FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

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.

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.

AI/ML Overview

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.

Acceptance Criteria Category	General Description of Acceptance Criteria (Inferred from context)	Reported Device Performance
Material/Catheter Properties	Conformance to specifications for open-ended, radiopaque polyurethane, reverse taper design, depth indicators, colorants, markings.	Met all predetermined acceptance criteria.
Mechanical Performance	Demonstrated appropriate assembly leak, tensile strength, elongation, modulus, fatigue, ISO Luer compliance, burst pressure, radiopacity, catheter leak under vacuum, and valve function.	Met all predetermined acceptance criteria.
Functionality	Demonstrated required gravity flow, priming volume, power injection capability, central venous pressure monitoring, stylet compatibility, and ink adherence.	Met all predetermined acceptance criteria.
Biocompatibility	Conformance to ISO 10993 series for cytotoxicity, pyrogenicity, subacute/subchronic toxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, subchronic/subcutaneous implant toxicity, genotoxicity, implantation studies, hemolysis, prothrombin time, unactivated thromboplastin time, dog thrombogenicity, platelet and leukocyte counts, and compliment activation, chronic toxicity.	Met all predetermined acceptance criteria.
Sterilization & Packaging	Conformance to ISO 11135 and ISO 11607 standards for validation and routine control of ethylene oxide sterilization and packaging requirements.	Met all predetermined acceptance criteria.
Risk Management	Conducted in accordance with ISO 14971:2012.	Successfully completed.

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.

Summary

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”