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The PowerPICC® EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

The PowerPICC SOLO® EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. 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® EtOH and PowerPICC SOLO® EtOH Catheters 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 (>30 days) to sample blood and administer fluids intravenously. The catheters are compatible with intraluminal solutions containing up to 70% ethanol, 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 devices.

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® EtOH | 4F (Single Lumen (SL))
| 5F (Dual Lumen (DL)) FT
| 5F (Triple Lumen (TL))
PowerPICC SOLO®2 EtOH | 4F (Single Lumen (SL))
| 5F (Dual Lumen (DL)) FT
| 5F (Triple Lumen (TL))

The subject catheters will be packaged with legally marketed components used in the placement procedure.

The following device descriptors apply to all French sizes and configurations of the subject Bard Access PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Catheters:

• The catheters are open-ended, radiopaque polyurethane;
• The catheters have a reverse taper design;
• Each catheter configuration has one power injectable lumen;
• Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
• Catheters are provided sterile in basic interventional radiology (IR), and basic, full, and max barrier nursing PICC configurations with legally marketed kit components;
• 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;
• Yellow colorant was added to the catheter junction material to provide the catheter with an appearance that allows the end user to differentiate Bard's ethanol compatible catheters from other catheters not compatible with ethanol;
• The catheter extension leg, luer hub, junction, and clamp ID tags are printed with markings to identify the catheter as PowerPICC® EtOH or PowerPICC SOLO®2 EtOH, and include information to facilitate proper use of the device; and
• The PowerPICC® EtOH catheter clamp and PowerPICC SOLO®2 EtOH luer are labeled with EtOH to indicate ethanol compatibility.

The following device descriptors apply to all French sizes of the subject Bard Access Systems PowerPICC® EtOH Catheters:

• Yellow colorant was added to the catheter extension leg clamp material to provide the catheter with an appearance that allows the end user to differentiate Bard's ethanol compatible catheter from other catheters that are not compatible with ethanol.

The following device descriptors apply to all French sizes of the subject Bard Access Systems PowerPICC SOLO®2 EtOH Catheters:

• The PowerPICC SOLO®2 EtOH catheter is a clampless, proximally valved catheter, and
• Yellow colorant was added to the lower portion of the luer hub to identify the catheter as a PowerPICC SOLO®2 EtOH catheter that is ethanol compatible.

The following device descriptors apply to specific French sizes of the subject Device Bard Access Systems PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Description Catheters:

• The 5F TL catheter product labeling warns against power injection procedures through the two small lumens,
• The 5F TL catheter's usable length is 50 cm,
• The 5F DL FT and 4F SL catheter's usable length is 55 cm,
• The 5 F DL FT catheter has a double taper design, and
• The 5 F DL FT catheter product labeling warns against trimming the catheter in the "No Trim Zone" to maintain product functionality.

The provided FDA submission for the PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Catheters does not contain a table of acceptance criteria and reported device performance in the typical format one might expect for a detailed performance study. Instead, it states that "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices."

The submission describes the types of tests performed and the standards referenced, implying that the acceptance criteria are linked to these standards and the performance of the predicate device. However, it does not explicitly list the specific numerical acceptance criteria (e.g., "burst pressure > X psi") or the exact reported performance values.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, a direct table is not present. The document generally states that "The subject devices met all predetermined acceptance criteria... and demonstrated substantially equivalent performance." The acceptance criteria would have been derived from the referenced standards and safety/performance tests.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for any of the tests. The document mentions "Verification and validation tests have been performed," but does not provide specific sample quantities (e.g., number of catheters tested for burst pressure).
• Data Provenance: The tests are referred to as "in-house protocols" performed by Bard Access Systems. The country of origin is not specified but implicitly would be the USA given the company's address and FDA submission. The nature of these tests (retrospective or prospective) is not discussed but for device performance tests, they would inherently be prospective (i.e., conducted on newly manufactured devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (expert review for ground truth) is typically relevant for AI/ML device submissions, particularly those involving image analysis or diagnostic interpretation. For a physical medical device like a catheter, "ground truth" is established by direct physical, chemical, and biological testing against established standards and validated methods. Therefore, this section is not applicable in the context of this device and submission. The "experts" would be the engineers, scientists, and technicians conducting and evaluating the performance and safety tests, and their qualifications are not detailed in this submission.

4. Adjudication method for the test set

Similarly, adjudication methods (like 2+1 or 3+1 consensus) are typically for subjective interpretations, such as clinical reads in AI/ML performance studies. For physical device performance tests, the results are generally objective and quantitative (e.g., a burst pressure value). Therefore, an explicit adjudication method is not applicable to the performance and safety tests described here. Results are evaluated against predetermined acceptance criteria.

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

An MRMC study is relevant for AI-assisted diagnostic devices. This submission pertains to a physical intravascular catheter. Therefore, an MRMC study was not conducted, and this section is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of an AI algorithm without human involvement. Since this is a physical medical device, not an AI/ML algorithm, a standalone algorithm performance study was not applicable and therefore not done.

7. The type of ground truth used

For this physical medical device, the "ground truth" for showing it meets acceptance criteria is established through:

• Engineering Specifications: Conformance to dimensional tolerances, material composition, etc.
• Validated Test Methods: The results of performance tests (e.g., burst pressure, flow rate, tensile strength) conducted according to recognized industry standards (ISO, ASTM) and internal protocols.
• Biocompatibility Standards: Assessment against the criteria outlined in the ISO 10993 series for biological safety.
• Predicate Device Performance: The primary comparison for substantial equivalence relies on demonstrating that the new device performs similarly to or better than legally marketed predicate devices, especially for existing functionalities. For new functionalities (like ethanol compatibility), dedicated tests (e.g., material degradation after ethanol exposure, though not explicitly detailed here) would establish its ground truth against the claim.

8. The sample size for the training set

This question relates to the development of AI/ML models. Since this submission is for a physical medical device and does not involve AI/ML, there is no training set in this context, and thus no sample size for a training set.

9. How the ground truth for the training set was established

Again, this is applicable to AI/ML device development. As there is no AI/ML component, there is no training set and therefore no ground truth established for a training set in this context.

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An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard proximally valved catheters. The extension set will connect the IV administration set to the catheter.

The Extension Set is designed for Bard proximally valved catheters and attaches to the end of the catheter hub for use in the administration of fluids. The Extension Set opens the valve to facilitate central venous pressure monitoring and/or blood sampling. Extension Sets are packaged individually for single use for a period no longer than 96 hours.

The provided submission describes non-clinical performance testing for the "Extension Set for Bard® Proximally Valved Catheters." This is a medical device for fluid administration, not an AI/ML powered device, therefore many of the requested categories are not applicable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific test. The testing is described as "bench performance testing," which implies laboratory-based testing of manufactured devices. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as no human data was involved.

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

Not applicable. This device is an extension set for catheters, and the testing involved bench performance criteria, not medical image interpretation or clinical outcomes requiring expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process described as the testing was non-clinical bench testing against predetermined engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, and no MRMC study or human reader performance evaluation was conducted or is relevant for this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an algorithmic device. The performance evaluation focuses on the physical properties and functionality of the extension set itself.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria are established engineering, mechanical, and safety standards and internal protocols (e.g., ISO standards for infusion equipment, Luer fittings, tensile strength requirements, leak integrity, and flow rates).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As there is no training set mentioned.

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The PowerPICC SOLO™ catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC SOLO™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The PowerPICC SOLO™ catheter is a clampless proximally valved catheter. The PowerPICC SOLO™ catheters are open-ended radiopaque polyurethane. The PowerPICC SOLO™ catheters are offered in 4 Fr Single Lumen (SL), 5 Fr Single Lumen (SL), 5 Fr Dual Lumen (DL), 6 Fr Dual Lumen (DL), and 6 Fr Triple Lumen (TL) configurations. Catheter usable length is 55 cm. The catheter has 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. Catheters are provided sterile in basic and full PICC configurations with legally marketed kit components. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' catheters. Lower portion of luer hub is blue to identify the catheter as PowerPICC SOLO™ catheter. The catheter extension leg, luer hub and junction were printed with markings to identify the catheter as PowerPICC SOLO™ and to include information to facilitate proper use of the device.

This document describes the premarket notification (510(k)) for the PowerPICC SOLO™ Catheter, specifically addressing its substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on regulatory compliance, device description, and safety testing rather than a clinical study evaluating specific performance metrics against acceptance criteria that are typically found in AI/ML-based device submissions.

Therefore, many of the requested sections (e.g., acceptance criteria, test set details, expert ground truth, MRMC study, training set details) are not directly applicable or available from the provided text for this non-AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This section is largely Not Applicable in the way it's typically understood for AI/ML device performance. For this medical device (a catheter), "acceptance criteria" and "performance" are framed in terms of meeting established industry standards and demonstrating substantial equivalence to predicate devices, rather than achieving specific numerical targets on a test set.

• FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General requirements
• ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 2
• ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use
• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
• ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
• AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
• IEC 60601-2-34: 2000-10, Medical electrical equipment - Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
• AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• ANSI/AAMI BP22: 1994, Blood Pressure Transducers | Met. Performance testing was conducted in accordance with the listed documents and standards, yielding "acceptable safety & performance outcomes." (Study type: Laboratory testing against numerous specific standards). |
  | Substantial Equivalence | Demonstration of substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to current commercially available/cited predicate devices. | Achieved. The device "met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." (Study type: Comparison to predicate devices and documentation of compliance with standards). |

2. Sample size used for the test set and data provenance

Not Applicable (N/A) for this type of device submission. The provided text details engineering and biocompatibility testing against established standards and predicate devices, not a test set of data (e.g., medical images for an AI algorithm). The provenance of data refers to the source of materials or components used in the device, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). This concept is for AI/ML models that rely on expert annotations for ground truth. This is a physical medical device.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth.

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 (N/A). This is not an AI-assisted device, and thus, no MRMC study involving human readers with/without AI assistance was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A). This is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable (N/A) in the context of clinical "ground truth" for diagnostic or prognostic endpoints. The "ground truth" for this device's performance is its adherence to established international and FDA medical device performance standards and its physical and material properties, as demonstrated through laboratory testing.

8. The sample size for the training set

Not Applicable (N/A). This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.

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