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The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The MobiCath™ Bidirectional Guiding Sheath is an 8.5 French, flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry that allows deflection of the distal portion of the device bi-directionally 150°. This feature provides steerability to facilitate the delivery of therapeutic devices into the heart including the left atrium, using minimally invasive techniques. The sheath is fitted with a hemostatic valve which minimizes blood loss and air intake by providing hemostasis sealing to venous pressures as well as reduce dilator insertion and removal force. The sheath is also equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath and dilator contain radiopaque material for visualization under fluoroscopy.

The provided text describes a 510(k) premarket notification for the MobiCath™ Bi-Directional Guiding Sheath, a medical device. The submission explicitly states that no animal or clinical study was deemed necessary for this device. Instead, substantial equivalence to previously cleared predicate devices was demonstrated through functional, dimensional, and material testing.

Therefore, the requested information regarding acceptance criteria derived from clinical studies, comparative effectiveness, standalone performance, ground truth establishment for test/training sets, and expert involvement is not applicable in this context.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. Performance verified through engineering and material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by medical experts for device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.

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. This device is not an AI-assisted diagnostic tool, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance was established through engineering specifications and industry standards for mechanical, material, and biocompatibility testing.

8. The sample size for the training set: Not applicable. No training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. No training set.

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