(94 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illio-femoral, popliteal, and infra popliteal 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.
This document describes the AngioSculpt® PTA Scoring Balloon Catheter, a device intended for dilating lesions in various arteries and for treating obstructive lesions in arteriovenous fistulae. While it details the device's intended use, design, and comparison to predicate devices, it does not contain information about specific acceptance criteria, device performance metrics, or a study design with sample sizes, expert involvement, or adjudication methods.
This document is a 510(k) Summary, a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission typically focuses on demonstrating equivalence through design and functional performance similarities and verification/validation testing, rather than reporting detailed clinical study results against pre-defined acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or multi-reader studies.
Here's what can be extracted from the document:
- Device Name: AngioSculpt® PTA Scoring Balloon Catheter
- Intended Use/Indications for Use:
- Dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries.
- Treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Not for use in the coronary or neuro-vasculature.
- Regulatory Class: Class II (two)
- Product Codes: PNO, DQY, and LIT (the first page mentions PNO, the summary mentions DQY and LIT)
- Predicate Devices:
- Device Description: A standard two-lumen catheter with a scoring balloon near the distal tip. The distal end 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 to minimize balloon slippage and assist with luminal expansion. The balloon has radiopaque markers.
- Statement on Performance: "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."
Missing Information (as per your request):
- A table of acceptance criteria and the reported device performance: Not present in this document. The document states "adequate device performance" but provides no specific metrics or criteria.
- Sample sized used for the test set and the data provenance: Not present. The document mentions "design verification and validation testing" but does not detail the testing methodology, sample sizes, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not present. This type of detail is usually found in clinical study reports, which are not part of this 510(k) summary. Given the device type, "ground truth" would likely refer to physical/mechanical testing results, not expert consensus on medical images.
- Adjudication method for the test set: Not applicable or not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is an angioplasty catheter, not an imaging AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is an angioplasty catheter.
- The type of ground truth used: For this device, ground truth would refer to engineering specifications and performance metrics (e.g., balloon burst pressure, trackability, pushability, material compatibility, dimensional accuracy). This document does not detail the specific "ground truth" used for its verification and validation.
- The sample size for the training set: Not applicable. This document is for a medical device (catheter), not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).