(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.

[89 FR 66560, Aug. 16, 2024]