(202 days)
Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation.
In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.
Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.
The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display.
Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction.
Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.
The Neonav ECG Tip Location System is intended for navigation and positioning of central venous access devices (CVADs). The acceptance criteria and supporting study details are outlined below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements of ISO 10993-1:2018 (Biological evaluation of medical devices), ISO 10993-7:2008 (Ethylene oxide sterilization residuals). The only patient-contacting component (ECG Adapter) is composed of biocompatible polycarbonate and stainless steel. |
| Sterilization Effectiveness | Met requirements of ISO 11135-7 and ISO 11135-2 (Sterilization of health-care products – Ethylene oxide). |
| Packaging Integrity and Shelf Life | Met requirements of ISO 11607-1:2019 and ISO 11607-2:2019 (Packaging for terminally sterilized medical devices), ASTM D543, ASTM F88/F88M-21, ASTM D4169-22, ASTM D7386-16, ASTM F2096-11, ISTA 3A 2018 General Simulation Performance Test. Accelerated aging was performed per ASTM F1980-21. |
| Electrical Safety & EMC | Met requirements of ANSI AAMI IEC 60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance) and IEC 60601-1-2:2020 (Electromagnetic disturbances - Requirements and tests), IEC/TR 60601-4-2. |
| Usability/Human Factors | Met requirements of IEC 60601-1-6:2020 (Usability) and IEC 62366-1:2020 (Application of usability engineering to medical devices). |
| Software Life Cycle Processes/MDR Compliance | Met requirements of IEC 62304:2015 (Medical device software life cycle processes). Followed guidance for Off-The-Shelf Software, Content of Premarket Submissions for Device Software Functions, and Cybersecurity in Medical Devices. |
| Specific Performance for ECG Monitoring | Met requirements of IEC 60601-2-27:2011 (Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment). |
| Small-Bore Connectors | Met requirements of ISO 80369-7:2021 (Connectors for intravascular or hypodermic applications). |
| ECG Trunk Cables and Patient Leadwires | Met requirements of ANSI/AAMI EC53:2013 (R2020). |
| Ability to capture data from 1Fr catheters | Demonstrated in non-clinical bench tests. This supports the expanded indication for catheter sizes of 1Fr and above (compared to the predicate's 3Fr and above). |
| Real-time P-wave display and analysis | Displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, and heart rate for user decision-making for catheter navigation. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size for a clinical test set used to prove the device meets acceptance criteria related to its primary function of tip location accuracy. The document primarily references non-clinical bench tests and compliance with various standards.
There is a mention of "most current literature and effectiveness of PICCs in infants and neonates" supporting expanded indications, but this is not described as a direct device performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for any performance study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The Neonav system "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," suggesting it's an assistance tool rather than a fully automated AI interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The description of Neonav states it "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," implying a human-in-the-loop operation. "Neonav does not provide computation of ECG signal for navigation. Neonav displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal."
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function and the comparison to X-ray and fluoroscopy, it is highly probable that ground truth in any clinical validation would involve imaging modalities (e.g., chest X-ray or fluoroscopy confirmation) or direct physician assessment of catheter tip position, but this is not explicitly detailed in the provided text.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information on how ground truth was established for a training set.
§ 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.”