---
kind: "section"
citation: "21 C.F.R. § 870.1252"
title: "21"
number: "870.1252"
heading: "Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access."
url: "https://uscodex.org/cfr/21/870.1252"
---

# §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.**

## Notes

### Amendments

[87 FR 9241, Feb. 18, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[87 FR 9241, Feb. 18, 2022]