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.

Device Description

The Modified Trevo ProVue Retriever consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. The shaped section is also radiopaque. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.

AI/ML Overview

The provided document describes the Modified Trevo ProVue Retriever, a device intended to restore blood flow in the neurovasculature for ischemic stroke patients. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cleared Trevo ProVue Retriever, K122478) based on design, materials, and function, with a specific modification to the platinum wire weave.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit from Testing)	Reported Device Performance
Maintain deliverability	All samples passed
Maintain deployment capability	All samples passed
Maintain reloadability	All samples passed
No new failure modes introduced	No new failure modes detected
No changes to existing failure modes	No changes to existing failure modes
Perform as designed	Device performs as designed
Suitable for intended use	Device is suitable for its intended use
Substantially equivalent to predicate device	Demonstrated as substantially equivalent

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact number of Modified Trevo ProVue Retriever samples tested. It states "All samples passed the acceptance criteria."
Data Provenance: The testing was conducted as bench testing using a silicone neurovascular model cast from actual human neurovascular arteries. This is a retrospective approach in terms of model derivation, but the testing itself is prospective for the device being evaluated. The 'country of origin' of the data is not explicitly stated, but it's part of a submission to the US FDA by a US-based company (Concentric Medical, Inc. in Mountain View, CA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" for this type of bench testing is typically the physical and functional characteristics of the device itself and its interaction with the simulated environment, rather than expert interpretation of images or clinical outcomes. The "success" or "failure" of deliverability, deployment, and reloadability would be directly observed and measured against pre-defined engineering specifications.

4. Adjudication method for the test set:

An adjudication method is not applicable or mentioned. This was a bench test evaluating physical performance, not a study requiring human interpretation or consensus for outcomes.

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:

No MRMC study was conducted. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This question is not applicable as the device is a mechanical thrombectomy device, not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for this bench testing was based on engineering specifications and observable physical performance criteria (e.g., successful navigation, deployment, and retrieval within a simulated anatomical model without device failure). It involved assessing whether the device met its design requirements for deliverability, deployment, and reloadability.

8. The sample size for the training set:

This question is not applicable. There is no training set mentioned, as this is bench testing of a medical device, not a machine learning model.

9. How the ground truth for the training set was established:

This question is not applicable as there is no training set involved.

Summary

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K133464

JAN 17 2014

510(k) Summary

Trade Name:	Modified Trevo ProVue Retriever
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Thrombus Retriever, 21CFR 870.1250 Class II
Product Code:	NRY
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 510-413-2681Fax 510-413-2558Facility Registration #2954917
Contact:	Sarah MeyerSenior Regulatory Affairs Specialist
Date Prepared:	December 13, 2013
Predicate Device:	Concentric Trevo ProVue Retriever (K122478)
Feature	Cleared Trevo ProVue Retriever(K122478)	Modified TrevoProVue Retriever
Indications for Use	The Trevo ProVue Retriever is intended to restoreblood flow in the neurovasculature by removingthrombus in patients experiencing ischemic strokewithin 8 hours of symptom onset. Patients who areineligible for intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapy arecandidates for treatment.	Same as cleareddevice
Device Description	The Retriever consists of a flexible, tapered corewire with a shaped section at the distal end. Aplatinum coil allows fluoroscopic visualization. Inaddition, the shaped section is also radiopaque. TheRetriever has a hydrophilic coating to reduce friction.The Retriever has a shaft marker to indicateproximity of Retriever tip relative to Microcatheter tip.A torque device and insertion tool are provided withthe Retriever.	Same as cleareddevice
Target Population	Patients with symptoms of an ischemic stroke	Same as cleareddevice
Anatomical Sites	Neurovasculature	Same as cleareddevice
Accessory DevicesProvided(not in direct contactwith patient)	Insertion tool and torque device provided in productpackage	Same as cleareddevice
Regulation Number	21CFR 870.1250	Same as cleareddevice
Regulation Name	Catheter, Thrombus Retriever	Same as cleareddevice
Regulatory Class	II	Same as cleareddevice
Product Code	NRY	Same as cleareddevice
Core Wire Material	Nitinol (nickel titanium alloy)	Same as cleareddevice
Distal ShapedSection Material	Nitinol	Same as cleareddevice
Feature	Cleared Trevo ProVue Retriever(K122478)	Modified TrevoProVue Retriever
Coil Material Distalto Distal ShapedSection	Platinum/Tungsten	Same as cleareddevice
Shaped SectionRadiopaque Wire	Platinum/Tungsten	Same as cleareddevice
Coil MaterialProximal toShaped Section	304 Stainless Steel	Same as cleareddevice
Solder	Gold/Tin	Same as cleareddevice
Hydrophilic Coating	Sodium hyaluronate mixture	Same as cleareddevice
Nominal Design Attributes
Overall Length	180 cm	Same as cleareddevice
Total ShapedSection Length(nominal)	37 mm	Same as cleareddevice
Active ShapedSectionLength (nominal)	20 mm	Same as cleareddevice
Distal Tip Length(nominal)	4 mm	Same as cleareddevice
Proximal Core WireDiameter	0.0180"	Same as cleareddevice
Shaped SectionDiameter (nominal)	4 mm	Same as cleareddevice
Distal TaperLength (nominal)	10 mm	Same as cleareddevice
Packaging
Materials andConfiguration	Polyethylene Hoop, polycarbonate mounting card,Tyvek/Film Pouch, HDPE Tubing Clips, Chipboardcarton	Same as cleareddevice
SterilizationMethod	100% EtO	Same as cleareddevice
How Supplied	Sterile/Single Use	Same as cleareddevice

Device Description

Indications for Use

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Technological Characteristics and Product Feature Comparison

The Modified Trevo ProVue Retriever with a modified platinum wire weave is substantially equivalent to the predicate device in terms of design, materials used, and function. A comparison of the subject device with predicate device is summarized in the below table.

Comparison of Cleared Trevo ProVue Retriever to the Modified Trevo ProVue Retriever

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Risk Assessment

Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate device raise no new questions of safety or effectiveness.

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Results of testing have demonstrated the Modified Trevo ProVue Retriever is substantially equivalent to the predicate device. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.

Testing Summary

The results of testing conducted on the Modified Trevo ProVue Retriever demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device:

Test	Test Method Summary	Results
SimulatedUse --Deliverability,Deployment,andReloadability	Simulated use testing used asilicone neurovascular modelcast from actual humanneurovascular arteries. Thisbench testing model replicatesthe tortuosity, diameter andlocation of the arteries in theneurovasculature including theinternal carotid artery (ICA)siphon. The model ends at themid carotid arteries and proximalsupport is provided by a guidecatheter. The modelincorporates a re-circulatingwater bath at 37°C pressurizedbetween 2 - 2.5 psi (100 - 126mm Hg) to simulate the humanarterial circulation. All testingfollows the proceduralinstructions outlined in theInstructions for Use. Simulatedthrombus is used to assess thedevices ability to retrieve clot	All samples passed theacceptance criteria.Device continues to meetsame design requirementsas predicate deviceK122478.

In summary, the results of simulated testing for deliverability, deployment, and reloadability that were conducted on the Modified Trevo ProVue Retriever demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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Summary of Substantial Equivalence

The Modified Trevo ProVue Retriever is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from risk assessments and the testing conducted using the Modified Trevo ProVue Retriever demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 17, 2014

Concentric Medical % Ms. Sarah Meyer Senior Regulatory Affairs Specialist 301 East Evelyn Ave. Mountain View, CA 94041

Re: K133464

Trade/Device Name: Trevo ProVue Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 18, 2013 Received: December 19, 2013

Dear Ms. Meyer:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sarah Meyer

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133464

Device Name: Trevo ProVue Retriever

Indications For Use:

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).