(61 days)
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bantam OTW PTA Catheter:
Executive Summary:
The Bantam OTW PTA Catheter (280mm balloon lengths) was cleared through a Special 510(k) pathway, demonstrating substantial equivalence to a predicate device (Bantam K093139). The clearance relies entirely on in vitro testing to show that its technological characteristics and performance criteria are comparable to the predicate. No clinical studies, human-in-the-loop performance, or AI-assisted studies were conducted or required for this type of device clearance.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" as pass/fail thresholds with specific numerical values for each test. Instead, it describes "performance criteria" that were evaluated through in vitro testing to demonstrate comparability to the predicate device. The reported device performance is implicitly understood to have met these criteria because the device was granted substantial equivalence.
| Acceptance Criteria Category (Evaluated Performance Criteria) | Reported Device Performance (as demonstrated by in vitro testing) |
|---|---|
| Visual and functional testing | Comparable to predicate device |
| Catheter Body Diameters | Comparable to predicate device |
| Inflation/Deflation time | Comparable to predicate device |
| Introducer sheath withdrawal | Comparable to predicate device |
| Leak and rated burst pressure testing | Comparable to predicate device |
| Guidewire lumen stability test | Comparable to predicate device |
| Tensile testing - Hub bond | Comparable to predicate device |
| Tensile testing - proximal bond | Comparable to predicate device |
| Working surface | Comparable to predicate device |
| Balloon compliance | Comparable to predicate device |
| Average burst | Comparable to predicate device |
Note: The document states that the results "demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device." This implies that the Bantam (280mm) performed within acceptable ranges relative to the Bantam K093139 for all tested parameters. Specific numerical values for the predicate or the new device are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each in vitro test. It generally states that "in vitro tests were performed."
- Data Provenance: The data is from in vitro testing conducted by Clearstream Technologies Ltd. The country of origin for the data is implicitly Ireland, where Clearstream Technologies Ltd. is located. This is a prospective study in the sense that the testing was performed specifically to support this 510(k) submission, but it is not a clinical (human) prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert ground truth or assessment of cases. The "ground truth" for these tests would be the established engineering standards and methodologies (e.g., ISO 10555-1) and the performance of the predicate device under these same tests.
4. Adjudication Method for the Test Set
Not applicable. As this was an in vitro engineering performance study, there was no human reader or panel involved in adjudicating the "correctness" of the findings in the way one would for a clinical study with subjective interpretations. The tests yield objective measurements against predefined standards or comparisons.
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
Not applicable.
- This submission is for a medical device (PTA catheter), not an AI algorithm.
- No MRMC or human-in-the-loop studies were conducted or required.
- The concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. There is no algorithm component to evaluate in a standalone manner.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on:
- Engineering standards: Compliance with ISO 10555-1.
- Predicate device performance: The performance of the legally marketed Bantam (K093139) under the same in vitro tests, as the new device is compared to it for "substantial equivalence."
- FDA guidance: Adherence to FDA guidance on non-clinical testing of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set 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).