QNX · External Compression Device For Internal Jugular Vein Compression

Neurology · 21 CFR 890.3050 · Class 2

Overview

Identification

An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use.

Classification Rationale

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

Special Controls

In combination with the general controls of the FD&C Act, the external compression device for internal jugular vein compression is subject to the following special controls: - The patient-contacting components of the device must be demonstrated to be 1. biocompatible. - 2. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: - compression testing; and a. - durability testing over the labeled use life. b. - 3. Human factors and usability testing must demonstrate that users can correctly use the device, including: - a. confirming the proper size and fit of the device; and - Understanding the device labeling, including the warning that the device does not b. prevent head injury and medical treatment should be sought following head injury. - 4. Labeling must include the following: - a. A warning that the device does not replace, and should be worn with, other protective sports equipment associated with specific sports activities, such as helmets and shoulder pads. - b. A warning that the device should not be worn if it interferes with other existing protective equipment. - c. A warning that users should avoid head and neck impacts to the extent possible. - d. A warning that serious harm can result from persistent, excessive pressure on the neck due to incorrect device size and fit.

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate that the device performs as intended under anticipated conditions of use for the duration of the labeled use life. (3) Human factors and usability testing must demonstrate that users can correctly use the device, including the user's ability to correctly determine device size and confirm the proper fit of the device. Users must understand product limitations, warnings, and precautions, including the warning that the device does not prevent head injury and medical treatment should be sought following head injury. (4) Labeling must include the following: (i) A warning that the device does not replace, and should be worn with, other protective sports equipment associated with specific sports activities, such as helmets and shoulder pads; (ii) A warning that the device should not be worn if it interferes with other existing protective equipment; (iii) A warning that users should avoid head and neck impacts to the extent possible; (iv) A warning that serious harm can result from persistent, excessive pressure on the neck due to incorrect device size and fit; and (v) A warning that the device has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated.

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