(34 days)
No
The summary describes a mechanical device for thrombus retrieval and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which directly addresses a medical condition and provides therapy. It is also used in the retrieval of foreign bodies during interventional radiological procedures.
No
The device is described as a retriever used for removing thrombus or foreign bodies, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical device made of Nitinol with shaped loops and a radiopaque coil, intended for mechanical retrieval of thrombus or foreign bodies. It is not software.
Based on the provided information, the Merci® Retriever is not an In Vitro Diagnostic (IVD) device.
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." This is a therapeutic and interventional procedure 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 blood vessels.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Merci® Retriever does not perform this function.
The Merci® Retriever is a medical device used for interventional procedures within the body, not for testing 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA the monglos candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neurs, peripheral and coronary vasculature.
Product codes
NRY
Device Description
Like the predicate devices, 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, 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)
All devices met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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. Merci Retriever Modification (PFI)
063774
Attachment 5
JAN 2 4 2007
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 |
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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA the monglos candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neurs, peripheral and coronary vasculature.
Predicate Devices
Merci® Retriever (K033736) Modified Merci® Retriever (K061059)
Device Description
Like the predicate devices, 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. Merci Retriever Modification (PFI)
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 equivalent to the predicate devices. The indications for use, function, and materials used are substantially equivalent.
2
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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
Re: K063774
Trade/Device Name: Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: December 20, 2006 Received: December 22, 2006
IAN 2 4 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 coaxi. 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, RDA 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 not 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,
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. Merci Retriever Modification (PFI)
Attachment 3
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 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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Num
Confidential
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