Trevo NXT ProVue Retriever

K210502 · Stryker Neurovascular · POL · Aug 27, 2021 · Neurology

Device Facts

• Record ID: K210502
• Device Name: Trevo NXT ProVue Retriever
• Applicant: Stryker Neurovascular
• Product Code: POL · Neurology
• Decision Date: Aug 27, 2021
• 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 (0-50cc 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.

Device Story

Trevo NXT ProVue Retriever is a neurovascular mechanical thrombectomy device. Input: fluoroscopic visualization of device within neurovasculature. Operation: device delivered via microcatheter to thrombus site; microcatheter retracted to deploy shaped section; aspiration catheter advanced over retriever while applying aspiration (syringe/pump); retriever, thrombus, and catheter removed as unit. Used in clinical/interventional settings by physicians. Output: restored blood flow (recanalization). Benefit: reduced disability in acute ischemic stroke patients.

Clinical Evidence

No new clinical trials performed. Evidence includes real-world data (RWD) from administrative claims, Trevo Retriever Registry, and ASSIST Registry. Regression analysis showed equivalence in functional outcomes (OR 0.72; 95% CI: 0.44-1.17) and safety endpoints when using smaller vs. larger aspiration catheters. Registry data confirmed revascularization rates and clinical outcomes (90-day mRS) were equivalent within a ±5% margin.

Technological Characteristics

Core wire: Nitinol; Shaped section: Nitinol; Distal/Radiopaque coils: Platinum/Tungsten; Mid coil: 304 Stainless Steel; Proximal coil: Pebax; Solder: Gold/Tin. Hydrophilic coating: Sodium hyaluronate mixture. Sterilization: 100% EtO. Single-use. Dimensions: 200cm length, 3-6mm diameter. No software/algorithm.

Indications for Use

Indicated for patients with acute ischemic stroke, persistent proximal anterior circulation large vessel occlusion, and smaller core infarcts. Candidates include those ineligible for or failing IV t-PA therapy. Treatment window: 0-6 hours (with IV t-PA), 0-8 hours (ineligible/failed IV t-PA), or 6-24 hours (ICA/MCA-M1 occlusion, specific core infarct volumes based on age).

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 NXT ProVue Retriever (K203219)

Submission Summary (Full Text)

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August 27, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Stryker Neurovascular Rebecca Rosman Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

### Re: K210502

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: July 22, 2021 Received: July 26, 2021

Dear Rebecca Rosman:

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, Ph.D. 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) K210502

Device Name Trevo NXTTM 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)-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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> </span> </div> |
|----------------------------------------------|-----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> </span> </div> |

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### 510(k) Summary K210502

# 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: | Ashley Twitty<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

August 23, 2021

Device Name and Classification:

Date Prepared:

| Trade/Proprietary Name: | Trevo NXTTM 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, 21CFR 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 NXT™ ProVue<br>Retriever | Stryker<br>Neurovascular | K203219 |

#### 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 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

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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 NXT ProVue Retriever with the modified IFU is substantially equivalent to the Predicate device, Trevo NXT ProVue Retriever (K203219) based on the same indications for use, device design, materials, manufacturing, packaging and sterilization methods. A comparison of the Subject device with the Predicate device is summarized in Table 1 below.

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

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

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| Feature | Predicate Device<br>Trevo NXT ProVue Retriever | Subject Device<br>Trevo NXT ProVue Retriever | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | pulled back to capture the thrombus. The<br>Retriever, thrombus, and Microcatheter or<br>Aspiration Catheter are removed as a unit<br>from the body. | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Procedural<br>Steps<br>Aspiration<br>Source | Syringe, Aspiration pump | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Accessory<br>Devices | Insertion tool and torque device provided<br>within product package | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sizes | 3x32mm<br>4x28mm<br>4x41mm<br>6x37mm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Compatibility | Retriever<br>Size Trevo Pro14<br>Microcatheter<br>Inner Diameter<br>0.017 inches<br>(0.43 mm) Trevo Trak 21<br>Microcatheter<br>Inner Diameter<br>0.021 inches<br>(0.53 mm) Trevo Pro18<br>Microcatheter<br>Inner Diameter<br>0.021 inches<br>(0.53 mm) Excelsior®<br>XT-27®<br>Microcatheter<br>(REF XT275081)<br>Inner diameter<br>0.027 inches<br>(0.69 mm) Recommended<br>Minimum<br>Vessel ID (mm) Trevo NXT<br>3x32 ✓ ✓ ✓ ✓ Trevo NXT<br>4x28 ✓ ✓ ✓ 2.5 Trevo NXT<br>4x41 ✓ ✓ ✓ ✓ Trevo NXT<br>6x37 ✓ ✓ ✓ Compatibility of the Retriever with other<br>microcatheters has not been established.<br>Performance of<br>the Retriever device may be impacted if a<br>different microcatheter is used.<br><br>Balloon Guide Catheters and Aspiration<br>Catheters (commercially available<br>aspiration catheters with minimum inner<br>diameter 0.058 inches (1.47mm)) are<br>recommended for use during thrombus<br>removal procedures. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Retriever<br>Size Trevo Pro14<br>Microcatheter<br>Inner Diameter<br>0.017 inches<br>(0.43 mm) Trevo Trak 21<br>Microcatheter<br>Inner Diameter<br>0.021 inches<br>(0.53 mm) Trevo Pro18<br>Microcatheter<br>Inner Diameter<br>0.021 inches<br>(0.53 mm) Excelsior®<br>XT-27®<br>Microcatheter<br>(REF XT275081)<br>Inner diameter<br>0.027 inches<br>(0.69 mm) Recommended<br>Minimum<br>Vessel ID (mm) Trevo NXT<br>3x32 ✓ ✓ ✓ ✓ Trevo NXT<br>4x28 ✓ ✓ ✓ 2.5 Trevo NXT<br>4x41 ✓ ✓ ✓ ✓ Trevo NXT<br>6x37 ✓ ✓ ✓ Compatibility of the Retriever with other<br>microcatheters has not been established.<br>Performance of<br>the Retriever device may be impacted if a<br>different microcatheter is used.<br><br>Balloon Guide Catheters and Aspiration<br>Catheters (commercially available<br>aspiration catheters with minimum inner<br>diameter 0.046 inches (1.17mm)) are<br>recommended for use during thrombus<br>removal procedures. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| MATERIALS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Core Wire | Nitinol (nickel titanium alloy) | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section | Nitinol | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Distal Coil | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section<br>Radiopaque<br>Wire | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Mid Coil | 304 Stainless Steel | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Proximal Coil | Pebax | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Solder | Gold/Tin | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Feature | Predicate Device<br>Trevo NXT ProVue Retriever | Subject Device<br>Trevo NXT ProVue Retriever |
|---------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------|
| Hydrophilic<br>Coating | Sodium hyaluronate mixture | Same |
| DIMENSIONAL DRAWING | | |
| Dimensional<br>Drawing | All Retriever sizes:<br>Image: Dimensional Drawing with labels A, B, C, D, E, and F | All Retriever sizes:<br>Same |
| Overall Length<br>(A) | 200cm | Same |
| Total Shaped<br>Section Length<br>(B) | 32, 36, 40, 44mm | Same |
| Full Diameter<br>Length (C) | 21, 25, 30, 35mm | Same |
| Shaped Section<br>Diameter (D) | 3, 4, 6mm | Same |
| Delivery Core<br>Wire Outer<br>Diameter (E) | 0.015, 0.019" | Same |
| Cell Coverage<br>Length (F) | 28, 32, 37, 41mm | Same |
| PACKAGING | | |
| Materials and<br>Configuration | Polyethylene Hoop, polycarbonate mounting<br>card, Tyvek/Film Pouch, Chipboard carton | Same |
| Sterilization<br>Method | 100% EtO | Same |
| How Supplied | Sterile/Single Use | Same |

The differences between the devices are not critical as demonstrated above and through the testing referenced below.

#### Risk Assessment

Risk assessment of the Trevo NXT ProVue Retriever has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined that the labeling changes to the Trevo NXT ProVue Retriever raise no new questions of safety or effectiveness. Results of testing are appropriate for determining that the Trevo NXT ProVue Retriever with the modified IFU is substantially equivalent to the legally marketed Predicate device.

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# Testing Summary

There are no changes to the device intended use or indications for use statement. Other than the proposed labeling changes regarding compatibility, there are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the Predicate device (K203219) are directly applicable. Relevant testing data supporting the Subject device are summarized as follows.

### Performance Data – Bench Testing

Stryker Neurovascular performed the following non-clinical bench test to assess the usability of the Trevo Retriever with 0.046 in. ID aspiration catheters. The additional bench testing is summarized in Table 2 below.

| Test | Test Method Summary | Conclusions |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Simulated Use | Simulated Use testing utilized a<br>neurovascular model to assess the<br>device's ability to retrieve the clot and<br>achieve recanalization. | Simulated Use testing<br>met acceptance criteria. |
| Particulate<br>Characterization | Purpose: The purpose of this test was to<br>document and assess the particulate<br>matter generated from the delivery of<br>neuro-interventional devices (including<br>the Trevo NXT ProVue Retriever)<br>through the inner lumen of the AXS<br>Vecta 46 Intermediate Catheter.<br><br>Method: Particulate testing was<br>conducted with AXS Vecta 46 and Trevo<br>NXT ProVue Retriever in a simulated<br>use condition based on the device IFU<br>and a clinically relevant tortuous model. | All test samples met the<br>applicable user needs<br>and acceptance criteria. |

Table 2. Performance Data - Design Verification Bench Testing

Performance Data – Animal

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To support the labeling modification, Stryker Neurovascular leveraged data from an animal study that was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate vascular trauma, recanalization and/or distal emboli of the proposed devices for performing a combined neurothrombectomy procedure.

## Performance Data – Clinical

To support the labeling modifications, Stryker Neurovascular conducted analyses of Real-World Data (RWD) from an administrative claims database, post-market registries (The Trevo Retriever Registry and The ASSIST Registry), as well as a review of relevant literature to assess safety and effectiveness of the recommended use of the Trevo with aspiration catheters with a minimum inner diameter (ID) of 0.046in (1.17mm).

Regression analysis of RWD indicated that using Trevo with smaller aspiration catheters is equivalent to using Trevo with larger aspiration catheters with similar odds of good functional outcome (0.72; 95% CI: 0.44-1.17) and similar odds for multiple safety endpoints. Further analysis of registry data confirmed equivalence of revascularization rates and clinical outcomes independent of catheter size with the 90% CI for the difference in means of the severity adjusted posterior probabilities for eTICI>2c to be from 0.003 to 0.009 (.30% to 0.90%). For 90-day MRS, the CI was from -0.050 to 0.042 (-5.0% to 4.2%). In both cases, the upper and lower bounds of the intervals were within the equivalence margin of ±5%.

#### Shelf Life Testing

Shelf life testing previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the changes to the device and can be found in K192207. Shelf life testing was not performed on the Subject device since there was no impact to device material, design, or safety and efficacy as a result of the labeling changes. As with the Predicate device, the Subject device is labeled with a 2-year shelf life.

# Sterilization

Sterilization evaluation previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device and can be found in K192207. The Trevo

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NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide and provided sterility assurance level (SAL) of 10 6 has been demonstrated. The Trevo NXT ProVue Retrievers meet EO residuals per EN ISO 10993-7 for limited contacting, externally communicated devices. The Trevo NXT ProVue Retrievers are for single use only.

# Biocompatibilitv

Biocompatibility testing previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device and can be found in K192207. The results of biocompatibility testing, and biological safety evaluation of the Trevo NXT ProVue Retrievers demonstrate that the devices meet biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours. The Trevo NXT ProVue Retrievers are considered to have no residual risk of biological hazards. Also, the devices and its packaging do not contain detectable latex. Therefore, the Trevo NXT ProVue Retriever devices, accessories, and primary packaging are considered biocompatible for their intended use.

# Conclusion

Based on the conclusions drawn from risk assessment, bench testing results, Real World Data from an Administrative Claims, and an analysis of relevant clinical literature summarized above, the Subject device demonstrates substantial equivalence to the legally marketed Predicate device (K203219).