(380 days)
The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.
Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.
The Piccolo Medical SmartPICC System is a device used by clinicians for guidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.
Additional components associated with the reusable system include a USB cable to connect the tablet to the controller and an external ECG (xECG) Trunk Cable to connect the xECG leads to the controller.
Additional accessories in the Stylet Kit include:
- Sterile Drape Clip to secure Stylet hub to sterile patient drape
- Sterile cover for the tablet
- Sterile scissors for opening sterile tubing pouch
- xECG Electrodes and Leads
- Instructions for Use
The Piccolo Medical SmartPICC System is intended to help position Peripherally Inserted Central Catheters (PICC) in adult patients by providing real-time catheter tip location information using intravascular ECG (ivECG) signals. It also includes a supplemental ionic dilution feature for qualitative blood flow information to assist catheter navigation.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage accuracy or precision target) for the performance of the SmartPICC system. Instead, the "Summary of Human Factors Testing" states that the simulated use testing "adequately reviewed" the device's application to ensure "safe, effective use" and demonstrated "suitability for its intended purpose." This suggests that the acceptance criteria for this study were likely qualitative and focused on the device's ability to facilitate correct PICC tip placement and user comprehension of the device's output.
While no precise performance metrics are given, the overall conclusion is that the device should "perform as intended" and is "substantially equivalent" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective Use | Demonstrated suitability for intended purpose through simulated use. Non-clinical data supports safety. |
| Proper PICC Tip Placement | System effectively aids in confirming tip location as an alternative to chest x-ray/fluoroscopy. |
| User Comprehension | Instructions for Use and hazard analysis considered adequate for safe and effective use. |
| Substantial Equivalence | Performance is substantially equivalent to the predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the "Simulated Use / Human Factors Testing." It only mentions "Human Factors Testing."
- Data Provenance: The document does not specify the country of origin of the data nor if it was retrospective or prospective. Given it was "Simulated Use," it was likely prospective, but the location is not mentioned.
3. Number of Experts and Qualifications for Ground Truth in Test Set
The document does not specify the number of experts used to establish ground truth for the human factors/simulated use testing, nor does it detail their qualifications. It only states that the testing was conducted to evaluate the application of the system.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the "Simulated Use / Human Factors Testing."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance versus without. The study described is a "Simulated Use / Human Factors Testing," which focuses on the device's application and user interaction, not a reader study of clinical images.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop) performance study evaluating the accuracy of the ivECG signal interpretation or ionic dilution feature in isolation. The human factors testing involved the device being used by humans.
7. Type of Ground Truth Used (Test Set)
For the "Simulated Use / Human Factors Testing," the type of ground truth used is not explicitly stated. However, since the test aimed to confirm "PICC tip position," it can be inferred that the ground truth would have been the actual, verified PICC tip position established by a gold standard method during the simulation, although the specific method is not detailed. The comparison to chest x-ray or fluoroscopy confirmation suggests these are the accepted gold standards the device aims to emulate or provide an alternative to.
8. Sample Size for the Training Set
The document does not mention a training set sample size. The text indicates that "Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device." This suggests the device's performance was not primarily established through a machine learning model requiring a large training set, but rather through engineering and human factors validation demonstrating equivalence to a predicate device.
9. How Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing ground truth for a training set is not applicable or provided in this document.
§ 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.”