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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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(528 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 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
| Acceptance Criteria (from Primary Endpoints & Special Controls) | Reported Device Performance (Clinical Study - ITT Population) |
|---|---|
| Safety: | |
| No device-related serious adverse events (SAEs) including: | Primary Safety Endpoint Met (0.0%) (Table 9) |
| - Vessel perforation during index | 0.0% (N=0) |
| - Vessel dissection during index | 0.0% (N=0) |
| - Electrical shock during index | 0.0% (N=0) |
| - Embolization in previously uninvolved arterial territory | 0.0% (N=0) |
| Effectiveness: | |
| 90-day maturation success rate > 49% (Performance Goal) | 89.3% (Table 10); p-value < 0.0001 (significantly higher than 49%) |
| - Maturation defined as: | |
| - Venous diameter > 4 mm | Achieved within the 89.3% success rate. |
| - Blood flow > 500 ml/min | Achieved within the 89.3% success rate. |
| Other Performance Indicators: | |
| Device Success Rate | 99.0% (Table 12) |
| Assisted Primary Patency Rate (at 12 months) | 81% (Figure 7, Table 24) |
| Average Estimated Study Days AVF Used for Hemodialysis | 228.3 days (Table 14) |
| Functional AVF at 12 Months | At least 72.8% of ITT subjects (61/103 used for hemodialysis, 14/103 functional but not used) (Table 16) |
| Rate of device-related harmful events through 12 months | 0% |
| Rate of serious procedure-related harmful events through 12 months | 1.9% (2/103) (Benefit/Risk Determination section) |
| Percentage of MAPs not associated with any adverse events | 94.5% (Table 23) |
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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