(120 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 aspiration 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 Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. 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 for the JETi AIO Peripheral Thrombectomy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria based on patient outcomes or detailed performance metrics.
Specifically, the document 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." This means there isn't a study that directly proves the device meets acceptance criteria related to efficacy or clinical performance in a rigorous, quantitative manner as one might expect for a novel device or a device requiring a PMA.
The Summary of Non-Clinical Performance Data section only vaguely mentions: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not specify what those "acceptance criteria" were, nor does it present the "reported device performance" against those criteria.
Therefore, I cannot provide the requested information from the given text regarding the acceptance criteria and a study proving the device meets those criteria, as such a study with detailed reporting is explicitly stated as not having been conducted for this 510(k) submission.
To directly answer your request based on the provided text, I must state that the information is not available. The document focuses on demonstrating substantial equivalence to a predicate device, and the "studies" mentioned are largely bench testing and design validation, which are not detailed enough to fulfill your specific requirements about clinical performance or acceptance criteria as you've outlined them.
§ 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).