(15 days)
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
The subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters Line Extension, 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, as labeled.
The provided text describes a 510(k) premarket notification for a medical device, specifically a line extension of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to determine specific performance metrics against acceptance criteria in the same way a diagnostic AI device would.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this SDO (Software as a Medical Device) type of submission.
However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate equivalence.
Acceptance Criteria and Device Performance Study for Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter Line Extension
This submission is a 510(k) for a "line extension" of an existing device (Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters). The core of a 510(k) is to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving performance against novel clinical acceptance criteria. The modifications were to "add balloon and catheter lengths."
The "acceptance criteria" in this context refer to engineering and performance specifications evaluated through in vitro tests to ensure the new lengths perform comparably to the predicate and meet established safety and functional requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance Statement |
|---|---|---|
| Mechanical/Physical | Dimensional Testing | Comparable to the predicate device |
| Distensibility Testing | Comparable to the predicate device | |
| Fatigue Testing | Comparable to the predicate device | |
| Balloon Burst Strength | Comparable to the predicate device | |
| Balloon Burst Mode | Comparable to the predicate device | |
| Balloon to Shaft Tensile (Strength) | Comparable to the predicate device | |
| Reinsertion | Comparable to the predicate device | |
| Catheter Shaft Leaks | Comparable to the predicate device | |
| Sheath Compatibility | Comparable to the predicate device | |
| Trackability | Comparable to the predicate device | |
| Functional | Inflation Time | Comparable to the predicate device |
| Deflation Time | Comparable to the predicate device |
Summary of Performance: The document states: "The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension is 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."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text for each individual test. These are typically in vitro bench tests, and sample sizes are determined by engineering and statistical requirements for device testing rather than patient case numbers.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective patient data. The data is from in vitro laboratory testing conducted by the manufacturer, Bard Peripheral Vascular, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is an in vitro device performance study, not a clinical diagnostic performance study requiring expert ground truth for patient data.
4. Adjudication Method for the Test Set
- Not Applicable. As this is an in vitro device performance study, there is no "adjudication method" in the sense of reconciling disagreements among human readers or experts on patient data. Test results are typically objective measurements against engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size
- Not Applicable. This type of study is for evaluating diagnostic performance of an AI system, not for a physical medical device's line extension.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm-based device. "Standalone performance" here would refer to the device's functional and mechanical performance, which was evaluated through the in vitro tests listed.
7. The type of ground truth used
- Engineering Specifications / Predicate Device Performance: The "ground truth" or reference for comparison in this 510(k) submission is the performance of the legally marketed predicate device and established engineering specifications and standards for balloon dilatation catheters. The tests are designed to confirm the new device lines perform within acceptable ranges relative to these benchmarks.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of device.
§ 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).