(117 days)
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 AI/ML.
Yes
The device is intended to treat ischemic stroke by removing thrombus and retrieving foreign bodies, directly addressing a medical condition.
No
Explanation: The device is designed to remove thrombus or foreign bodies (therapeutic intervention), not to identify or characterize a disease or condition (diagnostic).
No
The device description clearly outlines a physical medical device made of Nitinol with shaped loops and a radiopaque coil, intended for mechanical retrieval of thrombus or foreign bodies. It is not a software-only device.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Modified Merci Retriever is a device used inside the body (in vivo) to physically remove blood clots or foreign bodies from blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed within the patient's vasculature to restore blood flow or retrieve foreign objects. This is an interventional procedure, not a diagnostic test on a specimen.
Therefore, based on the provided information, the Modified Merci Retriever is an in vivo therapeutic device, not an IVD.
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 TV 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 (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)
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
Attachment 5
AUG 2 2 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 TV 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 Devices
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
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 consists of a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
Concentric Medical, Inc. % Ms. Kirsten Valley Senior VP, Operations & Regulatory Affairs 1380 Shorebird Way Mountain view, California 94043
Re: K071172
Trade/Device Name: Modified Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: June 5, 2007 Received: June 6, 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,
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. Modified Merci Retriever
Attachment 3
INDICATIONS FOR USE
510(k) Number (if known):
This application
Device Name:
Indications for Use:
Modified Merci Retriever
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.
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 (DIVIS AGE IF NEEDED) Division of Gen torative . Concurrence of CDRH, Office office of F
510(k) Number
Confidential