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The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The device that is the subject of this 510(k) is a modified Ellipsys Vascular Access System. The Ellipsys System gained market clearance through the 510(k) Premarket Notification pathway (K183615). The specific modification subject to this submission consists of an update to the Instructions for Use to allow an additional procedural step for balloon dilation of the anastomosis junction at the radial artery and adjacent outflow vein of the AVF immediately after creation with the Ellipsys Catheter.

The Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent perforating vein using direct current (DC) thermal heating. No changes have been made to the intended use, technological characteristics, design, function, or manufacturing processes of the Ellipsys Power Controller (AMI-1001), Ellipsys Needle (AMI-3000) or the Ellipsys Catheter (AMI-6005).

The provided text describes a 510(k) premarket notification for a modified medical device, the Ellipsys Vascular Access System. The core of the modification is an update to the Instructions for Use (IFUs) to include an additional procedural step: balloon dilation of the anastomosis junction immediately after AVF creation. The submission aims to prove that this modified device is substantially equivalent to its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating substantial equivalence to a predicate device, particularly that the modification (balloon dilation) does not raise new questions of safety or effectiveness. The performance data presented focuses on comparing outcomes with the modified procedure to those previously observed with the predicate device (without balloon dilation).

Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • US Study: 55 subjects
  • OUS Study: 200 subjects
  • Total: 255 subjects
• Data Provenance:
  • US Study: United States (retrospective or prospective is not explicitly stated but "prospective, IRB approved registry studies" suggests prospective.)
  • OUS Study: Outside the United States (prospective, IRB approved registry studies)

3. Number of Experts and Qualifications for Ground Truth

The text does not specify the number of experts used to establish ground truth or their qualifications. It mentions that data were collected on case report forms and reported by the "study investigators."

4. Adjudication Method for the Test Set

The text explicitly states: "although the data were not adjudicated or reviewed by independent third parties." This indicates no adjudication by independent parties was performed for the reported outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or any comparison of human readers with vs. without AI assistance. This device is a medical instrument used for creating a vascular access, not an AI-powered diagnostic tool for interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This submission pertains to a physical medical device and a modification to its procedural use, not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth or clinical outcomes for the test set were established through:

• Clinical observation: Reporting of adverse events (AEs) like thrombosis/stenosis, hematomas, deaths, pseudoaneurysm.
• Procedural outcomes: Technical success, clinical success, maturation procedures, maintenance procedures, procedural success for secondary procedures.
• Objective measures: Suitability for dialysis, AVF patency as determined by ultrasound and/or physical examination.

These were collected as part of prospective registry studies.

8. Sample Size for the Training Set

The text does not provide information regarding a "training set." The studies described are clinical performance evaluations of the modified device in use, not algorithm development or training.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an algorithm.

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The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The modified Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent vein using direct current (DC) thermal heating. The Ellipsys Power Controller (AMI-1001) is software driven and guides the user through the procedure using visual prompts via an LCD display. The Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Crossing Needle (AMI-3000) and Ellipsys Catheter (AMI-6005) are sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. Both the crossing needle and catheter are designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

This FDA 510(k) summary (K183615) describes a modification to the Avenu Medical, Inc. Ellipsys Vascular Access System (Ellipsys System), specifically separating the Ellipsys Crossing Needle and Catheter into individual sterile packages. The core device components (Power Controller, Crossing Needle, and Catheter) themselves, their designs, and intended use remain identical to the predicate device (K181725). Therefore, the acceptance criteria and supporting studies are largely based on the predicate device's performance, as the modification did not necessitate new comprehensive studies for the modified device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a modification based on individual packaging, the acceptance criteria and performance are essentially the same as the predicate device (K181725) as no changes were made to the core functionality or design of the active components.

2. Sample Size Used for the Test Set and Data Provenance

Direct sample sizes for test sets related to the modified device are not applicable as most performance data was adopted from the predicate device (K181725). The document explicitly states:

• Clinical Performance Testing: "Clinical data is not required in support of the special controls requirement and substantial equivalence since the intended use, technological characteristics, design and function of the Power Controller, Crossing Needle, and Catheter remain unchanged from the predicate." Therefore, no new clinical test set was used for this modification.
• Animal Testing, Non-Clinical Performance Testing, EMC and Electrical Safety Testing, Software Verification and Validation Testing, Biocompatibility, Sterilization Performance, Shelf Life Performance: For all of these, the "test data from the predicate has been adopted." This means the sample sizes and provenance would refer to the studies conducted for the predicate device (K181725), which are not detailed in this document.

The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as it refers back to the predicate submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not available in the provided document. As the studies for the modified device were largely adopted from the predicate, any expert involvement would have been for the predicate device (K181725).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not available in the provided document.

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 is not applicable. The Ellipsys Vascular Access System is a medical device for creating arteriovenous fistulas, not an AI-powered diagnostic imaging device or an AI assistant. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable for the same reasons as point 5. The device is a surgical tool, not an algorithm, and performance inherently involves a human operator (physician).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document refers to various types of performance data from the predicate, which would likely have involved:

• Clinical Data: (From K181725) Likely included outcomes data (fistula patency, successful creation, adverse events) as ground truth for clinical performance.
• Animal Testing: (From K181725) In vivo observations and potentially pathology of tissues to confirm the device's effects and safety.
• Non-Clinical Performance Testing: (From K181725) Engineering benchmarks, material specifications, and functional tests (e.g., force measurements, thermal profiles) as ground truth.

Specific details for ground truth establishment for the predicate device are not available here.

8. The Sample Size for the Training Set

This is not applicable. The Ellipsys System is a hardware medical device with software control, but it is not an AI/machine learning system that requires a "training set" in the context of typical AI development. Its software undergoes verification and validation, as described, but not "training" in the AI sense.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there wasn't a "training set" in the AI sense. Software verification and validation (V&V) typically involve testing against predefined requirements and specifications, which serve as the "ground truth" for V&V activities.

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The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The modified Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent vein using direct current (DC) thermal heating. The Ellipsys Power Controller (AMI-1001) is software driven and guides the user through the procedure using visual prompts via an LCD display. The Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Catheter and Crossing Needle (AMI-6005) are a sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. The catheter is designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

The provided text describes a 510(k) premarket notification for the Ellipsys Vascular Access System (K181725). This submission focuses on modifications to an already cleared predicate device (DEN170004). The document indicates that clinical performance testing was not performed in support of this specific submission. Instead, the substantial equivalence determination for this modified device largely relies on non-clinical performance data and the established performance of the predicate device.

Given that no clinical study was performed for this specific 510(k) submission (K181725), most of the requested information (acceptance criteria, device performance, sample size, ground truth, experts, adjudication method, MRMC study, standalone performance, training set) typically associated with a clinical trial to prove device effectiveness is not applicable or not provided in this document for the modified device.

However, the document does mention an animal study that was conducted. Therefore, I will extract information related to that, and acknowledge the absence of clinical data for this specific submission for the modified device.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no clinical study was performed for this specific 510(k) submission, explicit quantitative acceptance criteria for clinical performance and reported device performance metrics in humans are not provided in this document. The document primarily focuses on demonstrating substantial equivalence to the predicate device based on non-clinical and animal testing.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not explicitly stated as a number in the animal study section. It mentions "An acute animal study was conducted in the sheep model."
• Data provenance: Prospective animal study (sheep model). No country of origin is specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified in the document for the animal study.

4. Adjudication method for the test set

• Not specified in the document for the animal study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted based on this document. The device (Ellipsys Vascular Access System) is a medical device for creating arteriovenous fistulas, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the device is a medical device for creating fistulas, not an algorithm/AI for diagnosis or interpretation. The "Power Controller" has software, but its performance is measured in terms of controlling the thermal energy for fistula creation, not in interpreting data for human users.

7. The type of ground truth used

For the animal study:

• Pathology: Gross pathology and histopathology were used to assess vascular injury and downstream embolization.
• Physiological measurements: Patency and characterization of blood flow were assessed.

8. The sample size for the training set

• Not applicable/not provided for this submission, as no clinical or algorithmic training study for a diagnostic AI product is described. The device manufacturing and control software would have undergone internal development and testing, but this is distinct from training data for an AI model.

9. How the ground truth for the training set was established

• Not applicable/not provided for this submission.

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The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidnev disease requiring dialysis.

The Ellipsys® Vascular Access System is a catheter based system that is used to percutaneously create a vascular anastomosis between adjacent blood vessels using direct current (DC) thermal heating. The system consists of several components:

• Ellipsys Catheter ●
• Ellipsys Crossing Needle
• Ellipsys Power Controller ●

Here's a breakdown of the acceptance criteria and the study proving the Ellipsys Vascular Access System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The primary clinical study supporting the Ellipsys Vascular Access System was a non-randomized, prospective multi-center study.

• Test Set Sample Size: The Intent-to-Treat (ITT) population, which primarily serves as the test set for the clinical endpoints, consisted of 103 patients.
• Data Provenance: The study was conducted in the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state that experts established a "ground truth" for the test set in the traditional sense of image interpretation or diagnostic performance. Instead, the clinical study relied on direct measurements and clinical outcomes:

• Maturation definition (effectiveness endpoint): Venous diameter > 4 mm and blood flow > 500 ml/min, measured by duplex ultrasound. This is an objective measurement, not requiring expert consensus for a "ground truth" assessment of the definition itself.
• Safety endpoints: Defined as absence of specific device-related SAEs. These were adjudicated by an independent medical monitor. The qualifications of this monitor are not detailed beyond "independent medical monitor."
• Ultrasound measurements: Performed by clinical staff trained in ultrasound. No specific expert qualifications (e.g., radiologist with X years of experience) are provided for the individuals performing these measurements or interpreting them for the study.

4. Adjudication Method for the Test Set

• Adverse Events (AEs): All adverse events were adjudicated by an independent Medical Monitor. The method (e.g., single review, consensus) beyond "by an independent Medical Monitor" is not specified.
• Study Data: All study data were monitored by an independent study monitor.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The clinical study was designed to compare the device's performance against a historical performance goal for surgical AVF procedures, not against human readers with or without AI assistance in a diagnostic context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This device is not an AI algorithm for diagnostic purposes. It is a medical device for creating a fistula. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostics was not applicable or performed. The "standalone" performance here refers to the device itself performing its intended function without human intervention in the fistula creation process (beyond the physician's use of the device), which is addressed by the device success rate (99.0%).

7. The Type of Ground Truth Used

The "ground truth" for the clinical study's endpoints was based on:

• Objective Clinical Measurements:
  • Venous diameter > 4 mm and blood flow > 500 ml/min (for maturation) as measured by duplex ultrasound.
  • Direct observation of various adverse events (e.g., vessel perforation, dissection, electrical shock).
• Clinical Outcomes/Events: Patency, need for intervention (MAPs), ability to support 2-needle cannulation, CVC usage, and patient survival.
• Independent Adjudication: Safety events were adjudicated by an independent medical monitor.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device, not an AI system that requires a separate training set. Thus, there is no "training set" sample size for an AI algorithm in this context. The animal studies and bench testing can be considered analogous to early-stage development and testing, but not a "training set" as defined for AI.

9. How the Ground Truth for the Training Set Was Established

As there is no AI training set, this question is not applicable. For the animal studies, the "ground truth" about the fistulae created and safety aspects was established through:

• Direct observation: Acute and post-treatment assessments, gross necropsy.
• Imaging: Ultrasound to determine fistula diameter, patency, and flow.
• Histopathological examination: To evaluate chronic safety and healing response at the fistula and downstream organs.

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