(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 SE and Jetstream G3 SF Systems are atherectomy catheter devices intended for use in debulking and treating vascular disease in the peripheral vasculature. The Jetstream G3 SE System is designed with expandable cutting blades; the Jetstream G3 SF System has only a fixed diameter cutter; that is, it does not incorporate the expandable blades. Separate lumens within the Catheters 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 atherectomy procedure.
The Jetstream G3 SE and G3 SF Systems each consist 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:
- 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 a slightly increased catheter length and decreased catheter and tip diameter to achieve a slightly smaller crossing profile. The motor gear ratio is changed and the expandable blades are eliminated from one of the device models.
The provided document is a 510(k) summary for a medical device (Jetstream G3 SE and SF Systems), which details a manufacturer's submission for regulatory clearance based on substantial equivalence to predicate devices. It focuses on engineering and performance characteristics, but does not appear to contain information related to a study with clinical acceptance criteria involving human readers or ground truth established by experts as typically found in diagnostic accuracy studies.
Therefore, many of the requested details related to clinical performance, expert adjudicated ground truth, and multi-reader multi-case studies are not available in this document.
Here's the information that can be extracted from the provided text, along with a clarification of what is not present:
1. A table of acceptance criteria and the reported device performance
The document describes several "in vitro testing" categories but does not provide specific quantitative acceptance criteria or their corresponding performance values in a direct, tabulated format. It only states that the results "demonstrate that the technological and performance characteristics...are comparable to those of the predicate devices" and "support the safety and effectiveness of the modifications".
| Test Category | Acceptance Criteria (Not Explicitly Stated as Quantitative) | Reported Device Performance (Summary) |
|---|---|---|
| Dimensional Verification | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Burst | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Pull | Not explicitly stated | "comparable to those of the predicate devices" |
| System Reliability/Life | Not explicitly stated | "support the safety and effectiveness" |
| Speed Drop Flexibility | Not explicitly stated | "comparable to those of the predicate devices" |
| Accessory Compatibility | Not explicitly stated | "comparable to those of the predicate devices" |
| Infusion and Aspiration Flow Rates | Not explicitly stated | "comparable to those of the predicate devices" |
| Torque to Failure | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Trackability and Pushability | Not explicitly stated | "comparable to those of the predicate devices" |
| Aspiration Efficiency and Crossing Time | Not explicitly stated | "comparable to those of the predicate devices" |
| Heat Generation | Not explicitly stated | "comparable to those of the predicate devices" |
| Rotational Speed | Not explicitly stated | "comparable to those of the predicate devices" |
| Guidewire and Device Wear | Not explicitly stated | "comparable to those of the predicate devices" |
| Sterilization (EO) Validation | Not explicitly stated | "support the safety and effectiveness" |
| Control Pod Logic Verification | Not explicitly stated | "support the safety and effectiveness" |
| Electrical Safety | Not explicitly stated | "support the safety and effectiveness" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "in vitro testing" (bench testing) to demonstrate substantial equivalence. These are not clinical studies with "test sets" in the diagnostic performance sense.
- Sample size used for the test set: Not specified in the document for the in vitro tests.
- Data provenance: In vitro testing; no country of origin is specified for the data, nor is it described as retrospective or prospective clinical data.
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 information is not applicable to the provided document. The submission relies on "in vitro testing" to compare performance characteristics to predicate devices, not on a clinical ground truth established by experts for diagnostic evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the provided document, as it does not describe clinical testing with adjudicated ground truth.
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 information is not present and not applicable to the provided document. The device is an atherectomy catheter, not a diagnostic AI system, and the submission is for substantial equivalence based on engineering and performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an atherectomy catheter (a physical medical instrument), not an algorithm or AI system. The testing performed was related to the device's physical and mechanical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in vitro testing," the "ground truth" would be engineering specifications and predicate device performance, against which the new device's performance was compared. This is not clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable as the document describes performance testing of a physical medical device, not the training of a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above (not an algorithm or AI system).
§ 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).