(133 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 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 is a 510(k) summary for the AngioSculpt® PTA Scoring Balloon Catheter, which is a medical device. As such, it describes various tests and comparisons to predicate devices to establish substantial equivalence for regulatory approval. However, it does not contain specific acceptance criteria, reported device performance metrics in the format of a table, nor does it describe a study explicitly designed to prove device acceptance criteria in the way a clinical trial for a new diagnostic or AI-powered device would.
The document primarily focuses on bench testing, biocompatibility testing, and animal testing to demonstrate the device's safety and effectiveness in comparison to existing, already approved devices (predicate devices).
Here's an analysis based on the information provided, recognizing that some of your requested points are not applicable to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria (e.g., minimum tensile strength, maximum inflation time) alongside reported numerical performance. Instead, it states that "Mechanical testing of the AngioSculpt catheter was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards. The following bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability." The results are generally described as meeting requirements or demonstrating appropriate function.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The specific sample sizes for each bench test (e.g., Catheter Diameter, Device Burst Strength) are not explicitly stated. The data provenance would be internal AngioScore, Inc. laboratory testing, which is prospective for the purpose of this submission.
- Biocompatibility Testing: Biocompatibility tests were not conducted as part of this device modification because materials were shown to be equivalent to currently marketed AngioScore products. The original biocompatibility testing would have been prospective internal or contract lab testing.
- Animal Testing: "An acute GLP and non GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The studies were conducted in the llio-femoral peripheral arteries of one experimental animal." (Note: this is a very small sample size for animal testing, likely acceptable for minor device modifications and predicate device comparison). This was a prospective study. The country of origin is not specified but presumed to be where AngioScore, Inc. conducts its R&D or contracts animal studies.
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)
This point is not applicable as the device is a physical medical device (balloon catheter), not a diagnostic device or AI system that relies on expert interpretation for ground truth in a test set. The "ground truth" for this device's performance is determined by engineering specifications and direct physical measurements/observations in bench and animal testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This point is not applicable for the same reasons as #3.
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
This point is not applicable as the device is a physical medical device, not an AI or diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" is based on engineering specifications, established industry standards, and regulatory guidance documents. Performance is measured directly against these specified values (e.g., correct diameter, sufficient burst strength, acceptable inflation time).
- For biocompatibility testing, the "ground truth" is based on the results of standardized biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, thrombosis) against predefined acceptable limits according to ISO 10993 standards and FDA guidance.
- For animal testing, the "ground truth" is based on direct observation of device performance (deliverability, trackability, passability, inflation/deflation parameters, radiopacity, ease of removal) and lack of adverse events (dissection, perforation, embolization, thrombosis, loss of components) within the animal model, as interpreted by the study investigators.
8. The sample size for the training set
This point is not applicable as the device is a physical medical device, not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
This point is not applicable for the same reasons as #8.
In summary, this 510(k) submission demonstrates "substantial equivalence" of the AngioSculpt® PTA Scoring Balloon Catheter to its predicate devices through rigorous bench testing, biocompatibility evaluations, and acute animal studies. While it confirms that the device "met design requirements" and "demonstrated adequate device performance," it does so within the context of regulatory comparison to existing devices rather than proving a novel acceptance threshold through specific clinical performance metrics.
§ 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).