(258 days)
The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.
The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
The TrapIt Trapping Balloon Catheter is intended to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. It is not intended for use outside of the guide catheter.
The device's substantial equivalence was established through performance and biocompatibility tests.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Kink resistance/ flexibility | Not specified, but likely refers to maintaining lumen patency and structural integrity during bending. | The device passed. |
| Radiopacity | Not specified, but generally refers to sufficient visibility under fluoroscopy. | The device passed. |
| Catheter bond strength | Not specified, but likely refers to the strength of various junctions within the catheter. | The device passed. |
| Tip bond strength | Not specified, but likely refers to the strength of the bond at the catheter tip. | The device passed. |
| Crossing profile | Not specified, but generally refers to ease of navigation through vessels. | The device passed. |
| Balloon preparation, deployment & retraction | Not specified, but likely refers to smooth and consistent inflation/deflation and proper positioning. | The device passed. |
| Balloon rated burst | Not specified, but refers to the maximum pressure the balloon can withstand without bursting. | The device passed. |
| Balloon fatigue | Not specified, but refers to the ability of the balloon to withstand repeated inflation/deflation cycles. | The device passed. |
| Balloon compliance | Not specified, but refers to the balloon's ability to expand to its intended diameter at a given pressure. | The device passed. |
| Effective length | Not specified, but refers to the usable length of the catheter within the body. | The device passed. |
| Tip length | Not specified, but refers to the length of the catheter tip. | The device passed. |
| Balloon inflation time | Not specified, but refers to the time taken for the balloon to fully inflate. | The device passed. |
| Balloon deflation time | Not specified, but refers to the time taken for the balloon to fully deflate. | The device passed. |
| Shaft outer diameter | Not specified, but refers to the external diameter of the catheter shaft. | The device passed. |
| Coating Particulate Evaluation | Not specified, but refers to the absence of unacceptable levels of particulates from the coating. | The device passed. |
| Packaging integrity | Not specified, but refers to the ability of the packaging to maintain sterility and protect the device. | The device passed. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Hemocompatibility) | Per ISO 10993-1, indicating acceptable biological response. | The device passed all biocompatibility tests. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests. The tests were likely conducted on a representative sample of devices according to established engineering and quality control protocols. The provenance of this data is internal to the manufacturer (IMDS Operations B.V.). The tests are performed as part of the device verification process to demonstrate safety and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are engineering performance and biocompatibility evaluations, not clinical studies requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable, as this was not a clinical study involving human readers or interpretation of medical images. The acceptance of test results would be based on predefined criteria and successful completion of the tests.
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 device is a medical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The TrapIt Trapping Balloon Catheter is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests is established by the specifications and acceptance criteria for each test, based on engineering principles, material science, and relevant international standards (e.g., ISO 10993-1 for biocompatibility). For example, the ground truth for "Balloon rated burst" would be the pressure at which the balloon should not burst according to design specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).