(184 days)
Not Found
Not Found
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 explanation of "Intended Use / Indications for Use" clearly states that the device is intended to restore blood flow by removing thrombus in patients experiencing an ischemic stroke and for the retrieval of foreign bodies, which are direct therapeutic actions.
No
The Modified Merci Retriever is a thrombectomy device designed to remove clots or foreign bodies from blood vessels, which is a therapeutic, not a diagnostic, function.
No
The device description clearly outlines a physical medical device made of Nitinol and platinum, designed for mechanical thrombus retrieval. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "restore blood flow in the neurovasculature by removing thrombus" and for "retrieval of foreign bodies misplaced during interventional radiological procedures." This describes a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical device (flexible wire with loops) that is inserted into the body to physically interact with and remove blockages or foreign objects.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any testing of samples or analysis of biological markers.
Therefore, the Modified Merci Retriever is an interventional or therapeutic device, not an In Vitro Diagnostic device.
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 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.
Product codes
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature, neuro, peripheral and coronary vascular systems
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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 Way | |
| Mountain View, CA 94043 | |
| Phone: 650-938-2100 | |
| Fax: 650-938-2700 | |
| Establishment | |
| Registration Number | 2954917 |
| Contact | Kirsten Valley |
| Senior Vice President, Regulatory Affairs and | |
| Operations | |
| Prepared | July 18, 2006 |
Intended Use
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.
Predicate Device
Merci® Retriever X6
1
Kob 20 46
Device Description and Technology Comparison to Predicate Device
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.
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.
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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
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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
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