(78 days)
Not Found
Not Found
No
The document 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 device is intended to treat ischemic stroke by removing thrombus and foreign bodies, which are therapeutic interventions.
No
The Mercy Retriever is explicitly described as a device for removing thrombus or foreign bodies, which is a therapeutic intervention, not a diagnostic one. While the Mercy Microcatheter can be used during diagnostic procedures, the primary device in question, the Retriever, and the overall intended use of the system are therapeutic.
No
The device description clearly describes a physical medical device made of Nitinol with shaped loops and a radiopaque coil, intended for mechanical removal of thrombus. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to physically remove thrombus or foreign bodies from blood vessels. This is an in vivo procedure.
- Device Description: The description details a physical device (retriever and microcatheter) designed for mechanical interaction within the vasculature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to directly treat conditions within the body.
N/A
Intended Use / Indications for Use
Merci® Retriever
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.
Concentric Microcatheter
The Concentric Microcatheter is indicated for use in the selected placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NRY, DQO
Device Description
Like the predicate device, the 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 shaped loops of the Retriever are deployed distal to the thrombus or foreign body through the 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
Not Found
Anatomical Site
Neurovasculature (brain), peripheral vasculature, coronary vasculature (heart)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
DEC 1 & 2007
12
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 |
| and | |
| Trade Name | Merci® Microcatheter |
| Common Name | Intravascular Diagnostic Catheter |
| Classification | Class II, Catheter, thrombus Retriever per 21 CFR § 870.1200 |
| Submitter | Concentric® Medical, Inc. |
| 301 E. Evelyn Ave. | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-938-2700 | |
| Contact | Kirsten Valley |
| Senior Vice President, Operations and Regulatory Affairs |
Intended Use
Merci® Retriever
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.
Concentric Microcatheter
The Concentric Microcatheter is indicated for use in the selected placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
Predicate Device
Merci Retriever Merci Microcatheter
1
Device Description
Like the predicate device, the 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 shaped loops of the Retriever are deployed distal to the thrombus or foreign body through the 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.
Materials
All materials used in the manufacture of the various Retrievers and Microcatheters are suitable for the intended use of the device.
Testing Summary
All devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
The Merci® Retrievers and the Concentric Microcatheters are substantially equivalent to their respective predicate devices. In each case the indications for use, function, and materials used are equivalent.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a modern interpretation of the Rod of Asclepius, a traditional symbol of medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2007
Concentric Medical, Inc. % Ms. Kirsten Valley Sr. VP, Operations & Regulatory Affairs 301 East Evelyn Avenue Mountain View, California 94041
Re: K072796
Trade/Device Name: Merci Retriever and Merci Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY, DQO Dated: November 19, 2007 Received: November 20, 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
3
Page 2 -- Ms. Kirsten Valley
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.
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 (OSB's) Division of Prosmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical 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.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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. | |||
| Device Name: | Merci Microcatheter | ||
| Indications for Use: | The Merci Microcatheter is indicated for use in the selected | ||
| placement of fluids and/or other devices or agents into the | |||
| peripheral, coronary and neuro vasculature during diagnostic | |||
| and/or therapeutic procedures. | |||
| 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 (OØG)
ice Evaluation (ODI)
(Division Sign-Off) (Division Sign-On) Restorative, Division of Generalive,
Division of General, Devices Division of Geless and Neurological Devices
510(k) Number 11072796