(28 days)
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.
Like the predicate device, the design of the modified Merci Retriever 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 filiaments are attached to the distal end. The core wire proximal to the helix is coated with a fordrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcatheter during the procedure.
I am sorry, but the provided text does not contain information about acceptance criteria and the results of a study as you requested. The document describes a 510(k) submission for a modified Merci Retriever device, focusing on its substantial equivalence to a predicate device. It briefly mentions "design verification and validation testing" confirming conformity to "required specifications," but it does not detail these specifications as acceptance criteria or present specific outcomes of a study that would demonstrate the device meets them.
Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
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UN - 9 2008
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 AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-938-2700 |
| Contact | Kirsten ValleySenior Vice President, Operations and Regulatory Affairs |
Intended Use
The intended use for the modified Merci Retriever is the same as the intended use of the predicate Merci Retriever:
The Mercil Retnever 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 freatment. 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 Retriever, K071172
Device Description
Like the predicate device, the design of the modified Merci Retriever 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 filiaments are attached to the distal end. The core wire proximal to the helix is coated with a fordrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcatheter during the procedure.
Materials
The materials used in the modified Merci Retriever are the materials used in the predicate device.
All materials wed in the manufacture of the modified Merci Retriever are suitable for the intended use of the device and have been used in numerous previously cleared products.
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Testing Summary
Results of design verification and validation testing performed on the nodified Merci Retriever confirm that the device conforms to the required specifications and establish substantial equivalence to the predicate device.
Summary of Substantial Equivalence
The modified Merci Retriever is substantially equivalent to the predicate device with regard to intended use, operating principal, design concept, materials, shelf life, packaging and sterlization processes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2008
Concentric Medical, Inc. % Ms. Kirsten Valley Senior Vice President, Operations and Regulatory Affairs 301 East Evelyn Avenue Mountain View, California 94041
Re: K081305 Trade/Device Name: Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: May 05, 2008 Received: May 08, 2008
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
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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 Postmarket 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. Wilkinson
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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Concentric Medical, Inc. Special 510(k): Device Modification Merci Retriever
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 R.P. Ogle farmxm
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K081305
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§ 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).