(84 days)
The JETi AIO Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
The JETi All In One (AIO) Peripheral Thrombectomy System consists of one catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Kit and Sterile Kit are supplied for user convenience. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. Infusion is achieved by activating the Hyper Pulse® rocker switch. When in Hyper Pulse® mode, activating the handheld switch activates the SDU motor to infuse/deliver diagnostic or therapeutics to the targeted site. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart.
The provided text is a 510(k) Premarket Notification from the FDA, indicating the premarket clearance of the JETi AIO Peripheral Thrombectomy System by Walk Vascular, LLC.
However, the document does not contain information related to acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy, etc.), test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device approval.
Instead, this document describes a traditional 510(k) clearance based on substantial equivalence to a predicate device (JETi AIO Peripheral Thrombectomy System K201998). The evaluation primarily focused on:
- Device Description and Comparison: Detailing the components and comparing the new device (subject device) to the predicate device, highlighting key differences like the addition of a 6 Fr catheter size and a Hyper Pulse® rocker switch.
- Non-Clinical Performance Data: Summary of bench testing (e.g., catheter design verification, fluid flow rate, system leak testing, clot removal, electrical safety), indicating that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements."
- Biocompatibility and Sterilization: Stated that these tests were "not conducted, as the catheter and pump set materials/designs are identical/comparable to the predicate device."
- Transportation and Shelf Life: Not conducted for similar reasons or because the change (Hyper Pulse®) was deemed not to impact these.
- Pre-Clinical and Clinical Data: Explicitly states, "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/ML device, as this document pertains to a traditional medical device clearance where such metrics are not typically required or presented in this format.
The questions in your prompt (e.g., sensitivity, specificity, expert consensus, MRMC studies, training set details) are highly relevant to the clearance of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, which undergo a different type of evaluation process. This document describes the clearance of a mechanical thrombectomy system, not an AI/ML diagnostic or therapeutic device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).