(29 days)
The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.
The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is a dual lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
Here's an analysis of the provided information regarding the Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter:
The provided text does not contain detailed acceptance criteria or a comprehensive study report that demonstrates the device meets specific performance standards. Instead, it is a 510(k) summary focusing on substantial equivalence to predicate devices.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific functional, analytical, or clinical performance metrics (e.g., burst pressure, inflation/deflation times, lesion re-stenosis rates, success rates) | Not explicitly stated within the provided text. The document states: "Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter." This implies performance is comparable to the predicate, but specific criteria and results are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. (The document mentions "Bench testing," which implies laboratory testing, but details on the data origin, whether it involved human or animal subjects, or geographical location are absent.)
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. This type of device (balloon dilatation catheter) would not typically involve "experts" establishing a ground truth in the same way a diagnostic imaging AI would. Performance would be assessed through objective engineering and mechanical tests (bench testing).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance is assessed through objective bench testing, not through expert review needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is primarily relevant for diagnostic imaging devices or software where human interpretation plays a role. A balloon dilatation catheter's effectiveness is evaluated through physical performance and clinical outcomes, not through reader performance.
- Effect Size of Human Reader Improvement with AI vs. without AI Assistance: Not applicable. There is no AI component mentioned in this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent to its design and manufacture, tested through bench and potentially clinical performance, not an algorithm's standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: For bench testing, the "ground truth" would be established by engineering specifications and validated testing methodologies (e.g., maximum burst pressure specified by design, inflation time, guidewire compatibility, lumen patency, etc.). These are objective physical parameters. Pathology or outcomes data may be relevant in clinical trials but are not referenced here for this premarket notification's performance data.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical catheter, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of Device Performance and Study Information provided:
The core of the performance data for the Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter, as described in the 510(k) summary, relies on bench testing. The crucial statement is: "The design, materials and manufacturing process for the predicate and the modified device are the same. Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter." This indicates that the device's performance was compared to a previously cleared predicate device through laboratory (bench) tests, and it was found to be comparable. However, the specific test parameters, acceptance criteria, or quantitative results of these bench tests are not provided in this summary. The FDA's clearance (K012913) is based on this assertion of substantial equivalence.
§ 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).