(90 days)
The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.
The Jetstream G3 L and the Jetstream G3 Systems are designed to provide atherectorny and thrombus removal treatment with similar performance requirements. Both are designed with an expandable cutting tip and infusion and aspiration functions intended for use in debulking and treating vascular disease in the peripheral vasculature. These functions allow for the active removal of fluid, excised tissue, and thrombus from the peripheral treatment site. The Jetstream G3 L and the Jetstream G3 Systems thus retain the same two primary components: a Cathefer with Control Pod and a Console. These two system components are packaged separately and described generally below.
- Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double pouched tray.
- PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
The provided text is a 510(k) summary for the Jetstream G3 and Jetstream G3 L Systems, which are peripheral atherectomy catheters. This type of document focuses on establishing substantial equivalence to previously cleared devices through pre-clinical (bench and animal) testing rather than clinical studies with explicit acceptance criteria related to a specific disease and the reported performance of the device in a clinical setting.
Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment for test/training sets, expert qualifications, and MRMC studies, is not available in the provided document. These details are typically found in clinical trial reports or publications, which are not part of a 510(k) summary for a substantial equivalence determination where efficacy and safety are often inferred from the predicate device and pre-clinical data.
The document confirms:
- Device: Jetstream G3 L System and Jetstream G3 System
- Intended Use: Atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries.
- Not intended for: Coronary, carotid, iliac, or renal vasculature.
- Basis for Clearance: Substantial equivalence to predicate devices (K093918, K093456, K083489, K081328).
No information is provided in the document for the following requests:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of submission, which relies on substantial equivalence. Performance data in a clinical context with defined acceptance criteria is not presented.
- Sample sizes used for the test set and the data provenance: No clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human-established ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a mechanical atherectomy system, not an AI-powered diagnostic tool involving human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a mechanical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a mechanical device.
- The sample size for the training set: Not applicable as there is no mention of an algorithm or AI model in the document that would require a "training set."
- How the ground truth for the training set was established: Not applicable.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).