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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).

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The FlowMedica Benephit™ △ Bifurcated Infusion Catheter is intended for the infusion of fluids into the peripheral vasculature including but not limited to the renal arteries.

The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Benephit™ Δ Infusion System (Benephit™ Δ Bifurcated Infusion Catheter & Benephit™ Δ 5Fr. Introducer Sheath)

This document is a 510(k) clearance letter from the FDA for a medical device called the "FlowMedica Bifurcated Infusion System." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no information available regarding acceptance criteria or the study that proves the device meets those criteria. The letter is an administrative notice of clearance, not a summary of testing or performance data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for establishing ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This type of information would typically be found in the 510(k) submission itself, not in the FDA's clearance letter.

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Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries.

The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath.

The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.

The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches.

The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath.

The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.

The provided document is a 510(k) summary for the FlowMedica Bifurcated Infusion System and its associated FDA clearance letter. It describes the device, its intended use, predicate devices, and testing conducted to support substantial equivalence.

However, the document does not contain information related to acceptance criteria, specific device performance metrics, or details of a clinical study with human subjects that would typically involve a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance.

The "Testing in Support of Substantial Equivalence Determination" section only lists categories of testing:

• Design Verification Testing
• Biocompatibility Testing
• Animal Testing
• Predicate Device Comparative Testing

It explicitly states: "Comparative bench testing demonstrates that the performance and safety of the FlowMedica Bifurcated Infusion Catheter is equivalent to that of the predicate devices." This indicates that the primary evidence for substantial equivalence came from bench (laboratory) and animal testing, not a clinical study involving a test set of human cases with expert-established ground truth.

Therefore, I cannot provide the requested information from the provided text. The device in question is a medical device (catheter and introducer sheath), and its clearance was based on substantial equivalence to existing predicate devices, supported by non-clinical testing.

The following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No such table is present. The document generally states equivalence based on bench and animal testing.
2. Sample size used for the test set and the data provenance: No clinical test set involving human data is described. Animal testing is mentioned, but details on sample size or data provenance for that are not provided beyond the category.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with expert-established ground truth is described.
4. Adjudication method for the test set: Not applicable.
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. This device is a physical medical device, not an AI or image-based diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For the non-clinical testing (bench, animal), the "ground truth" would be established by direct measurement of device properties or observed physiological effects in animals, compared against predicate device performance. No human clinical ground truth (e.g., pathology, outcomes data) is mentioned for a test set.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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