(98 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 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.
| Acceptance Criteria (Implied for Animal Study) | Reported Device Performance (Animal Study) |
|---|---|
| Device performs as intended under anticipated conditions of use | Successfully demonstrated delivery, deployment, and retrieval. |
| Compatibility with other labeled devices | Demonstrated compatibility. |
| Patency of the fistula (equivalent to predicate) | Patency demonstrated to be equivalent. |
| Characterization of blood flow at fistula creation (equivalent to predicate) | Blood flow demonstrated to be equivalent. |
| Gross pathology and histopathology assessing vascular injury and downstream embolization (equivalent to predicate) | Gross pathology and histopathology demonstrated to be equivalent. |
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.
§ 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
(a)
Identification. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to create an arteriovenous fistula;
(iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis;
(iv) The ability of the fistula to be used for vascular access for hemodialysis;
(v) The patency of the fistula; and
(vi) The rates and types of all adverse events.
(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i) Delivery, deployment, and retrieval of the device;
(ii) Compatibility with other devices labeled for use with the device;
(iii) Patency of the fistula;
(iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and
(v) Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;
(ii) Tensile strengths of joints and components;
(iii) Accurate positioning and alignment of the device to achieve fistula creation; and
(iv) Characterization and verification of all dimensions.
(4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components.
(5) Software verification, validation, and hazard analysis must be performed for devices that use software.
(6) All patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(9) Labeling for the device must include:
(i) Instructions for use;
(ii) Identification of system components and compatible devices;
(iii) Expertise needed for the safe use of the device;
(iv) A detailed summary of the clinical testing conducted and the patient population studied; and
(v) A shelf life and storage conditions.