(28 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The modified AngioSculpt PTA catheter has very similar technological characteristics as the cleared AngioSculpt PTA catheter. The modified AngioSculpt PTA Catheter is exactly the same device as the cleared AngioSculpt PTA catheter, except for minor differences to the distal bond and intermediate bond of the 0.018" OTW platform, 20mm balloon length catheters.
Here's the information regarding the acceptance criteria and the study for the AngioSculpt® PTA Scoring Balloon Catheter, based on the provided document:
This document is a 510(k) summary for a modification to an already cleared device, the AngioSculpt PTA Scoring Balloon Catheter. Therefore, the "study" described focuses on demonstrating that the modified aspects of the device still meet expectations, not on a full-scale clinical trial to prove initial efficacy or safety for a new device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide specific numerical acceptance criteria (e.g., "Bond Tensile Strength >= X N") or precise numerical performance results (e.g., "Bond Tensile Strength = Y N"). Instead, it states that the modified design was evaluated against specifications and met them.
| Acceptance Criterion (Evaluated Product Attribute) | Reported Device Performance |
|---|---|
| Entry Profile (distal bond OD) | Met specifications |
| Profile (intermediate bond OD) | Met specifications |
| Fatigue Strength | Met specifications |
| Bond Tensile Strength | Met specifications |
| Visual inspection for distal bond imperfections | No observations of imperfections |
| Visual inspection for intermediate bond imperfections | No observations of imperfections |
2. Sample Size Used for the Test Set and Data Provenance
The document provides no explicit sample sizes for the non-clinical performance testing. It generally refers to "design verification testing" and "application of risk analysis and a change impact assessment."
The data provenance is non-clinical bench testing conducted by the manufacturer, AngioScore, Inc. Details such as country of origin for the data are not specified beyond the manufacturer's location in Fremont, CA, USA. This testing is retrospective in the sense that it's evaluating a modification to an existing design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was non-clinical bench testing of device attributes, not a clinical study requiring expert assessment of patient data. The "ground truth" was established by engineering specifications and testing protocols.
4. Adjudication Method for the Test Set
Not applicable. This was non-clinical bench testing. Results would typically be evaluated against pre-defined engineering specifications, not through a consensus or adjudication process involving multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes non-clinical engineering testing, not a clinical study involving human readers or patient cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical instrument (a balloon catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing was engineering specifications and established testing methodologies to measure physical properties like bond strength and profile.
8. The Sample Size for the Training Set
Not applicable. This involves non-clinical bench testing for a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is about a physical device, not an AI/ML system.
§ 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).