(90 days)
The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit® Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.
The Benephit® family of infusion systems comprises the Benephit® CV, Benephit® PV, Benephit® PVMini, Benephit® PVSolo, and Benephit® XT systems. Each system includes a bifurcated infusion catheter and a vascular introducer sheath with dilator.
Each Benephit® Infusion System consists of a bifurcated infusion catheter and a vascular introducer sheath with dilator. The bifurcated infusion catheter in each of the Benephit® systems is a single-lumen infusion catheter with a bifurcated distal end that allows access to two locations (e.g., two renal arteries) for infusion simultaneously. Each system's introducer sheath is a PTFE-lined, coil reinforced polymer sheath with matching radiopaque dilator.
The Benephit® CV system comprises a 2.4 Fr. bifurcated infusion catheter, utilizing a nitinol hypo tube shaft, and an 8 Fr. compatible introducer sheath with a unique Y-hub design.
The Benephit® PV, PVMini, PVSolo, and XT systems comprise a 4.8 Fr. bifurcated catheter utilizing a braid reinforced polymer shaft and a 5 Fr. compatible introducer sheath with a standard single hemostasis valve configuration.
The provided text describes a 510(k) submission for the FlowMedica Benephit® Infusion Systems. This submission is for a change in the indications for use of an already cleared medical device, not for a new device requiring extensive performance testing against acceptance criteria in the typical sense of a diagnostic AI algorithm.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truthing, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-powered diagnostic devices, is not present in this document.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for the modified indications for use.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable in the traditional sense for this submission. This submission is for a change in Indications for Use for already cleared devices. The acceptance criteria relate to demonstrating substantial equivalence for the modified indications, rather than meeting specific performance metrics for a novel diagnostic.
- The document states: "An evaluation of data gained through normal post-production monitoring and from a FlowMedica-sponsored post-market customer preference study provides support for the new indication proposed. These data show that the Benephit devices perform as intended, and are safe and effective for their intended use and for the new label indication as proposed."
- No specific quantitative acceptance criteria or corresponding device performance metrics (e.g., sensitivity, specificity, accuracy) are presented because the device is not a diagnostic tool and the submission is not for initial market clearance with novel performance claims.
2. Sample size used for the test set and the data provenance:
- Not applicable. No dedicated "test set" for performance evaluation of an AI/ML algorithm is described. The support for the new indication comes from "normal post-production monitoring" and a "FlowMedica-sponsored post-market customer preference study." No specific sample size or data provenance details for these are provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described, as the submission does not involve a diagnostic algorithm requiring such validation.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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:
- No. This document does not describe an MRMC study. The device is an infusion system, not an AI-powered diagnostic aide for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware infusion system, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable. The submission does not involve a diagnostic algorithm requiring ground truth. The "data" used to support the new indication are related to the device's performance in its existing and proposed intended uses, likely focusing on safety and effectiveness in a clinical context, rather than diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. No training set for an AI/ML algorithm is described.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment for it is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this document):
The "study" or evidence provided to support the new indication and substantial equivalence is described as:
- "An evaluation of data gained through normal post-production monitoring"
- "from a FlowMedica-sponsored post-market customer preference study"
These evaluations collectively demonstrated that "the Benephit devices perform as intended, and are safe and effective for their intended use and for the new label indication as proposed."
The core argument for acceptance is substantial equivalence to predicate devices (K033569 and K050205) because the proposed change is only in the indications for use, and not in the design, materials, processing, or technological characteristics of the devices themselves. The new indications clarify specific settings for the devices but do not alter their fundamental intended use (targeted renal therapy).
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).