(127 days)
The FlowPICC System 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 a 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 information.
The FlowPICC™ 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 Console integrates a data acquisition system, two DAQ cards, an isolation transformer and a PC pre-loaded with proprietary software. The Console, when used as intended, uses a blood velocity profile and heart electrical activity to provide user feedback and guiding indicators for proper PICC catheter tip placement in the caval-atrial junction. The Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify when the catheter is moving towards the heard, moving away from the heart, in the proper location or should be adjusted because there isn't enough information.
The provided text does not contain specific acceptance criteria or the details of a study that proves the device meets them. It is a 510(k) summary, which states that "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices," but it does not elaborate on these tests, their criteria, or the results.
Therefore, I cannot populate the requested table or answer most of the questions.
Here's a breakdown of what can be inferred from the provided text, and what is missing:
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1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified with quantitative metrics in the provided text. The statement "Performance test results support the performance characteristics of the device" is qualitative and lacks detail.
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2. Sample size used for the test set and the data provenance: Not provided.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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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: Not provided. The device is a "Console" that provides "user feedback and guiding indicators," suggesting human interaction, but no MRMC study details are given.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but the nature of the device ("Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify...") implies it's an assisted device, not a standalone diagnostic.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
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8. The sample size for the training set: Not provided.
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9. How the ground truth for the training set was established: Not provided.
In summary, the provided document is a high-level regulatory submission summary and does not contain the detailed performance study information, acceptance criteria, or experimental setup details that would be found in a full scientific study report.
§ 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).