(123 days)
The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.
The provided FDA 510(k) Clearance Letter for the Aperta NSE PTA Balloon Dilatation Catheter describes a device that is substantially equivalent to a predicate device. This document does not contain acceptance criteria for performance of the device in a clinical setting (e.g., success rates, complication rates) nor does it describe a study proving such performance.
Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing (bench testing, biocompatibility, and packaging) in comparison to the predicate device. The acceptance criteria described are for these non-clinical tests.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, ground truth type, training set size) are not applicable to this document as it does not report on clinical performance or AI algorithm development.
Here's the information that can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states that non-clinical testing was performed "After meeting all acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test or the detailed numerical "performance" results. It primarily indicates that the tests passed.
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench testing | Visual verification | (Not specified in document) | Met acceptance criteria |
| Dimensional verification (crossing profile & other) | (Not specified in document) | Met acceptance criteria | |
| Balloon compliance & RBP | (Not specified in document) | Met acceptance criteria | |
| Balloon RBP in stent | (Not specified in document) | Met acceptance criteria | |
| Catheter body burst pressure | (Not specified in document) | Met acceptance criteria | |
| Dimensional verification (element height) | (Not specified in document) | Met acceptance criteria | |
| Coating integrity (Pre & Post) | (Not specified in document) | Met acceptance criteria | |
| Simulated use | (Not specified in document) | Met acceptance criteria | |
| Balloon inflation/deflation time | (Not specified in document) | Met acceptance criteria | |
| Balloon fatigue | (Not specified in document) | Met acceptance criteria | |
| Torque strength | (Not specified in document) | Met acceptance criteria | |
| Flexibility and kink | (Not specified in document) | Met acceptance criteria | |
| Dimensional verification (Balloon element working length) | (Not specified in document) | Met acceptance criteria | |
| Balloon fatigue in stent | (Not specified in document) | Met acceptance criteria | |
| Catheter bond tensile strength | (Not specified in document) | Met acceptance criteria | |
| Tip pull tensile | (Not specified in document) | Met acceptance criteria | |
| Particulate evaluation | (Not specified in document) | Met acceptance criteria | |
| Biocompatibility | Cytotoxicity | (Not specified in document) | Met acceptance criteria |
| Sensitization | (Not specified in document) | Met acceptance criteria | |
| Irritation | (Not specified in document) | Met acceptance criteria | |
| Acute systemic toxicity | (Not specified in document) | Met acceptance criteria | |
| Material mediated pyrogenicity | (Not specified in document) | Met acceptance criteria | |
| Hemocompatibility | (Not specified in document) | Met acceptance criteria | |
| Packaging | Label, IFU, accessory integrity | (Not specified in document) | Met acceptance criteria |
| Packaging integrity | (Not specified in document) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical (bench and lab-based) testing, not a clinical study on a test set of patient data.
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 information is not applicable as the document describes non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical testing.
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
A MRMC comparative effectiveness study was not reported. This document is for a medical device (a catheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document is for a medical device (a catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established by the expected performance characteristics based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and the predicate device's performance. For biocompatibility, it's based on established biological safety endpoints. The document does not specify the exact methods for establishing these "truths" for each individual test, but implies adherence to the FDA Guidance Document titled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023."
8. The sample size for the training set
This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm.
§ 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).