---
kind: "section"
citation: "21 C.F.R. § 880.5220"
title: "21"
number: "880.5220"
heading: "Intravenous catheter force-activated separation device."
url: "https://uscodex.org/cfr/21/880.5220"
---

# §880.5220. Intravenous catheter force-activated separation device.

- (a) **Identification.** An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
  - (2) 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) Separation force testing;
    - (ii) Validation of anti-reconnect features;
    - (iii) Air and liquid leakage testing, both before and after separation;
    - (iv) Luer connection testing;
    - (v) Flow rate testing;
    - (vi) Particulate testing; and
    - (vii) **Microbial ingress testing.**
  - (3) The device must be demonstrated to be biocompatible.
  - (4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
  - (5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
  - (6) Device labeling must include:
    - (i) Instructions for use; and
    - (ii) **A discussion of catheter dressings intended to be used with the device.**

## Notes

### Amendments

[89 FR 66560, Aug. 16, 2024]

### Authority

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

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[89 FR 66560, Aug. 16, 2024]