(30 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 2.0 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.
| Acceptance Criteria Category | Reported Device Performance (Reference to Predicate K181725) |
|---|---|
| Premarket Control Requirements (21 CFR 870.1252 for Percutaneous Catheters for Creation of an Arteriovenous Fistula) | Met by adoption of predicate data |
| Clinical Performance | Not required for the modified device, as the intended use, technological characteristics, design, and function of the Power Controller, Crossing Needle, and Catheter remain unchanged from the predicate. Clinical data from the predicate (K181725) supports the broader system's efficacy. |
| Animal Testing | Adopted from the predicate (K181725), as the intended use, technological characteristics, design, function, and manufacturing processes of the Power Controller, Crossing Needle, and Catheter remain unchanged. |
| Non-Clinical Performance Testing | Adopted from the predicate (K181725), as the technological characteristics, design, function, and manufacturing processes of the Power Controller, Crossing Needle, and Catheter remain unchanged. This would include tests for mechanical properties, device integrity, etc. |
| Electromagnetic Compatibility (EMC) and Electrical Safety Testing | Adopted from the predicate (K181725), as the Power Controller, Crossing Needle, and Catheter remain unchanged in technological characteristics, design, function, and manufacturing processes. |
| Software Verification and Validation Testing | Adopted from the predicate (K181725), as no new software was incorporated into the modified device. This ensures the software's safety and functionality. |
| Biocompatibility of Patient-Contacting Components | Adopted from the predicate (K181725), as no new patient-contacting components were incorporated. This confirms the safety of materials in contact with the patient. |
| Sterilization Performance | The modified construction, packaging, and configuration were evaluated against the predicate and determined to pose no additional challenge to the existing EO sterilization process (SAL 10-6). The predicate's sterilization validation was adopted. |
| Shelf Life Performance | The construction and packaging of the modified product were deemed identical to the predicate in terms of challenge to the packaging system. The existing predicate's package shelf life validation was adopted. |
| Labeling | Labeling includes instructions for use, identification of system components and compatible devices, expertise needed for safe use, a detailed summary of clinical testing (from predicate), and shelf life/storage conditions. This is a crucial output, ensuring proper product use and information to users. |
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.
§ 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.