Search Results

The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording, and intravascular ultrasound for catheter guiding and positioning.

The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.

This FDA 510(k) summary for the FlowPICC™ Stylet (K081625) does not provide details of specific acceptance criteria or a dedicated study demonstrating the device meets those criteria.

The document states: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a general statement and does not include the detailed information requested in your prompt regarding acceptance criteria and a specific study plan.

Based on the provided text, here's what can be inferred and what is not present:

1. Table of acceptance criteria and reported device performance:

   • Not provided. The document does not list any specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) or acceptance thresholds for them.

2. Sample size used for the test set and data provenance:

   • Not provided. The document states "Performance test results" but does not specify the sample size, type of data (e.g., in-vitro, ex-vivo, in-vivo), patients included, or their country of origin. It also doesn't mention if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and qualifications:

   • Not provided. There is no mention of a ground truth establishment process, experts, or their qualifications.

4. Adjudication method for the test set:

   • Not provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Not done/reported. The document does not mention any MRMC study or evaluation of human readers with or without AI assistance. The FlowPICC System is described as providing "real-time catheter tip location information" to assist in placement, implying it's a tool for a clinician, but no study is described to quantify this assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study:

   • Not explicitly reported as a separate study with specific metrics. The device's function is to provide real-time information. While this implies a standalone measurement capability, the document doesn't detail a separate "standalone" performance study. The statement about "performance characteristics" is general.

7. Type of ground truth used:

   • Not provided. Since no specific study is detailed, the method for establishing ground truth (e.g., pathology, surgical confirmation, independent imaging) is not mentioned.

8. Sample size for the training set:

   • Not applicable / Not provided. The device is described as using "physiological (cardiac electrical activity and blood flow) information" and "intravascular ultrasound." This suggests a sensor-based system and signal processing, rather than a machine learning model that would typically have a "training set" in the common sense of AI/ML. There's no indication of a training set as would be relevant for an AI model.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. (See point 8).

Summary of what is present:

• Device Description: The FlowPICC System uses a Stylet with a Doppler sensor and an intravascular ECG (ivECG) signal sensing wire connected to a Console to provide real-time catheter tip location information using cardiac electrical activity and blood flow information.
• Intended Use: Supplemental aid in PICC placement to assist in tip placement of the PICC catheter.
• Performance Data Statement: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a generalized statement of sufficiency for 510(k) clearance, not a detailed study report.
• Predicate Devices: ComboMap (Volcano K041134) and Sherlock (Bard K063240) are cited, implying that the "performance test results" likely demonstrated equivalence to these devices based on their established performance.

In conclusion, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study with defined acceptance criteria and its outcomes. It does not contain the specific information requested in your prompt regarding detailed performance studies, ground truth, expert involvement, or sample sizes.

Ask a specific question about this device