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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.

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.

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The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable PICC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. 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 VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique 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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

• . 4 Fr, 1-Lumen, 40-55 cm catheter preloaded with VPS Stylet
• 5 Fr, 2-Lumen 40-55 cm catheter preloaded with VPS Stylet ●
• 6 Fr, 3-Lumen 40-55 cm catheter preloaded with VPS Stylet .

The Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media.

The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch. For user convenience, Arrow has created the Arrow PICC powered by Arrow VPS Stylet in which the Arrow PICC is provided pre-loaded with the Arrow VPS Stylet.

The provided text, K121941, describes a 510(k) premarket notification for a medical device (Arrow PICC powered by Arrow VPS Stylet). It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with acceptance criteria and performance data for a new device's efficacy or accuracy.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new AI/software-driven diagnostic or treatment device.

Here's why and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence. The "performance" discussed relates to physical characteristics like tensile strength and burst pressure for the catheter and stylet, not a clinical performance metric.

2. Sample size used for the test set and the data provenance: Not applicable for clinical performance. The nonclinical testing mentioned (tensile strength, burst, etc.) would have its own sample sizes, but these are not provided. There's no "test set" of clinical data for AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for AI performance.

4. Adjudication method: Not applicable. No clinical ground truth was established for AI performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it was not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, it was not. The VPS Stylet provides "real-time catheter tip location information" using physiological data, but this is a real-time guidance system, not an "algorithm only" diagnostic.

7. The type of ground truth used: For the "guidance and tip positioning" aspect, the VPS System uses "patient's physiological (cardiac electrical activity and blood flow) information" to indicate "desired location." The "ground truth" for confirming tip placement after using the device is still external verification (e.g., fluoroscopy or chest x-ray if a steady Blue Bullseye is not obtained). The submission claims the VPS System is an alternative method to fluoroscopy or chest x-ray when a steady Blue Bullseye is obtained. This implies that the 'Blue Bullseye' indicator is the surrogate for correct placement, but the document doesn't detail the validation of this 'Blue Bullseye' against an independent gold standard in a study context.

8. The sample size for the training set: Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be.

9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The submission K121941 is for a combination device: the "Arrow PICC powered by Arrow VPS Stylet." The core of the submission relies on demonstrating substantial equivalence to existing, already cleared devices:

• K103255: Vascular Positioning System (VPS System) Stylet
• K113277: Arrow ADVANTAGE Pressure Injectable Peripherally Inserted Central Catheter (PICC)
• K080604: Pressure Injectable PICC

The argument is that combining these two previously cleared devices "does not raise new issues of safety or effectiveness."

Nonclinical Testing:
The document states that "Nonclinical Testing" was performed for:

• Catheter performance: tensile strength, and burst tests.
• Stylet performance: tensile, Hi-pot, continuity, and removal testing.

The results of these tests "demonstrate that the Arrow PICC powered by Arrow VPS Stylet is as safe, as effective and performs comparably to the predicate VPS stylet and Pressure Injectable PICC." However, specific acceptance criteria or detailed numerical results from these tests are not provided in this summary.

In conclusion, this 510(k) summary focuses on demonstrating that a combination of two already-cleared physical devices is substantially equivalent to those individual devices, without presenting new clinical performance data or acceptance criteria for a novel AI/software component as requested.

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