(131 days)
The JETi 88 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 88 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi 88 Pump Set, one JETi 88 Peripheral Saline Drive Unit (SDU), and an Accessory Cart. 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 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 vacuum pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, an adjustable mounting arm, a mounting bracket for vacuum canisters, an IV pole and a vacuum pump are contained on an accessory cart.
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 vacuum.
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. Vacuum is achieved with a vacuum pump, turned on/off with the pinch valve on the side of the SDU, which is also controlled by the foot pedal. The vacuum sensor is connected to the vacuum 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 vacuum 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.
This document is a 510(k) premarket notification for a medical device called the JETi 88 Peripheral Thrombectomy System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document, as this type of information is typically found in clinical trial reports or detailed performance verification documents, not in a 510(k) summary focused on substantial equivalence.
Here's an analysis of what can be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, the specific acceptance criteria (e.g., "thrombus removal efficiency > X%") and the quantitative reported device performance against those criteria are not provided in this summary. The summary lists the types of tests performed but doesn't detail the pass/fail thresholds or the actual results.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Design Verification Testing | Within pre-determined product specifications and external standard requirements (Specific numerical criteria not provided) | "All data met the acceptance criteria" |
| Pull test of welded and glued joints | (Not specified) | Met acceptance criteria |
| Leak testing | (Not specified) | Met acceptance criteria |
| Pressure testing | (Not specified) | Met acceptance criteria |
| Flow testing | (Not specified) | Met acceptance criteria |
| Kink testing | (Not specified) | Met acceptance criteria |
| Embolic analysis | (Not specified) | Met acceptance criteria |
| Saline stream containment | (Not specified) | Met acceptance criteria |
| 60601-1 Product and electrical safety testing | (Adherence to IEC 60601-1 standards) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The testing mentioned (Design Verification) is "in vitro testing", implying laboratory bench testing. The data provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no human-involved ground truth assessment in the described in-vitro verification tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human-involved ground truth assessment or adjudication process described.
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
This is not applicable. The device is a physical thrombectomy system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in vitro testing" performed, the "ground truth" would be established by the engineering specifications and external standards (e.g., a specific pressure reading, flow rate, or bond strength). It is not expert consensus, pathology, or outcomes data, as these are not clinical or biological tests.
8. The sample size for the training set
This is not applicable as this is a physical device and not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).