(30 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 System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 atherectorny procedure.
The Jetstream G3 System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- . Jetstream G3 Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
This 510(k) is for the same device most recently cleared under 510(k) K093456, but with the primary modifications intended to ensure any ingress of aspirated material into the guidewire lumen is minimized. In addition, the PATHWAY JETWIRE™ has been added as a compatible guidewire in the product labeling.
The Pathway Medical Technologies Jetstream G3™ System (K101221) is a peripheral atherectomy catheter system. This 510(k) submission describes modifications primarily intended to minimize ingress of aspirated material into the guidewire lumen and the addition of the PATHWAY JETWIRE™ as a compatible guidewire.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it lists the types of in vitro testing performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" is summarized as the tests demonstrating that the "technological and performance characteristics of the modified Jetstream G3 System are comparable to the predicate devices."
Here's a summary of the types of tests mentioned as "acceptance criteria" through their performance evaluation:
| Acceptance Criteria (Test Type) | Reported Device Performance Summary |
|---|---|
| System Reliability/Life | Demonstrated comparable performance to predicate devices. |
| Speed Drop Flexibility | Demonstrated comparable performance to predicate devices. |
| Accessory Compatibility | Demonstrated comparable performance to predicate devices. |
| Infusion and Aspiration Flow Rates | Demonstrated comparable performance to predicate devices. |
| Catheter Trackability and Pushability | Demonstrated comparable performance to predicate devices. |
| Aspiration Efficiency and Crossing Time | Demonstrated comparable performance to predicate devices, particularly focusing on minimizing ingress into the guidewire lumen with the modifications. |
| Thrombus Aspiration Challenge | Demonstrated comparable performance to predicate devices. |
| Guidewire and Device Wear | Demonstrated comparable performance to predicate devices. |
| Sterilant (EO) Residuals | Demonstrated comparable performance to predicate devices. |
| Control Pod Logic Verification | Demonstrated comparable performance to predicate devices. |
| Intended Use | Confirmed device performs for its stated intended use: atherectomy of peripheral vasculature and breaking apart/removing thrombus from upper and lower extremity peripheral arteries, comparable to predicate devices. |
| Pyrogenicity | Demonstrated comparable performance to predicate devices. |
The document states, "The results from these tests: demonstrate that the technological and performance characteristics of the modified Jetstream G3 System are comparable to the predicate devices, support the safety and effectiveness of the modifications... and ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document only states that "in vitro testing" was performed.
- Sample Size: The specific sample sizes for each in vitro test are not provided in this summary.
- Data Provenance: The tests were "in vitro," meaning conducted in a controlled laboratory environment, not on human or animal subjects. The country of origin for the data is implied to be the manufacturer's location or its testing facilities, which is Kirkland, Washington, USA. The data is not retrospective or prospective patient data, but rather performance testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study involved in vitro performance testing of a medical device, not a diagnostic or AI-driven system requiring expert assessment for 'ground truth' in the clinical sense. The "ground truth" for these engineering and performance tests would be defined by established engineering and biological standards, measurement protocols, and comparison to the predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved in vitro performance testing. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple human readers or experts assess cases to establish a definitive diagnosis or outcome.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., radiologists, pathologists) evaluating cases, often with and without AI assistance, to measure diagnostic performance. The Jetstream G3™ System is a medical device for atherectomy, not an AI software diagnostic tool, and therefore, an MRMC study with human readers and AI assistance is not relevant to its evaluation in this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm only) performance study was not done in the context of AI without human-in-the-loop performance. The Jetstream G3™ System is a physical medical device, not a standalone AI algorithm. The performance evaluation focuses on the physical and functional characteristics of the device itself.
7. The Type of Ground Truth Used
For the in vitro performance tests, the "ground truth" was established by engineering specifications, standardized test methods, and quantitative measurements for device characteristics (e.g., flow rates, mechanical properties, wear, aspiration efficiency). The primary "ground truth" for demonstrating equivalence was the established performance of the predicate devices. The tests aimed to prove that the modified device met the same performance standards or demonstrated comparable characteristics as previously cleared versions.
8. The Sample Size for the Training Set
This information is not applicable. The Jetstream G3™ System is a physical medical device and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The device's design and manufacturing processes are based on engineering principles and validated through testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons above. There is no AI training set for this device.
§ 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).