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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker on the distal end facilitates angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. The Balloon Guide Catheter is identical to K010954 and K021899.

This document is a 510(k) premarket notification for a medical device called the "Concentric Balloon Guide Catheter." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving a device meets specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for this specific device is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance for the Concentric Balloon Guide Catheter. Instead, it relies on the principle of substantial equivalence to previously cleared devices (K010954 and K021899).

The "performance" described is that the device "is identical to K010954 and K021899 and there were no design changes." The submitter states, "The device design, materials used, function, physical properties and composition have not been changed."

Therefore, the "acceptance criteria" were essentially:

• Being identical in design, materials, function, physical properties, and composition to the predicate devices.
• Having the same Indications for Use as the predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for this 510(k) submission directly. This submission primarily relies on the identity to predicate devices.
• Data Provenance: The document states that Concentric Medical referenced "the bench testing, biocompatibility and sterility information in K010954 and K021899." It also referenced "the MERCI and Multi MERCI clinical trials in (K070521 and K082034)" to demonstrate safety and effectiveness.
  • K010954 and K021899 (Predicate Devices): The details of the original testing for these devices (sample size, provenance) are not provided here.
  • K070521 and K082034 (MERCI and Multi MERCI clinical trials): These are referenced for clinical trial data, implying the data would be prospective clinical data. However, the specific sample sizes for these trials as they relate to this specific 510(k) are not given. The trials are mentioned as supporting the safety and effectiveness in a broader sense, likely for the use case rather than the minute performance of this specific guide catheter in a dedicated study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) does not describe a new study with ground truth established by experts for this specific device. It relies on equivalence to predicate devices and previously reviewed clinical trial data.

4. Adjudication method

Not applicable. No new study with adjudication is described for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is typically for evaluating diagnostic imaging algorithms with human readers. This 510(k) is for a physical medical device (catheter) and does not describe such a study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used

For the safety and effectiveness mentioned by referencing the MERCI and Multi MERCI clinical trials, the "ground truth" would likely be patient outcomes data (e.g., successful recanalization, functional independence, adverse event rates), established through clinical diagnoses, imaging, and follow-up in those trials. For the predicate device bench testing, the ground truth would be against engineering specifications for physical properties.

8. The sample size for the training set

Not applicable. This 510(k) is not for an AI/algorithm device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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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 devices, the design of the modified Merci Retrievers 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 filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.

This 510(k) premarket notification for the Merci Retriever focuses on a device modification and does not include a study describing acceptance criteria and device performance in the way a clinical trial or performance study for a new diagnostic or prognostic device typically would.

The document indicates that the device modification is for the Merci Retriever, which is an endovascular thrombus retriever. The modified device's intended use and materials are the same as the predicate devices. The substantial equivalence determination is based on the modified device having the same intended use and materials as previously cleared devices. Therefore, the information typically requested about acceptance criteria and study design for proving performance is not present in this type of submission.

Here's an breakdown of the requested information, indicating why it's not applicable or present in this specific 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Not applicable/provided. This 510(k) is for a device modification, relying on substantial equivalence to predicate devices for its safety and effectiveness. It does not present new performance data against specific acceptance criteria for a novel device. The "performance" is implicitly considered equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/provided. No new clinical or performance study involving a test set is detailed in this 510(k) for the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/provided. There is no new test set or ground truth establishment described for this device modification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/provided. No new test set or adjudication process is described.

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

Not applicable/provided. This device is a mechanical thrombus retriever, not an AI-assisted diagnostic or prognostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/provided. This device is a mechanical thrombus retriever, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/provided. No new ground truth is established for this device modification.

8. The sample size for the training set

Not applicable/provided. This is a mechanical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable/provided. Not applicable as this is not a machine learning model.

Summary:

This 510(k) submission (K090085) for the Merci Retriever is a "Special 510(k): Device Modification." Such submissions typically demonstrate substantial equivalence to a predicate device based on design, materials, and intended use remaining largely the same, or minor changes not affecting safety or effectiveness. They do not usually include new clinical studies or elaborate performance data as would be found for an entirely new device or one requiring significant performance validation. The FDA's substantial equivalence determination ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms this approach.

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