The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Device Description

The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A platinum coil is attached over the helical distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Modified Concentric Retriever." This submission aims to demonstrate substantial equivalence to a predicate device, not to establish performance against specific quantitative acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.

Here's a breakdown of what can be extracted and what is not available based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for a 510(k) is substantial equivalence to the predicate device. This implies that the device should perform "as intended" and not raise new questions of safety or effectiveness.	The document states: "All components, subassemblies, and/or full devices met the required specifications for the completed tests." "The modified Concentric Retriever was tested in the same manner as the predicate Concentric Retriever (K003410)."
Implied Criteria: Same indications for use, function, methods of manufacturing, and materials as the predicate.	The device meets these implied criteria, as stated in the "Summary of Substantial Equivalence."

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

Not applicable. The document describes non-clinical testing for substantial equivalence, not a clinical study with a test set of patient data. The "tests" mentioned are likely bench or in-vitro tests on the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This information pertains to studies establishing ground truth, typically for AI/imaging devices, which is not the subject of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the context of clinical data requiring adjudication.

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. This device is a medical tool (catheter) for foreign body retrieval, not an AI or imaging diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this device would be its ability to physically perform its intended function (retrieval of foreign bodies) without failure or adverse events, as demonstrated through engineering and bench testing.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a "training set."

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

Not applicable.

Summary based on the document:

The 510(k) submission for the "Modified Concentric Retriever" focuses on demonstrating substantial equivalence to an existing predicate device (Concentric Retriever K003410). This is a regulatory pathway that allows devices to be marketed without requiring new clinical trials if they are shown to be as safe and effective as a legally marketed device.

The "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence consists of non-clinical testing. The document states that "The modified Concentric Retriever was tested in the same manner as the predicate Concentric Retriever (K003410). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This suggests that the device underwent rigorous engineering and performance testing (e.g., mechanical integrity, functional testing in simulated environments) to ensure it performs identically or equivalently to the predicate device.

The information provided does not include details about specific quantitative acceptance criteria or the specifics of these "required specifications" or the "completed tests," nor does it involve clinical studies with human subjects, expert review, or AI performance metrics.

Summary

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Concentric Medical, Inc.

11030476

510(k) Summary

MAR 1 1 2003

General Information

Classification	Class II, Percutaneous Catheter per 21 CFR § 870.1250
Trade Name	Modified Concentric Retriever
Submitter	Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043
	650-938-2100
Contact	Kevin F. MacDonaldVice President, Clinical and Regulatory Affairs

Intended Use

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Predicate Devices Concentric Retriever K003410 Manufactured by Concentric Medical, Inc.

Device Description

Materials

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

Testing Summary

The modified Concentric Retriever was tested in the same manner as the predicate Concentric Retriever (K003410). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The modified Concentric Retriever was designed under the Concentric Quality System which is in compliance with 21CFR 8820.30.

Summary of Substantial Equivalence

The modified Concentric Retriever is equivalent to the predicate product, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Concentric Medical, Inc. believes the Concentric Retriever is substantially equivalent to existing legally marketed devices.

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Image /page/1/Picture/2 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem that resembles an abstract representation of a bird or a symbol of protection and care.

MAR 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin F. MacDonald Vice President, Clinical and Regulatory Affairs Concentric Medical, Inc. 1380 Shorebird Way Mountain View, CA 94043

Re: K030476

Trade/Device Name: Modified Concentric Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 12, 2003 Received: February 13, 2003

Dear Mr. MacDonald:

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

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Page 2 - Mr. Kevin F. MacDonald

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. 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours.

V.R. Delatorre, M.D.

Bram D. Žuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application

Modified Concentric Retriever

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

X. C. M.

Number KD30474

(Optional Format 1-2-96)

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).