The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Device Description

Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.

AI/ML Overview

This 510(k) premarket notification for the Merci Retriever focuses on a device modification and does not include a study describing acceptance criteria and device performance in the way a clinical trial or performance study for a new diagnostic or prognostic device typically would.

The document indicates that the device modification is for the Merci Retriever, which is an endovascular thrombus retriever. The modified device's intended use and materials are the same as the predicate devices. The substantial equivalence determination is based on the modified device having the same intended use and materials as previously cleared devices. Therefore, the information typically requested about acceptance criteria and study design for proving performance is not present in this type of submission.

Here's an breakdown of the requested information, indicating why it's not applicable or present in this specific 510(k) submission:

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

Not applicable/provided. This 510(k) is for a device modification, relying on substantial equivalence to predicate devices for its safety and effectiveness. It does not present new performance data against specific acceptance criteria for a novel device. The "performance" is implicitly considered equivalent to the predicate devices.

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

Not applicable/provided. No new clinical or performance study involving a test set is detailed in this 510(k) for the modified device.

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)

Not applicable/provided. There is no new test set or ground truth establishment described for this device modification.

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

Not applicable/provided. No new test set or adjudication process is described.

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/provided. This device is a mechanical thrombus retriever, not an AI-assisted diagnostic or prognostic tool for human readers.

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

Not applicable/provided. This device is a mechanical thrombus retriever, not a standalone algorithm.

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

Not applicable/provided. No new ground truth is established for this device modification.

8. The sample size for the training set

Not applicable/provided. This is a mechanical device, not a machine learning model, so there is no "training set."

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

Not applicable/provided. Not applicable as this is not a machine learning model.

Summary:

This 510(k) submission (K090085) for the Merci Retriever is a "Special 510(k): Device Modification." Such submissions typically demonstrate substantial equivalence to a predicate device based on design, materials, and intended use remaining largely the same, or minor changes not affecting safety or effectiveness. They do not usually include new clinical studies or elaborate performance data as would be found for an entirely new device or one requiring significant performance validation. The FDA's substantial equivalence determination ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms this approach.

Summary

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FEB 1 2 2009

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

Trade Name	Merci® Retriever
Common Name	Endovascular Retriever
Classification	Thrombus 'Retriever, 21CFR 870.1250 - Class II
Submitter	Concentric® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-938-2700
Contact	Laraine PangelinaDirector, Regulatory Affairs

Intended Use

The intended use for the modified Merci Retrievers is the same as the intended use of the predicate Merci Retrievers:

Predicate Device

Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034)

Device Description

Materials

The materials used in the modified Merci Retrievers are the materials used in the predicate devices.

All materials used in the manufacture of the modified Merci Retrievers are suitable for the intended use of the device and have been used in numerous previously cleared products.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric® Medical, Inc. % Ms. Laraine Pangelina Director, Regulatory Affairs 301 E. Evelyn Avenue Mountain View, California 94041

FEB 1 2 2009

Re: K090085

Trade/Device Name: Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II. Product Code: NR Y Dated: January 12, 2009 Received: January 13, 2009

Dear Ms. Pangelina:

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.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it. may be subject to such 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): 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.

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Page 2 -- Ms. Laraine Pangelina

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (GSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R.P. Oyler

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Concentric Medical, Inc. Special 510(k): Device Modification Merci Retrievers

Kogooos

INDICATIONS FOR USE

510(k) Number (if known):

This application

Device Name:

Merci Retriever

Indications for Use:

The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Prescription Use X (Per 21 CFR 801.109)

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AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil h Doyle for mxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K090085

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).