(257 days)
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.
The Merci 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.
This document describes the 510(k) premarket notification for the Concentric Merci® Retriever Models X5 and X6. The information provided is directly from the submitted summary and FDA clearance letter.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the predicate device equivalence and testing, but does not explicitly state specific quantitative acceptance criteria or detailed performance metrics against those criteria. It uses language indicating that the device "met the required specifications" and that "no new issues of safety and effectiveness exist."
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | No new issues of safety and effectiveness | "The MERCI Clinical Study established that no new issues of safety and effectiveness exist when the Merci Retriever is used for thrombus removal versus foreign body removal from the neurovasculature." |
| Predicate Equivalence | Substantially equivalent to predicate device (Concentric Retriever K030476) in indications for use, function, methods of manufacturing, and materials. | "The Merci Retriever is equivalent to the predicate device, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent." |
| Specifications | Met required specifications for all components, subassemblies, and/or full devices. | "All components, subassemblies, and/or full devices met the required specifications for the completed tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions a "MERCI Clinical Study" but does not specify the sample size for this study.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Clinical studies for medical devices typically involve prospective data collection, but this is not confirmed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth within the MERCI Clinical Study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set in the MERCI Clinical Study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided document. The submission focuses on device clearance through substantial equivalence and a clinical study assessing safety and effectiveness, not direct comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This device is a physical medical device (a catheter for thrombus retrieval), not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission.
7. Type of Ground Truth Used
The document refers to a "MERCI Clinical Study" that established safety and effectiveness for "thrombus removal versus foreign body removal." This suggests that the ground truth would have been based on clinical outcomes data related to successful thrombus removal, restoration of blood flow, and potentially adverse events, as observed and documented during clinical procedures. Pathology or expert consensus on images alone would likely not be sufficient for assessing the performance of a physical retrieval device.
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. Since the Merci Retriever is a physical medical device, there is no explicit "training set" in the context of AI development. The device's design, manufacturing, and preclinical testing would involve various engineering and bench testing data, but not an AI training set.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no AI training set for this physical device. Therefore, this question is not applicable. The device's "ground truth" during its development would have been established through a combination of engineering specifications, material testing standards, and preclinical (in vitro and in vivo) performance evaluations against defined mechanical and functional requirements.
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Concentric Medical, Inc.
K033736 1/2
AUG 1 1 2004
510(k) Summary
General Information
| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|---|---|
| Trade Name | Concentric Merci® RetrieverModels X5 and X6 |
| Submitter | Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043 |
| Tel: 650-938-2100Fax: 650-938-2700 | |
| Contact | Kevin F. MacDonaldVice President, Clinical 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 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.
Predicate Devices K030476 Concentric Retriever Manufactured by Concentric Medical, Inc.
Device Description
The Merci 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.
Materials
All materials used in the manufacture of the Merci Retriever are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The Merci Retriever was tested in the same manner as the predicate Concentric Retriever (K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Merci Retriever was designed under the Concentric Quality System that is in compliance with 21CFR§820.30.
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KC 3373C
2/2
Summary of Clinical Testing
The MERCI Clinical Study established that no new issues of safety and effectiveness exist when the Merci Retriever is used for thrombus removal versus foreign body removal from the neurovasculature.
Summary of Substantial Equivalence
The Merci Retriever is equivalent to the predicate device, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Concentric Medical, Inc. believes the Merci Retriever is substantially equivalent to existing legally marketed device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2004
Mr. Kevin 1 . MacDonald Vice President, Clinical and Regulatory Affairs Concentric Medical, Inc. 1380 Shorebird Way Mountain View, California 94043
Re: K033736
Trade/Device Name: Concentric Merci® Retriever Models X5 and X6 Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, thrombus retriever Regulatory Class: II Product Code: NR Y Dated: May 28, 2004 Received: June 2, 2004
Dear Mr. MacDonald:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 roxy premier is substantially equivalent (for the indications felcrenced above und nave actoring ally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, de necs that have been receive approval of a premarket approval application (PMA). and Costicule Tec (110) that to neview subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of use ice, 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 If your device is classified (600 abovetrols. Existing major regulations affecting your device can may oc subject to such additions. 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 I lease of advised that I Drivision that your device complies with other requirements of the Act that I DT has made a wond regulations administered by other Federal agencies. You must or any it cactares and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin F. MacDonald
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting of substantial equivalence of your device to a legally premaired 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 If you desire specific davice 101 Jour 2011) 594-4659. Also, please note the regulation entitled, Connact the Office of Company of Company (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/dsma/dsmamain.html
Sincerely yours,
Celia M. Witt, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K033736 |
|---|---|
| Device Name: | Concentric Merci® RetrieverModels X5 and X6 |
| Indications for Use: | The Merci Retriever is intended to restore blood flow in theneurovasculature by removing thrombus in patients experiencingischemic stroke. Patients who are ineligible for treatment withintravenous tissue plasminogen activator (IV t-PA) or who fail IVt-PA therapy are candidates for treatment. The Merci Retriever isalso indicated for use in the retrieval of foreign bodies misplacedduring interventional radiological procedures in the neuro,peripheral and coronary vasculature. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the co
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_ ビムタイプ イン
§ 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).