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510(k) Data Aggregation
(105 days)
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
| Performance Metric / Acceptance Criterion | Comparison to Predicate (with no balloon dilation) |
|---|---|
| New Adverse Event Types | No new adverse event types experienced as a result of implementing balloon dilation. |
| Adverse Event (AE) Rates in US Study (90 days follow-up) | Numerically similar to rates observed in the predicate's IDE study (DEN170004). |
| Adverse Event (AE) Rates in OUS Study (mean 352 days follow-up) | Numerically similar to rates observed in the predicate's IDE study (DEN170004). |
| Death Rate (OUS Study at ~12 months) | 4.5% in OUS study vs. 7.8% in De Novo study. Appears substantially equivalent (numerically lower). |
| Acute Occlusions of AVF (within 24 hours of procedure) | 0.4% (1/255) in combined studies vs. 14.6% (15/103) in De Novo IDE study. Numerically lower. |
| Number of Secondary Procedures (for maturation and/or maintenance) | Numerically lower than in the De Novo IDE study. |
| AVF Patency and Anastomotic Complications (follow-up data) | Appears substantially equivalent to the predicate. |
| Functionality (with added procedural step) | No new or different questions of safety and effectiveness are raised. Device functions as intended. |
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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