(47 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 Systems are atherectomy catheter systems designed with either a fixed (Jetstream G3 SF System) or an expandable (Jetstream Navitus, G3 SE and G3 L Systems) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:
- . Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate devices, the Jetstream Catheters continue to utilize a differentially cutting tip and include 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 primary modifications of this 510(k) simplify the user interface by eliminating the two buttons that increase and decrease speed on the Control Pod Membrane. These modifications apply to the entire family of Jetstream Systems. In addition, non-significant changes made to the Jetstream G3 System (which is being given a new trade name -"Jetstream Navitus System" - with the modifications included in this 510(k)) and PV Console are also included.
The provided text does not contain typical acceptance criteria for device performance in the format of a table with specific metrics and thresholds, nor does it describe a study that directly proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, the document describes a 510(k) premarket notification for a medical device, the Jetstream Systems, highlighting its substantial equivalence to predicate devices.
The "Testing Summary" section details in vitro testing performed to demonstrate that the modified Jetstream Systems' technological and performance characteristics are comparable to predicate devices, ensuring modified safety and effectiveness. This is a common approach for 510(k) submissions, where the focus is on demonstrating equivalence rather than establishing new clinical effectiveness or diagnostic accuracy via traditional clinical trials with predefined acceptance criteria for clinical endpoints.
Here's a breakdown of the information provided, framed around the typical questions, with explanations for what is not present in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and corresponding thresholds. The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices. The study performed involved in vitro testing, not a clinical study with outcome-based performance criteria.
The types of tests conducted are listed as:
- System Reliability/Life Test
- Main Cable Joint Strength
- Control Pod Electrical Testing
- Control Pod Logic Verification
- Electrical Safety
- Intended Use
- Accessory Compatibility
- Infusion & Aspiration Flow Rates
- Aspiration Efficiency & Crossing Time
- Rotational Speed
- Material Liberation (Teflon & Polyimide)
- Aggressive Thrombus Testing
The document states that the results from these tests:
- "demonstrate that the technological and performance characteristics of the modified Jetstream Systems are comparable to the predicate devices"
- "modified safety and effectiveness of the modifications that are the subject of this 510(k)"
- "ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."
However, specific quantitative acceptance values for each of these tests, and the numerical results achieved, are not provided in this summary. For instance, it doesn't state "Aspiration Efficiency > X mL/min demonstrated Y mL/min".
2. Sample size used for the test set and the data provenance
The document mentions "in vitro testing" without specifying sample sizes for each test type. "In vitro" inherently implies the data provenance is from laboratory tests using models or excised tissue, not human subjects, and therefore originates from the testing facility. The document does not specify country of origin for these in vitro tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided. The testing described is in vitro engineering and performance testing on the device itself (e.g., electrical testing, mechanical strength, flow rates). It does not involve human interpretation or expert assessment for establishing a "ground truth" in the clinical sense (like a diagnosis or lesion presence).
4. Adjudication method for the test set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are used in studies where multiple human readers or experts interpret data to establish a ground truth or resolve discrepancies, typically in clinical or diagnostic accuracy studies. The described testing is in vitro performance testing of the device.
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
An MRMC study was not conducted. This document describes a 510(k) submission for a physical medical device (atherectomy catheter system) and its modifications. It is not an AI/CAD-related device, and thus, studies on human reader improvement with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro performance testing, the "ground truth" would be established by validated measurement techniques and scientific principles for each specific test (e.g., a calibrated flow meter for flow rates, a force gauge for joint strength, established electrical safety standards). It's based on engineering and scientific measurements rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable and therefore not provided. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is 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).