(63 days)
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.
§ 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).