(312 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its clinical performance, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to restore blood flow by removing thrombus in acute ischemic stroke patients, which directly treats a medical condition.
No
The device is designed for therapeutic use, specifically for removing thrombus to restore blood flow in stroke patients. It is not used to diagnose a medical condition.
No
The device description clearly details a physical medical device consisting of a core wire, shaped self-expanding section, radiopaque wires and markers, a hydrophilic coating, a torque device, and an insertion tool. It is delivered through a microcatheter and used for mechanical clot removal.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Trevo Retrievers are surgical devices designed to be inserted directly into the neurovasculature to physically remove blood clots. They are used in vivo (within the living body), not in vitro (in a lab setting with specimens).
- Intended Use: The intended use clearly states the device is used to "restore blood flow in the neurovasculature by removing thrombus." This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details a physical device with a core wire, self-expanding section, and coating, designed for mechanical clot retrieval.
- Input Imaging Modality: While imaging (CT, MRI, angiography, fluoroscopy) is used to guide the procedure and assess the outcome, the device itself does not process or analyze these images to provide a diagnosis. The imaging is a tool for the user of the device.
Therefore, based on the provided information, the Trevo Retrievers are medical devices used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Trevo Retrievers are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
Product codes
POL
Device Description
The Trevo ProVue and XP ProVue Retrievers consist of a flexible, tapered core wire with a shaped self-expanding section at the distal end for clot capture and removal. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. The Trevo Retrievers have a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retrievers. The Trevo Retrievers are delivered to the site of occlusion in the neurovasculature through a microcatheter. The torque device may be used to lock the core wire of the Trevo Retriever to the microcatheter during the procedure, allowing the Trevo Retriever and microcatheter to be retracted as a system through the guide catheter and removed from the body with captured clot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) or magnetic resonance imaging (MRI) scan, CT angiography (CTA), MR angiography (MRA) or digital subtraction angiography (DSA)
Anatomical Site
neurovasculature, proximal anterior circulation, large vessel occlusion
Indicated Patient Age Range
18 or older
Intended User / Care Setting
Not Found
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)
Clinical Performance Testing:
Study Type: Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial. Prospective, randomized, open label, controlled, multicenter trial.
Sample Size:
MR CLEAN: 500 patients (233 treatment ["IAT"], 267 control)
TREVO FDA cohort: 120 patients received first line intra-arterial treatment with a Trevo Retriever and, if eligible for IV t-PA, received IV t-PA.
MM control group: 249/267 patients from the MR CLEAN MM control group, excluding those who received IV t-PA greater than the FDA approved window of 3 hours from stroke symptom onset.
Key Results:
Primary Effectiveness Endpoint: functional independence (modified Rankin Scale (mRS) = 2a): 81.3% for Trevo.
Safety Endpoints:
- Mortality at 90 Days: TREVO FDA Cohort 13.3%, MM 22.89%.
- Symptomatic ICH within 24 Hours: TREVO FDA Cohort 6.67%, MM 4.42%.
- Neurological Deterioration: TREVO FDA Cohort 9.17%, MM 9.57%.
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.
Not Found
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.
K150616, K143077, K133464, K132641, K122478, K120961
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
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(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) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.
0
DE NOVO CLASSIFICATION REQUEST FOR TREVO PROVUE AND XP PROVUE RETRIEVERS
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
NEW REGULATION NUMBER: 21 CFR 882.5600
CLASSIFICATION: CLASS II
PRODUCT CODE: POL
BACKGROUND
DEVICE NAME: TREVO PROVUE AND XP PROVUE RETRIEVERS ("TREVO RETRIEVERS")
SUBMISSION NUMBER: DEN150049
DATE OF DE NOVO: OCTOBER 26, 2015
CONTACT: CONCENTRIC MEDICAL, INC. (A BUSINESS UNIT OF STRYKER NEUROVASCULAR) 301 EAST EVELYN AVENUE MOUNTAIN VIEW, CALIFORNIA 94041
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The Trevo Retrievers are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
1
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established in patients with large core infarcts (i.e., Alberta Stroke Program Early Computed Tomography (CT) score (ASPECTS) ≤ 7). There may be increased risks, such as intracerebral hemorrhage, in these patients.
The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established or evaluated in patients with occlusions in the posterior circulation (e.g., basilar or vertebral arteries) or for more distal occlusions in the anterior circulation.
Administration of IV t-PA should be within the FDA-approved window (within 3 hours of stroke symptom onset).
The safety and effectiveness data supporting the granting of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment is based on use of this device type in conjunction with IV t-PA. At the time of this granting, IV t-PA is approved for treatment of acute ischemic stroke within 3 hours after symptom onset. FDA-approved changes to the drug labeling may have an impact on the safety and effectiveness of the device type.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
The Trevo ProVue and XP ProVue Retrievers consist of a flexible, tapered core wire with a shaped self-expanding section at the distal end for clot capture and removal. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. The Trevo Retrievers have a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retrievers. The Trevo Retrievers are delivered to the site of occlusion in the neurovasculature through a microcatheter. The torque device may be used to lock the core wire of the Trevo Retriever to the microcatheter during the procedure, allowing the Trevo Retriever and microcatheter to be retracted as a system through the guide catheter and removed from the body with captured clot.
Figure 1 below includes images of the distal shaped sections of the Trevo ProVue and XP ProVue Retrievers. Table 1 below includes a summary of the Trevo ProVue and XP ProVue Retriever configurations.
2
Image /page/2/Figure/0 description: The image shows five different models of the Trevo XP PROVUE RETRIEVER. The models are labeled with their dimensions: 3x20mm, 4x20mm, 4x30mm, and 6x25mm. Each model appears to be a thin, wire-like device with a twisted or braided structure. The devices are displayed against a white background.
Figure 1: Trevo Retrievers Distal Shaped Section (Trevo ProVue and Trevo XP ProVue)
| Trevo
Retriever
Size (mm) | Shaped Section
Diameter (mm) | Clot Capture Area
(mm) (Active Shaped
Section Length) | Total Shaped
Section Length
(mm) | Overall
Length (cm) |
|---------------------------------|---------------------------------|-------------------------------------------------------------|----------------------------------------|------------------------|
| Trevo ProVue | | | | |
| 4x20 | 4 | 20 | 37 | 180 |
| Trevo XP ProVue | | | | |
| 3x20 | 3 | 20 | 36 | 190 |
| 4x20 | 4 | 20 | 32 | 180 |
| 4x30 | 4 | 30 | 44 | 180 |
| 6x25 | 6 | 25 | 40 | 180 |
Table 1: Summary of the Trevo ProVue and XP ProVue Retriever Configurations
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical bench studies considered in the review of the subject de novo submission that were leveraged from information previously evaluated for the Trevo Retrievers in prior submissions for different intended uses (K150616, K143077, K133464, K132641, K122478 and K120961) are summarized in the sections below. The technological characteristics and device design of the Trevo Retrievers for the subject de novo are the same as the devices previously cleared in K150616, K143077, K133464, K132641 and K122478.
3
BIOCOMPATIBILITY/MATERIALS
The Trevo Retrievers come in contact with the patient's circulating blood and are classified as external communicating devices of limited contact duration (.
The devices are labeled with a 24 month shelf-life, which is supported by accelerated shelf-life testing (Trevo XP ProVue 3x20, 4x20, 4x30, 6x25) and real-time shelf-life testing (Trevo ProVue 4x20), which includes packaging integrity and component functional performance testing (i.e., dimensional verification, tensile strength, radial force, tip flexibility, torque/tensile durability, retriever platinum wire and joint durability, radiopacity, deliverability, simulated use, coating integrity and particulate testing). Packaging integrity testing included testing to the following standards:
- . ASTM D4169:2009 - Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980:2011 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices
- . ASTM F1929:2004 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F2906:2011 Standard Test Method for Detecting Gross Leaks in ●
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Packaging by Internal Pressurization (Bubble Test)
- ASTM F88/ F88M:2009 Standard Test Method for Seal Strength of Flexible . Barrier Materials
PERFORMANCE TESTING – BENCH
The Trevo Retrievers were tested and passed the following performance (bench) tests summarized in Table 2 below. This information was leveraged from testing provided in prior submissions for the Trevo Retrievers (K150616, K143077, K133464, K132641, K122478 and K120961).
| Test | Test Method Summary |
|---|---|
| Dimensional | Verified dimensions using specified measurement tool. |
| Verification | |
| Retriever Mid Joint | Identified joint and cut sample for test. Recorded peak |
| Tensile Strength | tensile force results. |
| Retriever Tip Tensile | |
| Strength | Loaded sample. Recorded peak tensile force results. |
| Retriever Shaped | |
| Section Radial Force | Constrained and released shaped section of retriever to |
| specified diameter. Recorded radial force results. | |
| Retriever/Vessel | |
| Interaction (Tip | |
| Flexibility) | Loaded sample so that the distal tip was flexed. Recorded |
| peak compression/flex force results. | |
| Retriever Torque | |
| Tensile Durability | Gripped device and applied rotations to torque device. |
| Pulled tensile cycles to a max load then last cycle to | |
| failure. Recorded results. | |
| Retriever Platinum | |
| Wire Joint Strength | Identified joint and cut sample for test. Recorded peak |
| tensile force results for each individual platinum wire. | |
| Retriever Platinum | |
| Wire and Joint | |
| Durability | Wrapped and unwrapped the entire length of the shaped |
| section of the retriever (sheathed in insertion tool) around | |
| a pin and repeat. Performed visual inspection and recorded | |
| results. Performed deploy/reload cycles into insertion tool. | |
| Performed visual inspection and recorded results. | |
| Radiopacity | Radiopacity was assessed based on visual assessment of |
| the device being used under fluoroscopy. | |
| Retriever/Microcatheter | |
| Deliverability | Measured the force to push the device through a tortuous |
| model. | |
| Particulate Evaluation | Measured total number of particulate and size of |
| particulate generated during the simulated delivery, | |
| deployment and resheathing of the device. Particulate | |
| counting was assessed for ≥ 10um, ≥ 25um, and ≥ 50um | |
| size ranges. |
Table 2: Bench Testing and Test Method Summary
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| Test | Test Method Summary |
|---|---|
| Coating Integrity | |
| Evaluation | A visual assessment of the coating integrity of the subject |
| device was performed before (baseline) and after tracking | |
| through a tortuous path fixture representative of clinical | |
| conditions (simulated use). The visual assessment | |
| evaluation utilized high magnification and a dye to assess | |
| the adhesion of the coating. Proximal and distal coating | |
| edges were evaluated to determine if the coating was | |
| intact. The entire coating length of the device was | |
| evaluated for defects (visible voids or scratches). | |
| Simulated Use | Simulated use testing used a silicone neurovascular model |
| cast from actual human neurovascular arteries. This bench | |
| testing model replicates the tortuosity, diameter and | |
| location of the arteries in the neurovasculature including | |
| the internal carotid artery (ICA) siphon. The model ends at | |
| the mid carotid arteries and proximal support is provided | |
| by a guide catheter. The model incorporates a re- | |
| circulating water bath at 37 ℃ pressurized between 2 - 2.5 | |
| psi (100 - 126 mm Hg) to simulate the human arterial | |
| circulation. All testing follows the procedural instructions | |
| outlined in the Instructions for Use. Simulated thrombus is | |
| used to assess the device's ability to retrieve clot. |
PERFORMANCE TESTING - ANIMAL
The Trevo Retrievers were previously evaluated in animal studies to support device safety. These animal studies were previously provided in K120961, K143077 and K150616. Animal studies consisting of an acute animal (swine) study and a chronic animal (swine) study were performed using devices with up to 6 passes in the treated vessels. Safety (vessel response) was assessed based on the presence or absence of arterial transmural dissection or perforation due to device use in the treated vessels based on results of intra-procedural angiography and histopathology. The acute study angiography results revealed no evidence of vessel dissection, perforation, or thrombosis at Day 0. The chronic study angiography results revealed no evidence of dissection, perforation, or thrombosis at Day 0 and no evidence of stenosis, vessel irregularity, intimal flap or pseudoaneurysm at treatment sites at Day 30. Histopathology for treated vessels in both acute (Day 0) and chronic studies (Day 30), including semi-quantitative scoring of pathologic changes in treated vessels (e.g., endothelial loss, thrombus, hemorrhage, and medial injury), was found to be consistent with arterial healing affer routine catheterization commonly seen with guidewires / catheters.
SUMMARY OF CLINICAL INFORMATION
Clinical data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial was used to support the expanded indication for the Trevo Retrievers in the subject de novo. The clinical study design and results are further
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summarized below. While the MR CLEAN study allowed use of a variety of intra-arterial therapies, the data used to support the subject de novo request for the Trevo Retrievers was limited to data from MR CLEAN that only used the Trevo Retrievers as the thrombectomy device. Further, while these data were generated outside of the United States (US), FDA determined that these data represent valid scientific evidence and are applicable to the intended use population in the US.
Design:
MR CLEAN was a prospective, randomized, open label, controlled, multicenter trial in which every endovascular hospital center in the Netherlands participated. Intra-arterial treatment ("IAT"), which could include mechanical thrombectomy, plus best medical management (MM), which included intravenous administration of IV t-PA in eligible subjects, was compared with best MM alone (control group) in patients with acute ischemic stroke with a proximal intracranial arterial occlusion of the anterior circulation that was confirmed on vessel imaging. MR CLEAN randomized 500 patients (233 treatment ["IAT"], 267 control) at 16 medical centers. Retrievable stents (including the Trevo Retriever product family) were used in 190 of the 233 patients (81.5%) assigned to the IAT arm, of which 120/190 patients received first line intra-arterial treatment with a Trevo Retriever and if eligible for IV t-PA, received IV t-PA within 3 hours from symptoms onset (TREVO FDA cohort). The TREVO FDA cohort group was compared to the entire MR CLEAN MM control group, excluding the MM patients who received IV t-PA greater than the FDA approved window of 3 hours from stroke symptom onset (249/267 patients in the MM control group). The 18 patients who were excluded from the MM control group received IV t-PA within 3-4.5 hours from symptom onset. which is in accordance with the European Union (EU) approved administration for IV t-PA where the study was conducted. Most of the patients received IV t-PA within the FDA approved window of 3 hours from stroke symptom onset, including 104/120 patients in the IAT Trevo FDA group and 224/249 in the MM group.
Key inclusion criteria for MR CLEAN were: clinical diagnosis of acute ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score > 2; computed tomography (CT) or magnetic resonance imaging (MRI) scan ruling out intracranial hemorrhage; intracranial arterial occlusion of the distal ICA or proximal regions in the middle (M1/M2) or anterior (A1/A2) cerebral arteries, demonstrated with CT angiography (CTA), MR angiography (MRA) or digital subtraction angiography (DSA): treatment within 6 hours of symptom onset, age 18 or older and informed consent given.
Additional key inclusion criteria for Trevo Retriever subset analysis from MR CLEAN: first line treatment with Trevo Retriever and IV t-PA treatment within 3 hours of symptom onset.
Kev exclusion criteria for MR CLEAN were: arterial blood pressure >185/110 mmHz: blood glucose 22.2 mmol/L; intravenous treatment with thrombolytic therapy in a dose exceeding 0.9 mg/kg alteplase or 90 mg; intravenous treatment with thrombolytic therapy despite contraindications (i.e., major surgery, gastrointestinal bleeding or urinary tract bleeding within the previous 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days). cerebral infarction in the distribution of the relevant occluded artery in the previous 6 weeks; and
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laboratory evidence of coagulation abnormalities (i.e., platelet count 50 sec or international normalized ratio (INR) >3.0).
Results:
The primary effectiveness endpoint of the MR CLEAN trial was functional independence (modified Rankin Scale (mRS) 2) in the analysis. After these adjustments, the proportion of subjects with mRS at day 90 that met the primary effectiveness endpoint in the MM control arm was 48/249 (19.3%) with 95% exact confidence interval (14.6%, 24.7%); and was 28/96 (29.2%) with 95% exact confidence interval (20.3%, 39.3%) in the Trevo Retriever treatment group (Table 3). The associated odds ratio [95% confidence interval (CI)] was 1.88 [1.07, 3.29], with a p-value of 0.014.
| 90 DAY
mRS | TREVO excluding concomitant
carotid stenting
(N=96) | MM
(N=249) |
|--------------------------------------------------------------------|-----------------------------------------------------------|----------------|
| 0 | 4.2% (4/96) | 0.4% (1/249) |
| 1 | 8.3% (8/96) | 5.2% (13/249) |
| 2 | 17.7% (17/96) | 13.7% (34/249) |
| 3 | 15.6% (15/96) | 16.5% (41/249) |
| 4 | 32.3% (31/96) | 31.3% (78/249) |
| 5 | 7.3% (7/96) | 10.4% (26/249) |
| 6 | 14.6% (14/96) | 22.5% (56/249) |
| mRS [0,