(107 days)
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
The VPS System consists of a VPS Console and VPS Stylet. The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VSP Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.
Here's a breakdown of the acceptance criteria and study information for the VasoNova™ Vascular Positioning System™ (VPS™ System) Stylet, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy of PICC Tip Placement | Correct indication of proper PICC tip placement for a high percentage of procedures (implied by "alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation"). | 98.4% of placement procedures correctly indicated proper PICC tip placement. |
Note: The document explicitly states "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures". While not framed as a 'pre-defined' acceptance criterion with a specific numerical threshold like ">= 95%", the achievement of 98.4% is presented as the performance demonstrating effectiveness for its intended use as an alternative to imaging.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 77 patients
- Data Provenance: The study was a "prospective, single-armed, open design study clinical study." The country of origin of the data is not explicitly stated, but the submission is to the US FDA, implying it could be US-based or an international study accepted by the FDA. Given the company's address is in Menlo Park, CA, a US origin is likely.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. The document does not detail how the ground truth for "proper PICC tip placement" was established for the 77 patients in the clinical study. It is implied that post-procedure confirmation (likely via chest x-ray or fluoroscopy, which the device aims to replace) would serve as ground truth, but the specifics of who performed this assessment are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text. As the method for establishing ground truth isn't detailed, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical study described is a "single-armed" study, focusing on the performance of the VPS System itself, not a comparison involving multiple human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical study performed appears to be a standalone performance study of the device. The text states, "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures," implying the system's output (the "blue bullseye" guidance indicator) was assessed against the actual tip placement. While a human uses the device, the 98.4% figure reflects the system's ability to accurately guide/indicate.
7. The Type of Ground Truth Used
The type of ground truth used is not explicitly stated but is strongly implied to be the actual physical location of the catheter tip as determined by a "gold standard" method after the procedure. The device is intended as "an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation." Therefore, the ground truth for assessing the device's accuracy would logically be derived from these post-placement imaging modalities.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is typical for a device like this, which likely relies on physiological signal processing and established anatomical/physiological principles rather than machine learning models trained on vast datasets in the same way an AI imaging algorithm would.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As no training set is discussed, the method for establishing its ground truth is also not mentioned.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).