(25 days)
The Trellis™-6 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis-6 Peripheral 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. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire 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.
The provided documentation is a 510(k) premarket notification for the Trellis-6 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a standalone study. The document explicitly states: "The Trellis-6 Peripheral Infusion System was tested in the same manner as the Trellis-8. All components, subassemblies, and/or full devices met the required specifications for the completed tests."
Therefore, the acceptance criteria and study proving the device meets them would have been established for the predicate device, the Trellis-8 Infusion System (K050147), and the K071664 submission leverages that prior work by demonstrating the Trellis-6 system is equivalent.
Based on the provided text for K071664, I can infer the following about what would have been implicitly accepted based on the predicate device, but the document does not contain the detailed study results for the Trellis-6 itself.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Inferred from function) | Reported Device Performance (Implied by Substantial Equivalence to Trellis-8) |
|---|---|
| Mechanical Performance: | |
| Balloon inflation/deflation | Functions as intended, enabling isolation of treatment region. (Equivalent to Trellis-8) |
| Infusion capability | Allows controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature. (Equivalent to Trellis-8) |
| Dispersion Wire oscillation | Provides oscillation when activated, dispersing infused fluid within the isolated region. (Equivalent to Trellis-8) |
| Guidewire compatibility | Compatible with a 0.035" guidewire through its central lumen. (Equivalent to Trellis-8) |
| Aspiration capability | Allows post-procedure aspiration of the isolated area between occluding balloons through the catheter using the guidewire lumen. (Equivalent to Trellis-8) |
| Biocompatibility: | |
| Material safety | All materials are suitable for use and have been used in numerous previously cleared products, implying acceptable biocompatibility. (Equivalent to Trellis-8) |
| Functional Equivalence: | |
| Indications for Use | Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, matching the predicate. (Explicitly stated as substantially equivalent in indications for use) |
| Manufacturing Methods | Utilizes manufacturing methods substantially equivalent to the predicate, ensuring consistent quality and performance. (Explicitly stated as substantially equivalent in manufacturing methods) |
2. Sample size used for the test set and the data provenance:
- The document for K071664 does not specify the sample size for any test set or the data provenance. It only states that the Trellis-6 was "tested in the same manner as the Trellis-8" and "All components, subassemblies, and/or full devices met the required specifications for the completed tests." The details of these tests would be in the K050147 submission for the Trellis-8.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable or provided in a 510(k) submission focused on substantial equivalence for a device like the Trellis-6 Peripheral Infusion System, which is a mechanical delivery system rather than an diagnostic AI/imaging tool requiring expert interpretations for ground truth.
4. Adjudication method for the test set:
- Not applicable or provided for the same reasons as above.
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. The Trellis-6 is an infusion system, not an AI or imaging device that would involve human readers or comparative effectiveness studies of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Trellis-6 is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For mechanical devices like this, "ground truth" typically refers to engineering specifications, physical measurements, and performance benchmarks (e.g., flow rates, balloon integrity, material strength, oscillation frequency). The document implies these were assessed against "required specifications," but does not detail them.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
§ 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).