(195 days)
The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm DLX® 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® DLX Device, indicated for visual navigation of a peripherally inserted catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.
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® DLX Device with 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® DLX 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 Tip TipTracker™ Technology includes the software algorithms and accessory components (the non-sterile, reusable TipTracker™ T-piece and sterile, single-use TipTracker™ and proposed NaviCurve™ Stylet) which facilitate the real-time visualization of a Peripherally Inserted Central Catheter's (PICC) track and direction as it is inserted by the clinician through the vasculature. The TipTracker™ T-piece consists of a magnetic emitter array that is connected to the VPS Rhythm® DLX Device monitor. In use, the TipTracker™ T-piece is placed externally on the patient's chest. When the sterile, single-use TipTracker™ Stylet or NaviCurve Stylet is assembled with the peripherally inserted central catheter (PICC) and inserted by the clinician, the VPS Rhythm® DLX Device with TipTracker™ Technology facilitates the visualization of the PICC'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 catheter tip location.
The proposed VPS Rhythm® DLX Device introduces the ability to pair a commercially available Ultrasound probe (Interson Corporation: K163443) with the VPS Rhythm® DLX monitor to permit ultrasound visualization during the initial central catheter insertion procedure for vessel assessment and visualization on the display of the VPS Rhythm® DLX system. An optional catheter to vessel ratio tool can be used during vessel assessment.
As a new optional feature related to P-wave morphology changes, the DLX Software uses a time detected reference based on the R-Peak to show where the P-wave should exist in a patient with a normal sinus rhythm.
The provided text, a 510(k) summary for the VPS Rhythm® DLX Device with TipTracker™ Technology, describes the device and its demonstrated equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly a table of acceptance criteria with reported performance, or details about patient sample sizes, expert adjudication, or MRMC studies.
The document focuses on demonstrating substantial equivalence to an existing predicate device (VPS Rhythm® Device with TipTracker™ Technology, K160925) by highlighting non-clinical performance data and the absence of new safety or effectiveness concerns due to the modifications.
Here's a breakdown of what can be extracted from the document regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states that "testing verifying the performance requirements of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted and included in this premarket notification and the results support substantial equivalence."
The types of testing performed can be inferred as fulfilling the acceptance criteria, as the document concludes that the testing "has passed all acceptance criteria to verify that the proposed VPS Rhythm® DLX Device with TipTracker™ Technology meets its design, physical integrity, functional, software, and safety requirements."
Inferred "Acceptance Criteria" based on tests mentioned:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Passed IEC 60601-1, 3rd Edition Electrical Safety. |
| Electromagnetic Compatibility | Passed IEC 60601-1-2, 4th Edition Electromagnetic Compatibility. |
| Software Verification & Validation | Passed Software Verification and Validation Testing. |
| Cybersecurity | Passed Cybersecurity assessments in accordance with FDA Guidance. |
| Accessory Compatibility | Demonstrated compatibility. |
| Essential Performance | Demonstrated acceptable performance for: Distortion, Screen Freezing, ECG Impedance, ECG Waveform Performance. |
| ECG Display | Acceptable display of ECG waveforms. |
| Tracking Display | Acceptable display of tracking information. |
| Ultrasound Display | Acceptable display of ultrasound images (with optional probe). |
| Chemical Resistance | Demonstrated chemical resistance. |
| Cleaning and Disinfection | Demonstrated capability for cleaning and disinfection. |
| Cable Connector Flex Life | Passed ANSI/AAMI EC53 flex life tests. |
| Cable Connection Tensile Strength | Passed ANSI/AAMI EC53 tensile strength tests. |
| Shock Resistance (Monitor, T-piece, Remote Control) | Passed IEC 60068-2-27 shock tests. |
| Sinusoidal Vibration (Monitor, T-piece, Remote Control) | Passed IEC 60068-2-6 sinusoidal vibration tests. |
| Random Vibration (Monitor, T-piece, Remote Control) | Passed IEC 60068-2-64 random vibration tests. |
| Dielectric Withstand Voltage (T-piece, Remote Control, ECG Patient Cable) | Passed ANSI/AAMI EC53 dielectric withstand voltage tests. |
| Navigation Stylet Tensile Strength | Passed tensile strength tests per FDA Guidance. |
| Navigation Stylet Flexural Integrity | Passed ISO 11070 flexural integrity tests. |
| Navigation Stylet Insertion & Withdrawal Force | Passed insertion and withdrawal force tests. |
| Navigation Stylet Corrosion | Passed ISO 11070 corrosion tests. |
| Navigation Stylet Particulate Evaluation | Passed particulate evaluation. |
| Navigation Stylet Coating Integrity | Passed coating integrity tests. |
| Navigation Stylet Torque | Passed torque tests. |
| Navigation Stylet Radiopacity | Demonstrated radiopacity. |
| Navigation Stylet Kink Resistance | Demonstrated kink resistance. |
| Navigation Stylet Holding Force & Leak Resistance | Demonstrated holding force and leak resistance. |
| Navigation Stylet Electrical Impedance & Voltage Feedback | Passed electrical impedance and voltage feedback tests. |
| Biocompatibility (Cytotoxicity) | Passed ISO 10993-5 cytotoxicity assessment. |
| Biocompatibility (Sensitization & Irritation) | Passed ISO 10993-10 sensitization and irritation assessment. |
| Biocompatibility (Hemocompatibility) | Passed ISO 10993-4 hemocompatibility (for blood-contacting). |
| Biocompatibility (Systemic Toxicity) | Passed ISO 10993-11 systemic toxicity (for blood-contacting). |
| Human Factors/Usability | Met predetermined usability criteria as assessed by independent clinician participants. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a sample size for the test set for any of the non-clinical performance tests. It refers to "Human Factors: A human factors and usability report assessing the usability of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted. The studies conducted utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria." However, it does not state the number of participants.
- Data Provenance: The document explicitly states: "No human clinical data was provided to support substantial equivalence." The data described is "Non-Clinical Performance Data," implying in-vitro and bench testing, as well as a human factors study which involves users, not patients. Therefore, information regarding "country of origin of the data," "retrospective or prospective," or "patient samples" is not applicable based on what is provided.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable, as no human clinical data was provided and the human factors study involves participants for usability assessment, not for establishing medical ground truth for device accuracy.
- Qualifications of Experts: The human factors study used "independent clinician participants," but no specific qualifications (e.g., "radiologist with 10 years of experience") are provided.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical ground truth was established by experts for medical performance. The human factors study assessed usability against "predetermined usability criteria," implying internal validation, but no multi-expert adjudication process is described for device performance accuracy.
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." Therefore, there is no information on human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance:
- The document describes the device's overall performance in various non-clinical tests (e.g., "ECG Waveform Performance," "Tracking Display," "Ultrasound Display"). Since no human clinical data was presented, the "performance" described is effectively the "algorithm's" or device's inherent capability as measured in bench and engineering tests. However, it does not isolate "algorithm-only" performance as a separate study component distinct from the integrated device. The device itself uses the cardiac electrical activity and magnetic field technology for its functions.
7. Type of Ground Truth Used:
- For the non-clinical performance data, the ground truth is implicitly defined by the standards and specifications against which the device was tested (e.g., IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC53, ISO 11070, ISO 10993-1). These standards represent established engineering and safety benchmarks for medical devices.
- For the human factors study, the "ground truth" was predetermined usability criteria.
8. Sample Size for the Training Set:
- The document describes a 510(k) submission for a device that uses cardiac electrical activity and magnetic field technology, and mentions "software algorithms." However, it does not state that the device uses machine learning or AI that requires a "training set" in the typical sense of supervised learning. The software V&V refers to traditional software testing. Therefore, information on a training set size is not provided and likely not applicable in the context of this traditional medical device clearance.
9. How the Ground Truth for the Training Set Was Established:
- As a "training set" for AI/machine learning is not mentioned as part of the device's development or clearance, this information is not applicable and not provided. The device's functionality is based on known physiological principles (ECG changes to detect catheter tip location) and magnetic field-based tracking, rather than data-driven "learning" from a large dataset.
§ 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.”