The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age < 80 years, 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 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.

AI/ML Overview

This document describes the Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever, neurovascular mechanical thrombectomy devices reviewed under K203219. The submission confirms substantial equivalence to previous devices (K190779 and K200117) made by the same manufacturer. The core argument for substantial equivalence relies on the fact that the indications for use, materials, manufacturing processes, design, technology, biocompatibility, packaging, and sterilization methods remain the same, with the only change being a modification to the core wire dimension.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it provides a summary of various bench tests and their "Conclusions," stating that "Device integrity met acceptance criteria," "Deliverability force met acceptance criteria," etc. The specific quantitative acceptance values are not detailed.

Test	Test Method Summary	Conclusions (Reported Device Performance)
Insertion Tool Use, Dimensions	Evaluate device integrity after use of insertion tool. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.
Retriever / Microcatheter Deliverability (Track Test- First Push)	Measure the force required to track a retriever through a microcatheter placed in a clinically relevant vasculature model.	Deliverability force met acceptance criteria.
Retriever In-Vivo Resheathability	Evaluate device integrity after re-sheathing into microcatheter. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.
Retractability of Retriever into Balloon Guide Catheter	Evaluate device integrity after retracting retriever into Balloon Guide Catheter. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.
Retriever Shaft Kink Resistance	Evaluate device integrity after tracking through a tortuous anatomy. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.
Reloadability into Insertion Tool	Evaluate device integrity after reloading retriever into insertion tool. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.
Retriever Shaped Section Torque/Tensile Durability	Determine durability of shaped section after multiple torque and tensile loading cycles. Apply two clockwise (CW) or counter clockwise (CCW) revolutions and load proximal 50% of exposed shaped section to 1.7 lbf five times, then pull to failure. Acceptance: Device shall withstand six cycles at 1.7 lbf before fracture.	Torque/tensile durability met acceptance criteria.
Retriever Proximal Curl Resistance	Determine if curl formation is present after the required revolutions. Apply 5 clockwise (CW) or 5 counter clockwise (CCW) revolutions. Acceptance: Core wire shall not form a curl or fracture.	Curl resistance met acceptance criteria.
Retriever Mid Joint Tensile Strength	Determine mid joint tensile strength. Identify mid solder joint(s) and subject to tensile testing. Acceptance: Device shall withstand 1.7 lbf minimum before wire or solder joint failure.	Mid Joint Tensile met acceptance criteria.
Retriever platinum wire and joint durability	Determine durability of platinum wire weaves and solder joints. Identify Mid-Joint, position tubing with Retriever inside, wrap tubing containing shaped section around Dowel Pin (one layer) until entire shaped section is wrapped around pin, unwrap and repeat for 6 times. Unsheath and examine.	Platinum wire and joint met acceptance criteria.
Retriever platinum wire joint tensile strength	Determine platinum wire solder joint tensile strength. Free Platinum wires, unweave from Nitinol struts. Subject joint to tensile testing. Acceptance: Joint shall withstand 0.1 lbf minimum before wire or solder joint failure.	Platinum wire solder joint met acceptance criteria.
ISO Fracture	Testing for fracture based on EN ISO 11070:2014, Annex F. Retriever wire wound around a cylindrical former (<=10x max OD) for at least eight complete turns, then unwound and examined for fractures.	Fracture resistance met acceptance criteria.
ISO Flexure	Testing for resistance to damage by flexing based on EN ISO 11070:2014, Annex G. Retriever delivery wire subjected to 20 cycles of repeated reverse bending and straightening, then examined for damage and flaking.	Flexure resistance met acceptance criteria.
Retrievability of Retriever with Intermediate Catheter	Evaluate device integrity after retrieval of Retriever with Intermediate Catheter. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.	Device integrity met acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states that for some bench tests (e.g., Insertion Tool Use, Resheathability, Retractability, Kink Resistance, Reloadability, Retrievability), the device was subjected to "3 runs of simulated use." For other tests like torque/tensile durability, curl resistance, and various tensile strength tests, specific run counts or minimum forces are mentioned, but not the total number of devices or components tested to achieve those results.

The data provenance is bench testing only. No patient data (clinical or retrospective/prospective) was used for evaluation of the modified device in this submission, as per their statement: "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests are bench tests comparing the physical properties of the modified device to the predicate. There is no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes for this submission.

4. Adjudication Method for the Test Set

Not applicable. This was predominantly bench testing of device components, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (mechanical thrombectomy retriever), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" or reference standard would be the established engineering specifications and performance characteristics of the predicate device, or relevant industry standards (e.g., ISO standards mentioned). The assessment is against these predefined engineering and safety specifications, not against clinical outcomes or pathology reports.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is a mechanical device, not an algorithm based on a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2020

Stryker Neurovascular Kathy Nguyen Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K203219

Trade/Device Name: Trevo XP ProVue Retriever, Trevo NXT ProVue Retriever Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: October 30, 2020 Received: November 2, 2020

Dear Kathy Nguyen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K203219

Device Name

Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever

Indications for Use (Describe)

The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Introduction:

According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.

Submitter Name, Address and Content:

Submitter:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Kathy NguyenStaff Regulatory Affairs SpecialistPhone: 510-413-2366Fax: 510-413-2588Email: Kathy.Nguyen@stryker.com
Date Prepared:	December 22, 2020

Device Name and Classification:

Trade/Proprietary Name:	Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
Common Name:	Trevo Retriever
Classification Name:	Neurovascular Mechanical Thrombectomy Device for Acute IschemicStroke Treatment, 21 CFR 882.5600, Class IIPercutaneous Catheter, 21 CFR 870.1250 – Class II
Product Code:	POL, NRY

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Legally Marketed Predicate Device

Name of Predicate Device	Name ofManufacturer	510(k)Number
Trevo XP ProVueRetriever	StrykerNeurovascular	K190779
Trevo NXT™ ProVueRetriever	StrykerNeurovascular	K200117

Device Description

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.
1. 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.
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 of the internal carotid

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

Technological Characteristics and Product Feature Comparison

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

Comparison of Technological Characteristics with the Primary Predicate Device:

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

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

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

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

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

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

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Feature	Predicate DeviceTrevo XP ProVue Retriever (K190779)	Subject DeviceTrevo XP ProVueRetriever
Device Description	The Retriever consists of a flexible, tapered core wire with ashaped section at the distal end. Platinum markers at the distal endallow fluoroscopic visualization. In addition, the shaped section isalso radiopaque. Retriever dimensions are indicated on productlabel. The Retriever has a hydrophilic coating to reduce frictionduring use. The Retriever has a shaft marker to indicate proximityof Retriever tip relative to Microcatheter tip. A torque device isprovided with the Retriever to facilitate manipulation. The torquedevice is used to lock the core wire to the microcatheter during theprocedure. Locking of the torque device to the wire allows themicrocatheter and Retriever to be retracted as a system during clotretrieval. An insertion tool is provided to introduce the Retrieverinto a Microcatheter. The Insertion Tool is a sheath in which theRetriever comes preloaded. Once half the retriever's length isinserted into the microcatheter, the insertion tool is removed.Retrievers have a modified proximal end that permits attachmentof the Abbott Vascular DOC Guide Wire Extension (REF 22260).Joining Guide Wire Extension to Retriever facilitates removal orexchange of a catheter while maintaining Retriever position inanatomy. After exchange has been completed, the extension canbe detached.	Same
Principle of Operation	The Trevo Retriever is delivered to the thrombus using amicrocatheter. The Microcatheter is then retracted to deploy theshaped section of the Retriever. If using an Aspiration Catheter,remove Microcatheter. Advance Aspiration Catheter overproximal section of Retriever while applying aspiration using a 60mL syringe or an aspiration pump. The Retriever withMicrocatheter or Aspiration Catheter are pulled back to capturethe thrombus. The Retriever, thrombus, and Microcatheter orAspiration Catheter are removed as a unit from the body.	Same
Procedural StepsAspiration Source	Syringe, Aspiration pump	Same
Sizes	3x20mm4x20mm4x30mm6x25mm	Same
Accessory Devices	Insertion tool and torque device provided within product package	Same
Compatibility	Retriever Size Trevo Pro14 Microcatheter Trevo Pro18 Microcatheter Excelsior® XT-27 Microcatheters (150cm x 6cm straight REF XT275081 Recommended Minimum Vessel ID (mm) Trevo XP ProVue V V Trevo XP ProVue V Trevo ProVue 4X20mm V 2.5 Trevo XP ProVue 4X30mm V V Trevo XP ProVue 6X25mm V		Same
Core Wire	Nitinol (nickel titanium alloy)	Same

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Feature	Predicate DeviceTrevo XP ProVue Retriever (K190779)	Subject DeviceTrevo XP ProVueRetriever
Shaped Section	Nitinol	Same
Distal Coil	Platinum/Tungsten	Same
Shaped SectionRadiopaque Wire	Platinum/Tungsten	Same
Outer Jacket	Not applicable.	Not applicable.
Mid Coil	304 Stainless Steel	Same
Proximal Coil / ProximalSupport / Length	304 Stainless Steel	Same
Solder	Gold/Tin	Same
Hydrophilic Coating	Sodium hyaluronate mixture, L578 formulation	Same
Dimensional Drawing	3x20, 4x20mm Retriever sizes:Image: [Diagram of 3x20, 4x20mm Retriever]4x30, 6x25mm Retriever sizes:Image: [Diagram of 4x30, 6x25mm Retriever]	Same
Core Wire Dimension	Flatten Thickness0.0030" +/- 0.0003"	Flatten Thickness0.0040" +/- 0.0003"
Overall Length (A)	180, 190cm	Same
Total Shaped SectionLength (nominal) (B)	32, 36, 40, 44mm	Same
Full Diameter Length(C) 4x30 & 6x25	20, 25, 30mm	Same
Active Shaped SectionLength(C) 3x20 & 4x20(D) 4x30 & 6x25	Retriever Size (mm) Dimension C (mm) 3x20 NA 4x20 NA 4x30 35 6x25 30		Same
Shaped Section Diameter(nominal)(D) 3x20 & 4x20	3, 4, 6mm	Same

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Feature	Predicate DeviceTrevo XP ProVue Retriever (K190779)	Subject DeviceTrevo XP ProVueRetriever
Proximal Core WireDiameter(E) 3x20 & 4x20(F) 4x30 & 6x25	Retriever Size(mm) 3x20 4x20		Dimension E(inches) 0.015 0.018	Same
	Retriever Size(mm) 4x30 6x25		Dimension F(inches) 0.018 0.018
Materials andConfiguration	Polyethylene Hoop, polycarbonate mounting card, Tyvek/FilmPouch, HDPE Tubing Clips, Chipboard carton	Same
Sterilization Method	100% EtO	Same
How Supplied	Sterile/Single Use	Same

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

Feature	Predicate DeviceTrevo NXT ProVue Retriever (K200117)	Subject DeviceTrevo NXT ProVueRetriever
Regulation Number	• 21 CFR 882.5600• 21 CFR 870.1250	Same
Regulation Name	• Neurovascular Mechanical Thrombectomy Device forAcute Ischemic Stroke Treatment• Percutaneous Catheter	Same
Classification	Class II	Same
Product Code	• POL• NRY	Same
Intended Use	Neurovascular mechanical thrombectomy device for acuteischemic stroke treatment used in the treatment of acuteischemic stroke to improve clinical outcomes.	Same
Indications for Use	1. The Trevo Retriever is indicated for use to restoreblood flow in the neurovasculature by removing thrombusfor the treatment of acute ischemic stroke to reducedisability in patients with a persistent, proximal anteriorcirculation, large vessel occlusion, and smaller coreinfarcts who have first received intravenous tissueplasminogen activator (IV t-PA). Endovascular therapywith the device should start within 6 hours of symptomonset.2. The Trevo Retriever is intended to restore bloodflow in the neurovasculature by removing thrombus inpatients experiencing ischemic stroke within 8 hours ofsymptom onset. Patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates for treatment.3. The Trevo Retriever is indicated for use to restoreblood flow in the neurovasculature by removing thrombus	Same
Feature	Predicate DeviceTrevo NXT ProVue Retriever (K200117)	Subject DeviceTrevo NXT ProVueRetriever
	for the treatment of acute ischemic stroke to reducedisability in patients with a persistent, proximal anteriorcirculation, large vessel occlusion of the internal carotidartery (ICA) or middle cerebral artery (MCA)-M1segments with smaller core infarcts (0-50 cc for age < 80years, 0-20 cc for age ≥ 80 years). Endovascular therapywith the device should start within 6-24 hours of time lastseen well in patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PAtherapy.
Target Population	Patients experiencing acute ischemic stroke	Same
Anatomical Sites	Neurovasculature	Same
TECHNOLOGICAL CHARACTERISTICS
Device Description	The Retriever consists of a flexible, tapered core wire witha shaped section at the distal end. Platinum markers at thedistal end allow fluoroscopic visualization. In addition, theshaped section is also radiopaque. Retriever dimensions areindicated on product label. The Retriever delivery wire hasa hydrophilic coating on the distal 101cm to reduce frictionduring use. The Retriever has a shaft marker to indicateproximity of Retriever tip relative to Microcatheter tip. Atorque device is provided with the Retriever to facilitatemanipulation and retrieval. The Retriever comes preloadedin an insertion tool to introduce the Retriever into aMicrocatheter.	Same
Principle of Operation	The Trevo Retriever is delivered to the thrombus using amicrocatheter. The Microcatheter is then retracted todeploy the shaped section of the Retriever. If using anAspiration Catheter, remove Microcatheter. AdvanceAspiration Catheter over proximal section of Retrieverwhile applying aspiration using a 60 mL syringe or anaspiration pump. The Retriever with Microcatheter orAspiration Catheter are pulled back to capture thethrombus. The Retriever, thrombus, and Microcatheter orAspiration Catheter are removed as a unit from the body.	Same
Procedural StepsAspiration Source	Syringe, Aspiration pump	Same
Accessory Devices	Insertion tool and torque device provided within productpackage	Same
Sizes	3x32mm4x28mm4x41mm6x37mm	Same

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

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

Risk Assessment

Risk assessment of the modifications has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined the modifications to the Predicate device raise no new questions of safety or effectiveness.

Results of verification testing are appropriate for use in determining that the Trevo Retriever devices are substantially equivalent to the Predicate device. Furthermore, the modifications associated with the Subject device did not result in the identification of any new failure modes nor were there any changes to existing failure modes, including no change to severity or occurrence, and, therefore, no change to overall residual risk.

Testing Summary

There are no changes to the device intended use or indications for use statement. Other than the modification of the core wire dimension, there are no changes in the device materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the Predicate device (K10779 & K200117) are directly applicable. Relevant testing data supporting the Subject device are summarized as follows.

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Performance Data – Bench Testing

Testing on the Subject device was conducted for core wire dimension change. The results of design verification testing conducted on the Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever demonstrates that it is substantially equivalent to the legally marketed Predicate device. The design verification bench testing are summarized in Table 3 below.

Test	Test Method Summary	Conclusions
Insertion Tool Use,Dimensions	Purpose: Evaluate device integrity after use ofinsertion toolMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.
Retriever /MicrocatheterDeliverability (TrackTest- First Push)	Purpose: To determine the trackability of retrieverMethod: Measure the force required to track aretriever through a microcatheter placed in aclinically relevant vasculature model.	Deliverability forcemet acceptancecriteria.
Retriever In-VivoResheathability	Purpose: Evaluate device integrity after re-sheathing into microcatheterMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.
Retractability ofRetriever intoBalloon GuideCatheter	Purpose: Evaluate device integrity after retractingretriever into Balloon Guide CatheterMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.
Retriever Shaft KinkResistance	Purpose: Evaluate device integrity after trackingthrough a tortuous anatomyMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.

	Table 3- Performance Data - Bench Testing

Test	Test Method Summary	Conclusions
Reloadability intoInsertion Tool	Purpose: Evaluate device integrity after reloadingretriever into insertion toolMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.
Retriever ShapedSectionTorque/TensileDurability	Purpose: To determine durability of shapedsection after multiple torque and tensile loadingcycles.Method: Apply two clockwise (CW) or counterclockwise (CCW) revolutions and load proximal50% of exposed shaped section to 1.7 lbf fivetimes, then pull to failure. Device shall withstandsix cycles at 1.7 lbf before fracture.	Torque/tensiledurability metacceptance criteria.
Retriever ProximalCurl Resistance	Purpose: To determine if curl formation is presentafter the required revolutions.Method: Apply 5 clockwise (CW) or 5 counterclockwise (CCW) revolutions, the core wire shallnot form a curl or fracture.	Curl resistance metacceptance criteria.
Retriever Mid JointTensile Strength	Purpose: To determine the mid joint tensilestrength of a retrieverMethod: Identify mid solder joint(s) and subjectto tensile testing. The device shall withstand 1.7lbf minimum before wire or solder joint failure.	Mid Joint Tensilemet acceptancecriteria.
Retriever platinumwire and jointdurability	Purpose: To determine the durability of platinumwire weaves and solder joints of a retrieverMethod: Identify Mid-Joint and position tubingwith Retriever inside. Wrap tubing containingshaped section around Dowel Pin in one layeruntil the entire shaped section is wrapped aroundthe pin, unwrap and repeat a total of 6 times.Unsheath device and examine the platinum wireand solder joint areas of Retriever.	Platinum wire andjoint metacceptance criteria.
Retriever platinumwire joint tensilestrength	Purpose: To determine the platinum wire solderjoint tensile strength of a retrieverMethod: Free Platinum wires by cutting platinumwire and then unweaving from Nitinol struts. Thejoint is subjected to tensile testing. The joint shallwithstand 0.1 lbf minimum before wire or solderjoint failure	Platinum wiresolder joint metacceptance criteria.
Test	Test Method Summary	Conclusions
ISO Fracture	Purpose: For testing for fracture of endovascularretrievers (called retriever herein) basedon EN ISO 11070:2014, Sterile single-useintravascular introducers, dilatorsand guidewires, Annex F, Test method forfracture of guidewires.	Fracture resistancemet acceptancecriteria.
	Method: The retriever wire is wound around acylindrical former for at least eightcomplete turns, then unwound and examined forfractures. The diameter of the cylindrical formeris less than or equal to ten times the maximumoutside diameter (OD) of the wire.
ISO Flexure	Purpose: For testing for resistance of guidewires, delivery wires, or introducer wires todamage by flexing based on EN ISO 11070:2014,Annex G: Sterile, single-use intravascularcatheter introducers, Test for resistance of guidewires to damage by flexing.	Flexure resistancemet acceptancecriteria.
	Method: The retriever delivery wire is subjectedto 20 cycles of repeated reverse bending andstraightening, then examined for damage andflaking of lamination.
Retrievability ofRetriever withIntermediate Catheter	Purpose: Evaluate device integrity after retrievalof Retriever with Intermediate CatheterMethod: Device is prepared per IFU andinspected prior to use. The device is subjected to3 runs of simulated use in a clinically relevantvasculature model and inspected after each run.	Device integritymet acceptancecriteria.

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Performance Data – Animal, Clinical

No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology. Substantial equivalence of the Subject device has been established to the Predicate devices through the results of bench testing.

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Shelf Life Testing

Shelf life testing previously conducted for the Trevo XP ProVue Retriever and Trevo NXT Pro Vue Retriever were leveraged to support the changes to the device and can be found in K190779 and K200117. Shelf life testing was not performed on the Subject device since there was no impact to device material, or safety and efficacy as a result of the core wire design modification. As with the Predicate device, the Subject device is labeled with a 2-year shelf life.

Sterilization

Sterilization evaluation previously conducted for the Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever were leveraged to support the labeling changes to the device and can be found in K190779 and K200117. The Trevo XP ProVue Retrievers and Trevo NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 10 6 has been demonstrated. The Trevo XP ProVue Retrievers and 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 XP ProVue Retriever and Trevo NXT ProVue Retriever was leveraged to support the core wire design modification to the device and can be found in K190779 and K200117. The results of biocompatibility testing, and biological safety evaluation of the Trevo XP ProVue Retriever and 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 XP ProVue Retriever and 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 XP ProVue Retriever and Trevo NXT ProVue Retriever devices, accessories, and primary packaging are considered biocompatible for their intended use.

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Conclusion

Based on the conclusions drawn from risk assessment and the bench testing results summarized above, the Subject device demonstrates substantial equivalence to the legally marketed Predicate device (K190779 and K200117).

Regulation Number and Section

§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.