(30 days)
The Trellis™ Reserve Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis Reserve Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
This FDA document is a 510(k) premarket notification for the "Trellis Reserve Infusion System." It outlines the device's technical specifications and asserts its substantial equivalence to a previously marketed predicate device.
However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: This document states that the device "met the required specifications for the completed tests" (page 5), but it does not list specific quantitative acceptance criteria for performance metrics (e.g., infusion rate, balloon inflation pressure, dispersion efficiency, safety parameters) nor does it provide the numerical results or reported device performance against those criteria.
- Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): The document mentions "Testing Summary" and that the device "was tested in the same manner as the original Trellis Reserve Infusion System (K023514)" (page 5). However, it does not provide any specifics about the studies conducted, such as:
- The sample size used for any test sets.
- The provenance of the data (country, retrospective/prospective).
- The number or qualifications of experts.
- Any adjudication methods.
- Whether comparative effectiveness studies (MRMC) or standalone algorithm performance studies were done.
- The type of ground truth used.
- The sample size or ground truth establishment for a training set (if applicable to this type of device, which is a physical medical device, not an AI/software device).
Therefore, based on the provided text, I cannot complete the table or answer the specific questions about the study design and results.
The document is a regulatory submission focused on establishing substantial equivalence, primarily by demonstrating that the device's design, materials, and intended use are similar to a predicate device, and that it has passed internal verification testing. It does not go into the level of detail regarding clinical trial design, ground truth establishment, or performance metrics typically found for AI/software as a medical device (SaMD) clearances or more extensive clinical studies.
§ 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).