The Modified Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing an 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 Modified Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Device Description

Like the predicate device, the Modified Merci Retriever consists of a flexible, Nitinol core wire with shaped distal loops covered by a platinum coil for radiopacity. It is coated with a hydrophilic lubricious coating.

Both the Modified Merci Retriever and the predicate device are placed distal to the thrombus or foreign body using a microcatheter which is retracted to deploy the loops of the Retriever. The Retriever and microcatheter are pulled back into the thrombus or foreign body, engaging it 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 text is a 510(k) summary for the Modified Merci® Retriever. It details the device's description, intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or the details of a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or outcomes.

This document focuses on demonstrating substantial equivalence to a previously cleared device (Merci® Retriever X6) through materials and testing methods. It states: "The Modified Merci Retriever was tested in the same manner as the predicate device. All devices met the required specifications for the completed tests." This implies that the 'acceptance criteria' were likely internal engineering specifications for the device's physical properties and function, rather than clinical performance metrics in a study.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it pertains to clinical study design and performance evaluation, which is not present here.

Here's what can be answered based on the provided text, and what cannot:

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

Cannot be provided. The document does not explicitly list acceptance criteria (e.g., target thrombus removal rates, recanalization success, complication rates) or reported performance metrics in a clinical context. It only states that all devices "met the required specifications for the completed tests," which refers to product-level engineering tests, not clinical performance.

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

Cannot be provided. A clinical "test set" and its provenance are not mentioned.

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):

Cannot be provided. This information would be relevant to a clinical study, which is not detailed in this submission.

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

Cannot be provided. This is relevant to a clinical study.

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:

Cannot be provided. This device is an endovascular retriever, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not applicable.

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

Cannot be provided. This device is a physical medical instrument, not a standalone algorithm.

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

Cannot be provided. Ground truth is a concept for evaluating diagnostic or imaging systems against a definitive reference. This document for a physical medical device does not discuss such ground truth in relation to performance.

8. The sample size for the training set:

Cannot be provided. This would be relevant for an AI/machine learning model, which this device is not.

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

Cannot be provided. Not applicable to this type of device submission.

Summary of what is available from the text relevant to testing:

Testing Approach: The Modified Merci® Retriever was tested "in the same manner as the predicate device."
Outcome of Tests: "All devices met the required specifications for the completed tests."
Quality System: The device was designed under the Concentric Quality System, which complies with 21CFR8820.30.

This submission relies on demonstrating "substantial equivalence" to a predicate device (Merci® Retriever X6), implying that if the new device performs comparably in engineering design and materials, and meets similar specifications, it is considered safe and effective for similar indications. The document does not contain the level of detailed clinical study data often found for new devices or AI/diagnostic tools.

Summary

{0}------------------------------------------------

062046

510(k) Summary

Image /page/0/Picture/2 description: The image shows the logo for Concentric Medical. The logo consists of a stylized graphic to the left of the company name. The graphic is a series of concentric ovals. The text "Concentric" is on the first line, and "Medical" is on the second line.

JAN 1 9 2007

General Information

Trade Name	Modified Merci® Retriever
Common Name	Endovascular Retriever
Classification	Class II, Catheter, Thrombus Retriever per 21 CFR §870.1250
Submitter/Owner	Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043Phone: 650-938-2100Fax: 650-938-2700
EstablishmentRegistration Number	2954917
Contact	Kirsten ValleySenior Vice President, Regulatory Affairs andOperations
Prepared	July 18, 2006

Intended Use

Predicate Device

Merci® Retriever X6

{1}------------------------------------------------

Kob 20 46

Device Description and Technology Comparison to Predicate Device

Materials

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

Testing Summary

The Modified Merci Retriever was tested in the same manner as the predicate device. All devices met the required specifications for the completed tests. The Modified Merci Retriever was designed under the Concentric Quality System that is in compliance with 21CFR8820.30.

Summary of Substantial Equivalence

The Modified Merci Retriever is substantially equivalent to the predicate device, the Merci Retriever X6.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the right. The eagle's body is represented by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern 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

JAN 1 9 2007

Re: K062046

Trade/Device Name: Modified Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: November 17, 2006 Received: November 20, 2006

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 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 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, 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.

{3}------------------------------------------------

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

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

Enclosure

{4}------------------------------------------------

4. Indications for Use Statement

KO62046 510(k) Number (if known): (intentionally left blank)

Device Name: Modified Merci® Retriever

The Modified Merci Retriever is intended to restore blood flow Indications for Use: 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 Modified 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 .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)

Division Sign-Off

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

510(k) Number K062046

4-1

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).