(60 days)
Not Found
No
The description focuses on the mechanical function of the device and does not mention any AI/ML components or capabilities.
Yes
The device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The device, the Modified Merci® Retriever, is described as a tool for removing thrombus or foreign bodies from vasculature, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of a physical Nitinol core wire with shaped loops and a radiopaque coil, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Modified Merci® Retriever is a mechanical device designed to physically remove thrombus or foreign bodies from blood vessels within the body. It is used in vivo (within the living organism), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's vasculature to restore blood flow or retrieve foreign objects.
Therefore, the function and intended use of the Modified Merci® Retriever classify it as a therapeutic medical 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 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.
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. The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body 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
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
All devices met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Merci Retriever
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
Y
2
Attachment 5
APR 2 4 2007
510(k) SUMMARY
General Information
| Trade Name | Modified 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
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 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.
Predicate Device
Merci Retriever
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.
The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.
1
Concentric Medical, Inc. Modified Merci Retriever February 2007
Materials
All materials used in the manufacture of the Retriever are suitable for the intended use of the device and have been used in numerous previously cleared products.
Testing Summary
All devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
The Modified Merci® Retriever is substantially equivalent to the predicate device. The indications for use, function, and materials used are equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
APR 2 4 2007
Re: K070521
Trade/Device Name: Modified Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: March 23, 2007 Received: March 26, 2007
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) 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,
for Mark N. Melkerson
Director
Peter Remm
DEP DIR
m2
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 February 2007
Attachment 3
INDICATIONS FOR USE
Modified Merci Retriever
510(k) Number (if known):
This application
Device Name:
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 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.
Nda. Ramos
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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)