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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.

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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.

Bard Access Systems, Inc.'s 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 long or short-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 subject devices include a silicone valve on the proximal end. The subject devices included in this notification are of varying French size and catheter configuration types, as summarized in the table below.

Summary of Subject Devices
Catheter Configuration | French size (Number of Lumens)
PowerPICC Provena Catheters with SOLO² Valve Technology | 3 French Single Lumen (SL)
PowerPICC Provena Catheters with SOLO² Valve Technology | 4 French Dual Lumen (DL)

The following device descriptors apply to all French sizes and configurations of the subject catheters:
● Catheters are open-ended, radiopaque polyurethane;
● Catheters incorporate a silicone valve on the proximal end;
● Catheters have a reverse taper design;
● Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
● Purple colorant is included in the catheter material to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters;
● Catheter extension legs, luer hubs, and junction are printed with markings to identify the catheter as PowerPICC Provena Catheters with SOLO² Valve Technology, and include information to facilitate proper use of the device.

The subject devices are provided sterile in basic interventional radiology (IR) kits, 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.

The provided text describes specific performance tests conducted for the PowerPICC Provena Catheters with SOLO² Valve Technology to demonstrate substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information provided does not align with the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria.

However, based on the provided text, I can infer the "acceptance criteria" from the "Risk Acceptability Criteria (Acceptance Criteria of Test)" column and the reported performance from the "Verification / Validation Method" column. The study described is a series of in-house and standard-based performance tests, not an MRMC or standalone AI study.

Here's an interpretation based on the provided content, acknowledging its limitations regarding AI/ML:

This document describes the testing and verification of a medical catheter, not an AI/ML-driven device. Therefore, many of the requested criteria specific to AI/ML systems (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, effect size, standalone performance) are not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and stated performance for the catheter device as presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantial equivalence as compared to the cited predicate device."

AI/ML Specific Questions (Cannot be answered from the provided text as it's not an AI/ML device)

2. Sample sizes used for the test set and data provenance: Not applicable. This is a physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device is established through physical and mechanical testing against standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established through meeting material, mechanical, and functional performance specifications defined by internal standards, ISO standards (e.g., ISO 10555-1:2013), and FDA guidance documents.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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