(62 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 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
- The PowerPICC™ Catheters are open-ended radiopaque polyurethane catheters. .
- Catheter size is 6 Fr DL with 50 cm usable length. ●
- 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 PICC configurations. .
- Purple colorants were added to the catheter materials to provide the catheter with an . appearance that allows the end user to differentiate the PowerPICC from other PICC catheters.
- The catheter extension leg, junction and clamp ID tag were printed with markings to identify . the catheter as PowerPICC and to include information to facilitate proper use of the device.
This 510(k) summary describes a medical device, the 6 Fr DL PowerPICC™ Catheter, and its substantial equivalence to predicate devices. It does not contain information about studies proving the device meets acceptance criteria, as is common for this type of submission which primarily focuses on demonstrating substantial equivalence to existing, cleared devices.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The 6 Fr DL PowerPICC™ catheter meets all the predetermined performance acceptance criteria of the testing performed..." and "Performance data gathered in design verification testing demonstrated that the 6 Fr DL PowerPICC™ catheter is substantially equivalent to the predicate 5 Fr SL PowerPICC™ catheter..."
However, the specific acceptance criteria and the corresponding reported performance values are not provided in this document. The document refers to testing performed "according to protocols based on the above referenced guidance document recommendations and standards, as well as in-house protocols," but it does not detail these protocols or their results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 provided in the document. This is not a study involving human interpretation of data where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. This device is a catheter, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. As this is not an AI algorithm, standalone performance as described for AI devices is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. For a physical device like a catheter, "ground truth" would relate to its physical and functional performance against engineering specifications and international standards, rather than diagnostic accuracy.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary of available information:
| Category | Information from Document |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly detailed, but implied to be "predetermined performance acceptance criteria" based on FDA guidance and international standards (ISO 10555-1:1997, ISO 10555-3:1997, AAMI/ANSI/ISO 11135:1994, and FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters). |
| Reported Performance: "The 6 Fr DL PowerPICC™ catheter meets all the predetermined performance acceptance criteria of the testing performed..." and "Performance data gathered in design verification testing demonstrated that the 6 Fr DL PowerPICC™ catheter is substantially equivalent to the predicate 5 Fr SL PowerPICC™ catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA." Specific performance metrics and their values are not provided. | |
| 2. Sample size and Data Provenance (test set) | Not provided. |
| 3. Number and Qualifications of Experts (for ground truth) | Not applicable/Not provided. (Ground truth in this context would be related to engineering specifications and performance, not expert interpretation of data). |
| 4. Adjudication Method (test set) | Not applicable/Not provided. |
| 5. MRMC Comparative Effectiveness Study (AI assist) | Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. |
| 6. Standalone Performance (algorithm only) | Not applicable. This is a physical medical device. |
| 7. Type of Ground Truth Used | Not explicitly stated in terms of "ground truth" as it would be for diagnostic AI. For a physical device, performance is typically measured against established engineering specifications, material properties, and functionality requirements outlined in the referenced international standards and guidance documents. |
| 8. Sample Size for Training Set | Not applicable. This is a physical medical device, not an AI/ML algorithm. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |
Conclusion:
The provided 510(k) summary for the 6 Fr DL PowerPICC™ Catheter asserts that the device meets its predetermined performance acceptance criteria through design verification testing. This testing demonstrated substantial equivalence to predicate devices, and risks were assessed with FMEA. However, the document does not detail the specific acceptance criteria, the quantitative results of the performance testing, the sample sizes used, or the specifics of how the "ground truth" (in the context of device performance) was established beyond referencing industry standards and internal protocols. This level of detail is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than providing a detailed study report.
§ 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.”