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 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 modified Merci Retriever consists of a flexible, Nitinol core wire with shaped loops at the distal end. A radiopaque coil covers the tip allowing visualization under fluoroscopy.

The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.

AI/ML Overview

The provided documents describe a 510(k) submission for a modified Merci Retriever, a device used to remove thrombus in ischemic stroke patients and retrieve foreign bodies. However, this submission focuses on demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria based on performance metrics.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Substantial Equivalence	Equivalence to predicate devices in: - Indications for Use - Function - Materials used	"The modified Merci Retriever is equivalent to the predicate devices. The indications for use, function, and materials used are substantially equivalent."	This is the primary "acceptance criterion" for a 510(k) submission, not performance metrics. No specific quantitative performance criteria (e.g., success rates, complication rates) are provided.
Material Suitability	"All materials used... are suitable for the intended use."	"All materials used in the manufacture of the Retriever are suitable for the intended use of the device and have been used in numerous previously cleared products."	This is a qualitative statement, not a specific, measurable criterion with associated performance data.
Required Specifications (General)	Met required specifications for completed tests.	"All devices met the required specifications for the completed tests."	This is a general statement. The specific tests and their required specifications are not detailed in the provided text. It likely refers to bench testing (e.g., mechanical, biocompatibility) rather than clinical performance.

Missing Information:

Specific, quantitative performance-based acceptance criteria (e.g., a target success rate for thrombus retrieval, a maximum allowable device-related complication rate, specific mechanical test thresholds).
Detailed results of the "completed tests" that led to the statement "All devices met the required specifications."

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

This information is not provided in the given text.

Sample Size: No information on the number of patients or cases used for any clinical testing. The submission focuses on substantial equivalence based on device characteristics rather than new clinical data from a dedicated test set.
Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. As no clinical or imaging study data is presented, there's no mention of ground truth establishment by experts.

4. Adjudication Method

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The submission does not describe a clinical study comparing human readers with and without AI assistance. This device is a physical medical device (retriever), not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/not provided. The Merci Retriever is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

This information is not provided. If bench testing was performed, the "ground truth" would be the engineering specifications. For clinical performance, it would typically be clinical outcomes or expert adjudication, but no such data is presented.

8. Sample Size for the Training Set

This information is not applicable/not provided. This is a physical device, not a machine learning algorithm, so there is no "training set."

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

This information is not applicable/not provided.

Summary of the Study Discussed (510(k) Submission):

The provided documents describe a 510(k) Premarket Notification for a modification to the Merci® Retriever. The "study" described is essentially the documentation and rationale presented to the FDA to demonstrate substantial equivalence to previously cleared predicate devices (Merci® Retriever K033736 and Modified Merci® Retriever K061059).

Purpose of the "Study": To demonstrate that the modified Merci® Retriever is as safe and effective as existing legally marketed predicate devices, mainly by showing that its indications for use, function, and materials are substantially equivalent.
Key Findings: The submission states that the modified device is substantially equivalent, and that "All materials used in the manufacture of the Retriever are suitable for the intended use of the device and have been used in numerous previously cleared products" and "All devices met the required specifications for the completed tests."
Nature of the Evidence: The evidence primarily comprises:
- Comparison of design features and materials to predicate devices.
- Statements regarding the suitability of materials.
- A general statement that "all devices met the required specifications for the completed tests" (likely referring to bench testing, but details are not provided).
Clinical Data: No new clinical trial data, human subject testing, or expert reviews of clinical outcomes are detailed in the provided text for this specific 510(k) modification. This type of submission often relies on a comparison to predicate devices, and sometimes existing clinical data for the predicate device, rather than new, extensive clinical studies for minor modifications.

Summary

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Concentric Medical, Inc. Merci Retriever Modification (PFI)

063774

Attachment 5

JAN 2 4 2007

510(k) SUMMARY

General Information

Trade Name	Merci® Retriever
Common Name	Endovascular Retriever
Classification	Class II, Catheter, thrombus Retriever per 21 CFR § 870.1250
Submitter	Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043Tel 650-938-2100Fax 650-938-2700
Contact	Kirsten ValleySenior Vice President, Operations and Regulatory Affairs

Intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA the monglos candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neurs, peripheral and coronary vasculature.

Predicate Devices

Merci® Retriever (K033736) Modified Merci® Retriever (K061059)

Device Description

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Concentric Medical, Inc. Merci Retriever Modification (PFI)

K063774

Materials

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

Testing Summary

All devices met the required specifications for the completed tests.

Summary of Substantial Equivalence

The modified Merci Retriever is equivalent to the predicate devices. The indications for use, function, and materials used are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. % Ms. Kirsten Valley Senior VP, Operations and Regulatory Affairs 1380 Shorebird Way Mountain View, California 94043

Re: K063774

Trade/Device Name: Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: December 20, 2006 Received: December 22, 2006

IAN 2 4 2007

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 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 coaxi. 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 either 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, RDA 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 not 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. Kirsten Valley

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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. Merci Retriever Modification (PFI)

Attachment 3

INDICATIONS FOR USE

510(k) Number (if known):

This application

Device Name:

Merci® Retriever

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

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)

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

510(k) Num

Confidential

Page 29 of 33

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).