(19 days)
The Trellis™ Plus Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis Plus 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 which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid.
The provided documents describe a 510(k) premarket notification for the Trellis Plus Infusion System, a medical device for infusing fluids into the peripheral vasculature. The submission focuses on demonstrating substantial equivalence to a predicate device (the Trellis Infusion System, K013635). As such, it does not include a study or acceptance criteria in the typical sense of a novel device performance study. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device, meaning the new device performs at least as well as the predicate for its intended use, and the "study" is the battery of tests performed to demonstrate this equivalence.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not present a formal table of specific acceptance criteria (e.g., specific quantitative performance metrics like accuracy, sensitivity, specificity, or error rates) for the Trellis Plus Infusion System, nor does it report detailed quantitative device performance data against such metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is substantially equivalent to its predicate.
| Acceptance Criteria (Implied by Equivalence) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional Equivalence: The device should perform its intended function (controlled and selective infusion, isolation of treatment region, fluid dispersion) similarly to the predicate device. | The Trellis Plus Infusion System "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," aligning with the description of its intended use. It was "tested in the same manner as the Trellis Infusion System" and "All components, subassemblies, and/or full devices met the required specifications for the completed tests." |
| Material Compatibility: Materials used should be suitable for use and equivalent to those in previously cleared products. | "All materials used in the manufacture of the Trellis Plus are suitable for this use and have been used in numerous previously cleared products." |
| Manufacturing Standards: Device should be designed and manufactured under appropriate quality systems. | "The Trellis Plus was designed under the Bacchus Quality System which is in compliance with 21CFR 820.30." |
| Safety and Effectiveness: Implied to be similar to the predicate device, meaning it should not introduce new questions of safety or effectiveness. | The FDA’s substantial equivalence determination implies that the device is as safe and effective as the predicate for its indicated use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for any "test set" in terms of patient data. The "Testing Summary" indicates that "All components, subassemblies, and/or full devices met the required specifications," implying in-vitro or bench testing rather than in-vivo human studies for this 510(k).
- Data Provenance: Not applicable as no human patient data is described. The testing described appears to be laboratory-based (bench testing).
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of 510(k) submission, particularly for a mechanical device demonstrating substantial equivalence, is generally based on engineering specifications, regulatory standards, and performance of the predicate device, not on expert consensus from clinical image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set, as the evaluation type is focused on engineering and functional testing rather than clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document makes no mention of an MRMC comparative effectiveness study. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is a key component, which is not the case for an infusion system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This concept is not relevant to the Trellis Plus Infusion System, which is a physical medical device (catheter system) with mechanical functions, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence claim is effectively:
- Engineering specifications and regulatory requirements: The device's components and overall system performance meeting predefined technical requirements.
- Performance of the predicate device: The Trellis Plus Infusion System is considered substantially equivalent if its performance characteristics (function, materials, manufacturing) are similar to the legally marketed Trellis Infusion System (K013635).
8. The Sample Size for the Training Set
Not applicable. The Trellis Plus Infusion System is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this type of device.
In summary, for the Trellis Plus Infusion System, the "acceptance criteria" and "study" are framed within the context of a 510(k) submission demonstrating substantial equivalence to a predicate device. This involves rigorous engineering and functional testing against established specifications, rather than clinical trials with patient-specific ground truth data or AI model performance metrics.
§ 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).