(84 days)
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
The subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are small vessel balloon catheters consisting of an over the wire catheter with a balloon fixed at the distal tip. The semi-compliant, low profile balloon has two radiopaque marker bands to delineate the working length of the balloon and aid in balloon placement. The coaxial, over the wire catheter is compatible with 0.014" and 0.018" guidewires.
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters underwent a series of non-clinical in vitro tests to demonstrate substantial equivalence to a predicate device and ensure they met predetermined acceptance criteria.
1. Acceptance Criteria and Reported Device Performance:
The document describes a comprehensive set of in vitro tests performed to evaluate the physical and performance characteristics of the Ultraverse® catheters. The acceptance criteria for these tests are generally implied to be conformity with established standards, guidance documents, and internal risk assessments. The reported performance is that the devices "met all predetermined acceptance criteria" and "demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use."
Here's a table summarizing the tested parameters and the reported outcome:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material/Design Specifications: | |
| Catheter Length | Met acceptance criteria |
| Guidewire Inner Lumen Diameter | Met acceptance criteria |
| Shaft Outer Diameter | Met acceptance criteria |
| Balloon Outer Diameter at Operating Pressure | Met acceptance criteria |
| Balloon Length | Met acceptance criteria |
| Marker Band Spacing/Alignment | Met acceptance criteria |
| Tip Length | Met acceptance criteria |
| Tip Taper | Met acceptance criteria |
| Guidewire Compatibility | Met acceptance criteria |
| Mechanical Performance: | |
| Distensibility | Met acceptance criteria |
| Balloon Fatigue | Met acceptance criteria |
| Balloon Inflation and Deflation | Met acceptance criteria |
| Balloon Burst Strength | Met acceptance criteria |
| Balloon to Catheter Shaft Bond Strength | Met acceptance criteria |
| Joint Strength of Hub to Shaft | Met acceptance criteria |
| Hub Torsion Testing | Met acceptance criteria |
| Hub Stress Testing | Met acceptance criteria |
| Catheter Shaft Leaks | Met acceptance criteria |
| Catheter Elongation | Met acceptance criteria |
| Crossing Profile | Met acceptance criteria |
| Rewrapping with Stylet | Met acceptance criteria |
| Usability/Visibility: | |
| Simulated Use: Introducer Sheath Compatibility | Met acceptance criteria |
| Simulated Use: Trackability | Met acceptance criteria |
| Marker Band Visibility | Met acceptance criteria |
| Compatibility with Standard Luer Locks | Met acceptance criteria |
| Packaging/Sterility: | |
| Package Integrity | Met acceptance criteria |
| Dye Penetration of Packaging | Met acceptance criteria |
| Pouch Seal Strength | Met acceptance criteria |
2. Sample Size for the Test Set and Data Provenance:
The document describes in vitro tests, which are laboratory-based tests. Therefore, the concept of a "test set" in the context of clinical data (like patient data with a specific provenance) does not directly apply here. The sample sizes for each specific in vitro test (e.g., number of balloons tested for burst strength) are not explicitly stated in this document but would have been defined in the individual test protocols. The data provenance is from in vitro laboratory testing, conducted according to FDA Guidance Documents and internal Risk Assessment procedures.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For in vitro engineering and performance tests of medical devices, "ground truth" is typically established by physical measurements, established engineering standards, and pre-defined acceptance limits, rather than expert consensus on interpretive data (like in image analysis).
4. Adjudication Method for the Test Set:
Not applicable. As described above, the acceptance was based on meeting pre-defined physical and engineering specifications and performance criteria, not on human adjudication of medical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This document describes in vitro engineering and performance testing for a medical device (balloon catheters), not a diagnostic algorithm or imaging system requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. Standalone (Algorithm Only) Performance Study:
No. This document does not describe the evaluation of an algorithm or AI system. It focuses on the physical and mechanical performance of a medical device.
7. Type of Ground Truth Used:
For the in vitro tests, the "ground truth" was based on established engineering specifications, physical measurements, and performance benchmarks derived from FDA Guidance Documents and internal risk assessments. For example, a balloon's burst strength would be compared against a pre-defined minimum pressure it must withstand.
8. Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this study is not for a machine learning or AI algorithm. It involves direct physical and functional testing of device prototypes/samples.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI algorithm mentioned, the process of establishing ground truth for a training set is irrelevant to this submission.
§ 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).