(38 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 Vascular Positioning 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 Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The Vascular Positioning 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. NOTE: If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location.
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 with tablet display and a VPS Stylet. The VPS G4 Console consists of two key integrated software-driven components: a data acquisition module and an embedded computer with processing capabilities. The data acquisition module within 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 provides the user with guidance for tip positioning of central venous access devices. The separately provided 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 of the stylet connects to an extension cable that connects to the VPS Console.
The provided text describes the 510(k) summary for the Vascular Positioning System™ (VPS™) G4 Console. It does not contain a comprehensive study proving the device meets specific acceptance criteria in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K103260 VasoNova Vascular Positioning System™ (VPSTM) Console) by showing that the technological characteristics are similar and that the device complies with relevant electrical safety, electromagnetic compatibility, and software verification/validation standards.
Therefore, many of the requested details about acceptance criteria and study methodology are not explicit in this summary. However, I can extract the information that is present and highlight what is not available from the provided text.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not present specific clinical or performance acceptance criteria in the typical sense of metrics like sensitivity, specificity, accuracy, or positive/negative predictive values for tip placement. Instead, the "acceptance criteria" are implied by compliance with regulatory standards and verification/validation testing.
| Characteristic | Standard/Test | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility | IEC 60601-1-2: 2007-03 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance: Collateral standard: Electromagnetic compatibility - Requirements and tests | Compliant |
| Electrical Safety and Acoustic Safety | IEC 60601-1:1988 (A1:1991 + A2:1995) - Medical electrical equipment - Part 1: General requirements for safety | |
| IEC 60601-1-4: 1996 (A1:1999)/EN 60601-1-4:2000- Medical electrical equipment - Part 1-4: Collateral Standard: Programmable electrical medical systems | ||
| IEC 60601-2-37:2001 (A1:2004 + A2:2005) - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment | Compliant | |
| Software verification and validation | VasoNova Software and Algorithm Verification and Validation testing | Compliant |
| Guidance indicator functionality | Evaluation against the predicate device's guidance indicator (Colored icons, waveform data) | Same as predicate (Colored icons, waveform data) |
| Guidance signal type(s) | Evaluation against the predicate device's signal types (ivECG, Doppler ultrasound) | Same as predicate (ivECG, Doppler ultrasound) |
| Signal Conductor | Evaluation against the predicate device's signal conductor (Two conductor stylet wires: coax cable and ivECG wire) | Same as predicate (Two conductor stylet wires: coax cable and ivECG wire) |
| Acoustic Output | Evaluation against the predicate device's acoustic output (One setting; not controlled by the user) | Same as predicate (One setting; not controlled by the user) |
| User Interface | Evaluation against the predicate device's user interface (PC-based system connected to a touchscreen tablet display) | Similar to predicate (PC-based system connected to a touchscreen tablet display) |
| Software Interface | Evaluation against the predicate device's software interface (Custom GUI) | Same as predicate (Custom GUI) |
The primary "performance" stated is that the device is compliant with safety and functionality standards and is "substantially equivalent" to its predicate in terms of safety, efficacy, and performance. The intended use also specifies that: "When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location." However, performance data demonstrating the accuracy of this "Blue Bullseye" indication against a gold standard (like X-ray) is not provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The filing focuses on technological equivalence and compliance with engineering standards rather than clinical performance data from a specific test set.
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 provided in the given text. As no specific clinical test set data is presented, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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 provided in the given text. The device is a "Vascular Positioning System" that guides catheter placement, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is designed for "guidance and tip positioning" of central venous catheters, meaning it provides real-time information to a human operator. The system "provides the user with guidance for tip positioning" and "When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location." This implies it's a human-in-the-loop system. A standalone performance assessment without human interaction is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The 510(k) summary does not describe specific ground truth data for a clinical test set. The intended use mentions that 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." It also states: "If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location." This implies that standard imaging (fluoroscopy or chest x-ray) would be the clinical gold standard (ground truth) if such a performance study were done, but no such study is detailed here.
8. The sample size for the training set
This information is not provided in the given text. Given that this is a 510(k) summary for a substantial equivalence determination based on technological characteristics and compliance with standards, details about machine learning training sets are typically not included unless the device's core functionality relies on a novel AI/ML algorithm that requires specific training data for its performance claims. The device relies on "physiological (cardiac electrical activity and blood flow) information" and "software algorithm to determine the symbols used to indicate catheter migration," but the details of any "training" are not specified.
9. How the ground truth for the training set was established
This information is not provided in the given text, for the reasons mentioned in point 8.
§ 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).