(262 days)
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.
The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.
The provided document is a 510(k) premarket notification for the "VPS Rhythm™ Device with Optional TipTracker™ Technology." It indicates that no human clinical data was provided to support substantial equivalence (Section 8). Therefore, it is not possible to describe a study that proves the device meets acceptance criteria based on clinical performance.
However, the document does list non-clinical performance data that was submitted. This non-clinical data focuses on verifying the device's technical performance, electrical safety, electromagnetic compatibility, software, material properties, sterilization, biocompatibility, and usability.
Based on the provided information, I can address the available non-clinical performance data and the usability study.
Here's a breakdown of the requested information based on the non-clinical data and the usability study:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) and no clinical studies are reported, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) for the device are not described in the document. The non-clinical testing, however, implies meeting industry standards and internal design requirements.
| Acceptance Criteria Category (Implied from testing) | Reported Device Performance (Summary from doc) |
|---|---|
| Electrical Safety (per IEC 60601-1, 3rd Ed.) | Testing conducted and results support substantial equivalence. |
| Electromagnetic Compatibility (EMC) (per IEC 60601-1-2, 3rd Ed.) | Testing conducted and results support substantial equivalence. |
| Software Verification and Validation | Testing conducted and results support substantial equivalence. |
| TipTracker Stylet Performance & Physical Integrity (including tensile strength, flexural integrity, insertion/withdrawal force, holding force, leak resistance, electrical impedance/voltage feedback, corrosion, PICC compatibility, particulate testing) | Testing conducted (after 1 year aging) and results support substantial equivalence. |
| Sterile Barrier Package Integrity (per ASTM F2096) | Testing conducted and results support substantial equivalence. |
| Sterilization Residuals (per ISO 10993-7) | Testing conducted and results support substantial equivalence. |
| Biocompatibility (cytotoxicity, hemocompatibility, sensitization, irritation, systemic toxicity per ISO 10993-1, -4, -5, -10, -11) | Testing conducted and results support substantial equivalence. |
| Usability (per CDRH guidance & IEC 62366-1) | A human factors study was conducted, assessing primary operating functions against predetermined usability criteria. Results were compiled and assessed, supporting substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Human Factors Study Test Set (Usability): The document mentions "independent clinician participants" but does not specify the sample size for this test set.
- Data Provenance for Human Factors Study: This was a prospective study conducted with clinicians. The country of origin is not explicitly stated, but given the context of a US FDA submission, it can be inferred to be a US-based study or following US regulatory guidelines.
- Other Non-Clinical Testing: Sample sizes for material integrity, electrical, EMC, and software testing are not specified. These are typically lab-based tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- For the Usability Study (Human Factors): The "ground truth" here would be the predefined usability criteria and the assessment of whether clinicians could successfully perform tasks. The "experts" would be the independent clinician participants, but their specific qualifications (e.g., years of experience) are not detailed. The study assessed the device's functions against predetermined usability criteria.
- For other non-clinical tests: Ground truth is established by engineering specifications, international standards (IEC, ISO, ASTM), and internal design requirements.
4. Adjudication Method for the Test Set
- For the Usability Study (Human Factors): An explicit adjudication method (e.g., 2+1) is not described. The document states that "The results of the human factors study were compiled and assessed," suggesting an analysis against predefined usability criteria rather than an expert consensus on a subjective outcome.
- For other non-clinical tests: Adjudication is typically against established engineering specifications and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states "No human clinical data was provided to support substantial equivalence." An MRMC study would fall under clinical data.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Yes, in the context of the device's ECG technology and TipTracker navigation:
- The "VPS Rhythm Device" as a standalone component uses software algorithms to acquire, process, and display ECG waveforms for catheter tip location. Its performance in this function relies on the algorithm interpreting cardiac electrical activity.
- The "TipTracker Technology" also involves "software algorithms" to facilitate real-time visualization of the catheter's track and direction using magnetic field-based technology. This is also a standalone algorithmic function.
- The non-clinical testing, particularly "Software Verification and Validation Testing" and "TipTracker Stylet Performance," would evaluate these standalone algorithmic and system performances against specified requirements.
7. Type of Ground Truth Used
- For the Human Factors Study (Usability): "Predetermined usability criteria" established prior to the study, likely by device designers and regulatory/human factors experts.
- For TipTracker Stylet Performance and Physical Integrity: Engineering specifications, material science standards (e.g., ISO 11070), and internal design requirements.
- For Electrical Safety, EMC, Sterilization Residuals, Biocompatibility: International and national standards (e.g., IEC 60601 series, ISO 10993 series, ASTM F2096).
8. Sample Size for the Training Set
- The document does not mention a training set for any AI/machine learning models. The description of the device's technology points to signal processing and magnetic tracking algorithms rather than learnable AI models in the modern sense. Therefore, "training set" is not applicable in the context described.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned (see point 8), this information is not applicable/provided.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”