(24 days)
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The DIVER C.E. Catheter is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheter features an aspiration lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of the catheter to the extension line (High Pressure Tubing), stopcock, and syringe that are included in the catheter package. The DIVER C.E. Catheter has a central aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheter is available in two configurations - with and without sideholes. The catheter is a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheter is compatible with guide wires with a maximum diameter of 0.014". Additionally, a 40u filter basket is also included to allow the physician to perform a post-procedure examination of the aspirated thrombi/emboli material removed during the procedure.
The provided document is a 510(k) summary for the DIVER C.E. Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics against pre-defined clinical acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC).
The section "Summary of Testing" states: "Performance Data: The results of verification testing demonstrated that the DIVER C.E. Catheter and its accessories met the established acceptance criteria and performs in a manner equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing program."
However, the specific acceptance criteria and the detailed results of the study that "prove" the device meets them are not provided in this document. The document primarily focuses on demonstrating substantial equivalence through comparison of technological characteristics and intended use, and confirming sterilization validation and general performance testing.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document states that "established acceptance criteria" were met, but does not list them or the specific performance values.
2. Sample sized used for the test set and the data provenance:
- Missing. The document mentions "verification testing" but does not provide details on sample sizes, country of origin, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing. No information on experts or ground truth establishment for a test set is provided. This type of detail is typically not part of a 510(k) summary focused on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. Not applicable given the document's content.
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:
- Missing. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Missing. Not applicable as this is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Missing. The document refers to "verification testing" and equivalence to predicate devices, not clinical ground truth establishment in the context of diagnostic accuracy.
8. The sample size for the training set:
- Missing. Not applicable to this type of device and submission.
9. How the ground truth for the training set was established:
- Missing. Not applicable to this type of device and submission.
In summary, the provided 510(k) summary for the DIVER C.E. Catheter confirms that verification testing was conducted and met "established acceptance criteria," but it does not disclose the details of those criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) as these are not typically required for a 510(k) demonstrating substantial equivalence for a device of this nature.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).