(57 days)
Not Found
No
The provided text describes a mechanical device for clot retrieval and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke, which directly treats a medical condition.
No
This device, the Trevo Retriever, is a medical device designed for the treatment of acute ischemic stroke by physically removing blood clots (thrombus) to restore blood flow. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components like a core wire, shaped section, platinum markers, hydrophilic coating, shaft marker, and a torque device. This indicates it is a hardware device, not software-only.
Based on the provided information, the Trevo Retriever is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Trevo Retriever's Intended Use: The Trevo Retriever is a medical device used within the body (in vivo) to physically remove blood clots from the neurovasculature. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Device Description: The description details a physical device designed for insertion and manipulation within blood vessels.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze a specimen.
- Anatomical Site: The device operates within the neurovasculature, which is inside the body.
Therefore, the Trevo Retriever is a therapeutic medical device used for the treatment of acute ischemic stroke, not an IVD.
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 patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age = 80 years.
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data – Bench Testing:
Study Type: Bench Testing (Design Verification Testing)
Sample Size: Not explicitly stated for each test, but methods describe testing on devices.
Key Results: All tests demonstrated that the device met acceptance criteria, supporting that it is substantially equivalent to the predicate device.
Tests conducted:
- Insertion Tool Use, Dimensions: Evaluate device integrity after use of insertion tool. Conclusion: Device integrity met acceptance criteria.
- Retriever / Microcatheter Deliverability (Track Test- First Push): To determine the trackability of retriever. Conclusion: Deliverability force met acceptance criteria.
- Retriever In-Vivo Resheathability: Evaluate device integrity after re-sheathing into microcatheter. Conclusion: Device integrity met acceptance criteria.
- Retractability of Retriever into Balloon Guide Catheter: Evaluate device integrity after retracting retriever into Balloon Guide Catheter. Conclusion: Device integrity met acceptance criteria.
- Retriever Shaft Kink Resistance: Evaluate device integrity after tracking through a tortuous anatomy. Conclusion: Device integrity met acceptance criteria.
- Reloadability into Insertion Tool: Evaluate device integrity after reloading retriever into insertion tool. Conclusion: Device integrity met acceptance criteria.
- Retriever Shaped Section Torque/Tensile Durability: To determine durability of shaped section after multiple torque and tensile loading cycles. Conclusion: Torque/tensile durability met acceptance criteria.
- Retriever Proximal Curl Resistance: To determine if curl formation is present after the required revolutions. Conclusion: Curl resistance met acceptance criteria.
- Retriever Mid Joint Tensile Strength: To determine the mid joint tensile strength of a retriever. Conclusion: Mid Joint Tensile met acceptance criteria.
- Retriever platinum wire and joint durability: To determine the durability of platinum wire weaves and solder joints of a retriever. Conclusion: Platinum wire and joint met acceptance criteria.
- Retriever platinum wire joint tensile strength: To determine the platinum wire solder joint tensile strength of a retriever. Conclusion: Platinum wire solder joint met acceptance criteria.
- ISO Fracture: For testing for fracture of endovascular retrievers based on EN ISO 11070:2014, Annex F. Conclusion: Fracture resistance met acceptance criteria.
- ISO Flexure: For testing for resistance of guide wires, delivery wires, or introducer wires to damage by flexing based on EN ISO 11070:2014, Annex G. Conclusion: Flexure resistance met acceptance criteria.
- Retrievability of Retriever with Intermediate Catheter: Evaluate device integrity after retrieval of Retriever with Intermediate Catheter. Conclusion: Device integrity met acceptance criteria.
Animal, Clinical Studies: No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 side of the logo 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.
December 29, 2020
Stryker Neurovascular Kathy Nguyen Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K203219
Trade/Device Name: Trevo XP ProVue Retriever, Trevo NXT ProVue 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: October 30, 2020 Received: November 2, 2020
Dear Kathy Nguyen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203219
Device Name
Trevo XP ProVue Retriever and Trevo NXT ProVue 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 patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Introduction:
According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.
Submitter Name, Address and Content:
| Submitter: | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538-6515
(FDA Registration Number: 3008853977) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy Nguyen
Staff Regulatory Affairs Specialist
Phone: 510-413-2366
Fax: 510-413-2588
Email: Kathy.Nguyen@stryker.com |
| Date Prepared: | December 22, 2020 |
Device Name and Classification:
| Trade/Proprietary Name: | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever |
|---|---|
| Common Name: | Trevo Retriever |
| Classification Name: | Neurovascular Mechanical Thrombectomy Device for Acute Ischemic |
| Stroke Treatment, 21 CFR 882.5600, Class II | |
| Percutaneous Catheter, 21 CFR 870.1250 – Class II | |
| Product Code: | POL, NRY |
4
Legally Marketed Predicate Device
| Name of Predicate Device | Name of
Manufacturer | 510(k)
Number |
|--------------------------------|--------------------------|------------------|
| Trevo XP ProVue
Retriever | Stryker
Neurovascular | K190779 |
| Trevo NXT™ ProVue
Retriever | Stryker
Neurovascular | K200117 |
Device Description
The Trevo 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 delivery wire has a hydrophilic coating on the distal 101cm length 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 and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
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 patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid
5
artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age