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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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