(28 days)
The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
The 6 FR TL PowerPICC® Catheters are open-ended radiopaque polyurethanc. . 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 radiology and nursing PICC configurations. 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' power injectable catheters. The catheter has one power injectable lumen. The product labeling warns against power injection procedures through the two small lumens. The catheter extension legs, junction and clamp ID tags were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.
This document is a 510(k) Summary for the 6 Fr TL PowerPICC® Catheter, indicating it's a premarket notification for a medical device. The focus of the summary is on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against detailed acceptance criteria from a comprehensive study.
Based on the provided text, the document states:
- Acceptance Criteria and Reported Device Performance: General statements are made that "The 6 Fr TL PowerPICC® catheter meets all the prodetermined performance acceptance criteria of the testing performed" and that "Performance data gathered in design verification testing demonstrated that the 6 Fr TL PowerPICC® catheter is substantially equivalent to the predicate devices." However, specific quantitative acceptance criteria or detailed reported performance metrics are not provided in this summary. The summary refers to compliance with various ISO standards and FDA guidance documents, implying that performance was evaluated against the requirements outlined in those documents.
A table of acceptance criteria and reported device performance cannot be generated from the given text because the specific criteria and corresponding performance metrics are not explicitly listed.
Here's an analysis of the other requested information based on the text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text. The testing was "in-house," implying it was conducted by Bard Access Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. The study described is a device verification and validation study, not a study involving human interpretation of data where "ground truth" would be established by experts in the typical clinical sense (e.g., in an AI diagnostic device).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. This type of adjudication is relevant for studies involving human reviewers or AI interpretations, which is not the nature of this device's performance testing.
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
- No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device (PICC catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense of establishing ground truth for diagnostic accuracy. The "ground truth" for this device would be established by direct physical measurements and engineering tests to ensure the catheter meets design specifications (e.g., flow rates, pressure resistance, material compatibility, strength). The text mentions performance data was gathered from "design verification testing" based on international standards (ISO) and FDA guidance for intravascular catheters. This implies the "ground truth" was derived from predefined engineering and material science specifications and test methodologies rather than clinical outcomes or expert consensus on clinical images/data.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for a physical device.
§ 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.”