(254 days)
Not Found
Not Found
No
The description focuses on the mechanical function of the device (capturing debris with filters) and does not mention any AI/ML components or functions.
Yes
The device is described as an "embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures," indicating a direct therapeutic action of preventing embolization.
No
The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris during transcatheter aortic valve replacement procedures. It is a protective device used during a procedure, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical catheter system with filters designed to capture debris, indicating it is a hardware device.
No, the Sentinel® Cerebral Protection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Sentinel System Function: The Sentinel System is a physical device inserted into arteries to capture and remove embolic material during a medical procedure (TAVR). It does not analyze biological specimens in vitro.
- Intended Use: The intended use clearly states it's an "embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures." This is a therapeutic and protective function performed in vivo.
- Device Description: The description details a catheter with filters, designed for physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on laboratory tests.
While the performance studies utilize imaging (DW-MRI) to assess the effectiveness of the device in reducing new lesions (a consequence of embolic events), the device itself is not performing the diagnostic analysis. The MRI is a separate diagnostic tool used to evaluate the outcome of the procedure where the Sentinel System was used.
N/A
Intended Use / Indications for Use
The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.
Product codes (comma separated list FDA assigned to the subject device)
PUM
Device Description
The Sentinel® Cerebral Protection System (Figure 1) is a 6 French, 95 cm working length, single use, temporary, percutaneously-delivered embolic protection catheter inserted into the right radial or brachial artery. The system is designed to capture and remove embolic material (thrombus/debris) during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel System employs two embolic filters, one delivered to the brachiocephalic artery (Proximal Filter), and one to the left common carotid artery (Distal Filter). The nominal filter diameters are 15 mm (Proximal Filter) and 10 mm (Distal Filter).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachiocephalic artery, left common carotid artery
Indicated Patient Age Range
at least 18 years of age
Intended User / Care Setting
physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endovascular procedures.
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)
Study Type: Clinical Study - "Cerebral Protection in Transcatheter Aortic Valve Replacement – The SENTINEL Study". Prospective, single blind, multi-center, randomized study.
Sample Size: A total of three hundred and sixty-three (363) patients at nineteen (19) centers in the United States and Germany were randomized across three arms (Safety, Test, and Control) in a 1:1:1 fashion. 65 roll-in subjects were also treated in SENTINEL in a training phase.
Key Results:
Primary Safety Endpoint: The primary safety endpoint was the occurrence of all MACCE at 30 days compared to a historical performance goal. The sentinel device demonstrated a 30-Day Adjudicated MACCE Rate of 7.4% (18/244) with imputation and 7.3% (17/234) without imputation, which was statistically significant compared to the performance goal of 18.3% (p-value
§ 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
(a)
Identification. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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) Simulated-use testing in a clinically relevant bench anatomic model to assess the following:
(A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and
(B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv) Characterization and verification of all dimensions.
(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i) Delivery, deployment, and retrieval, including quantifying procedural time.
(ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv) Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3) All patient contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use;
(ii) Compatible transcatheter intracardiac procedure devices;
(iii) A detailed summary of the clinical testing conducted; and
(iv) A shelf life and storage conditions.
(7) Clinical performance testing must demonstrate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to filter embolic material while not impeding blood flow;
(iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and
(iv) Evaluation of all adverse events including death, stroke, and vascular injury.
0
DE NOVO CLASSIFICATION REQUEST FOR SENTINEL® CEREBRAL PROTECTION SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Temporary catheter for embolic protection during transcatheter intracardiac procedures. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.
NEW REGULATION NUMBER: 21 CFR 870.1251
CLASSIFICATION: II
PRODUCT CODE: PUM
BACKGROUND
DEVICE NAME: Sentinel® Cerebral Protection System
SUBMISSION NUMBER: DEN160043
DATE OF DE NOVO: September 19, 2016
Claret Medical, Inc. CONTACT: 1745 Copperhill Parkway, Suite 1 Santa Rosa, California 95403
INDICATIONS FOR USE
The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.
LIMITATIONS
The sale, distribution, and use of the Sentinel® Cerebral Protection System are restricted to prescription use in accordance with 21 CFR 801.109.
The Sentinel® Cerebral Protection System should only be used by physicians who have received appropriate training and are familiar with the principles, clinical applications,
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complications, side effects, and hazards commonly associated with endovascular procedures.
The safety and effectiveness of the Sentinel® Cerebral Protection System have not been demonstrated with transcatheter aortic valves other than the Edwards SAPIEN XT, Edwards SAPIEN 3, Medtronic CoreValve®, and Medtronic CoreValve® Evolut R®.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Sentinel® Cerebral Protection System (Figure 1) is a 6 French, 95 cm working length, single use, temporary, percutaneously-delivered embolic protection catheter inserted into the right radial or brachial artery. The system is designed to capture and remove embolic material (thrombus/debris) during transcatheter aortic valve replacement (TAVR) procedures.
Image /page/1/Figure/5 description: This image shows a medical device called the Sentinel Cerebral Protection System. The device has several labeled components, including a rear handle with a flush port and lock, a front handle with a flush port and lock, a deflection knob labeled as "2", and distal and proximal filter sliders labeled as "3" and "1" respectively. The device also features distal and proximal filters, and an articulating sheath.
Figure 1: Sentinel® Cerebral Protection System
The Sentinel System employs two embolic filters, one delivered to the brachiocephalic artery (Proximal Filter), and one to the left common carotid artery (Distal Filter). The nominal filter diameters are 15 mm (Proximal Filter) and 10 mm (Distal Filter). Target vessels sizes are shown in Table 1 below.
Table 1: Filter and Target Vessel Sizes
| Proximal Filter
Size (mm) | Target Proximal
Vessel Size (mm) | Distal Filter
Size (mm) | Target Distal
Vessel Size (mm) |
|------------------------------|-------------------------------------|----------------------------|-----------------------------------|
| 15 | 9.0-15 | 10 | 6.5-10 |
Please refer to the Instructions for Use for additional details.
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SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Sentinel System is an externally communicating device in contact with circulating blood with limited contact duration ( 30% target (Table 12).
Table 11: Primary Effectiveness Criterion 1 - Median 2-7 Day DW-MRI Total New Lesion Volume (Protected Territories)
| | Test Arm
median
(IQR),
n,
min, max | Control Arm
median
(IQR),
n,
min, max | Observed Treatment
Difference
(Test - Control) | p-value¹ |
|--------------------------|--------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------|----------|
| ITT with Imputation, mm³ | 109.1
(36.9, 379.7),
n=121,
0 min, 5175.9 max | 174
(39.6, 469.3),
n=119,
0 min, 24300 max | -64.9 | 0.24 |
| ITT, mm³ | 102.8
(36.9, 423.2),
n=91,
0 min, 5175.9 max | 178
(34.3, 482.5),
n=98,
0 min, 24300 max | -75.1 | 0.33 |
Based on two-sided Wilcoxon test
Table 12: Primary Effectiveness Criterion 2 - 30% Reduction in 2-7 Day DW-MRI Median Total Lesion Volume (Protected Territories)
| | Test Arm
median
(IQR),
n,
min, max | Control Arm
median
(IQR),
n,
min, max | Target | Observed % Reduction
(Test-Control)/Control |
|----------|-------------------------------------------------------|----------------------------------------------------|--------|------------------------------------------------|
| ITT, mm3 | 102.8
(36.9, 423.2),
n=91,
0 min, 5175.9 max | 178
(34.3, 482.5),
n=98,
0 min, 24300 max | 30% | 42.2 |
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Key Secondary Safety Endpoints: A breakdown of the MACCE components compared to the concurrent Control Arm is provided in Table 13.
| | (Safety + Test Arms)
% patients with event
(n patients with event/N patients)
[exact 95% CI] | Control Arm
% patients with event
(n patients with event/N patients)
[exact 95% CI] |
|---------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Any MACCE | 7.3%
(17/234)
[4.3%,11.4%] | 9.9%
(11/111)
[5.1%,17.0%] |
| Death | 1.3%
(3/234)
[0.3%,3.7%] | 1.8%
(2/111)
[0.2%,6.4%] |
| Stroke | 5.6%
(13/231)
[3.0%,9.4%] | 9.1%
(10/110)
[4.4%,16.1%] |
| Disabling | 0.9%
(2/231)
[0.1%,3.1%] | 0.9%
(1/109)
[0.0%,5.0%] |
| Non-disabling | 4.8%
(11/231)
[2.4%,8.4%] | 8.2%
(9/110)
[3.8%,15.0%] |
| AKI (Class 3) | 0.4%
(1/231)
[0.0%,2.4%] | 0%
[0.0%,3.3%] |
Table 13: 30-Day MACCE and Component Rates (ITT)
Secondary Safety Analyses are provided below (ITT population).
- In-Hospital MACCE: Numerically lower between the Safety + Test Arms [5.7% (14/244)] . versus the Control Arm [8.4% (10/119)]. The observed stroke rate in the Safety + Test Arms (4.9%) versus the Control Arm (8.4%) resulted in a 41.7% relative reduction.
- 30-Day MACCE (Test Arm vs Control Arm): 6.0% (7/117) and stroke rate of 4.3% (5/116) . in the Test Arm were numerically lower than the Control Arm, [9.9% (11/11) and 9.1% (10/110) respectively].
- Major vascular complications (Index procedure and within 30 days): Incidence of . adjudicated major vascular events were low during the index procedure with no radial or brachial events during the procedure, and only one brachial event (0.4%) within 30 days of the index procedure.
- . Serious Adverse Events (30 days): Site reported serious adverse events were similar between the Safety + Test Arms and the Control Arm. The events did not exceed rates reported from contemporary TAVR studies, with 42.6% (104/244) being reported for the Safety + Test Arms and 42.9% (51/119) for the Control Arm.
Safety was evaluated out to 90 days for all patients. Similar to the 30-Day MACCE rate, 90-Day MACCE was numerically lower between the Safety Cohort [11.3% (24/213)] and Control Arm [12.9% (12/93). Specifically, strokes were numerically lower between the Safety + Test Arms [6.4% (13/202)] and the Control Arm [12.0% (11/92)].
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Key Secondary Effectiveness Endpoints:
The table below compares results observed in the regions of the brain protected by the Sentinel System and the entire brain (all territories).
| Protected Territories | All Territories | |||||
|---|---|---|---|---|---|---|
| Test Arm | ||||||
| median (IQR), | ||||||
| n, | ||||||
| min, max | Control Arm | |||||
| median (IQR), | ||||||
| n, | ||||||
| min, max | Observed | |||||
| Treatment | ||||||
| Difference | ||||||
| (Test – Control) | ||||||
| (mm³) | Test Arm | |||||
| median (IQR), | ||||||
| n, | ||||||
| min, max | Control Arm | |||||
| median (IQR), | ||||||
| n, | ||||||
| min, max | Observed | |||||
| Treatment | ||||||
| Difference | ||||||
| (Test – Control) | ||||||
| (mm³) | ||||||
| ITT with | ||||||
| Imputation, mm³ | 109.1 | |||||
| (36.9, 379.7), | ||||||
| n=121 | ||||||
| 0 min, 5175.9 max | 174 | |||||
| (39.6, 469.3), | ||||||
| n=119 | ||||||
| 0 min, 24300 max | -64.9 | 247.2 | ||||
| (97.6, 572.2), | ||||||
| n=121 | ||||||
| 0 min, 14179 max | 311.1 | |||||
| (110.7, 848.4), | ||||||
| n=119 | ||||||
| 0 min, 24300 max | -63.9 | |||||
| ITT, mm³ | 102.8 | |||||
| (36.9, 423.2), | ||||||
| n=91 | ||||||
| 0 min, 5175.9 max | 178 | |||||
| (34.3, 482.5), | ||||||
| n=98 | ||||||
| 0 min, 24300 max | -75.1 | 294 | ||||
| (69.2, 786.4), | ||||||
| n=91 | ||||||
| 0 min, 14179 max | 309.8 | |||||
| (105.5, 859.6), | ||||||
| n=98 | ||||||
| 0 min, 24300 max | -15.8 |
Table 14: Protected and All Territories 2-7 Day Median Total New Lesion Volume
A neurocognitive test battery of composite z-scores from baseline to follow-up between the Test and Control Arms was performed at 30 days. no difference in the mean change in z-score between the Test Arm and the Control Arm were observed, possibly due to 82% of the population having been below the age adjusted norm (i.e. floor effect). The composite z-score is an overall cognition score that is the average of the z-scores from each of the five cognitive domains assessed: attention, executive function, processing speed, verbal memory and visual memory. A relative negative z-score indicates worsening neurocognition while a relative positive z-score indicates an improvement in neurocognition. In SENTINEL, the range of changes in zscore from baseline to 30 days was -1.45 to 1.39 and was not statistically significant between the test and control arms (reference Table 15 for the mean change in z-score).
Table 15: Change in Composite Z-Score (Baseline - 30 Days)
| | Test Arm
Mean ± SD, n | Control Arm
Mean ± SD, n |
|-----|--------------------------|-----------------------------|
| ITT | $-0.09 \pm 0.44$ , 93 | $-0.03 \pm 0.37$ , 92 |
Remaining Secondary Endpoint Results for prospectively defined secondary endpoints not discussed above as performed on the ITT population are included below:
- 2-7 Day Median Number of New Lesions (Protected Territories): The number of new . lesions was numerically lower in the Test Arm (2) versus the Control Arm (3).
- . 2-7 Day Median Number of New Lesions (All Territories): The number of new lesions was numerically lower in the Test Arm (3) versus the Control Arm (5) but was not statistically significant.
- Difference in Neurocognitive Battery Composite Z-Score from Baseline to 30 Days: The . difference in composite z-score was not statistically different between the Test Arm and Control Arm.
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- 30-Day Median Total New Lesion Volume (Protected Territories): The total new lesion . volume at 30 days was zero for both the Test Arm and Control Arm and was not significant.
- . 30-Day Median Number of New Lesions (Protected & All Territories): The number of new lesions at 30 days was zero for both the Test Arm and Control Arm in both protected and all territories and was not significant.
- . 2-7 Day Maximum and Median New Lesion Volume (Protected & All Territories): None of the results from this evaluation were found to be statistically significant.
- 30-Day Maximum and Median New Lesion Volume (Protected & All Territories): None of . the results from this evaluation were found to be statistically significant.
- Correlation of 2-7 Day Lesion Volume to 2-7 Day and 90 Day Z-Score: The correlations . were not found to be statistically significant at these time points.
- Correlation of 30-Day Lesion Volume to 30 Day and 90 Day Z-Score: The correlations . were not found to be statistically significant at these time points.
- . 30-Day Median Total New Lesion Volume (All Territories): The total new lesion volume at 30 days was zero for both the Test Arm and Control Arm and was not significant.
- . Difference in Neurocognitive Battery Composite Z-Score from Baseline to 2-7 Days & 90-Days: The difference in composite z-score was not statistically different between the Test Arm and Control Arm at either time point.
- Acute Delivery and Retrieval Success: Acute delivery and retrieval success was achieved . in 94.4% (218/231) of patients (both filters deployed). At least on filter was deployed in 99.6% of patients.
- . Change in Individual Neurocognitive Domain Scores: No statistically significant changes were observed in any of the domain analyses.
Conclusions: The SENTINEL trial demonstrated that the Sentinel System is safe and effectively captures debris. Sentinel System deployment was achieved in 94.4% of patients and 100% of devices were successfully retrieved with only one vascular injury (0.4%). The primary safety endpoint was met and 30-day MACCE events in patients treated with the Sentinel System were less than the prespecified performance goal of 18.3% with a p-value