(63 days)
The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
The modified 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 diagneter and length at a specific pressure.
This document is a 510(k) premarket notification for the AngioSculpt® PTA Scoring Balloon Catheter, specifically addressing a modification. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical study results or acceptance criteria in the format requested.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully extracted from the provided text. The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised," but it does not detail those tests or their specific acceptance criteria.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "Design verification and validation testing demonstrated adequate device performance," but it does not specify what those performance criteria were or the quantitative results of those tests. It focuses on demonstrating substantial equivalence in fundamental design, scientific technology, functional performance, and materials to a predicate device (AngioSculpt® Scoring Balloon Catheter K050629) and similar dimensions/size configurations to another predicate (Cordis Savvy® PTA Dilatation Catheter K971010).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from the provided text. The document mentions "Design verification and validation testing" but does not provide details on sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be determined. This document describes a medical device submission, not a study evaluating an AI algorithm with expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be determined. This document describes a medical device submission, not a study involving expert adjudication of data.
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
- No. This is not an AI device. The document describes a physical medical device (a scoring balloon catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The document refers to "Design verification and validation testing," which for a physical device would involve engineering tests (e.g., burst pressure, fatigue, dimensional accuracy, force profiles) rather than establishing ground truth like pathology or expert consensus for clinical disease states.
8. The sample size for the training set
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
Summary based on the provided document:
The provided document is a 510(k) submission for a modified AngioSculpt® PTA Scoring Balloon Catheter. The primary method for demonstrating the device's acceptability is through substantial equivalence to predicate devices. The document explicitly states:
- "The modified AngioSculpt catheter shares the same fundamental design, scientific technology (operating principle), functional performance, and similar materials as the original AngioSculpt catheter."
- "The modified AngioSculpt catheter has similar dimensions and size configurations as the Savvy catheter."
- "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised."
However, the specific "acceptance criteria" (such as quantitative thresholds for performance metrics) and the detailed results of the "design verification and validation testing" are not included in this summary document. The document functions as a high-level notification to the FDA about a device modification and its substantial equivalence, not a detailed technical report of testing data.
§ 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).