Search Results

The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include a silicone valve on the proximal end.
The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.

This document, K180548, is a 510(k) premarket notification for a medical device, specifically PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials like a PMA. Therefore, the information provided focuses on comparative testing against established standards and the predicate device, rather than a clinical study with human patients, AI integration, or expert consensus on a test set in the traditional sense of an AI/ML clinical study.

Given the nature of this 510(k) submission for a non-AI/ML device, many of the requested criteria regarding AI/ML performance studies, such as multi-reader multi-case studies, ground truth establishment for clinical data, and training/test set sizes for algorithms, are not applicable.

However, we can extract information regarding acceptance criteria for the device's physical and functional performance and the study (testing) methods used to demonstrate that the device meets these criteria as part of the substantial equivalence determination.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for PowerPICC Provena Catheters

Since this is a physical medical device (catheter) and not an AI/ML diagnostic or therapeutic system, the "acceptance criteria" listed here are for the device's physical and functional performance specifications. The "study" refers to the engineering and bench testing performed to verify these specifications, primarily comparing them to predicate devices and relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance tests conducted due to a material change in the extension leg (from Polycarbonate Polyurethane to Polyether Polyurethane). The acceptance criteria are generally "Risk Acceptability Criteria" as defined by internal standards (BAS) and ISO standards. The reported device performance is that the "subject devices met design requirements and demonstrated substantial equivalence." Specific numerical results are not provided in this summary, but the type of performance demonstrated is indicated.

• Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
• Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence" to predicate device, implying the tensile strength criteria were met. |
  | Dimensional Characterization
• Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension legs.
• Standard: BAS internal standards and procedures | Device "met design requirements and demonstrated substantial equivalence," implying dimensional conformity. |
  | Leak Decay Testing
• Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is occluded.
• Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence," implying no leaks or leaks within acceptable limits. |
  | Hydraulic Burst Testing
• Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum flow conditions.
• Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence," implying burst pressure exceeded requirements. |
  | Biocompatibility Evaluation
• Evaluation conducted based upon the specific modification per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
• Utilized information from reference device PowerPICC SOLO (K072230) which uses the same material for extension legs as subject devices. | Biocompatibility evaluation concluded device "met design requirements and demonstrated substantial equivalence." |
  | Risk Management
• Conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. | Risk management activities confirmed substantial equivalence. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of units/parts tested for each performance test (e.g., Assembly Tensile Testing, Leak Decay Testing). Standard engineering practices for medical devices typically involve statistically significant sample sizes, but these are not disclosed in the 510(k) summary.
• Data Provenance: The testing appears to be in-house bench testing conducted by the manufacturer, Bard Access Systems, Inc. The document does not indicate country of origin for test data beyond the manufacturer's location in Salt Lake City, UT, USA. The testing is prospective in the sense that it was conducted specifically for this regulatory submission to demonstrate performance of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this device. "Ground truth" in this scenario refers to established engineering specifications and compliance with ISO standards (e.g., tensile strength minimums, leak limits). These are determined by published standards and internal design requirements, not by expert human interpretation of data in the way radiologists interpret images.

4. Adjudication Method for the Test Set

This question is not applicable. As the "test set" involves physical and functional performance testing against objective criteria (e.g., burst pressure, tensile strength), there is no need for human adjudication of results in the way image interpretation might require. The results are quantitative measurements compared against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. This device is a physical catheter, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• International Standards: e.g., ISO 10555-1:2013 (for intravascular catheters), ISO 10993-1:2009 (for biocompatibility), BS EN ISO 14971:2012 (for risk management).
• Internal Manufacturer Specifications and Procedures: ("BAS internal standards and procedures").
• Comparison to Predicate Device Performance: The primary method for 510(k) clearance is demonstrating substantial equivalence to a predicate device that has previously met these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device. This is not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As there is no training set, there is no ground truth for it.

Ask a specific question about this device