The Modified 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

Like the predicate device, the Modified Trevo 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 and new radiopaque platinum wires in the shaped section allow fluoroscopic visualization. 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 text describes a 510(k) premarket notification for a medical device called the "Modified Trevo Retriever." This submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy against specific acceptance criteria for a new clinical indication. Therefore, the information typically associated with acceptance criteria for a medical AI device, a study design to meet those criteria, and the detailed statistical results expected for such a study is not present in the provided document.

The document focuses on demonstrating that modifications to an existing device (the Trevo Retriever) do not raise new questions of safety or effectiveness, and that the modified device performs as designed and is substantially equivalent to the predicate.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

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

Since this is a 510(k) for a modified device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or image quality, but rather in terms of engineering and functional performance relative to the predicate device. The performance is assessed through various physical and simulated use tests.

Acceptance Criteria (Implied by Testing)	Reported Device Performance
Ability to be used in a neurovascular model per procedural instructions	Successfully evaluated (Simulated Use Testing)
Mechanical integrity under tensile loads	Successfully evaluated (Tensile Testing)
Resulting radial force when constrained radially	Successfully evaluated (Radial Force Testing)
Force to deflect the distal tip	Successfully evaluated (Tip Deflection Force Testing)
Ability to withstand torque and tensile load cycles without fracture	Successfully evaluated (Torque/Tensile Durability Testing)
Ability of the device shaft to resist kinking	Successfully evaluated (Kink Resistance)
Platinum wire and joint integrity following loading cycles	Successfully evaluated (Platinum Wire and Joint Durability)
Platinum wire attachment strength	Successfully evaluated (Platinum Wire Attachment)
Visibility of the platinum shaped section under fluoroscopy during use	Successfully evaluated (Radiopacity)
Substantial equivalence to the predicate device in design, materials, use	Demonstrated through testing; no new safety/effectiveness issues identified

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes (e.g., number of devices tested for each engineering test). It also does not mention data provenance in terms of country of origin or whether any prospective/retrospective clinical data was used, as the testing described is primarily bench and simulated use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. The "ground truth" here is based on engineering specifications and successful completion of physical and simulated performance tests, not on expert clinical review of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to the provided document. Adjudication methods are typically used in clinical studies involving human reviewers to establish a consensus ground truth for diagnostic decisions. The testing described is physical and simulated.

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 such study was done or mentioned. This document pertains to a physical medical device (thrombus retriever), not an AI-powered diagnostic or assistive technology.

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

This question is not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluated is based on established engineering principles, material science, and the ability of the device to meet predefined functional specifications (e.g., in terms of tensile strength, radial force, visibility). For "simulated use testing," the ground truth would be the ability to successfully complete the procedure according to the Instructions for Use in a model.

8. The sample size for the training set

This question is not applicable, as there is no "training set" in the context of this physical device submission.

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

This question is not applicable for the reasons stated above.

Summary

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K122478

2012

510(k) Summary

Trade Name:	Modified Trevo Retriever
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Catheter, Thrombus Retriever, 21CFR 870.1250 Class II
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917
Contact:	Kirsten ValleyVice President, Technology and Regulatory Affairs
Date Prepared:	October 24, 2012
Predicate Device:	Trevo Retriever (K120961)

Device Description

Indications for Use

The Indications for Use are identical to that of the predicate devices and are as follows:

The intended therapeutic use of the device is not impacted and no new issues of safety and effectiveness are raised by the modification.

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Technological Characteristics

The Modified Trevo Retriever has the same technological characteristics as the predicate device. The basic design, materials used, and function have not been changed. Radiopaque platinum wires have been added to the shaped section to allow fluoroscopic visualization.

Testing Summary

The results of verification and validation testing conducted on the Modified Trevo 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:

. Simulated Use Testing: the device's ability to be used in a neurovascular model per procedural instructions outlined in the Instructions for Use was successfully evaluated.
. Tensile Testing: the device's mechanical integrity under tensile loads was successfully evaluated.
. Radial Force Testing: the resulting radial force when the device is constrained radially was successfully evaluated.
. Tip Deflection Force Testing: the force to deflect the distal tip of the device was successfully evaluated.
Torque/Tensile Durability: the ability of the device to withstand torque and tensile load cycles . without fracture was successfully evaluated.
. Kink Resistance: the ability of the device shaft to resist kinking was successfully evaluated.

Verification and Validation of modified components includes:

Platinum Wire and Joint Durability: the platinum wire and joint integrity following loading . cycles was successfully evaluated.
. Platinum Wire Attachment: the platinum wire attachment strength was successfully evaluated.
. Radiopacity: the visibility of the platinum shaped section under fluoroscopy during use was successfully evaluated.

Summary of Substantial Equivalence

The Modified Trevo Retriever is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from the verification and validation testing conducted using the Modified Trevo Retriever demonstrate that it 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/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Concentric Medical, Inc. c/o Ms. Kirsten Valley Vice President, Technology and Regulatory Affairs 301 E. Evelyn Avenue Mountain View, CA 94041

OCT 31 2012

Re: K122478

Trade/Device Name: Modified Trevo Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: August 13, 2012 Received: August 14, 2012

Dear Ms. Valley:

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 101 abouted in the encreated of the enactment date of the Medical Device Amendments, or to econmised pror to May 20, 2011 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 general controls provincitire, 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 If your device is exassified (500 aros). 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.

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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 or any i vith 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 forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ruh. Reann, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K122478

4. Statement of Indications for Use

510(k) Number (if known):	This application
Device Name:	Modified Trevo Retriever
Indications for Use:	The Modified Trevo 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.

INDICATIONS FOR USE

Prescription Use X (Per 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 CDRH, Office of Device Evaluation (ODE)

Samuel K. Shimp III

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K122478

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).