035 PTA Dilatation Catheter, and its substantial equivalence to a predicate device. This document is a 510(k) summary from the FDA, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
However, the document does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, it details non-clinical (in vitro) and biocompatibility tests to show substantial equivalence.
Therefore, an exhaustive answer to your request cannot be fully provided based solely on the given text. I will extract the available information and explicitly state where the requested information is not present.
Here's a breakdown of the available information structured to best answer your prompt:
1. A table of acceptance criteria and the reported device performance
The document lists various in vitro and biocompatibility tests performed. For the biocompatibility tests, it explicitly states "PASS" for each, indicating they met the acceptance criteria for those specific tests. For the in vitro tests, it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 035 PTA Dilatation Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market with the same intended use." Specific numeric acceptance criteria or detailed device performance results (e.g., specific measurements for dimensional verification, exact burst pressures) are not provided in this summary.
| Test Category | Specific Test | Reported Device Performance (Acceptance Criteria) |
|---|---|---|
| In Vitro Tests | Dimensional Verification (Tip length, Balloon Outer Diameter, Balloon Length, Shaft Outer Diameter, Catheter Shaft Length) | Comparable to predicate devices; performs equivalently for intended use (Specific numeric criteria not provided) |
| Gradient Marking Position | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Gradient Marking Legibility | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Gradient Marking Durability | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Trackability | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Sheath Compatibility | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Flushability | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Reinsertion | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Stylet/Refold | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Device Compatibility | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Guidewire Compatibility | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon Distensibility | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Inflation | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Deflation | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon Rated Burst Pressure | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Leak | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Burst Mode | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Fatigue | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon Fatigue in a Stent/Stent Graft | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon Burst in a Stent/Stent Graft | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon Removal from a Stent/Stent Graft | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Balloon to Shaft Tensile | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Catheter Elongation | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Hub to Shaft Tensile | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Tip Taper | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Tip Radiopacity | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Marker Band Radiopacity | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Marker Band Alignment | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Hub Torque/Hub Stress | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Packaging (Visual Inspection, Dye Penetration, Pouch Tensile) | Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided) | |
| Biocompatibility | Cytotoxicity (MEM Elution Test) | PASS |
| Sensitization (Murine Local Lymph Node Assay) | PASS | |
| Sensitization (Guinea Pig Maximization Test) | PASS | |
| Intracutaneous (Intracutaneous Injection Test) | PASS | |
| Acute Systemic Toxicity (Systemic Injection Test) | PASS | |
| Hemocompatibility (In Vivo Hemolysis) | PASS | |
| Hemocompatibility (Thrombogenicity) | PASS | |
| Hemocompatibility (Complement Activation) | PASS | |
| USP Pyrogen Study (Material Mediated Pyrogenicity) | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "in vitro tests" and "biocompatibility testing." These are laboratory-based tests of the device itself, not clinical studies involving patient data or images. Therefore, the concepts of "test set sample size" and "data provenance" in the typical AI/medical imaging context (e.g., country of origin, retrospective/prospective clinical data) do not apply to the testing described. The sample sizes for each specific in vitro and biocompatibility test are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question relates to clinical studies and expert review for ground truth, which is not applicable to the pre-market notification (510k) summary provided, as it describes in vitro and biocompatibility testing of a physical medical device, not an AI or imaging diagnostic device requiring expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As per point 3, this question is not applicable to the type of testing described in the document.
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
The document describes a physical medical device (catheter), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance was not done and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also related to AI/algorithm performance. As the device is a physical catheter, this is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" or reference for "PASS" is an objective laboratory determination based on established test methods and standards (e.g., ISO 10993-1).
For the in vitro tests, the "ground truth" for evaluating performance would be engineering specifications and standards for the physical and functional properties of the device.
No expert consensus, pathology, or outcomes data are mentioned as ground truth in this 510(k) summary, as these typically relate to clinical evaluations, which are not the primary focus of this type of pre-market submission for this device.
8. The sample size for the training set
The document describes a physical medical device undergoing in vitro and biocompatibility testing, not an AI algorithm requiring a training set. Therefore, a "training set sample size" is not applicable.
9. How the ground truth for the training set was established
As per point 8, this question is not applicable.
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