(344 days)
The Q-Collar is a non-invasive device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts.
The Q-Collar (Figure 1) is a C-shaped collar intended to be worn around the neck during sports activities. The protuberances located at each end of the device are designed to ensure the correct location of pressure on the neck to provide compressive force to the internal jugular vein (IJV). In order to confirm whether the Q-Collar is properly sized and fits the wearer correctly, an ancillary fitting tool, referred to as the Fit Check (Figure 2), is packaged with the Q-Collar. The Q-Collar and Fit Check are packaged with a carry case (Figure 3) for transport and storage.
The provided text describes the Q-Collar, an external compression device for internal jugular vein compression, and details the studies conducted to support its de novo classification by the FDA. The following information summarizes the acceptance criteria, device performance, and study characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details non-clinical bench testing acceptance criteria and results. Clinical studies focused on safety and efficacy in reducing neuroanatomical and neurophysiological changes associated with head impacts rather than specific quantitative performance criteria related to medical imaging.
| Test Title | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench Testing - Force Test | Assess the minimum and maximum forces exerted by the Q-Collar. | Q-Collars to provide a minimum of 0.75 pound-force when the tip gap is 1.5 inches, and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | Passed: Q-Collars exert a minimum of (b) (4) when the tip gap is (b) (4) and maximum of (b) (4) when the tip gap is (b) (4). |
| Cytotoxicity Testing | Determine the cytotoxicity of extractable substances from the Q-Collar. | ANSI/AAMI/ISO 10993-5 standard states that the achievement of a numerical grade greater than 2 is considered a cytotoxic effect, or a failing score. | Passed: Each test article received a score $\le$ 2. |
| Sensitization Testing | Determine the potential allergenic or sensitizing capacity of the test articles. | ISO 10993-10 Tests for Irritation and Skin Sensitization guidelines. | Passed: No systemic signs of toxicity were observed in treated or control animals. (b) (4) |
| Irritation Testing | Determine the potential irritation effects of the test article extracts. | ISO 10993-10 Tests for Irritation and Skin Sensitization guidelines. | Passed: None of the animals exhibited overt signs of toxicity at any of the observation points. The (b) (4) of the test articles did not show a significantly greater biological reaction than the sites injected with the control articles. |
| Cycle and extreme temperature testing | Assess Q-Collar function and visual appearance before and after exposure to extreme temperature and cyclic loading. | Proper function of the Q-Collar is defined as exerting a minimum of 0.75 pound-force when the tip gap is 1.5 inches and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | Passed: function properly and pass visual inspection. |
| Ultraviolet resistance testing | Assess Q-Collar function and visual appearance following exposure to ultraviolet (UV) environmental cycling. | Proper function of the Q-Collar is defined as exerting a minimum of 0.75 pound-force when the tip gap is 1.5 inches and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | Passed: Q-Collars can be expected to generate a force no lower than (b) (4) at the minimum tip gap and no greater than (b) (4) at the maximum tip gap at least (b) (4) % of time. |
| Cleaning compatibility and chemical durability testing | Assess Q-Collar function and visual appearance (inspection for tears, deformities, and delamination) following exposure to cleaning agents and chemicals potentially present in the device's intended use environment. | Proper function of the Q-Collar is defined as exerting a minimum of 0.75 pound-force when the tip gap is 1.5 inches and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | Passed: Q-Collars function properly and pass visual inspection following exposure to cleaning agents and chemicals potentially present in the Q-Collar's intended use environment. |
| Accelerated aging study | Assess Q-Collar function and visual appearance following simulated aging conditioning for the specified storage life requirement. | Proper function of the Q-Collar is defined as exerting a minimum of 0.75 pound-force when the tip gap is 1.5 inches and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | In Process: Q-Collars function properly after simulated aging conditioning of 1 year and 2 years. |
| Transit testing | Assess Q-Collar function and visual appearance (inspection for tears, deformities, and delamination) following shipping conditioning (e.g., low temperature, high temperature, shock and vibration) and use conditioning (e.g., 520 falls from 1 m). | Proper function of the Q-Collar is defined as exerting a minimum of 0.75 pound-force when the tip gap is 1.5 inches and a maximum of 3.5 pound-force when the tip gap is 2.5 inches. | Passed: Q-Collars can be expected to generate a force no lower than (b) (4) at the minimum tip gap and no greater than (b) (4) at the maximum tip gap at least 95% of time. |
Human Factors and Usability Testing:
- Acceptance Criteria for Fit Check Tool: Users should be able to correctly use the Fit Check Tool to confirm proper sizing and fit.
- Reported Performance: (b) (4) out of (b) (4) participants were able to use the Fit Check Tool correctly.
- Acceptance Criteria for Labeling Comprehension (Head Injury Action): Users should understand to seek medical care immediately following a head injury while wearing the Q-Collar, and that the device does not prevent head injury.
- Reported Performance: (b) (4) out of (b) (4) participants successfully responded to questions related to actions taken after incurring a head injury, indicating understanding that the Q-Collar does not prevent head injury and medical treatment should be sought. (b) (4) participants overlooked the specific instruction "Seek medical care immediately if you experience symptoms of a concussion." and one participant demonstrated negative transfer by stating they would not act differently.
Clinical Efficacy (Pivotal Studies):
- Primary Effectiveness Endpoint (Football Study): Changes in DTI metrics (MD, AD, RD) in whole brain from pre-season to post-season in Q-Collar vs. non-Q-Collar groups.
- Reported Performance: Significant pre-season to post-season reductions in MD, AD, and RD were found in extensive white matter regions in the no-Collar group (p (b) (4)). Significant greater RD reductions were shown in the no-Collar group compared to the Collar group (p
§ 890.3050 External compression device for internal jugular vein compression.
(a)
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.(b)
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.