(344 days)
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Not Found
No
The device description and performance studies focus on the physical mechanism of the collar and the analysis of imaging data to assess its effect, with no mention of AI/ML being used in the device itself or the data analysis process.
Yes
The device is intended to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts, which is a therapeutic rather than diagnostic or prognostic function.
No
The Q-Collar is described as a "non-invasive device intended to be worn around the neck of athletes...to aid in the protection of the brain." Its purpose is protective, not diagnostic. While imaging (DTI, MRI, fMRI) was used in clinical trials to assess its protective effect, the device itself does not perform diagnostics.
No
The device description explicitly states the Q-Collar is a "C-shaped collar" and mentions a "Fit Check" tool and a "carry case," all of which are physical hardware components.
Based on the provided information, the Q-Collar is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the Q-Collar is to be worn around the neck to aid in the protection of the brain from the effects of head impacts. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical collar designed to apply pressure to the neck. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Q-Collar does not perform any such function.
- Performance Studies: While the performance studies utilize imaging modalities (DTI, MRI, fMRI) to assess the effects of wearing the device, the device itself is not performing the diagnostic imaging or analysis. The imaging is used to evaluate the outcome of using the physical device.
In summary, the Q-Collar is a physical medical device intended for protection, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QNX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
diffusive tensor imaging (DTI), magnetic resonance imaging (MRI), functional MRI (fMRI)
Anatomical Site
Brain, Neck (Internal Jugular Vein)
Indicated Patient Age Range
13 years and older
Intended User / Care Setting
Athletes aged 13 years and older during sports activities.
Care setting not explicitly stated but implied as sports activities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Pilot studies
- Pilot Hockey Study 2014-5009 (NCT02271451)
- Study type: Clinical study
- Sample size: Q-Collar (n=7), control (n=8)
- Key results: use of the Q-Collar resulted in no adverse events, indicating safety. Additionally, imaging suggested changes in cerebral white matter microstructure were in control groups but not those using the Q-Collar.
- Pilot Football Study 2015-2205 (NCT02696200)
- Study type: Prospective, controlled clinical study
- Sample size: Q-Collar (n=31), control (n=30)
- Key results: use of the Q-Collar resulted in no adverse events, indicating safety. Additionally, imaging suggested changes in cerebral white matter microstructure were in control groups but not those using the Q-Collar.
- Pilot Soccer Study 2016-0988 (NCT03014492)
- Study type: Prospective longitudinal controlled cohort study
- Sample size: Q-Collar (n=?), control (n=?) (numbers redacted)
- Key results: use of the Q-Collar resulted in no adverse events, indicating safety. Additionally, imaging suggested changes in cerebral white matter microstructure were in control groups but not those using the Q-Collar.
B. Pivotal Study 1 - Football Study 2018-1123 (NCT0406883)
- Study Design: Prospective longitudinal study
- Sample size: Q-Collar group (n=?) (40 originally), no-Collar group (n=?) (numbers redacted).
- Key results: Significant pre-season to post-season reductions in MD, AD, and RD were found in extensive white matter regions in the no-Collar group but not in the Collar group. Significant greater RD reductions are shown in the no-Collar group compared to the Collar group. Both Collar and no-Collar groups show significant pre-season to post-season increases in FA and/or AD in some white matter region. Increases of FA and AD were not significantly different between Q-Collar and no-Collar group. The relationships between cumulative head impact exposure and pre-season to post-season changes in DTI metrics were modulated by the Q-Collar at the higher exposure thresholds but not at lower threshold. The Q-Collar reduces changes in DTI metrics when controlling for total head impact exposure and that the Q-Collar modulates the relationship between head impact exposure and changes in pre-season to post-season DTI metrics at higher magnitude exposure levels. No adverse events or serious adverse events reported.
C. Pivotal Study 2 - Soccer Study 2018-1123 (NCT0406883)
- Study Design: Prospective longitudinal study
- Sample size: Q-Collar group (n=?) (numbers redacted), no-Collar group (n=?) (numbers redacted).
- Key results: fMRI-derived graph measures show significant increase in Cg and change in path length (L) for the no-Collar group. Additionally, the change in Cg was significantly different between groups. Cn in general were increased in the no-Collar group, but no significant difference was found at any node after controlling for multiple comparisons. No significant changes were observed for the Collar group for any graph measure in any of the 3 models. DTI derived graph measures show significant increase in Q for the no-Collar group. No significant changes were observed for the Collar group for any graph measure. Change in Q was significantly greater in the no-Collar group vs. Collar group when controlling for scanner only, but not when additional controlling for filtered accelerometer data. The results indicate that there may be alterations in brain structure and function after a soccer season with sub-concussive head impacts and that the Q-Collar may mitigate such alterations in brain network properties. No adverse events or serious adverse events reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR Q-COLLAR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial venous volume to reduce the occurrence of specific changes in the brain following head impacts.
NEW REGULATION NUMBER: 890.3050
CLASSIFICATION: Class II
PRODUCT CODE: QNX
BACKGROUND
DEVICE NAME: O-Collar
SUBMISSION NUMBER: DEN200017
DATE DE NOVO RECEIVED: May 19, 2020
SPONSOR INFORMATION:
O30 Sports Science, LLC 257 Riverside Avenue Westport. CT 06880
INDICATIONS FOR USE
The O-Collar is indicated as follows:
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.
LIMITATIONS
- . The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated.
- The use of imaging studies as a future indicator of brain injury has not been validated. ●
- Data do not demonstrate that the device can prevent concussion or serious brain injury. ●
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- The Q-Collar should not be worn if it interferes with other existing protective equipment.
- Wearers of the device should not depend on the device to protect them from all harmful effects of head impacts.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
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).
Image /page/1/Picture/5 description: The image is a product shot of a Q-Collar. The collar is black on the outside and blue on the inside. The collar is designed to be worn around the neck.
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.
FIGURE 2: FIT CHECK
The Q-Collar and Fit Check are packaged with a carry case (Figure 3) for transport and storage.
De Novo Summary (DEN200017)
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FIGURE 3: CARRY CASE EXTERIOR CONSTRUCTION
EXTERIOR FEATURES: Materials and Aimmbly Details
| A: Exterior Case Material | PMS 426 (dark grey) Polyester Jersey |
|---|---|
| B: Embossed/Raised QRI Logo | |
| C: #5 Nylon Lustre Zipper | PMS 537/5C coil with Black Ribbon trim/DX stitching |
| D: Rubber Overmold Cast Zipper Pulls with Debossed QRI Logo | PMS 175C Enamel Finish |
Sketch Picture!#### Principle of Operation:
The Q-Collar is designed to lightly compress (no more than 100 pound-force and "10 mmHg pressure) the sternocleidomastoid muscles in the neck, which provides compressive force to the internal jugular vein (IJV). The restriction in blood flow is designed to result in an increase in the volume of blood in the venous capacitance vessels within the skull. Whereas the brain generally has room to move slightly within the skull, the increased blood volume is intended to create a tighter fit and reduce intracranial movements within the skull. By reducing the movement of the brain within the cranial space, the Q-Collar may aid in the protection of the brain from the effects of head impacts.
SUMMARY OF NONCLINICAL/BENCH STUDIES
| Test | Purpose | Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| Bench Testing | Assess the minimum | |||
| and maximum | ||||
| forces exerted by the | ||||
| Q-Collar. | Force Test | Q-Collars to provide a | ||
| minimum of 0.75 | ||||
| pound-force when the | ||||
| tip gap (the distance | ||||
| between the two front | ||||
| tips of the device) 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. | The Minimal Essential | |||
| Media (MEM) Elution | ||||
| Test | 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 | Kligman Maximization | |||
| Tests | 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) | ||||
| capacity of the test | ||||
| articles. | (b) (4) | |||
| Irritation | ||||
| Testing | Determine the | |||
| potential irritation | ||||
| effects of the test | ||||
| article extracts. | Intracutaneous Injection | |||
| Tests (b) (4) | 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. | 1) (b) (4) cycles |
- Exposure to at least
hours of (b)(4) °F (b)(4) °C)
temperature and (b)(4) °F
(b)(4) °C) temperature. | 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. | 1) exposure to (b)(4)
hours ((b)(4) days) of
ASTM G154-12a,
Cycle 2 (alternating
hour periods of UV
light and condensation). - exposure to (b) (4)
hours ((b)(4) days) of
ASTM G154-12a,
Cycle 2 (alternating
hour periods of UV
light and condensation). | 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. | 1) cleaning with the
following solutions at
least (b)(4) times: (b) (4) - exposure to saltwater
or chlorinated water
conditions for (b) (4)
hours ((b)(4) days). | 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 | (b) (4) years of
simulated storage in the
final packaging. | 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 | In Process: Q-Collars function
properly after simulated aging
conditioning of 1 year and 2
years. |
| | storage life
requirement. | | of 3.5 pound-force
when the tip gap is 2.5
inches. | |
| 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) | 1) the Q-Collar
functions after exposure
in its shipping container
to extreme cold,
uncontrolled relative
humidity per ISTA 2A
(partial simulation test
for individual packaged
products); 2) the Q-
Collar functions after
exposure in its shipping
container to hot, humid
and extreme heat,
moderate relative
humidity per ISTA 2A; - the Q-Collar
functions after shock
and vibration testing in
its shipping container
per ISTA 2A; 4) the Q-
Collar functions after
(b) (4) falls from (b) meter
and is classified as fit
for use based on visual
inspection for tears,
deformities,
delamination, and
applying correct force. | 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. |
Bench force, biocompatibility and shelf life testing was required for the Q-Collar.
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SUMMARY OF HUMAN FACTORS AND USABILITY TESTING
Human factors and usability testing were conducted which included a simulated use test and labeling comprehension test with " participants from two different user groups:
- Adult users (18 years or older) involved in physical activities that may result in sports . related impacts
- Parent/guardian-adolescent pairs, where the parents/guardians are 18 years or older and ● adolescents are 12 - 17 years old, involved in physical activities that may involve sports related impacts
Participants within these two user groups self-reported participating in sports that use protective equipment (e.g., football, hockey, lacrosse) and sports that do not use protective equipment (e.g., volleyball, soccer, cheerleading).
Users were provided with online instructional materials (informational content and videos) to determine the size of Q-Collar appropriate for themselves or an adolescent. Participants had access to the product website with instructional video and Fit Guide, a mirror, and measurement
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equipment (e.g., measuring tape and other tools) but were not prompted to use any of the materials. Formal training was not provided. After selecting a size, the corresponding Q-Collar product was provided to the user in a sealed package. Both observational data and subjective evaluations were collected. Users also participated in a labeling comprehension study to demonstrate that users can identify and understand product warnings/cautions and how to correctly perform tasks.
out of " participants were able to use the Fit Check Tool to confirm the proper fit of the Q-Collar or to determine the selected Q-Collar was not an appropriate fit. (0) (4) participants erroneously confirmed the fit of the Q-Collar by either misinterpreting results of the Fit Check tool or by incorrectly using the Fit Check tool.
(b) (4) out of "(4) participants successfully responded to questions related to actions taken after incurring a head injury while wearing the Q-Collar, indicating they understand the Q-Collar does not prevent head injury and medical treatment should be sought following head injury. (0) (4) participants overlooked "Seek medical care immediately if you experience symptoms of a concussion." in the device instructions and one participant demonstrated negative transfer by stating that they would not act differently than how they currently do in response to head impacts.
Overall, human factors and usability testing demonstrated that users understood how the device is intended to be used, including with other protective equipment..
SUMMARY OF CLINICAL INFORMATION
Five clinical trials. including three pilot studies and two pivotal studies, were conducted. Each trial is summarized below.
A. Pilot studies
1. Pilot Hockey Study 2014-5009 (NCT02271451)
This clinical study was conducted in hockey athletes wearing the Q-Collar (n=7) and a control group of hockey athletes who did not wear the Q-Collar (n=8) during hockey competitions to test the Q-Collar's effect in reducing neuroanatomical and neurophysiological changes to the brain following head impacts. Participants were tested at pre-season, mid-season, and post-season using diffusive tensor imaging (DTI) and event related potentials (ERP) utilizing electroencephalography.
2. Pilot Football Study 2015-2205 (NCT02696200)
This prospective, controlled clinical study was conducted in football athletes (males: (b) (4) years) who wore the Q-Collar during practices and games (n=31) and a control group of athletes who did not wear the O-Collar (n=30) to test the O-Collar's effect in reducing neuroanatomical changes to the brain following head impacts during a football season, measured using DTI.
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3. Pilot Soccer Study 2016-0988 (NCT03014492)
This study utilized a prospective longitudinal controlled cohort study design to evaluate the effect of the Q-Collar (n="" relative to control (no-Q-Collar: n=""" on long-term white matter changes in females (10) (4) years) over three time-points spanning 9 months. Subjects underwent magnetic resonance imaging (MRI) scans pre-season, postseason, and 3 months post-season. The aims of the study were to: (1) quantify white matter alterations using DTI metrics during the soccer season and characterize the progression of white matter alteration 3 months post-season; (2) determine the association between white matter alterations and exposure to sub-concussive head impacts; and (3) evaluate the efficacy of mild jugular vein compression to ameliorate these white matter alterations over the three time points.
Results from all three pilot studies demonstrated that use of the O-Collar resulted in no adverse events, indicating safety. Additionally, imaging suggested changes in cerebral white matter microstructure were in control groups but not those using the Q-Collar in each study. These studies informed the following pivotal trials.
B. Pivotal Study 1 - Football Study 2018-1123 (NCT0406883)
1. Study Design
This Pivotal Football Clinical Study was a prospective longitudinal study in which (0) (4) high school male football athletes were allocated to one of two investigational groups, 1) Athletes who wore the Q-Collar during the sports season (n=40 (4) or 2) Athletes who did not wear the Q-Collar during the sports season (n-(b) (4) that were stratified by school (four teams primarily wore the Q-Collar and three teams primarily did not wear the Q-Collar).
An accelerometer device was affixed behind the ear of each athlete with an adhesive patch and measured the magnitude of every impact to the head sustained by the athlete by measuring linear accelerations and rotational velocities of the head. The data were filtered to remove spurious impact data and false-positive recordings. In addition, these head impact data were categorized into thresholds between 20 g (inclusive) and 150 g in 10 g intervals. This resulted in 13 additional head impact exposure levels (a total of 14 thresholds when including 20 g). Number of impacts and total g forces were calculated for each exposure threshold.
Each athlete underwent one pre-season magnetic resonance imaging (MRI) scan and one post-season MRI scan in order to determine differences in longitudinal brain imaging change between pre-season and post-season. Post-season scanning was completed at the end of the regular football season but before the start of any playoff games to account for the fact that teams could be eliminated at different times during the playoff period and may thus have different relative head impact exposures.
2. Enrollment
Inclusion Criteria
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- . Normal healthy volunteer
- Able to provide written consent .
- Must be 13 years or older and a participant on a high school football team ●
Exclusion Criteria
- Unable to provide written consent ●
- History of neurological deficits, previous cerebral infarction, or severe head . trauma as indicated through pre-season screening
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis, or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension) ●
- . Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
- . Prothrombotic or hyperthrombotic condition
- Cerebral cavernous malformation ●
- Athletes not medically cleared to play sports .
3. Clinical Endpoints
Primary Effectiveness Endpoint
Change in pre-defined DTI metrics [Mean Diffusivity (MD), Axial Diffusivity (AD) and Radial Diffusivity (RD)] in whole brain from pre-season to post-season in athletes who wore the Q-Collar and athletes who did not wear the Q-Collar.
Primary Safety Endpoint
Incidence of serious adverse events, e.g., syncope, loss of consciousness, associated with the Q-Collar during the sports season.
4. Results
Significant pre-season to post-season reductions in MD, AD, and RD were found in extensive white matter regions [left and right anterior thalamic radiation (ATR), Jeft and right cingulum (cingulate gyrus part), forceps minor, left and right inferior frontooccipital fasciculus (IFOF), left and right superior longitudinal fasciculus (SLF), left and right uncinate fasciculus (UF), and the right temporal SLF] in the no-Collar group (n = (6) (4) p (b) (4) Column C: Between-group differences demonstrating a significantly greater pre-season to post-season RD reduction for the no-Q-Collar group compared to the Q-Collar group (p " g, and time interval between last head impact to post-season scanning.
Post-hoc analysis revealed that 1) delta FA was positively correlated with head impact exposure in the no-Collar group (p " g, and time interval between last head impact to post-season scanning. These results indicate that the relationships between cumulative head impact exposure
and pre-season to post-season changes in DTI metrics were modulated by the Q-Collar at the higher exposure thresholds but not at lower threshold (from > 000 g to > (6) (4) g). Results from this study demonstrated that that the Q-Collar reduces changes in DTI metrics when controlling for total head impact exposure and that the O-Collar modulates the relationship between head impact exposure and changes in pre-season to post-season DTI metrics at higher magnitude exposure levels (6) (4) g to (b)(4) g).
No adverse events or serious adverse events (e.g., syncope, loss of consciousness, etc.) due to device use were reported during the study.
C. Pivotal Study 2 - Soccer Study 2018-1123 (NCT0406883)
1. Study Design
This Pivotal Soccer Clinical Study was a prospective longitudinal study in which (0)(4) high school female soccer athletes were allocated to one of two investigational groups, 1) Athletes who wore the Q-Collar during the sports season (n=(b) (4) or 2) Athletes who did not wear the Q-Collar during the sports season (n-10)(4) that were stratified by school (4 teams primarily wore the Q-Collar and 4 teams primarily did not wear the O-Collar).
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An accelerometer device was affixed behind the ear of each athlete with an adhesive patch and measured the magnitude of every impact to the head sustained by the athlete by measuring linear accelerations and rotational velocities of the head. The data were filtered to remove spurious impact data and false-positive recordings.
Each athlete underwent one pre-season MRI scan and one post-season MRI scan in order to determine differences in longitudinal brain imaging change between pre-season and post-season. Post-season scanning was completed at the end of the regular soccer season but before the start of any playoff games to account for the fact that teams could be eliminated at different times during the playoff period and may thus have different relative head impact exposures.
2. Enrollment
Inclusion Criteria
- Normal healthy volunteer ●
- Able to provide written consent ●
- Must be 13 years or older and a participant on a high school soccer team ●
Exclusion Criteria
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head . trauma as indicated through pre-season screening
- Medical contraindications to restriction of venous outflow via the internal jugular . veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension) ●
- Hydrocephalus
- . Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity ●
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
- Prothrombotic or hyperthrombotic condition ●
- Cerebral cavernous malformation ●
- Athletes not medically cleared to play sports ●
3. Clinical Endpoints
Primary Effectiveness Endpoint
Change in DTI derived brain networks and functional MRI (fMRI)-derived brain network measures (global clustering coefficient (Cg), characteristic path length (L), modularity (Q), normalized clustering coefficient (y), normalized path length (1), small world-ness (o), and clustering coefficient at the nodal level (Cn)) in whole brain from pre-season to
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post-season in athletes who wore the Q-Collar and athletes who did not wear the Q-Collar.
Primary Safety Endpoint
Incidence of serious adverse events, e.g., syncope, loss of consciousness, associated with the Q-Collar during the sports season.
4. Results
fMRI-derived graph measures show significant increase in Cg and change in path length (L) for the no-Collar group. Additionally, the change in Cg was significantly different between groups. Cn in general were increased in the no-Collar group, but no significant difference was found at any node after controlling for multiple comparisons. No significant changes were observed for the Collar group for any graph measure in any of the 3 models. DTI derived graph measures show significant increase in Q for the no-Collar group. No significant changes were observed for the Collar group for any graph measure. Change in O was significantly greater in the no-Collar group vs. Collar group when controlling for scanner only, but not when additional controlling for filtered accelerometer data.
Graph theory is used to translate functional and structural connectivity data into a simplified model of the brain as a network at a macroscopic level. The fMRI-derived brain networks of no-Collar group exhibited an increased Cg (meaning functional similar nodes become increasingly connected) and L (meaning an erosion of connectivity between functionally distinct nodes). The DTI-derived brain networks did not exhibit increase L in the no-Collar group but showed increase in O may be driven by decreases in connectivity between nodes in different modules and/or increases in connectivity between nodes in the same module). Both DTI and fMRI-derived networks from Collar group displayed no significant changes.
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FIGURE 13: LONGITUDINAL CHANGES IN AUC OF CLUSTERING COEFFICIENT AT THE NODAL LEVEL (CN) FOR NO-Q-COLLAR (A, B) AND Q-COLLAR (C, D) GROUPS
Image /page/12/Figure/1 description: The image shows the text "GROUPS" at the top, followed by "(b) (4)" on the left side. At the bottom of the image, there is a sentence that reads, "Spheres represent nodes and are positioned at the center of mass of their respective Automated Anatomical Labeling". The rest of the image is a gray background.
Spheres represent nodes and are positioned at the center of mass of their respective Automical Labeling (AAL) defined region of interest. Lines are representative of the average subject's network edges at a density level of 0.2; cross-hemispheric connections are hidden to improve readability.
The results indicate that there may be alterations in brain structure and function after a soccer season with sub-concussive head impacts and that the O-Collar may mitigate such alterations in brain network properties.
No adverse events or serious adverse events (e.g., syncope, loss of consciousness, etc.) associated with the Q-Collar occurred during the study.
LABELING
The Q-Collar instructions for use are consistent with the clinical data and cover all the hazards and other clinically relevant information that may impact use of the device. The labeling is sufficient and satisfies the requirements of 21 CFR § 801 Subpart C - Labeling Requirements for Over-the-Counter Devices.
The following warnings and precautions are included within device labeling:
- The Q-Collar does not replace, and should be worn with, other protective sports . equipment associated with specific sports activities, such as helmets and shoulder pads.
- The Q-Collar should not be worn if it interferes with other existing protective equipment. .
- Users should avoid head and neck impacts to the extent possible. .
- Serious harm can result from persistent, excessive on the neck due to incorrect . Q-Collar size and fit.
- Data do not demonstrate that the device can prevent concussion or serious brain injury. .
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- o Wearers of the device should not depend on the device to protect them from all harmful effects of head impacts.
- The use of imaging studies as a future indicator of brain injury has not been validated.
- The O-Collar has not been tested and should not be used on athletes with the following conditions:
- Increased pressure in the skull (including uncontrolled ocular-glaucoma) -
- Increased presence of acid in the body or excessive blood alkalinity -
- Open head injury (including in or around the eye) within the past six months -
- Pseudotumor cerebri (false brain tumor) -
- -Presence of brain or spinal shunt
- Accumulation of cerebrospinal fluid within the brain -
- Known seizure disorder -
- -Known trachea abnormality
- Known airway obstruction -
- Known carotid hypersensitivity -
- -Blood clot in the brain
- Increased likelihood of blood clotting (coagulation) -
- Collections of small blood vessels in the brain that are enlarged and irregular in structure
- Skin injury, rash, or other abnormality on or around the neck -
The labeling also includes:
- Information on how the device operates and the typical sensations experienced during use
- Information in the Instructions for Use regarding how to place the device on the user
- Storage and cleaning instructions for the device ●
- Physical limitations of the device including suitable temperature range, duration of use, . and expected product life.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of an external compression device for internal jugular vein compression and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Syncope due to excessive compression | Human factors testing |
| Non-clinical performance testing | |
| Labeling | |
| Use error, interference with other | |
| equipment, or ineffective treatment | |
| leading to impact-related trauma or | |
| injury | Human factors testing |
| Labeling | |
| Adverse tissue reaction | Biocompatibility evaluation |
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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.
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- 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.
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- 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.
-
- 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.
BENEFIT-RISK DETERMINATION
The risks of the external compression device for internal jugular vein compression are based on data collected in the clinical studies described above. Although no adverse events or serious adverse events (e.g., syncope, loss of consciousness, etc.) were reported during the studies, based on products with a similar mechanism of action and other clinical knowledge, there are probable risks to patient health without adequate mitigations in place:
- Small amounts of excessive pressure to the muscles surrounding the IJV could disrupt the ● flow of oxygenated blood through the arteries to the brain leading to syncope.
- Use error could cause injury to the user including excessive head impacts caused by a . false sense of protection, use of the device by athletes who should not wear the device, or interference with existing protective equipment (e.g., helmet).
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- . Incompatible materials could lead to adverse tissue reaction, such as skin irritation.
The probable benefits of the device are also based on data collected in clinical studies as described above. Benefit was demonstrated as reductions in brain structure/function, as evidenced with DTI and fMRI, that are thought to be related to protection of the brain following repetitive sub-concussive head impacts. These benefits were demonstrated in athletes who used the device through a sports season. These changes in DTI have not been validated as a measure of brain injury or linked to clinical outcomes. Similarly, there is uncertainty surrounding the relationship of fMRI-derived brain network measures with brain structure/function. The metrics used in the study were not those that were pre-specified, lending to uncertainty in the results. However, given the urgent need for protection of the brain following mild head impacts as a result of sports and the low risk of this device, the probable benefits outweigh the probable risks.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
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 probable benefits outweigh the probable risks for the O-Collar. The device provides benefits and the risks can be mitigated by using general controls and the identified special controls.
CONCLUSION
The De Novo request for the Q-Collar is granted and the device is classified as follows:
Product Code: QNX Device Type: External compression device for internal jugular vein compression Regulation Number: 21 CFR 890.3050 Class: II