Trevo NXT ProVue Retriever

K192207 · Stryker · POL · Nov 22, 2019 · Neurology

Device Facts

• Record ID: K192207
• Device Name: Trevo NXT ProVue Retriever
• Applicant: Stryker
• Product Code: POL · Neurology
• Decision Date: Nov 22, 2019
• 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

Trevo NXT ProVue Retriever is a neurovascular mechanical thrombectomy device used to restore blood flow by removing thrombi in acute ischemic stroke patients. The device consists of a flexible, tapered core wire with a radiopaque, shaped distal section and platinum markers for fluoroscopic visualization. It is delivered to the thrombus site via a microcatheter. Once positioned, the microcatheter is retracted to deploy the shaped section, which captures the thrombus. The device, along with the microcatheter or an aspiration catheter (using a syringe or pump), is then withdrawn from the body as a unit. Used in clinical settings by trained physicians, the device provides visual feedback via fluoroscopy to guide retrieval. By removing the occluding thrombus, the device aims to restore cerebral perfusion, potentially reducing patient disability. The device is single-use and sterile.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence is supported by bench testing, including dimensional verification, kink resistance, tip flexibility, radial force, corrosion resistance, particulate characterization, coating integrity, ISO fracture/flexure testing, and simulated-use validation in tortuous anatomical models.

Technological Characteristics

Materials: Nitinol core wire/shaped section, Platinum/Tungsten distal coil/markers, 304 Stainless Steel mid-coil, Pebax proximal coil. Features: Hydrophilic coating (sodium hyaluronate mixture), torque device, insertion tool. Connectivity: None. Sterilization: 100% Ethylene Oxide. Form factor: Flexible tapered wire with shaped distal section. Software: None.

Indications for Use

Indicated for patients with acute ischemic stroke, including those with persistent proximal anterior circulation large vessel occlusion and smaller core infarcts. Candidates include patients who have received IV t-PA, are ineligible for IV t-PA, or have failed IV t-PA therapy. Treatment window is within 6-24 hours of symptom onset depending on clinical criteria.

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)

Reference Devices

• AXS Catalyst Distal Access Catheter (K173841)
• AXS Catalyst 7 Distal Access Catheter (K183464)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 22, 2019

Stryker Neurovascular Rhoda Santos Senior Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

### Re: K192207

Trade/Device Name: 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 22, 2019 Received: October 23, 2019

Dear Rhoda 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. 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

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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) 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 (OS) 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,

# Xiaolin Zheng -S

Xiaolin Zheng, Ph.D., M.S. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192207

Device Name 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 artely (ICA) or middle cerebral artely (MCA)-Ml 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.

| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Type of Use (Select one or both, as applicable) | |

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# 510(k) Summary K192207

| Trade Name:<br>Common Name:<br>Classification Name: | Trevo NXT ProVue Retriever<br>Trevo Retriever<br>- Neurovascular Mechanical Thrombectomy Device for Acute<br>Ischemic Stroke Treatment, 21 CFR 882.5600, Class II<br>- Percutaneous Catheter, 21CFR 870.1250, Class II |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | POL, NRY |
| Submitter: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538<br>Tel [phone]<br>Fax [phone]<br>Facility Registration #3008853977 |
| Contact: | Rhoda M. Santos<br>Senior Principal Regulatory Affairs Specialist |
| Date Prepared: | October 22, 2019 |
| Primary Predicate Device: | Trevo XP ProVue Retriever (K190779, cleared June 25, 2019) |
| Reference Predicate<br>Device: | AXS Catalyst Distal Access Catheter (K173841 cleared March 18,<br>2018)<br>AXS Catalyst 7 Distal Access Catheter, (K183464 cleared March<br>13, 2019) |

#### 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.

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#### 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 artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc 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.

### 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. Refer to table below for comparison of technological characteristics associated with Subject Device and Primary Predicate Device.

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Neurovascular mechanical thrombectomy device<br>for acute ischemic stroke treatment used in the<br>treatment of acute ischemic stroke to improve<br>clinical outcomes. | Same | NA |
| Indications for Use | 1. The Trevo Retriever is indicated for use to<br>restore blood flow in the neurovasculature by<br>removing thrombus for the treatment of acute<br>ischemic stroke to reduce disability in patients<br>with a persistent, proximal anterior circulation,<br>large vessel occlusion, and smaller core<br>infarcts who have first received intravenous<br>tissue plasminogen activator (IV t-PA).<br>Endovascular therapy with the device should<br>start within 6 hours of symptom onset.<br>2. The Trevo Retriever is intended to restore blood<br>flow in the neurovasculature by removing<br>thrombus in patients experiencing ischemic<br>stroke within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy are candidates for<br>treatment. | Same | NA |
| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
| | 3. The Trevo Retriever is indicated for use to<br>restore blood flow in the neurovasculature by<br>removing thrombus for the treatment of acute<br>ischemic stroke to reduce disability in patients<br>with a persistent, proximal anterior circulation,<br>large vessel occlusion of the internal carotid<br>artery (ICA) or middle cerebral artery (MCA)-<br>M1 segments with smaller core infarcts (0-50cc<br>for age <80 years, 0-20cc for age ≥80 years).<br>Endovascular therapy with the device should<br>start within 6-24 hours of time last seen well in<br>patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy. | | |
| Regulation Number/<br>Name/ Class/<br>Product Code | 21 CFR 882.5600, Neurovascular Mechanical<br>Thrombectomy Device for Acute Ischemic Stroke<br>Treatment, Class II, POL<br>21 CFR 870.1250, Percutaneous Catheter, Class II,<br>NRY | Same | NA |
| Target Population | Patients experiencing acute ischemic stroke | Same | NA |
| Anatomical Sites | Neurovasculature | Same | NA |
| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
| Device Description | The Retriever consists of a flexible, tapered core<br>wire with a shaped section at the distal end.<br>Platinum markers at the distal end allow<br>fluoroscopic visualization. In addition, the shaped<br>section is also radiopaque. Retriever dimensions<br>are indicated on product label. The Retriever has a<br>hydrophilic coating to reduce friction during use.<br>The Retriever has a shaft marker to indicate<br>proximity of Retriever tip relative to Microcatheter<br>tip. A torque device is provided with the Retriever<br>to facilitate manipulation. The torque device is<br>used to lock the core wire to the microcatheter<br>during the procedure. Locking of the torque device<br>to the wire allows the microcatheter and Retriever<br>to be retracted as a system during clot retrieval. An<br>insertion tool is provided to introduce the Retriever<br>into a Microcatheter. The Insertion Tool is a sheath<br>in which the Retriever comes preloaded. Once half<br>the retriever's length is inserted into the<br>microcatheter, the insertion tool is removed.<br>Retrievers have a modified proximal end that<br>permits attachment of the Abbott Vascular DOC<br>Guide Wire Extension (REF 22260). Joining Guide<br>Wire Extension to Retriever facilitates removal or<br>exchange of a catheter while maintaining Retriever<br>position in anatomy. After exchange has been<br>completed, the extension can be detached. | The Retriever consists of a flexible, tapered core<br>wire with a shaped section at the distal end.<br>Platinum markers at the distal end allow<br>fluoroscopic visualization. In addition, the shaped<br>section is also radiopaque. Retriever dimensions<br>are indicated on product label. The Retriever<br>delivery wire has a hydrophilic coating on the<br>distal 101cm to reduce friction during use. The<br>Retriever has a shaft marker to indicate proximity<br>of Retriever tip relative to Microcatheter tip. A<br>torque device is provided with the Retriever to<br>facilitate manipulation and retrieval. The Retriever<br>comes preloaded in an insertion tool to introduce<br>the Retriever into a Microcatheter. | Yes.<br>Revised for clarity<br>and brevity for<br>description of torque<br>device usage. Also<br>identifies length of<br>hydrophilic coating.<br>Reference to Abbott<br>Vascular DOC<br>Guide Wire<br>Extension (REF<br>22260) has been<br>deleted as this<br>feature has been<br>removed as part of<br>the modifications<br>for the Trevo NXT<br>ProVue Retriever. |
| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
| Principle of<br>Operation | The Trevo Retriever is delivered to the thrombus<br>using a microcatheter. The Microcatheter is then<br>retracted to deploy the shaped section of the<br>Retriever. If using an Aspiration Catheter, remove<br>Microcatheter. Advance Aspiration Catheter over<br>proximal section of Retriever while applying<br>aspiration using a 60 mL syringe or an aspiration<br>pump. The Retriever with Microcatheter or<br>Aspiration Catheter are pulled back to capture the<br>thrombus. The Retriever, thrombus, and<br>Microcatheter or Aspiration Catheter are removed<br>as a unit from the body. | Same | NA |
| Procedural Steps<br>Aspiration Source | Syringe, Aspiration pump | Same | NA |
| Sizes | 3x20mm<br>4x20mm<br>4x30mm<br>6x25mm | 3x25mm<br>4x21mm<br>4x35mm<br>6x30mm | Yes.<br><br>Modification based<br>on customer<br>preference.<br><br>As there are no<br>changes to the actual<br>design of the shaped<br>section, safety and<br>effectiveness of the<br>device is unaffected. |
| Accessory Devices | Insertion tool and torque device provided within<br>product package | Same | NA |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | | | | | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | | | | | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? | |
|-----------------------------------|-----------------------------------------------------------------|------------------------------|------------------------------|----------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|------------------------------|---------------------------------|------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Compatibility | Retriever Size | Trevo Pro14<br>Microcatheter | Trevo Pro18<br>Microcatheter | Excelsior® XT-27®<br>(150cm x 6cm<br>straight REF<br>XT275081) | Recommended<br>Minimum<br>Vessel ID (mm) | Retriever Size | Trevo Pro14<br>Microcatheter | Trevo Trak 21<br>Microcatheter* | Trevo Pro18<br>Microcatheter | Excelsior® XT-27<br>(REF XT275081)<br>Microcatheter | Recommended<br>Minimum<br>Vessel ID (mm) | Yes.<br>Trevo Trak 21<br>Microcatheter is<br>currently pending<br>FDA review under<br>K192122. |
| | Trevo XP ProVue<br>3X20mm | √ | √ | | | Trevo<br>NXT 3x25 | √ | √ | √ | √ | | |
| | Trevo XP ProVue<br>4X20mm | √ | √ | | | Trevo<br>NXT 4x21 | | √ | √ | √ | | |
| | Trevo ProVue<br>4X20mm | | √ | | 2.5 | Trevo<br>NXT 4x35 | | √ | √ | √ | 2.5 | |
| | Trevo XP ProVue<br>4X30mm | √ | √ | √ | | Trevo<br>NXT 6x30 | √ | √ | | √ | | |
| | Trevo XP ProVue<br>6X25mm | | | √ | | | | | | | | |
| Materials | | | | | | | | | | | | |
| Core Wire | Nitinol (nickel titanium alloy) | | | | | Same | | | | | NA | |
| Shaped Section | Nitinol | | | | | Same | | | | | NA | |
| Distal Coil | Platinum/Tungsten | | | | | Same | | | | | NA | |
| Shaped Section<br>Radiopaque Wire | Platinum/Tungsten | | | | | Same | | | | | NA | |
| Mid Coil | 304 Stainless Steel | | | | | Same | | | | | NA | |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
|-------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proximal Coil /<br>Proximal Support /<br>Length | 304 Stainless Steel | Pebax | Yes.<br>Biocompatibility<br>and bench testing<br>has demonstrated<br>that the change in<br>the proximal coil<br>material does not<br>affect the safety and<br>performance of the<br>device. |
| Solder | Gold/Tin | Same | NA |
| Hydrophilic Coating | Sodium hyaluronate mixture | Same except with updated formulation | Yes.<br>Biocompatibility<br>and bench testing<br>has demonstrated<br>that the change in<br>the hydrophilic<br>coating formulation<br>does not affect the<br>safety and<br>performance of the<br>device. |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensional<br>Drawing | 3x20, 4x20mm Retriever sizes:<br>Image: Dimensional drawing of 3x20, 4x20mm Retriever sizes<br><br>4x30, 6x25mm Retriever sizes:<br>Image: Dimensional drawing of 4x30, 6x25mm Retriever sizes | All Retriever sizes:<br>Image: Dimensional drawing of All Retriever sizes | Yes.<br>Modification based<br>on customer<br>preference.<br>As there are no<br>changes to the<br>actual design of the<br>shaped section,<br>safety and<br>effectiveness of the<br>device is<br>unaffected. |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
|------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overall Length | 180, 190cm | 200cm | Yes.<br>Increased length of<br>the delivery core<br>wire allows for<br>compatibility with<br>longer devices.<br>Bench testing has<br>demonstrated that<br>the change in the<br>delivery core wire<br>length does not<br>affect the safety and<br>effectiveness of the<br>device. |
| Total Shaped Section<br>Length (nominal) | 32, 36, 40, 44mm | Same | NA |
| Active Shaped<br>Section Length | 20, 25, 30mm | Same | NA |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially Equivalent to<br>Predicate Device(s)? | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Full Diameter Length<br>(nominal) | 4x30, 6x25mm Retriever sizes:<br>Retriever Size (mm) Dimension C (mm) 3x20 NA 4x20 NA 4x30 35 6x25 30 | | | | | | | | | | | All Retriever sizes:<br>Retriever Size (mm) Dimension C (mm) 3x25 25 4x21 21 4x35 Same 6x30 Same | | | | | | | | | | | Yes.<br>Labeling changes to replace the Active Shaped Section Length with Full Diameter Length is based on customer preference.<br>As there are no changes to the actual design of the shaped section, safety and effectiveness of the device is unaffected. | | |
| Shaped Section Diameter (nominal) | 3, 4, 6mm | Same | NA | | | | | | | | | | | | | | | | | | | | | | |
| Proximal Core Wire<br>Diameter | Retriever Size (mm) Dimension E (inches) 3x20 0.015 4x20 0.018<br>Retriever Size (mm) Dimension F (inches) 4x30 0.018 6x25 0.018 | | | | | | | | | | | | | Retriever Size (mm) Dimension E (inches) 3x20 0.015 4x20 0.019 4x30 0.019 6x25 0.019 | | | | | | | | | | | Yes.<br>Modification accommodates SNV procedures.<br>As there are no actual changes to the delivery core wire outer diameter, the safety and effectiveness of the device is unaffected. |

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| Feature | Primary Predicate Device<br>Trevo XP ProVue Retriever (K190779) | Subject Device<br>Trevo NXT ProVue Retriever (K192207) | Subject Device<br>Substantially<br>Equivalent to<br>Predicate<br>Device(s)? |
|--------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Materials and<br>Configuration | Polyethylene Hoop, polycarbonate mounting card,<br>Tyvek/Film Pouch, HDPE Tubing Clips,<br>Chipboard carton | Longer Polyethylene Hoop, polycarbonate<br>mounting card, Tyvek/Film Pouch, Chipboard<br>carton | Yes.<br>Hoop was modified<br>to accommodate<br>longer device<br>length, and<br>sterilization<br>validation has been<br>completed. |
| Sterilization Method | 100% EtO | Same | NA |
| How Supplied | Sterile/Single Use | Same | NA |

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#### Performance Data – Non-Clinical

The following performance data were provided in support of the substantial equivalence determination.

#### Performance Testing:

To confirm that the performance of the Subject device, Trevo NXT ProVue Retriever, is substantially equivalent to the performance of the Primary Predicate, device verification and validation testing was conducted on those aspects of the devices that could be affected by the differences between the Primary Predicate device and the Subject device.

#### Validation:

In accordance with FDA's guidance, "Pre-Clinical and Clinical Studies for Neurothrombectomy Devices," issued June 18, 2007, an in vitro Simulated-use study was completed to assess the usability of the subject device, Trevo NXT ProVue Retriever. Users evaluated the device in a simulated use tortuous anatomical model under simulated clinical conditions per the proposed Directions for Use (DFU).

All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations defined in the Trevo NXT ProVue Retriever design validation protocol, when utilized in simulated use tortuous anatomy. There were no additional risks identified by the Users. All Trevo NXT ProVue Retrievers used in testing adequately met the customer needs defined in internal documentation.

#### Leveraged Non-Clinical Data:

Data supporting the performance characteristics that were not impacted by the proposed modifications were leveraged from the Primary Predicate device. Previous data remains valid as there are no changes to the design / geometry of the shaped section associated with the proposed modifications for the Trevo NXT ProVue Retrievers. As there are no changes to the design of the shaped section, the following tests and associated data were leveraged as listed below:

- Dimensional Verification ●
- Retriever Shape Section Radial Force ●
- Retriever Torque/Tensile Durability
- Retriever Mid Joint Tensile Strength ●
- Retriever Tip Tensile Strength
- Retriever Wire Joint Tensile Strength
- . Retriever Wire and Joint Durability
- Simulated Use ●

#### Non-Clinical Data:

#### In accordance with FDA's guidance, "Pre-Clinical and Clinical Studies for

Neurothrombectomy Devices," issued June 18, 2007, additional design verification and validation testing conducted on the Trevo NXT ProVue Retriever demonstrates that it performs as designed and is suitable for its intended use. The test results are appropriate to support a determination of substantial equivalence to the Primary Predicate device.

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| Test | Test Method Summary | Conclusions |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Dimensional<br>Verification | Verified dimensions using specified measurement tool. | Dimensional<br>verification meets<br>acceptance criteria. |
| Retriever Delivery<br>Wire Kink<br>Resistance | Using appropriate simulated use model in 37°C<br>water/saline bath, complete retrieval procedure per IFU<br>for three retrieval attempts. Remove device from the<br>model and inspect delivery core wire for damage.<br>Record results. | Retriever Delivery Wire<br>Kink Resistance meets<br>acceptance criteria. |
| Tip Flexibility | Load sample so that the distal tip will be flexed. Use<br>Instron tensile te…