(38 days)
Merci® Retriever X6
No
The summary describes a mechanical device for thrombus retrieval and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended use explicitly states its purpose is to restore blood flow in patients experiencing ischemic stroke and for the retrieval of foreign bodies, both of which are therapeutic interventions.
No
The device is an interventional tool designed to remove thrombus or foreign bodies, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a physical device made of Nitinol with shaped loops and a radiopaque coil, intended for mechanical removal of thrombus or foreign bodies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke" and "retrieval of foreign bodies misplaced during interventional radiological procedures." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical device (flexible wire with loops) used to physically interact with and remove material from within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
This device is clearly designed for a therapeutic procedure performed in vivo (within the living body), not for testing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The Modified 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 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.
Product codes
NRY
Device Description
Like the predicate device, 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.
Both the predicate Retriever and the Modified Merci Retriever 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 microcather are then removed from the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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
The Modified Merci Retriever was tested in the same manner as the predicate Merci Retriever X6. All devices met the required specifications for the completed tests. The Modified Merci Retriever was designed under the Concentric Quality System in compliance with 21CFR 8820.30.
Key Metrics
Not Found
Predicate Device(s)
Merci® Retriever X6
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. Modified Merci Retriever
MAY 2 5 2006
Attachment D
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 Way | |
| Mountain View, CA 94043 | |
| Tel 650-938-2100 | |
| Fax 650-938-2700 | |
| Contact | Kirsten Valley |
| Senior Vice President, Operations and Regulatory Affairs | |
| Date | April 14, 2006 |
Intended Use
The Modified 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 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.
Predicate Device
Merci® Retriever X6
Device Description
Like the predicate device, 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.
Both the predicate Retriever and the Modified Merci Retriever 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 microcather are then removed from the body.
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.
Confidential
1
Testing Summary
The Modified Merci Retriever was tested in the same manner as the predicate Merci Retriever X6. All devices met the required specifications for the completed tests. The Modified Merci Retriever was designed under the Concentric Quality System in compliance with 21CFR 8820.30.
Summary of Substantial Equivalence
The Modified Merci Retriever is equivalent to the predicate device, Merci® Retriever X6. The indications for use, function, and materials used are substantially equivalent.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures intertwined. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Concentric Medical, Inc. % Ms. Kirsten Valley Senior VP, Operations and Regulatory Affairs 1380 Shorebird Way Mountain View, California 94043
Re: K061059
Trade/Device Name: Modified Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: April 26, 2006 Received: April 28, 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) Fins letter with and my Jorne 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
emelli.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Concentric Medical, Inc. Modified Merci Retriever
K06 1059
PREMARKET NOTIFICATION
INDICATIONS FOR USE
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Modified Merci® Retriever |
| Indications for Use: | The Modified 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 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 801.109)
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)
ellmelli
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOS 1059 510(k) Number_
Confidential