(113 days)
No
The device description focuses on the mechanical aspects of a medical device for clot retrieval and does not mention any software, algorithms, or data processing that would indicate AI/ML. The performance studies describe clinical trial results, not the performance of an AI/ML algorithm.
Yes
The device's intended use is to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability, which directly addresses a disease condition (stroke) and aims to improve a patient's health.
No
The device description and intended use clearly state that the Trevo Retriever is a mechanical thrombectomy device designed to physically remove thrombus to restore blood flow in stroke patients. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly details physical components such as a core wire, shaped section, platinum markers, hydrophilic coating, shaft marker, torque device, and insertion tool, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Trevo Retriever is to physically remove thrombus (blood clots) from the neurovasculature to restore blood flow in patients experiencing acute ischemic stroke. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a mechanical retriever designed to be inserted into blood vessels to grasp and remove clots. It is a physical tool used in a surgical or interventional procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Trevo Retriever does not perform any such analysis of biological specimens.
The information about imaging modalities (CT, MRI, CTA, MRA) and performance studies (clinical trial data) are relevant to the clinical use and evaluation of the device, but they do not change its fundamental nature as a therapeutic device used in vivo.
N/A
Intended Use / Indications for Use
-
The Trevo Retriever is 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.
-
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
-
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patient, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age 0.99991.
- Functional Independence (mRS 0-2):
- Treatment arm: 48.6% (52/107)
- Control arm: 13.1% (13/99)
- Core adjusted posterior treatment benefit: 32.8%, 95% Credible Interval 21.1% to 44.1%.
- Probability of superiority: >0.9999.
- Functional independence demonstrated durability across the 12-24 hour time spectrum from last seen well to randomization (TLSW).
Secondary Effectiveness Outcome: Early Neurological Response
- Defined as NIHSS drop of >= 10 points from baseline or NIHSS 0 or 1 at day 5-7 or discharge (whichever was earlier).
- Treatment Arm: 47.7%
- Control Arm: 19.2%
- Mean Absolute Difference: 28.5% (16.2%, 40.7%), Risk Ratio 2.5 (1.6, 3.9), p-value 2b was 84.8% in the Treatment arm.
Primary Safety Outcome: Incidence of Stroke-Related Mortality at 90 days
- Treatment Arm: 15.9% (17/107)
- Control Arm: 18.2% (18/99)
- Difference: -2.3% [-12.6%, 8.0%] (p=0.7126). No significant difference.
Secondary Safety Outcome: Incidence of sICH (within 24 (-6/+24) hours post randomization)
- Treatment Arm: 5.6% (6/107)
- Control Arm: 3.0% (3/99)
- Difference: 2.6% [-2.9%, 8.1%] (p=0.5011). No statistical difference.
Secondary Safety Outcome: Incidence of Neurological Deterioration
- Defined as >= 4 point increase in NIHSS score from baseline through Day 5-7/Discharge post randomization.
- Treatment Arm: 14.0% (15/107)
- Control Arm: 26.3% (26/99)
- Difference: -12.2% [-23.1%, -1.4%] (p=0.0358). Occurred less frequently in the thrombectomy group.
Secondary Safety Outcome: Difference of All-Cause Mortality by CEC Adjudication (at 90 days)
- Treatment Arm: 18.7% (20/107)
- Control Arm: 18.2% (18/99)
- Difference: 0.5% [-10.1%, 11.1%] (p=1.0000).
Secondary Safety Outcome: Serious Adverse Events
- No new safety risks identified. Risks similar to currently cleared indications.
- Vascular perforation: Treatment Arm 0.9% (1/107) (procedure related)
- Intramural arterial dissection: Treatment Arm 1.9% (2/107) (procedure related)
- Access site complication requiring surgical repair or blood transfusion: Treatment Arm 0.9% (1/107) (procedure related)
- Embolization to a new territory: Treatment Arm 3.7% (4/107) (device and procedure related)
- Nervous System Disorders SOC had highest rate of SAEs in Treatment arm (19.6%) and Control arm (30.3%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Utility-Weighted mRS-mean (SD): Trevo Arm 5.5 (3.8), Control Arm 3.4 (3.1)
- Functional Independence (mRS 0-2): Trevo Arm 48.6%, Control Arm 13.1%
- Early Response: 47.7% in Treatment, 19.2% in Control
- Revascularization rates at 24 hours: 76.6% in Treatment, 38.4% in Control
- Incidence of all stroke-related mortality at 90 days: 15.9% in Treatment, 18.2% in Control
- sICH at 24 (-6/+24) hrs post randomization: 5.6% in Treatment, 3.0% in Control
- Incidence of neurological deterioration between baseline and Day 5 to 7/Discharge: 14.0% in Treatment, 26.3% in Control
- Incidence of all-cause mortality at 90 days: 18.7% in Treatment, 18.2% in Control
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.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2018
Concentric Medical, Inc. Rhoda M. Santos Senior Principal Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, California 94041
Re: K173352
Trade/Device Name: Trevo ProVue Retriever and Trevo XP ProVue Retriever (Trevo Retriever) Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: January 12, 2018 Received: January 16, 2018
Dear Ms. Rhoda M. Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173352
Device Name
Trevo ProVue Retriever and Trevo XP ProVue Retriever (Trevo Retriever)
Indications for Use (Describe)
-
The Trevo Retriever is 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.
-
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
-
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patient, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Trade Name: | Trevo ProVue Retriever and Trevo XP ProVue Retriever (Trevo Retriever) |
|---|---|
| Common Name: | Trevo Retriever |
| Classification Name: | Neurovascular Mechanical Thrombectomy Device for Acute |
| Ischemic Stroke Treatment, 21 CFR 882.5600, Class II, POL - | |
| Percutaneous Catheter, 21CFR 870.1250, Class II, NRY | |
| Product Code: | POL, NRY |
| Submitter: | Concentric Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 510-413-2269 | |
| Fax 510-413-2558 | |
| Facility Registration #2954917 | |
| Contact: | Rhoda M. Santos |
| Senior Principal Regulatory Affairs Specialist | |
| Date Prepared: | February 6, 2018 |
| Predicate Device: | Trevo ProVue Retriever and Trevo XP ProVue Retriever |
| (DEN150049) | |
| Reference Predicate Device: | Trevo Retriever (K120961) |
Device Description
The Trevo Retriever family, including the Trevo ProVue and Trevo XP ProVue Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever has a hydrophilic coating to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining Guide Wire Extension to Retriever facilitates removal or exchange of a catheter while maintaining Retriever position in anatomy. After exchange has been completed, the extension can be detached.
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Accessories
The Retriever is provided with two accessories: a torque device facilitates manipulation of the Retriever; and an insertion tool is used to introduce the Retriever into a microcatheter.
Indications for Use
The Indications for Use for the Trevo ProVue and Trevo XP ProVue Retrievers are as follows:
-
- The Trevo Retriever is 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.
-
- The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
-
- The Trevo Retriever is 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age 10, informed consent given and age 18 or over; In patients younger than 80, a stroke score equal to or greater than 10 must be associated with a core volume less than 51 ml. In patients 80 or older, the stroke score must be greater than 10 and volume less than 21 ml. Clinical-core mismatch which is defined as the mismatch between baseline infarct volume (or core) on CT or MRI imaging and the extent of total brain tissue at risk.
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Key Exclusion criteria
Rapid improvement in neurological status to an NIHSS 185/110 mmHg; laboratory evidence of electrolyte imbalance (i.e., sodium 6 mEq/L); laboratory evidence of renal failure (i.e., serum creatinine > 3.0 mg/dL (264 umol/L); laboratory evidence of coagulation abnormalities (i.e., platelet count 3 times normal or INR > 3.0, if given factor Xa inhibitor 24-48 hours ago must have normal PTT); laboratory evidence of bleeding (i.e., hemoglobin 0.9999.
Table 3: Co-Primary outcomes ITT population
| Outcome | Trevo
Arm
(N=107) | Control
Arm
(N=99) | Mean Absolute
Difference
(95% CI) | Posterior mean
benefit,
core-adjusted
(95% credible
interval) * | Probability of
superiority |
|-----------------------------------|-------------------------|--------------------------|-----------------------------------------|-----------------------------------------------------------------------------|-------------------------------|
| Utility-Weighted mRS-mean (SD) | 5.5 (3.8) | 3.4 (3.1) | 2.1
(1.2, 3.1) | 2.0
(1.1, 3.0) | >0.99991 |
| Functional Independence (mRS 0-2) | 48.6% | 13.1% | 35.5%
(23.9%, 47.0%) | 32.8%
(21.1%, 44.1%) | >0.9999 |
*Estimated by Bayesian general linear model adjusting for Core Infarct
1The overall probability of a device benefit is then the average of the benefit probabilities for the imputed by the imputation probabilities of those data sets. This probability is 0.999986.
To provide additional context, the UW-mRS expected benefit of 2.04 represents 20.4% of the total value of preventing a single death and, instead, achieving a normal neurologic
12
outcome for that individual patient. Accordingly, the number needed to treat to save one life is 10/2.04 = 4.9 (95% credible interval 3.4-9.1). This value indicates that 4.9 patients need to be treated with Trevo thrombectomy rather than medical care alone for the accrued benefit to equal saving one life with return to normal function. Additionally, the number needed to treat to achieve functional independence (90-day mRS 0-2) is 2.8.
Primary Endpoint by Time
The randomization stratification of the DAWN Trial included a stratification variable of 6-12 hours and 12-24 hours to ensure balance of randomization across time. The minimum and maximum TLSW were 6.1 to 23.9 hours demonstrating subjects across the entire intended time spectrum were enrolled.
Figure 1 below plots the unadjusted probability of 90 day functional independence (mRS 0-2) by TLSW, demonstrating durability of treatment benefit across the 12-24 hour time spectrum.
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Image /page/13/Figure/1 description: The image is a graph titled "Functional Independence (mRS 0-2) by Time Since Time Last Seen Well To Randomization". The x-axis is labeled "Time since time last seen well to randomization (hrs)" and ranges from 5 to 25. The y-axis is labeled "Estimated Probability" and ranges from 0.0 to 1.0. There are two lines on the graph, one blue and one red, representing different treatment assignments, MM and Trevo, respectively.
Figure 1: Functional Independence (mRS 0-2) by TLSW
Table 4 further sub-groups 90 day functional independence (mRS 0-2) by 3 hour intervals. Although some intervals (i.e. 18-21 and 21-24 hours) had small numbers, the benefit of thrombectomy as measured by absolute difference was observed in each subgroup.
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| TLSW Intervals | Treatment | Control | Difference | P-value |
|---|---|---|---|---|
| 6-9 hrs | 50.0% (9/18) | 14.3% (3/21) | 35.7% | |
| [ 8.2%, 63.2%] | 0.0346a | |||
| 9-12 hrs | 58.1 % (18/31) | 26.1%(6/24) | 33.1% [8.5%, | |
| 57.6%] | 0.0273 a | |||
| 6-12 hrs Total | 55.1% (27/49) | 20.0% (9/45) | 35.1% | |
| [ 16.9%, 53.3%] | 0.0006a | |||
| 12-15 hrs | 37.5% (6/16) | 9.1% (2/22) | 28.4% | |
| [1.8%,55.0%] | 0.0498a | |||
| 15-18 hrs | 50.0% (13/26) | 5.3% (1/19) | 44.7% | |
| [ 23.1%, 66.4%] | 0.0025a | |||
| 18-21 hrs | 36.4% (4/11) | 0.0% (0/8) | 36.4% | |
| [ 7.9%, 64.8%] | 0.1032a | |||
| 21-24 hrs | 40.0% (2/5) | 20.0% (1/5) | 20.0% | |
| [-35.4%,75.4%] | 1.0000a | |||
| 12-24 Total* | 43.1% (25/58) | 7.4% (4/54) | 35.7% | |
| [ 21.2%, 50.2%] | 2b was 84.8% in the Treatment arm. Revascularization rates are shown in Table 6. The absolute difference in revascularization at 24 hours was 40.2% demonstrating superiority of Trevo thrombectomy compared to standard of care medical management (p |