(94 days)
The JETi 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 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set, one JETi Peripheral Saline Drive Unit (SDU), one Peristaltic Pump, and an Accessory Stand. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the peristaltic 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 peristaltic pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, peristaltic pump, an adjustable mounting arm, an accessory basket, and an IV pole are contained on an accessory stand.
The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.
For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.
For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow.
The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Aspiration is achieved with a peristaltic pump that is connected to the SDU and is also turned on/off with the foot pedal. The pressure sensor is connected to the suction tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and pressure to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
The provided text describes the JETi Peripheral Thrombectomy System and its 510(k) premarket notification (K192439) to the FDA. The document primarily focuses on demonstrating substantial equivalence to a predicate device (JETi 88 Peripheral Thrombectomy System, K183403) through non-clinical performance data.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and mentions that the results were compliant.
The table below presents the functional specifications of the device that can be inferred from the comparison table between the predicate and subject device, along with the implied "acceptance criteria" (i.e., that the new device met these specifications, often matching the predicate or a new measured value).
| Design Feature (Performance Aspect) | Predicate JETi 88 Peripheral Thrombectomy System (Implied Acceptance Criteria) | Subject JETi Peripheral Thrombectomy System (Reported Performance) |
|---|---|---|
| Aspiration Flow Rate | 650 mL/min (Predicate Value) | 450 mL/min |
| Pressure – Free Flow | -23.6 inHg (Predicate Value) | -12.9 inHg |
| Pressure - Engaged in Clot |
§ 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).