(38 days)
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 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.
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.
Both the predicate Retriever and the Modified Merci Retriever are placed distal to the thrombus or foreign body using a microcatheter which is retracted to deploy the loops of the Retriever. The Retriever and microcatheter are pulled back into the thrombus or foreign body, engaging it in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcather are then removed from the body.
This document is a 510(k) summary for the Concentric Medical, Inc. Modified Merci Retriever. It aims to demonstrate substantial equivalence to the predicate device, the Merci® Retriever X6, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of specific, quantifiable acceptance criteria or reported device performance in the context of typical clinical study results (e.g., sensitivity, specificity, accuracy, workflow time, etc.). Instead, it states that the device was tested and found to meet "required specifications."
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (Merci® Retriever X6): Implicit expectation that the Modified Merci Retriever performs as well as or better than the predicate in all critical functions. | "All devices met the required specifications for the completed tests." |
| Material Suitability: Implicit expectation that materials are safe and effective for intended use. | "All materials used 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." |
| Design Compliance: Implicit expectation that the device adheres to quality system regulations. | "The Modified Merci Retriever was designed under the Concentric Quality System in compliance with 21CFR 8820.30." |
| Intended Use Equivalence: Implicit expectation that the new device supports the same indications. | "The Modified Merci Retriever is equivalent to the predicate device, Merci® Retriever X6. The indications for use, function, and materials used are substantially equivalent." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document indicates "All devices" were tested, implying all manufactured units or a representative sample from a production lot were subjected to engineering/performance tests, but no test set in the context of clinical data is mentioned.
- Data Provenance: Not applicable. The testing described appears to be engineering and design verification, not clinical data from patients or a specific geographical region.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes product testing (design verification, material suitability) rather than a study requiring expert-established ground truth for clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of clinical data or adjudication processes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a 510(k) submission for a medical device (thrombus retriever), not an AI diagnostic tool. Therefore, an MRMC study related to AI performance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for clinical ground truth. For the engineering tests, the "ground truth" would be the predefined specifications and performance metrics for the device (e.g., tensile strength, flexibility, material composition, deployment mechanism integrity), which are internally established by the manufacturer and often align with industry standards or recognized test methods.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a machine learning or AI product.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
Summary of the Study (as described):
The "study" described in the document is a design verification and validation process for the Modified Merci Retriever. It is a comparison to a predicate device (Merci® Retriever X6) to establish substantial equivalence.
- Study Type: Design verification and validation.
- Objective: To demonstrate that the Modified Merci Retriever is substantially equivalent to the predicate device (Merci® Retriever X6) in terms of indications for use, function, materials, and safety/performance.
- Methodology: The device underwent "the same manner" of testing as the predicate device. This implies a series of internal engineering and performance tests (e.g., mechanical tests, material compatibility tests, deployment tests in a simulated environment) to ensure the device meets its design specifications and performs comparably to the predicate.
- Conclusion: The manufacturer concluded that "All devices met the required specifications for the completed tests" and that the Modified Merci Retriever is "substantially equivalent" to the predicate device.
This 510(k) summary focuses on demonstrating that the new device does not raise new questions of safety or effectiveness compared to a previously cleared device, which is the standard for 510(k) submissions. It does not provide detailed clinical trial data or performance metrics from a large patient cohort, as would be expected for a novel device or an AI clinical decision support tool.
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Concentric Medical, Inc. Modified Merci Retriever
MAY 2 5 2006
Attachment D
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 WayMountain View, CA 94043Tel 650-938-2100Fax 650-938-2700 |
| Contact | Kirsten ValleySenior Vice President, Operations and Regulatory Affairs |
| Date | April 14, 2006 |
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 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 X6
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.
Both the predicate Retriever and the Modified Merci Retriever are placed distal to the thrombus or foreign body using a microcatheter which is retracted to deploy the loops of the Retriever. The Retriever and microcatheter are pulled back into the thrombus or foreign body, engaging it in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcather are then removed from the body.
Materials
All materials used 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.
Confidential
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Testing Summary
The Modified Merci Retriever was tested in the same manner as the predicate Merci Retriever X6. All devices met the required specifications for the completed tests. The Modified Merci Retriever was designed under the Concentric Quality System in compliance with 21CFR 8820.30.
Summary of Substantial Equivalence
The Modified Merci Retriever is equivalent to the predicate device, Merci® Retriever X6. The indications for use, function, and materials used are substantially equivalent.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures intertwined. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Concentric Medical, Inc. % Ms. Kirsten Valley Senior VP, Operations and Regulatory Affairs 1380 Shorebird Way Mountain View, California 94043
Re: K061059
Trade/Device Name: Modified Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: April 26, 2006 Received: April 28, 2006
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.
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Page 2 - Ms. Kirsten Valley
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter with and my Jorne 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
emelli.
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. Modified Merci Retriever
K06 1059
PREMARKET NOTIFICATION
INDICATIONS FOR USE
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Modified Merci® Retriever |
| Indications for Use: | The Modified Merci® Retriever is intended to restore blood flowin the neurovasculature by removing thrombus in patientsexperiencing ischemic stroke. Patients who are ineligible forintravenous tissue plasminogen activator (IV t-PA) or who failIV t-PA therapy are candidates for treatment. The ModifiedMerci® Retriever is also indicated for use in the retrieval offoreign bodies misplaced during interventional radiologicalprocedures 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)
ellmelli
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOS 1059 510(k) Number_
Confidential
§ 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).