(56 days)
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.
| Criteria Category | Acceptance Criteria (Not explicit as numerical targets, but compliance with standards) | Reported Device Performance and Study Type |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1: Evaluation and Testing and FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices. | Met. Biocompatibility requirements have been met. (Study type: Laboratory testing against ISO 10993 standards). |
| Catheter Performance | Compliance with various FDA guidance documents and international standards including: |
- 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.
§ 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.”