(a) Identification. This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:

(i) The ability to safely implant the device;

(ii) The ability of the arteriovenous fistula supported by the device to attain a blood flow rate and diameter suitable for hemodialysis;

(iii) The ability of the fistula to be used for vascular access;

(iv) The primary, assisted primary, and secondary patency of the fistula;

(v) The rates and types of device integrity events and any associated clinical sequelae;

(vi) The rates and types of all adverse events; and

(vii) The rates and outcomes of reinterventions.

(2) If FDA determines that premarket clinical information is insufficient to evaluate long-term safety and effectiveness of the product, postmarket data must be collected through an adequately designed and powered postmarket study to assess the following:

(i) The functionality and patency of the fistula through a clinically meaningful timeframe;

(ii) The rates and types of access-related, reintervention-related, and cannulation-related adverse events; and

(iii) The reasons for, rates, types, and outcomes of reinterventions.

(3) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:

(i) Implantation of the device;

(ii) Patency of the fistula; and

(iii) Gross pathology and histopathology assessing vascular injury and downstream embolization.

(4) 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) Resistance to kinking;

(ii) Resistance to crush and local compression;

(iii) Tensile strength of joints and components;

(iv) Device integrity;

(v) Corrosion resistance; and

(vi) Characterization and verification of all dimensions.

(5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment.

(6) All patient-contacting components of the device must be demonstrated to be biocompatible.

(7) Performance data must demonstrate 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) Specific instructions regarding device size selection and device placement;

(ii) Expertise needed for safe use of the device;

(iii) A detailed summary of the clinical testing conducted and the patient population studied, including information on effectiveness and device- and procedure-related complications;

(iv) A detailed summary of the device technical parameters;

(v) A shelf life and storage conditions; and

(vi) MR information.