Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

K203219 · Stryker Neurovascular · POL · Dec 29, 2020 · Neurology

Device Facts

• Record ID: K203219
• Device Name: Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
• Applicant: Stryker Neurovascular
• Product Code: POL · Neurology
• Decision Date: Dec 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Device Story

Neurovascular mechanical thrombectomy device; consists of flexible, tapered nitinol core wire with shaped distal section; platinum markers for fluoroscopic visualization; hydrophilic coating on distal shaft. Delivered via microcatheter to thrombus site; microcatheter retracted to deploy shaped section; aspiration catheter may be used over retriever; device, thrombus, and catheter removed as a unit. Used in neurointerventional procedures by physicians to restore blood flow in acute ischemic stroke; reduces patient disability. Provided sterile, single-use.

Clinical Evidence

Bench testing only; no clinical or animal studies conducted as fundamental technology and indications remain unchanged.

Technological Characteristics

Nitinol core wire and shaped section; platinum/tungsten distal coil; 304 stainless steel mid/proximal coils; gold/tin solder; sodium hyaluronate hydrophilic coating. Dimensions vary by model. Sterilized via 100% Ethylene Oxide. Single-use, sterile. No software/electronics.

Indications for Use

Indicated for acute ischemic stroke patients with persistent, proximal anterior circulation, large vessel occlusion (ICA or MCA-M1) and smaller core infarcts. Applicable to patients within 6-24 hours of symptom onset, including those ineligible for or failing IV t-PA therapy.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment is subject to the following special controls:

*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.

Predicate Devices

• Trevo XP ProVue Retriever (K190779)
• Trevo NXT ProVue Retriever (K200117)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K203219

#### Device Name

Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever

#### Indications for Use (Describe)

1. 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.

2. 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.

3. 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, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 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<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515<br>(FDA Registration Number: 3008853977) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy Nguyen<br>Staff Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>Stroke Treatment, 21 CFR 882.5600, Class II<br>Percutaneous Catheter, 21 CFR 870.1250 – Class II |
| Product Code: | POL, NRY |

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# Legally Marketed Predicate Device

| Name of Predicate Device | Name of<br>Manufacturer | 510(k)<br>Number |
|--------------------------------|--------------------------|------------------|
| Trevo XP ProVue<br>Retriever | Stryker<br>Neurovascular | K190779 |
| Trevo NXT™ ProVue<br>Retriever | Stryker<br>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

- 1. 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.
- 2. 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.
- 3. 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

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artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

# Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever is substantially equivalent to the Predicate device. Trevo XP Provue Retriever (K190779) and Trevo NXT ProVue Retriever (K20117) based on the same indications for use, device design, materials, manufacturing, packaging and sterilization methods.

# Comparison of Technological Characteristics with the Primary Predicate Device:

The intended use remains as a neurovascular mechanical thrombectomy device for acute ischemic stroke treatment used in the treatment of acute ischemic stroke to improve clinical outcomes. The technological characteristics and principles of operation remain unchanged.

The Subject device is substantially equivalent to the Predicate device cleared under K190779 & K200117 based on the following:

- . Same indications for use
- . Same materials and manufacturing processes
- . Same device design and technology
- . Same biocompatibility information
- . Same materials and processes for packaging
- . Same sterilization method and process for devices

A comparison of the Subject device with the Predicate device is summarized in Table 1 (Trevo XP ProVue Retriever) and Table 2 (Trevo NXT ProVue Retriever) below.

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| Feature | Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo XP ProVue<br>Retriever |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use | Neurovascular mechanical thrombectomy device for acute<br>ischemic stroke treatment used in the treatment of acute ischemic<br>stroke to improve clinical outcomes. | Same |
| Indications for Use | 1. The Trevo Retriever is indicated for use to restore blood flow in<br>the neurovasculature by removing thrombus for the treatment of<br>acute ischemic stroke to reduce disability in patients with a<br>persistent, proximal anterior circulation, large vessel occlusion,<br>and smaller core infarcts who have first received intravenous<br>tissue plasminogen activator (IV t-PA). Endovascular therapy<br>with the device should start within 6 hours of symptom onset.<br>2. The Trevo Retriever is intended to restore blood flow in the<br>neurovasculature by removing thrombus in patients<br>experiencing ischemic stroke within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA therapy are candidates<br>for treatment.<br>3. The Trevo Retriever is indicated for use to restore blood flow in<br>the neurovasculature by removing thrombus for the treatment of<br>acute ischemic stroke to reduce disability in patients with a<br>persistent, proximal anterior circulation, large vessel occlusion<br>of the internal carotid artery (ICA) or middle cerebral artery<br>(MCA)-M1 segments with smaller core infarcts (0-50 cc for<br>age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular<br>therapy with the device should start within 6-24 hours of time<br>last seen well in patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA<br>therapy. | Same |
| Regulation Number/ Name/<br>Class/ Product Code | 21 CFR 882.5600, Neurovascular Mechanical Thrombectomy<br>Device for Acute Ischemic Stroke Treatment, Class II, POL | Same |
| | 21 CFR 870.1250, Percutaneous Catheter, Class II, NRY | |
| Target Population | Patients experiencing acute ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Same |

# Table 1. Product Feature Comparison of Subject Device to Predicate Device

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| Feature | Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo XP ProVue<br>Retriever | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| Device Description | The Retriever consists of a flexible, tapered core wire with a<br>shaped section at the distal end. Platinum markers at the distal end<br>allow fluoroscopic visualization. In addition, the shaped section is<br>also radiopaque. Retriever dimensions are indicated on product<br>label. The Retriever has a hydrophilic coating to reduce friction<br>during use. The Retriever has a shaft marker to indicate proximity<br>of Retriever tip relative to Microcatheter tip. A torque device is<br>provided with the Retriever to facilitate manipulation. The torque<br>device is used to lock the core wire to the microcatheter during the<br>procedure. Locking of the torque device to the wire allows the<br>microcatheter and Retriever to be retracted as a system during clot<br>retrieval. An insertion tool is provided to introduce the Retriever<br>into a Microcatheter. The Insertion Tool is a sheath in which the<br>Retriever comes preloaded. Once half the retriever's length is<br>inserted into the microcatheter, the insertion tool is removed.<br>Retrievers have a modified proximal end that permits attachment<br>of the Abbott Vascular DOC Guide Wire Extension (REF 22260).<br>Joining Guide Wire Extension to Retriever facilitates removal or<br>exchange of a catheter while maintaining Retriever position in<br>anatomy. After exchange has been completed, the extension can<br>be detached. | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Principle of Operation | The Trevo Retriever is delivered to the thrombus using a<br>microcatheter. The Microcatheter is then retracted to deploy the<br>shaped section of the Retriever. If using an Aspiration Catheter,<br>remove Microcatheter. Advance Aspiration Catheter over<br>proximal section of Retriever while applying aspiration using a 60<br>mL syringe or an aspiration pump. The Retriever with<br>Microcatheter or Aspiration Catheter are pulled back to capture<br>the thrombus. The Retriever, thrombus, and Microcatheter or<br>Aspiration Catheter are removed as a unit from the body. | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Procedural Steps<br>Aspiration Source | Syringe, Aspiration pump | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sizes | 3x20mm<br>4x20mm<br>4x30mm<br>6x25mm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Accessory Devices | Insertion tool and torque device provided within product package | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Compatibility | Retriever Size Trevo Pro14 Microcatheter Trevo Pro18 Microcatheter Excelsior® XT-27 Microcatheters (150cm x 6cm straight REF XT275081 Recommended Minimum Vessel ID (mm) Trevo XP ProVue V V Trevo XP ProVue V Trevo ProVue 4X20mm V 2.5 Trevo XP ProVue 4X30mm V V Trevo XP ProVue 6X25mm V | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Same |
| Core Wire | Nitinol (nickel titanium alloy) | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Feature | Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo XP ProVue<br>Retriever | | | | | | | | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--|--|--|--|--|--|--|--|------|
| Shaped Section | Nitinol | Same | | | | | | | | | | |
| Distal Coil | Platinum/Tungsten | Same | | | | | | | | | | |
| Shaped Section<br>Radiopaque Wire | Platinum/Tungsten | Same | | | | | | | | | | |
| Outer Jacket | Not applicable. | Not applicable. | | | | | | | | | | |
| Mid Coil | 304 Stainless Steel | Same | | | | | | | | | | |
| Proximal Coil / Proximal<br>Support / Length | 304 Stainless Steel | Same | | | | | | | | | | |
| Solder | Gold/Tin | Same | | | | | | | | | | |
| Hydrophilic Coating | Sodium hyaluronate mixture, L578 formulation | Same | | | | | | | | | | |
| Dimensional Drawing | 3x20, 4x20mm Retriever sizes:<br>Image: [Diagram of 3x20, 4x20mm Retriever]<br><br>4x30, 6x25mm Retriever sizes:<br>Image: [Diagram of 4x30, 6x25mm Retriever] | Same | | | | | | | | | | |
| Core Wire Dimension | Flatten Thickness<br>0.0030" +/- 0.0003" | Flatten Thickness<br>0.0040" +/- 0.0003" | | | | | | | | | | |
| Overall Length (A) | 180, 190cm | Same | | | | | | | | | | |
| Total Shaped Section<br>Length (nominal) (B) | 32, 36, 40, 44mm | Same | | | | | | | | | | |
| Full Diameter Length<br>(C) 4x30 & 6x25 | 20, 25, 30mm | Same | | | | | | | | | | |
| Active Shaped Section<br>Length<br>(C) 3x20 & 4x20<br>(D) 4x30 & 6x25 | Retriever Size (mm) Dimension C (mm) 3x20 NA 4x20 NA 4x30 35 6x25 30 | | | | | | | | | | | Same |
| Shaped Section Diameter<br>(nominal)<br>(D) 3x20 & 4x20 | 3, 4, 6mm | Same | | | | | | | | | | |

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| Feature | Predicate Device<br>Trevo XP ProVue Retriever (K190779) | | Subject Device<br>Trevo XP ProVue<br>Retriever | | | | |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--|------------------------------------------------|---------------------------------------|--|--|------|
| Proximal Core Wire<br>Diameter<br>(E) 3x20 & 4x20<br>(F) 4x30 & 6x25 | Retriever Size<br>(mm) 3x20 4x20 | | | Dimension E<br>(inches) 0.015 0.018 | | | Same |
| | Retriever Size<br>(mm) 4x30 6x25 | | | Dimension F<br>(inches) 0.018 0.018 | | | |
| Materials and<br>Configuration | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film<br>Pouch, HDPE Tubing Clips, Chipboard carton | | Same | | | | |
| Sterilization Method | 100% EtO | | Same | | | | |
| How Supplied | Sterile/Single Use | | Same | | | | |

# Table 2. Product Feature Comparison of Subject Device to Predicate Device

| Feature | Predicate Device<br>Trevo NXT ProVue Retriever (K200117) | Subject Device<br>Trevo NXT ProVue<br>Retriever |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Regulation Number | • 21 CFR 882.5600<br>• 21 CFR 870.1250 | Same |
| Regulation Name | • Neurovascular Mechanical Thrombectomy Device for<br>Acute Ischemic Stroke Treatment<br>• Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | • POL<br>• NRY | Same |
| Intended Use | Neurovascular mechanical thrombectomy device for acute<br>ischemic stroke treatment used in the treatment of acute<br>ischemic stroke to improve clinical outcomes. | Same |
| Indications for Use | 1. The Trevo Retriever is indicated for use to restore<br>blood flow in the neurovasculature by removing thrombus<br>for the treatment of acute ischemic stroke to reduce<br>disability in patients with a persistent, proximal anterior<br>circulation, large vessel occlusion, and smaller core<br>infarcts who have first received intravenous tissue<br>plasminogen activator (IV t-PA). Endovascular therapy<br>with the device should start within 6 hours of symptom<br>onset.<br><br>2. The Trevo Retriever is intended to restore blood<br>flow in the neurovasculature by removing thrombus in<br>patients experiencing ischemic stroke within 8 hours of<br>symptom onset. Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA<br>therapy are candidates for treatment.<br><br>3. The Trevo Retriever is indicated for use to restore<br>blood flow in the neurovasculature by removing thrombus | Same |
| Feature | Predicate Device<br>Trevo NXT ProVue Retriever (K200117) | Subject Device<br>Trevo NXT ProVue<br>Retriever |
| | for the treatment of acute ischemic stroke to reduce<br>disability in patients with a persistent, proximal anterior<br>circulation, large vessel occlusion of the internal carotid<br>artery (ICA) or middle cerebral artery (MCA)-M1<br>segments with smaller core infarcts (0-50 cc for age < 80<br>years, 0-20 cc for age ≥ 80 years). Endovascular therapy<br>with the device should start within 6-24 hours of time last<br>seen well in patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA<br>therapy. | |
| Target Population | Patients experiencing acute ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Same |
| TECHNOLOGICAL CHARACTERISTICS | | |
| Device Description | The Retriever consists of a flexible, tapered core wire with<br>a shaped section at the distal end. Platinum markers at the<br>distal end allow fluoroscopic visualization. In addition, the<br>shaped section is also radiopaque. Retriever dimensions are<br>indicated on product label. The Retriever delivery wire has<br>a hydrophilic coating on the distal 101cm to reduce friction<br>during use. The Retriever has a shaft marker to indicate<br>proximity of Retriever tip relative to Microcatheter tip. A<br>torque device is provided with the Retriever to facilitate<br>manipulation and retrieval. The Retriever comes preloaded<br>in an insertion tool to introduce the Retriever into a<br>Microcatheter. | Same |
| Principle of Operation | The Trevo Retriever is delivered to the thrombus using a<br>microcatheter. The Microcatheter is then retracted to<br>deploy the shaped section of the Retriever. If using an<br>Aspiration Catheter, remove Microcatheter. Advance<br>Aspiration Catheter over proximal section of Retriever<br>while applying aspiration using a 60 mL syringe or an<br>aspiration pump. The Retriever with Microcatheter or<br>Aspiration Catheter are pulled back to capture the<br>thrombus. The Retriever, thrombus, and Microcatheter or<br>Aspiration Catheter are removed as a unit from the body. | Same |
| Procedural Steps<br>Aspiration Source | Syringe, Aspiration pump | Same |
| Accessory Devices | Insertion tool and torque device provided within product<br>package | Same |
| Sizes | 3x32mm<br>4x28mm<br>4x41mm<br>6x37mm | Same |

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| Feature | Predicate Device<br>Trevo NXT ProVue Retriever (K200117) | Subject Device<br>Trevo NXT ProVue Retriever | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| Compatibility | Retriever Size Trevo Pro14 Microcatheter Trevo Trak 21 Microcatheter* Trevo Pro18 Microcatheter Excelsior® XT-27 Microcatheter (REF XT275081) Recommended Minimum Vessel ID (mm) Trevo NXT 3x32 √ √ √ √ Trevo NXT 4x28 √ √ √ Trevo NXT 4x41 √ √ √ 2.5 Trevo NXT 6x37 √ √ √<br>Balloon Guide Catheters and Aspiration Catheters<br>(commercially available aspiration catheters with minimum<br>inner diameter 0.058 inches (1.47mm)) are recommended<br>for use during thrombus removal procedures. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Same |
| MATERIALS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Core Wire | Nitinol (nickel titanium alloy) | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section | Nitinol | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Distal Coil | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section<br>Radiopaque Wire | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Mid Coil | 304 Stainless Steel | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Proximal Coil | Pebax | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Solder | Gold/Tin | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hydrophilic Coating | Sodium hyaluronate mixture, T070 formulation | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| DIMENSIONS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Dimensional Drawing | All Retriever sizes:<br>Image: Dimensional Drawing | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Core Wire Dimensions | Flatten Thickness<br>$0.0030" +/- 0.0003"$ | Flatten Thickness<br>$0.0040" +/- 0.0003"$ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Overall Length (A) | 200cm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total Shaped Section | 32, 36, 40, 44mm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Feature | Predicate Device Trevo NXT ProVue Retriever (K200117) | Subject Device Trevo NXT ProVue Retriever |
|---------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------|
| Full Diameter Length (C) | 21, 25, 30, 35mm | Same |
| Shaped Section Diameter (D) | 3, 4, 6mm | Same |
| Delivery Core Wire Outer Diameter (E) | 0.015, 0.019" | Same |
| Cell Coverage Length (F) | 28, 32, 37, 41mm | Same |
| PACKAGING | | |
| Materials and Configuration | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, Chipboard carton | Same |
| Sterilization Method | 100% EtO…