(28 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 Navitus L System is an atherectomy catheter system designed with an expandable 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 Navitus L System consists 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 Navitus L Catheter with Control Pod: A sterile, single-use unit . consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the Jetstream Navitus L 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.
This 510(k) is for modifications to the Jetstream Navitus System. The primary modifications of this 510(k) are to increase the cutting tip and expandable blade diameters (i.e., from 2.1 to 2.4 mm for the cutting tip, and from 3.0 to 3.4 mm for the expandable blades), and decrease the overall catheter length (from 135 to 120 cm).
The provided document does not describe a study in the context of an AI/ML medical device. Instead, it is a 510(k) summary for a medical device called the "JETSTREAM Navitus L System," which is a peripheral atherectomy catheter system. The "acceptance criteria" and "device performance" in this document refer to the results of in vitro engineering and performance tests conducted to demonstrate substantial equivalence to a predicate device, not the performance of an AI/ML algorithm.
Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how ground truth for training was established) are not applicable to this type of device submission.
Here's an attempt to extract the relevant information based on the prompt's request, acknowledging the fundamental difference in the nature of the device and its evaluation:
1. Table of acceptance criteria and the reported device performance:
The document lists various tests performed to demonstrate substantial equivalence. It doesn't explicitly state quantitative acceptance criteria for each test in a table format, but it implies that the results were deemed comparable to the predicate device. The "reported device performance" is the conclusion that the modified device's technological and performance characteristics are comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional verification meets design specifications and is comparable to predicate. | "Demonstrate that the technological and performance characteristics of the modified Jetstream Navitus System are comparable to the predicate Jetstream Navitus System." |
| Heat generation within acceptable limits and comparable to predicate. | (Same as above) |
| System reliability/life test results comparable to predicate. | (Same as above) |
| Aspiration efficiency & crossing time comparable to predicate. | (Same as above) |
| Speed drop flexibility comparable to predicate. | (Same as above) |
| Material liberation (Teflon & Polyimide) comparable to predicate. | (Same as above) |
| Rotational speed comparable to predicate. | (Same as above) |
| Accessory compatibility maintained. | (Same as above) |
| Infusion & aspiration flow rates comparable to predicate. | (Same as above) |
| Catheter pull force comparable to predicate. | (Same as above) |
| Catheter trackability and pushability comparable to predicate. | (Same as above) |
| Torque to failure comparable to predicate. | (Same as above) |
| Contrast injection performance comparable to predicate. | (Same as above) |
| Aorta strip test results comparable to predicate. | (Same as above) |
| Layered dissection model performance comparable to predicate. | (Same as above) |
| Overall safety and effectiveness of modifications supported. | "Support the safety and effectiveness of the modifications that are the subject of this 510(k)..." |
| Modified device performs equivalently to predicate with identical intended use. | "...and ensure the modified device can perform in a manner equivalent to the predicate Jetstream Navitus System with the identical intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes (e.g., number of catheters, number of tests) for each in vitro test. It mentions "in vitro testing."
- Data Provenance: The data provenance is "in vitro testing," meaning laboratory tests, not human subject data. Country of origin is not specified but implicitly from the manufacturer's testing. Retrospective or prospective is not applicable to in vitro engineering tests; these are designed experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the evaluation involved in vitro device performance characteristics and engineering measurements, not clinical interpretation requiring expert ground truth establishment.
4. Adjudication method for the test set:
This is not applicable as there was no expert review or human interpretation of cases. The tests were objective engineering measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
This is not applicable as this is an atherectomy catheter system, not an imaging or diagnostic device that would typically undergo an MRMC study. There is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as there is no algorithm or AI component in this device. It is a mechanical catheter system with electronic controls.
7. The type of ground truth used:
The "ground truth" here refers to objective engineering and performance standards or measurements established by the manufacturer's test protocols and comparison to the predicate device's known characteristics. It's not expert consensus, pathology, or outcomes data in the sense of clinical studies.
8. The sample size for the training set:
This is not applicable as there is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no AI/ML algorithm requiring a training set.
§ 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).