(106 days)
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, 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 bull's-eye, 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 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 VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.
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.
Here's an analysis of the acceptance criteria and study details from the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proper PICC tip placement indication | 98.4% of placement procedures |
Study Details
-
Sample Size used for the test set and the data provenance:
- Sample Size: 77 patients
- Data Provenance: Not explicitly stated, but the study was prospective and single-armed, indicating it was conducted during the device's development/evaluation phase, likely in a clinical setting. Country of origin is not specified but given the submitter's address (Menlo Park, CA), it's reasonable to infer a US-based study, although not guaranteed. The study was prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The text only states that the VPS System "correctly indicated proper PICC tip placement" but doesn't detail how this "correctness" (ground truth) was established or who adjudicated it.
-
Adjudication method for the test set:
- This information is not provided in the given text.
-
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:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. The study described focuses on the standalone performance of the device in indicating proper PICC tip placement. The VPS System is itself providing the "guidance indicator" for the user.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The reported 98.4% accuracy reflects the device's ability to "correctly indicate proper PICC tip placement." While a human operator uses the device, the 98.4% figure represents the accuracy of the device's output compared to the ground truth of tip placement, not the performance of human readers using or not using the device. The device's "guidance indicator shows a blue bull's-eye" when the tip is in the desired location, implying an algorithmic determination.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The specific method for establishing ground truth is not explicitly stated. However, the intended use clearly states the system is an "alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation." This strongly suggests that the ground truth for the study was established using one or both of these traditional imaging methods (fluoroscopy or chest x-ray) to independently verify the actual PICC tip location.
-
The sample size for the training set:
- The text does not provide any information about a training set or its sample size. The clinical study described refers to the test set used to evaluate the device's performance.
-
How the ground truth for the training set was established:
- As no information about a training set is provided, this question cannot be answered from the given text.
§ 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).