(257 days)
K030476 Concentric Retriever
Not Found
No
The 510(k) summary describes a mechanical device for thrombus removal and foreign body retrieval, with no mention of AI or ML in the intended use, device description, or performance studies. The input imaging modality is fluoroscopy, which is used for visualization during the procedure, not for AI/ML processing.
Yes
The device is described as restoring blood flow and removing thrombus in stroke patients, and retrieving foreign bodies, which are direct therapeutic interventions.
No
Explanation: The device is intended to remove thrombus and foreign bodies, which are treatment interventions, not diagnostic functions.
No
The device description clearly states it is a physical device made of Nitinol and platinum, designed for mechanical thrombus removal. It is not software.
Based on the provided information, the Merci Retriever is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Merci Retriever is to restore blood flow by removing thrombus directly from the neurovasculature and to retrieve foreign bodies from within blood vessels. This is an interventional procedure performed in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- The device description and intended use clearly describe a medical device used for a therapeutic procedure. It's a physical tool used to interact directly with the patient's anatomy.
Therefore, the Merci Retriever falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature, neuro, peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030476 Concentric Retriever
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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® Retriever |
| Models X5 and X6 | |
| Submitter | Concentric Medical, Inc. |
| 1380 Shorebird Way | |
| Mountain View, CA 94043 | |
| Tel: 650-938-2100 | |
| Fax: 650-938-2700 | |
| Contact | Kevin F. MacDonald |
| Vice 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.
1
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.
2
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.
3
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
4
Indications for Use
| 510(k) Number (if known): | K033736 |
|---|---|
| Device Name: | Concentric Merci® Retriever |
| Models X5 and X6 | |
| 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 _____________________________________________________________________________________________________________________________________________________________ (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)
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Division of General, Restorative, and Neurological Devices
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