(29 days)
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with three embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
The provided text is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter and focuses on demonstrating substantial equivalence to a previously cleared predicate device. It does not describe a clinical study or detailed acceptance criteria for device performance based on clinical outcomes. Instead, it relies on non-clinical bench testing to demonstrate that the new device performs as intended and is comparable to the predicate.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study with human subjects, ground truth, and training sets are not applicable to the information provided.
Here's a breakdown of what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "acceptance criteria" generally for non-clinical testing but does not provide specific quantitative criteria or detailed performance results in a table format. It states generally that "The subject device meets all acceptance criteria" and "In vitro bench testing demonstrated that the subject device performed as intended."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Catheter Delivery, Deployment, and Retraction | Performed as intended |
| Balloon Fatigue | Performed as intended |
| Catheter Torsion | Performed as intended |
| Catheter Flex/Kink | Performed as intended |
| Catheter Tensile Test | Performed as intended |
| Biocompatibility | Biocompatible (based on no new materials or manufacturing changes compared to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study was non-clinical bench testing, not involving a test set of human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth for human data is not relevant for this non-clinical bench testing.
4. Adjudication Method for the Test Set
Not applicable. No test set involving human data or expert review.
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
Not applicable. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., pathology, outcomes data) is not relevant for this non-clinical bench testing. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards which the device was tested against.
8. The Sample Size for the Training Set
Not applicable. This is not referring to an AI device or a study with a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).