Trevo NXT ProVue Retriever

K223305 · Stryker Neurovascular · POL · Mar 29, 2023 · Neurology

Device Facts

• Record ID: K223305
• Device Name: Trevo NXT ProVue Retriever
• Applicant: Stryker Neurovascular
• Product Code: POL · Neurology
• Decision Date: Mar 29, 2023
• 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 used to restore blood flow in acute ischemic stroke patients. Device consists of a flexible, tapered nitinol core wire with a shaped distal section and platinum/tungsten markers for fluoroscopic visualization. Operated by physicians in a clinical setting, the device is delivered to the thrombus site via a microcatheter. Once deployed, the retriever is used in conjunction with an aspiration catheter (connected to a syringe or pump) to capture and remove the thrombus as a single unit. The device features a hydrophilic coating to reduce friction and a torque device for manipulation. By removing the occlusion, the device aims to restore cerebral perfusion, potentially reducing patient disability. The subject device is identical in design, materials, and operation to the predicate, with updated labeling regarding compatibility with smaller vessel diameters (1.5 mm).

Clinical Evidence

Retrospective subgroup analysis of The ASSIST Registry data. Evaluated performance of 3 mm and 4 mm models in vessels with diameters of 1.5 to 2.5 mm compared to vessels ≥ 2.5 mm. Results demonstrated a similar performance and safety profile for the smaller vessel diameter range.

Technological Characteristics

Nitinol core wire and shaped section; platinum/tungsten distal coil and radiopaque wire; 304 stainless steel mid-coil; Pebax proximal coil; gold/tin solder; sodium hyaluronate hydrophilic coating. Dimensions: 200 cm length, 3-6 mm shaped section diameter. Sterilization: 100% Ethylene Oxide (EtO). Single-use, sterile.

Indications for Use

Indicated for patients with acute ischemic stroke, including those with persistent, proximal anterior circulation, large vessel occlusion (ICA or MCA-M1 segments) and smaller core infarcts. Applicable to patients within 6-24 hours of symptom onset/last seen well, 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 NXT ProVue Retriever (K210502)

Submission Summary (Full Text)

{0}------------------------------------------------

March 29, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Stryker Neurovascular Heli Chambi Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

## Re: K223305

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: February 21, 2023 Received: February 23, 2023

Dear Heli Chambi:

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

{1}------------------------------------------------

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,

# Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K223305

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 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> <line stroke="black" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510(k) Summary K223305

## 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 Contact:

| Submitter: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515<br>(FDA Registration Number: 3008853977) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Heli Chambi<br>Staff Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 29, 2023 |

Device Name and Classification:

| Trade/Proprietary Name: | 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>Catheter, Thrombus Retriever, 21 CFR 870.1250 – Class II |
| Product Code: | POL, NRY |

## Legally Marketed Predicate Device

| Name of Predicate Device | Name of<br>Manufacturer | 510(k)<br>Number |
|-------------------------------|--------------------------|------------------|
| Trevo NXT ProVue<br>Retriever | Stryker<br>Neurovascular | K210502 |

{4}------------------------------------------------

## 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 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.

{5}------------------------------------------------

## Technological Characteristics and Product Feature Comparison

There are no differences in the technological characteristics between the subject device and predicate device because they both have the same indications for use, device design, materials, manufacturing, packaging, and sterilization methods. The changes made to the subject device are solely labeling changes to update compatibility information in the Instructions for Use (IFU).

The differences between the subject and predicate devices are summarized in Table 1 below.

| Feature | Predicate Device | Subject Device |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever |
| Regulation Number | 21 CFR 882.5600 21 CFR 870.1250 | Same |
| Regulation 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 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><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 (IV | Same |
| Feature | Predicate Device | Subject Device |
| | Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever |
| | t-PA) or who fail IV t-PA therapy are<br>candidates for treatment. | |
| | 3. The Trevo Retriever is indicated for use<br>to restore blood flow in the neurovasculature<br>by removing thrombus for the treatment of<br>acute ischemic stroke to reduce disability in<br>patients 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 with<br>smaller core infarcts (0-50cc for age <80<br>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<br>in patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy. | |
| Target<br>Population | Patients experiencing acute ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Same |
| 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. The<br>Retriever delivery wire has a hydrophilic<br>coating on the distal 101cm to reduce friction<br>during use. The Retriever has a shaft marker<br>to indicate proximity of Retriever tip relative<br>to Microcatheter tip. A torque device is<br>provided with the Retriever to facilitate<br>manipulation and retrieval. The Retriever<br>comes preloaded in an insertion tool to<br>introduce the Retriever into a 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 aspiration<br>using a 60 mL syringe or an aspiration pump.<br>The Retriever with Microcatheter or | Same |

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

{6}------------------------------------------------

{7}------------------------------------------------

| Feature | Predicate Device | Subject Device | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Aspiration Catheter are pulled back to capture the thrombus. The Retriever, thrombus, and Microcatheter or Aspiration Catheter are removed as a unit from the body. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Procedural Steps<br>Aspiration Source | Syringe, Aspiration pump | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Accessory Devices | Insertion tool and torque device provided within product package | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sizes | 3x32mm<br>4x28mm<br>4x41mm<br>6x37mm | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 √ √ √ 2.5 Trevo NXT 4x41 √ √ √ Trevo NXT 6x37 √ √ √ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 √ √ √ 1.5 Trevo NXT 4x41 √ √ √ Trevo NXT 6x37 √ √ √ 2.5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balloon Guide Catheters and Aspiration Catheters (commercially available aspiration catheters with minimum inner diameter 0.046 inches (1.17mm)) are recommended for use during thrombus removal procedures. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Core Wire | Nitinol (nickel titanium alloy) | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section | Nitinol | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Distal Coil | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shaped Section Radiopaque Wire | Platinum/Tungsten | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Mid Coil | 304 Stainless Steel | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

{8}------------------------------------------------

| Feature | Predicate Device | Subject Device |
|---------------------------------------------|---------------------------------------------------------------------------------------|----------------------------|
| | Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever |
| Proximal Coil | Pebax | Same |
| Solder | Gold/Tin | Same |
| Hydrophilic<br>Coating | Sodium hyaluronate mixture | Same |
| Dimensional<br>Drawing | All Retriever sizes:<br>Image: [Dimensional Drawing] | Same |
| Overall Length<br>(A) | 200 cm | Same |
| Total Shaped<br>Section Length<br>(B) | 32, 36, 40, 44 mm | Same |
| Full Diameter<br>Length (C) | 21, 25, 30, 35 mm | Same |
| Shaped Section<br>Diameter (D) | 3, 4, 6 mm | Same |
| Delivery Core<br>Wire Outer<br>Diameter (E) | 0.015, 0.019 inches | Same |
| Cell Coverage<br>Length (F) | 28, 32, 37, 41 mm | Same |
| Packaging<br>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 |

{9}------------------------------------------------

#### 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.

## 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 (K210502) are directly applicable. Relevant testing data supporting the subject device are summarized as follows.

# Performance Data – Bench Testing

There are no changes to the device intended use or indications for use statement. Other than the labeling modification to recommend use of some Trevo retriever models in vessels with minimum diameter of 1.5 mm, there are no changes to the device design, materials, manufacturing and packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K210502) are directly applicable.

## Performance Data – Clinical

To support the labeling modifications for the subject Trevo NXT ProVue Retriever 3 mm and 4 mm models, a retrospective analysis of device performance per vessel size was performed using The ASSIST Registry data. This retrospective subgroup analysis demonstrates that use of the subject Trevo NXT ProVue Retriever 3 mm and 4 mm models in vessels with diameters of 1.5 to 2.5 mm has a similar performance and safety profile using available procedural data compared to their use in vessels with diameters ≥ 2.5 mm.

#### Shelf-Life Testing

Shelf-life testing previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device. Shelf-life testing was not performed on the subject device

{10}------------------------------------------------

since there was no impact to device material, design, or safety and efficacy as a result of the labeling changes.

#### Sterilization

Sterilization evaluation previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device. The Trevo NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide (EO) and provided sterile. A 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.

## Biocompatibility

Biocompatibility testing previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device. 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 Pro Vue Retriever devices, accessories, and primary packaging are considered biocompatible for their intended use.

#### Conclusion

Based on the conclusions drawn from the risk assessment and the analysis of clinical data from The ASSIST Registry, the subject demonstrates substantial equivalence to the legally marketed predicate device (K210502).