(30 days)
No
The document describes a mechanical device for thrombus retrieval and does not mention any AI/ML components or functionalities.
Yes
The device is intended to treat a medical condition (ischemic stroke, foreign body removal) by restoring blood flow and removing obstructions, which classifies it as therapeutic.
No
The device description states its purpose is to restore blood flow by removing thrombus and retrieving foreign bodies, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines physical components made of Nitinol, platinum, and polymer, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Merci Retriever Function: The Merci Retriever is a mechanical device designed to physically remove blood clots (thrombus) from blood vessels within the body. It is used in vivo (within the living organism) during a medical procedure.
The description clearly indicates it's an interventional device used directly within the patient's vasculature, not a device used to test samples outside the body.
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
NRY
Device Description
Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063774, K062046, K071172, K070521, K081305, K082034
Reference Device(s)
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
FEB 1 2 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| Trade Name | Merci® Retriever |
|---|---|
| Common Name | Endovascular Retriever |
| Classification | Thrombus 'Retriever, 21CFR 870.1250 - Class II |
| Submitter | Concentric® Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-938-2700 | |
| Contact | Laraine Pangelina |
| Director, Regulatory Affairs |
Intended Use
The intended use for the modified Merci Retrievers is the same as the intended use of the predicate Merci Retrievers:
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 Device
Merci® Retrievers (K063774, K062046 K071172, K070521, K081305, K082034)
Device Description
Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.
Materials
The materials used in the modified Merci Retrievers are the materials used in the predicate devices.
All materials used in the manufacture of the modified Merci Retrievers are suitable for the intended use of the device and have been used in numerous previously cleared products.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Concentric® Medical, Inc. % Ms. Laraine Pangelina Director, Regulatory Affairs 301 E. Evelyn Avenue Mountain View, California 94041
FEB 1 2 2009
Re: K090085
Trade/Device Name: Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II. Product Code: NR Y Dated: January 12, 2009 Received: January 13, 2009
Dear Ms. Pangelina:
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 cither 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.
2
Page 2 -- Ms. Laraine Pangelina
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (GSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Neil R.P. Oyler
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Concentric Medical, Inc. Special 510(k): Device Modification Merci Retrievers
Kogooos
INDICATIONS FOR USE
510(k) Number (if known):
This application
Device Name:
Merci Retriever
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 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)
Neil h Doyle for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090085