(74 days)
The SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The SpiralFuse Peripheral Infusion System is a simpler version of the Trellis catheter that enables the physician to infuse fluids to a treatment region and disperse the fluid through a treatment region. The SpiralFuse is a multi-lumen catheter with an infusion lumen with holes located along the treatment zone to disperse the infused fluid. The other lumen is a through-lumen that is compatible with a 0.035" guidewire. The shaped infusion lumen is deployed once catheter position is achieved. The device is introduced through a standard 6F introducer sheath and passed over a 0.035" guidewire to the treatment site. Then, physicians will infuse fluid and allow it to disperse. Device removal is the same as the predicates.
This document is a 510(k) premarket notification for the SpiralFuse Peripheral Infusion System. It is an administrative correction letter from the FDA regarding a previous substantial equivalence determination for the device. The updated letter pertains to a new product code to better categorize the device technology. The original 510(k) submission was not re-reviewed.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided document describes the SpiralFuse Peripheral Infusion System and its substantial equivalence to a predicate device (Trellis-6 Infusion System). It states: "All components, subassemblies, and/or full devices met the required specifications for the completed tests." However, the document does not provide a table of specific acceptance criteria (e.g., specific thresholds for flow rates, burst pressures, etc.) nor does it list detailed reported device performance against such criteria. It only broadly asserts that specifications were met.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Testing Summary: The SpiralFuse Peripheral Infusion System was tested in the same manner as the Trellis-6." However, it does not specify the sample size used for the test set, nor does it provide any information on the data provenance (country of origin, retrospective or prospective). The testing seems to be limited to physical device performance, not clinical data that would typically have provenance details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided in this document. The SpiralFuse Peripheral Infusion System is a medical device (catheter) for fluid infusion into the peripheral vasculature. The testing described is physical performance testing (e.g., mechanical, material compatibility), not a diagnostic or AI-driven system that would require expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the same reasons as point 3. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is the focus of this 510(k) summary.
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
This information is not applicable and not provided. The SpiralFuse Peripheral Infusion System is a physical medical device, not an AI-assisted diagnostic tool or an imaging system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device is a physical catheter, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. As explained, the testing appears to be primarily engineering/performance based. "Ground truth" in the clinical or diagnostic sense is not relevant here. The ground truth for device performance would be the established engineering specifications and physical test results (e.g., verifying that a catheter can withstand a certain pressure without bursting, or that a lumen flows at a specified rate).
8. The sample size for the training set
This information is not applicable and not provided. The SpiralFuse Peripheral Infusion System 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
This information is not applicable and not provided for the same reasons as point 8.
§ 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).