(267 days)
The Possis AngioJet Rapid Thrombectomy System is intended for breaking apart and removing unorganized thrombus from A-V access grafts.
The AngioJet Rapid Thrombectomy System consists of three components: the Drive Unit, disposable Pump Set, and disposable Catheter. Currently, two Catheter models are available. The present 510(k) seeks market clearance for these components, and other future Catheter models as described below.
AngioJet Catheter: The single use AngioJet Catheter consists of a manifold, Catheter body, and tip. The manifold contains connections for the high pressure saline supply and effluent removal lines and a hemostasis valve for sealing around a 0.014-0.018 inch diameter guide wire. A stainless steel hypodermic tube extends the length of the Catheter to carry high pressure saline to the distal tip. This tube is located in one lumen plastic tube. The other, larger lumen in the plastic tube is used for evacuation of the lysed thrombus and for passage of the guide wire.
The Catherer tip is a stainless steel subassembly through which the stainless steel hypodermic tube extends and terminates in a loop. This loop features proximally-directed jet orifices, aimed at the evacuation lumen entrance. In addition to their effect in breaking up thrombus, these jets provide the dynamic pressure to drive thrombotic debris down the exhaust lumen of the Catheter.
The two current Catheter models have several different features, as identified below. The F105 was the original design. The LF140 was developed to ease treatment of very distal lesions accessed through more tortuous anatomy. The table below compares the two models.
| F105 | LF140 | |
|---|---|---|
| Drive Unit Mode Setting | Mode 1 | Mode 2 |
| Working Length | 105 cm | 140 cm |
| Maximum Shaft Diameter | 5 French | 5 French |
| Distal Shaft Taper | None | 4-3.5 French |
| Flexibility | Standard | Enhanced |
| Stainless Steel Tip | 5 French | 5 French |
| Tip Cap | No | Yes |
| Intended Guidewire | .018 inch | .014-.018 inch |
| Jets | 3 high-pressure, | |
| proximally directed | ||
| 3 low-pressure, radially directed | 6 high pressure, | |
| proximally directed |
AngioJet Pump Set: The single use Pump Set consists of a high pressure saline supply line, a high pressure pulsatile pump, an effluent evacuation line, and an effluent collection bag. The pulsatile pump is a stainless steel assembly capable of functioning over a range of -0 to at least 15,000 psi; however, the Drive Unit controls the pump operation in the range of approximately 7.000 to 12,000 psi. (This refers to the peak pressure; the pump is pulsatile, and therefore operates from zero pressure between pulses up to this maximum pressure during the pump stroke.)
Saline is supplied to the pump from a standard intravenous saline bag accessed with a cannula and a length of plastic tubing (the low pressure supply line) attached to the pump. A bubble trap is located in this line. A 7-foot high pressure supply line consisting of stainless steel tubing encased in one lumen of a dual-luman plastic tube terminates with a high pressure quick connect nut. The other lumen of the dual-luman tube attaches to the Catherer manifold through a luer connection and is used to carry effluent away from the Catheter to a collection bag hung on the side of the Drive Unit.
AngioJet Drive Unit; This component generates the forces and motions necessary to operate the Catheter. The Drive Unit is built into a mobile cart. All mechanical and electrical components needed for operating and controlling the Drive Unit are contained within the cart, with the exception of a foot switch which the operator uses to activate the system and perform the thrombectomy. Drive Unit controls are contained in a membrane switch control panel.
The force and motion for driving the high pressure pump is generated by means of an electronically-controlled, motor-driven mechanism. A peristaltic pump is located on the Drive Unit for the purpose of controlling the removal rate of thrombotic debris-containing effluent.
The Drive Unit is designed to accommodate three Mode settings (of which two are currently available), each appropriate to specific Catheter model(s).
The Drive Unit incorporates a series of safety alarms to ensure the proper flow of fluids to and from the patient. This includes a flow sensor/bubble detector on the low pressure supply between the saline bag and the high pressure pump, a flow sensor/bubble detector on the effluent line just upstream of the peristaltic pump, a motion sensor to detect proper operation of the peristaltic pump, a pressure sensor to ensure proper performance of the high pressure disposable pump, and sensors to detect the presence of a proberly primed high pressure pump. Also included are sensors to detect that the pump bay (the recess on the Drive Unit into which the pump is loaded) is not blocked, that rear cabinet doors are closed, and that the effluent tubing is properly loaded in the peristaltic pump. These functions are controlled from a logic control board located within the Drive Unit, Activation of any of these sensors will prevent the Drive Unit from operating if the proper conditions for safe operation are not met. Status of the safety alarms is displayed on the control panel.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for the AngioJet Rapid Thrombectomy System. Instead, the clinical study aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing success rates between the AngioJet and Fogarty-type catheters.
| Metric (Defining "Success") | AngioJet Performance (n=75) | Control (Fogarty-type) Performance (n=62) | P-value (Fisher's Exact Test) |
|---|---|---|---|
| Overall Success Rate (Success + Partial Success) | 79% (55/70 scorable treatments) | 84% (51/61 scorable treatments) | 0.510 |
| Complication Rate | 81% (60/74 patients) | 68% (42/62 patients) | Not specified |
Note: The "Overall Success Rate" calculation is derived from the text: AngioJet (48 Success + 7 Partial Success) / (48+7+15) = 55/70 = 78.57% ~ 79%. Control (49 Success + 2 Partial Success) / (49+2+10) = 51/61 = 83.6% ~ 84%. The text combines "failure" with scorable treatments for the denominator implying "not scorable" cases were excluded.
2. Sample Size Used for the Test Set and Data Provenance
- Phase 1 (Feasibility Study):
- Sample Size: 26 AngioJet treatments on 21 patients.
- Data Provenance: Retrospective (implied, as it's a feasibility study evaluating initial use) at three study sites (country not specified, likely US given the 510(k) submission).
- Phase 2 (Randomized Comparative Study):
- Sample Size: 137 study-assigned treatments in total.
- AngioJet: 75 treatments (66 with F105, 9 with LF140).
- Control (Fogarty-type catheters): 62 treatments.
- Data Provenance: Prospective, randomized clinical trial (country not specified, likely US given the 510(k) submission).
- Sample Size: 137 study-assigned treatments in total.
- LF140 Catheter Coronary Study:
- Sample Size: 90 patients (91 lesions).
- Data Provenance: Feasibility study (implied prospective) – country not specified.
- German Study:
- Sample Size: 49 patients (47 leg conduits).
- Data Provenance: Prospective at four German sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies. The endpoints (restoration of dialysis, improvement in ABI or SVS/ISCVS score) are objective clinical measures, suggesting that the "ground truth" was based on these measurable outcomes rather than subjective expert consensus on images or pathology.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The primary endpoint measurements (dialysis restoration, ABI, SVS/ISCVS score) are generally objective clinical assessments. Complications were reported, but the process of confirming or adjudicating these reports is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was described. The clinical study compares device performance (AngioJet vs. Fogarty-type) directly using patient outcomes, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The AngioJet system is a medical device, not an AI algorithm. It requires human operation for its function. The clinical studies assess the device's performance in a human-in-the-loop scenario (i.e., used by a physician on a patient).
7. Type of Ground Truth Used
The ground truth for the clinical studies was based on objective clinical outcomes and measurements:
- For A-V access grafts: Restoration of dialysis through the treated graft within 72 hours of treatment.
- For leg conduits: Improvement in Ankle-Brachial Index (ABI) or SVS/ISCVS score within 72 hours of treatment.
- For LF140 Coronary Study: Primary endpoint of "acute success" (definition not detailed, but implies a positive clinical outcome).
- For German Study: Demonstrable thrombus reduction, improved SVS/ISCVS score, improved ABI, increased walking distance.
Complications and mortalities were also tracked, serving as critical safety outcomes.
8. Sample Size for the Training Set
This question is not applicable. The AngioJet Rapid Thrombectomy System is a mechanical device, not a machine learning model that requires a "training set." The development involved physical, functional, biocompatibility, and animal tests to validate the design, which are analogous to engineering validation, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of this mechanical device. The "ground truth" for its development was established through engineering specifications, performance standards, in vitro testing (flow rate, stagnation pressure, evacuation rate, leak and bond testing, thrombus removal, particulate generation, hemolysis), and animal studies.
§ 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).