The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Device 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 has a hydrophilic coating 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. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining the Guide Wire Extension to the Retriever facilitates removal or exchange of a catheter while maintaining the Retriever position in anatomy. After the exchange has been completed, the extension can be detached.

AI/ML Overview

The provided text is a 510(k) Summary for the Stryker Neurovascular Trevo XP ProVue Retriever. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria for an AI device. The information requested in your prompt (e.g., acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, MRMC studies) is typically found in regulatory submissions for AI/ML-based medical devices, which assess algorithm performance.

The provided document does not contain the specific type of information needed to fully answer your request regarding acceptance criteria and performance data for an AI-powered device.

However, I can extract the information that is present concerning the Trevo Retriever, which is a mechanical thrombectomy device, and interpret it in the context of device performance, even if it's not an AI device.

Let's break down what is available and what is not:

What is Available (relevant to a physical medical device, not AI/ML):

Device Type: Neurovascular Mechanical Thrombectomy Device (a physical medical device, not an AI/ML algorithm).
Purpose: To restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke.
Performance Data - Non-Clinical:
- Test: Simulated Use
- Test Method Summary: "Simulated Use testing utilized a neurovascular model with a re-circulating water bath at 37℃ to simulate the human arterial circulation and to assess the device's ability to retrieve the clot and achieve recanalization."
- Conclusion/Performance: "Simulated Use met acceptance criteria."
Performance Data - Clinical:
- Data Source: Analysis of Real World Data (RWD) from the Trevo Retriever Registry.
- Purpose: To assess safety or effectiveness on the combination use of Trevo Retriever and intermediate catheter aspiration approach.
- Additional Support: Comprehensive review of relevant clinical literature.

What is NOT available (and would be expected for an AI/ML device as per your prompt):

A table of acceptance criteria and reported device performance for an AI/ML algorithm. The document only states that "Simulated Use met acceptance criteria" without specifying the precise quantitative criteria or results.
Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective). The "Simulated Use" refers to a bench test, not a patient test set, and the "Trevo Retriever Registry" is mentioned for clinical data, but no specifics about its use as a "test set" for performance evaluation against acceptance criteria are given.
Number of experts used to establish ground truth for the test set and their qualifications. This is relevant for AI/ML evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size. This is specific to AI clinical utility.
If a standalone (algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary in relation to your prompt, given the provided document:

Since the provided text describes a physical medical device (a thrombectomy device) and not an AI/ML algorithm, most of the requested points related to AI/ML software validation (like training set, ground truth experts, MRMC studies) are not applicable and thus not present in the document.

The "acceptance criteria" mentioned in the non-clinical performance section only states that the "Simulated Use met acceptance criteria," but it does not specify what those criteria were (e.g., success rate, time to recanalization, etc.) nor does it provide the exact performance metrics achieved.

Therefore, I cannot construct the table or provide the detailed answers to most of your questions based on the provided text, as it does not pertain to an AI/ML device.

Summary

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

June 25, 2019

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

Re: K190779

Trade/Device Name: Trevo XP 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: March 26, 2019 Received: March 27, 2019

Dear Rhoda M. Santos:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, 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) K190779

Device Name Trevo XP 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)-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.

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)	Prescription Use (Part 21 CFR 801 Subpart D)		Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Trade Name:	Trevo XP ProVue Retriever
Common Name:	Trevo Retrievers
Classification Name:	- Neurovascular Mechanical Thrombectomy Device for AcuteIschemic Stroke Treatment, 21 CFR 882.5600, Class II- Percutaneous Catheter, 21CFR 870.1250, Class II
Product Code:	POL, NRY
Submitter:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Tel 510-413-2269Fax 510-413-2724Facility Registration #3008853977
Contact:	Rhoda M. SantosSenior Principal Regulatory Affairs Specialist
Date Prepared:	March 26, 2019
Primary Predicate Device:	Trevo XP ProVue Retriever (K173352)
Reference PredicateDevice:	Trevo Retriever (K120961)

Device Description

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Accessories

The Retriever is provided with two accessories: a torque device which facilitates manipulation of the Retriever, and an insertion tool that is used to introduce the Retriever into a Microcatheter.

Indications for Use

The Indications for Use are as follows:

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 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

The Trevo XP ProVue Retriever subject devices are identical to the Primary Predicate and Reference Predicate devices and differ only by the modifications to the Instructions for Use (IFU). The technological characteristics and principles of operation remain unchanged except for the alternate use of an aspiration catheter with an aspiration pump. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility, bench-top data, sterilization and stability data from the Primary Predicate device (K173352) and Reference Predicate device (K120961) are directly applicable.

Table 1 below provides a comparison between the Subject, the Primary Predicate and Reference Predicate devices.

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Feature	Reference Predicate DeviceTrevo ProVue Retriever(K120961)	Primary Predicate DeviceTrevo ProVue Retriever and Trevo XPProVue Retriever (K173352)	Subject DeviceTrevo XP ProVue Retrieverwith Modified DFU	Rationale forModification (ifapplicable)
Intended Use	The Trevo Retriever is intended torestore blood flow in theneurovasculature by removingthrombus in patients experiencingischemic stroke within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV-tPA) orwho fail IV t-PA therapy arecandidates for treatment.	Neurovascular mechanicalthrombectomy device for acute ischemicstroke treatment used in the treatment ofacute ischemic stroke to improve clinicaloutcomes.	Same as predicate K173352.	Not applicable.
Indications for Use	The Trevo Retriever is intended torestore blood flow in theneurovasculature by removingthrombus in patients experiencingischemic stroke within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV-tPA) orwho fail IV t-PA therapy arecandidates for treatment.	1. The Trevo Retriever is indicated foruse to restore blood flow in theneurovasculature by removingthrombus for the treatment of acuteischemic stroke to reduce disability inpatients with a persistent, proximalanterior circulation, large vesselocclusion, and smaller core infarctswho have first received intravenoustissue plasminogen activator (IV t-PA). Endovascular therapy with thedevice should start within 6 hours ofsymptom onset.2. The Trevo Retriever is intended torestore blood flow in theneurovasculature by removingthrombus in patients experiencingischemic stroke within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy arecandidates for treatment.3. The Trevo Retriever is indicated foruse to restore blood flow in the	Same as predicate K173352.	Not applicable.
Feature	Reference Predicate DeviceTrevo ProVue Retriever(K120961)	Primary Predicate DeviceTrevo ProVue Retriever and Trevo XPProVue Retriever (K173352)	Subject DeviceTrevo XP ProVue Retrieverwith Modified DFU	Rationale forModification (ifapplicable)
		neurovasculature by removingthrombus for the treatment of acuteischemic stroke to reduce disability inpatients with a persistent, proximalanterior circulation, large vesselocclusion of the internal carotid artery(ICA) or middle cerebral artery(MCA)-M1 segments with smallercore infarcts (0-50 cc for age < 80years, 0-20 cc for age ≥ 80 years).Endovascular therapy with the deviceshould start within 6-24 hours of timelast seen well in patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy.
REGULATORY INFORMATION
Regulation Number/Name/ Class/ ProductCode	21 CFR 870.1250, PercutaneousCatheter, Class II, NRY	21 CFR 882.5600 / NeurovascularMechanical Thrombectomy Device forAcute Ischemic Stroke Treatment, ClassII, POL21 CFR 870.1250, Percutaneous Catheter,Class II, NRY	Same as predicate K173352.	Not applicable.

Target Population	Patients experiencing acute ischemic stroke		Same as predicate K173352and K120961.	Not applicable.
Anatomical Sites	Neurovasculature		Same as predicate K173352and K120961.	Not applicable.
TECHNOLOGICAL CHARACTERISTICS
Feature	Reference Predicate Device	Primary Predicate Device	Subject Device	Rationale for
	Trevo ProVue Retriever	Trevo ProVue Retriever and Trevo XP	Trevo XP ProVue Retriever	Modification (if
	(K120961)	ProVue Retriever (K173352)	with Modified DFU	applicable)
Device Description	The Retriever consists of a flexible,tapered core wire with a shapedsection at the distal end. A platinumcoil allows fluoroscopicvisualization. The Retriever has ahydrophilic coating to reducefriction. The Retriever has a shaftmarker to indicate proximity ofRetriever tip relative toMicrocatheter tip. A torque deviceand insertion tool are provided withthe Retriever.	The Retriever consists of a flexible,tapered core wire with a shaped section atthe distal end. Platinum markers at thedistal end allow fluoroscopicvisualization. In addition, the shapedsection is also radiopaque. Retrieverdimensions are indicated on product label.The Retriever has a hydrophilic coating toreduce friction during use. The Retrieverhas a shaft marker to indicate proximityof Retriever tip relative to Microcathetertip. A torque device is provided with theRetriever to facilitate manipulation. Thetorque device is used to lock the core wireto the microcatheter during the procedure.Locking of the torque device to the wireallows the microcatheter and Retriever tobe retracted as a system during clotretrieval. An insertion tool is provided tointroduce the Retriever into aMicrocatheter. The Insertion Tool is asheath in which the Retriever comespreloaded. Once half the retriever's lengthis inserted into the microcatheter, theinsertion tool is removed. Retrievers havea modified proximal end that permitsattachment of the Abbott Vascular DOCGuide Wire Extension (REF 22260).Joining Guide Wire Extension toRetriever facilitates removal or exchangeof a catheter while maintaining Retrieverposition in anatomy. After exchange hasbeen completed, the extension can bedetached.	The Retriever consists of aflexible, tapered core wire witha shaped section at the distalend. Platinum markers at thedistal end allow fluoroscopicvisualization. In addition, theshaped section is alsoradiopaque. Retrieverdimensions are indicated onproduct label. The Retriever hasa hydrophilic coating to reducefriction during use. TheRetriever has a shaft marker toindicate proximity of Retrievertip relative to Microcatheter tip.A torque device is providedwith the Retriever to facilitatemanipulation and retrieval. Aninsertion tool is provided tointroduce the Retriever into aMicrocatheter. The InsertionTool is a sheath in which theRetriever comes preloaded.Once half the retriever's lengthis inserted into themicrocatheter, the insertion toolis removed. Retrievers have amodified proximal end thatpermits attachment of theAbbott Vascular DOC GuideWire Extension (REF 22260).Joining Guide Wire Extensionto Retriever facilitates removalor exchange of a catheter whilemaintaining Retriever positionin anatomy. After exchange hasbeen completed, the extensioncan be detached.	Clarification for useof Retriever.
Feature	Reference Predicate DeviceTrevo ProVue Retriever(K120961)	Primary Predicate DeviceTrevo ProVue Retriever and Trevo XPProVue Retriever (K173352)	Subject DeviceTrevo XP ProVue Retrieverwith Modified DFU	Rationale forModification (ifapplicable)
Principle ofOperation	The Trevo Retriever is delivered to the thrombus using a Microcatheter. TheMicrocatheter is then retracted to deploy the shaped section of the Retriever. TheRetriever and Microcatheter are pulled back to capture the thrombus. TheRetriever, thrombus and Microcatheter are then removed from the body.	The Trevo Retriever is delivered to the thrombus using a Microcatheter. TheMicrocatheter is then retracted to deploy the shaped section of the Retriever. TheRetriever and Microcatheter are pulled back to capture the thrombus. TheRetriever, thrombus and Microcatheter are then removed from the body.	The Trevo Retriever is deliveredto the thrombus using aMicrocatheter. TheMicrocatheter is then retractedto deploy the shaped section ofthe Retriever. If using anAspiration Catheter, removeMicrocatheter. AdvanceAspiration Catheter overproximal section of Retrieverwhile applying aspiration usinga 60 mL syringe or an aspirationpump. The Retriever withMicrocatheter or AspirationCatheter are pulled back tocapture the thrombus. TheRetriever, thrombus, andMicrocatheter or AspirationCatheter are removed as a unitfrom the body.	Revised to reflectalternative use ofAspiration Catheterwith an aspirationpump. Benchtesting, clinicaldata, and a reviewof relevant clinicalliteraturedemonstrates thealternativeaspiration sourcedoes not raise newissues of safety oreffectiveness.
Procedural StepsAspiration Source	Syringe		Aspiration pump	Bench testing,clinical data, and areview of relevant clinical literaturedemonstrates thealternativeaspiration sourcedoes not raise newissues of safety oreffectiveness.
Sizes	4x20mm	3x20mm, 4x20mm, 4x30mm, 6x25mm	Same as predicate K173352.	Not applicable.
Accessory Devices	Insertion tool and torque device provided within product package		Same as predicate K173352and K120961.	Not applicable.

Table 1: Product Feature Comparison of Subject Device to Primary Predicate Device and Reference Predicate Device

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Feature	Reference Predicate DeviceTrevo ProVue Retriever (K120961)	Primary Predicate DeviceTrevo ProVue Retriever and Trevo XP ProVue Retriever (K173352)					Subject DeviceTrevo XP ProVue Retriever with Modified DFU	Rationale for Modification (if applicable)
Compatibility	Retriever sizeTrevo ProVue 4X20mm	Retriever size	Trevo Pro14 MC	Trevo Pro18 MC	Excelsior ® XT-27® Microcath eters (150cm x 6cm straight REF 275081)	Recommended Vessel Minimum ID (mm)	Same as predicate K173352.	Not applicable.
	Trevo 18 MC✓	Trevo XP ProVue 3X20mmTrevo XP ProVue 4X20mmTrevo ProVue 4X20mmTrevo XP ProVue 4X30mmTrevo XP ProVue 6X25mm	✓	✓
Materials						2.5
Core Wire	Nitinol (nickel titanium alloy)						Same as predicate K173352 and K120961.	Not applicable.
Shaped Section	Nitinol						Same as predicate K173352 and K120961.	Not applicable.
Distal Coil	Platinum/Tungsten						Same as predicate K173352 and K120961.	Not applicable.
Shaped SectionRadiopaque Wire	Not applicable.	Platinum/Tungsten					Same as predicate K173352.	Not applicable.
Proximal Coil	304 Stainless Steel						Same as predicate K173352 and K120961.	Not applicable.
Solder	Gold/Tin						Same as predicate K173352 and K120961.	Not applicable.
Hydrophilic Coating	Sodium hyaluronate mixture						Same as predicate K173352 and K120961.	Not applicable.
Dimensions

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Feature	Reference Predicate DeviceTrevo ProVue Retriever(K120961)	Primary Predicate DeviceTrevo ProVue Retriever and Trevo XPProVue Retriever (K173352)	Subject DeviceTrevo XP ProVue Retrieverwith Modified DFU	Rationale forModification (ifapplicable)
DimensionalDrawing	Trevo ProVue Retriever:Image: [Dimensional Drawing of Trevo ProVue Retriever]	Trevo ProVue Retriever:Image: [Dimensional Drawing of Trevo ProVue Retriever]Trevo XP ProVue Retriever:Image: [Dimensional Drawing of Trevo XP ProVue Retriever]	Same as predicate K173352.	Not applicable.
Overall Length (A)	180cm	180, 190cm	Same as predicate K173352.	Not applicable.
Total Shaped SectionLength (nominal) (B)	37mm	32, 36, 37, 40, 44mm	Same as predicate K173352.	Not applicable.
Active ShapedSection Length(nominal) (C)	20mm	20, 25, 30mm	Same as predicate K173352.	Not applicable.
Shaped SectionDiameter (nominal)(D)	4mm	3, 4, 6mm	Same as predicate K173352.	Not applicable.
Proximal Core WireDiameter (E)	0.018 inches	0.015, 0.018 inches	Same as predicate K173352.	Not applicable.
Packaging
Materials andConfiguration	Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, HDPETubing Clips, Chipboard carton		Same as predicate K173352and K120961.	Not applicable.
Sterilization Method	100% EtO		Same as predicate K173352and K120961.	Not applicable.
How Supplied	Sterile/Single Use		Same as predicate K173352and K120961.	Not applicable.

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Performance Data - Non-Clinical

Stryker Neurovascular performed the following non-clinical bench test to assess the usability of the Trevo Retriever with the AXS Catalyst Distal Access Catheter (DAC) as part of the AXS Universal Aspiration System.

Test	Test Method Summary	Conclusions
Simulated Use	Simulated Use testing utilized aneurovascular model with a re-circulating water bath at 37℃ tosimulate the human arterial circulationand to assess the device's ability toretrieve the clot and achieverecanalization.	Simulated Use metacceptance criteria.

Performance Data - Clinical

To support the labeling modifications, Stryker Neurovascular conducted an analysis of Real World Data (RWD) from the Trevo Retriever Registry to assess safety or effectiveness on the combination use of Trevo Retriever and intermediate catheter aspiration approach in the clinical study. Additionally, a comprehensive review of relevant clinical literature supports the broad usage of various commercially available aspiration catheters and stent retrievers.

Conclusion

Based on the successful completion of the Simulated Use study, additional bench testing, and clinical data from the Trevo Registry and clinical literature review, the combination neurothrombectomy approach of using the Trevo® Retriever and the AXS Catalyst® Distal Access Catheter) with the AXS Universal™ Aspiration System as an alternative aspiration source for removal of thrombus in the neurovasculature is substantially equivalent to the Primary Predicate device (K173352) and Reference Predicate device (K120961).

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.