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The Akura Thrombectomy Catheter System:
As part of the Akura Thrombectomy System, the Akura Thrombectomy Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Akura Thrombectomy Accessory Kit:
As part of the Akura Thrombectomy System, the Akura Accessory Kit is indicated to connect the Akura Thrombectomy Catheter to the Akura Thrombectomy Console.

The Akura Thrombectomy Console:
The Akura Thrombectomy Console is indicated as a vacuum source for the Akura Thrombectomy System.

The subject Akura Thrombectomy System is designed to remove thrombus from the vasculature. The System is used by interventionalists trained in percutaneous endovascular thrombectomy procedures. The subject Akura Thrombectomy System is comprised of several devices.

• Akura Thrombectomy Catheter System
  • Akura Thrombectomy Catheter
  • Akura Thrombectomy Sheath
  • Akura Thrombectomy Dilator
• Akura Thrombectomy Console
• Akura Accessory Kit
  • Saline Pump
  • Irrigation Tubing
  • Aspiration Canister Assembly

During use, the Akura Thrombectomy Catheter System and Akura Thrombectomy Accessory Kit are connected to the Akura Thrombectomy Console that is placed outside the sterile field. The Akura Thrombectomy System is introduced through percutaneous access using a commercially available 16F vascular introducer sheath and a 0.035 in exchange length guidewire. The Akura Thrombectomy Catheter System is delivered to the target treatment site under fluoroscopic guidance. The Akura Thrombectomy Dilator is removed from the Akura Thrombectomy Sheath. The Akura Thrombectomy Catheter is inserted through the Akura Thrombectomy Sheath, and the Akura Thrombectomy Catheter funnel is deployed. Thrombus is removed by fragmentation using internal saline jets and aspiration. After the procedure, the Akura Thrombectomy Catheter System is removed from the vasculature and disposed of using standard hospital practices. The Akura Thrombectomy Console is cleaned and stored in accordance with the Akura Thrombectomy System User Manual.

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The Expanse ICE Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse ICE Aspiration System is a peripheral thrombectomy system consisting of several components:

• ICE Aspiration Catheter -
• ICE Aspiration Sheath -
• -Vacuum Fitting
• -High Flow Stopcock Connector
• -Y-Connector with Hemostatic Valve
• Hand Actuator Clip -

The ICE Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheterbased system with the ability to infuse fluid. The ICE Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The ICE Aspiration System is introduced to the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

This document is a 510(k) premarket notification for the ICE Aspiration System, a medical device. It's a regulatory submission to the FDA, not a study report demonstrating acceptance criteria with a specific test set, ground truth, or MRMC study for AI assistance.

The document primarily focuses on establishing "substantial equivalence" of the ICE Aspiration System to existing predicate devices (Indigo Aspiration System and JETi 88 Peripheral Thrombectomy System) for regulatory clearance. It does not contain information about a study proving specific performance metrics against an AI-driven acceptance criteria for a diagnostic or AI-assisted device.

Therefore, I cannot provide the requested information from this document because it does not contain the details of an AI-related performance study. The "Performance Data" section (Section 5) refers to "Bench and animal testing" and lists various non-clinical tests (e.g., biocompatibility, fatigue, kink resistance), which are standard for most medical device clearances, but not the type of AI-specific performance study you are asking about.

The document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI study.
• Sample size, data provenance, or details about test sets for AI evaluation.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone AI performance.
• Type of ground truth for AI.
• Training set sample size or how ground truth for training was established for an AI system.

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