(104 days)
The PowerHickman™ catheter is intended for short or long term access to the central venous system for intravenous therapy and blood sampling.
The PowerHickman™ catheter is indicated for short or long term access to the central venous system. The PowerHickman™ catheter is designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal, power injection of contrast media and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The PowerHickman™ catheters are open-ended, long-term central venous catheters. The catheters are made of polyurethane material to which a purple colorant has been added. 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 PowerHickman™ catheters are available in 8 Fr single lumen and 9.5 Fr dual lumen catheter configurations. The catheters are packaged in intermediate and microintroducer kits that incorporate kit components designed to meet the needs of the respective placer.
The provided text is a Traditional 510(k) summary for the PowerHickman™ Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device, the PowerLine™ Central Venous Catheter.
However, the document does not contain specific acceptance criteria, a detailed study design, or reported device performance metrics in the format requested in the prompt. Instead, it generally states that "The PowerHickman™ Central Venous Catheters met performance criteria of the safety and effectiveness tests performed," and lists the standards and guidance documents that informed the bench testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for a test or training set based solely on the provided text.
The document indicates that bench testing was performed based on applicable standards and an FDA guidance document to assess the new characteristics (new catheter sizes and use of ChronoFlex polyurethane material). The conclusion of this testing was that the device met performance criteria and demonstrated substantial equivalence.
Here's what can be extracted and what is missing, based on your prompt:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided definitively from the text. The document states "The PowerHickman™ Central Venous Catheters met performance criteria of the safety and effectiveness tests performed," but it does not specify what those criteria were or what the actual performance values were.
- The tests were based on standards like ISO 10555-1, ISO 10555-3, ISO 594-2, ASTM F640, AAMI/ANSI/ISO 11135, AAMI/ANSI/ISO 10993-1, IEC 60601-2-34, AAMI TIR9, and ANSI/AAMI BP22, along with the "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95." These standards would contain the acceptance criteria, but the specific values or results from the PowerHickman™ catheter's testing are not enumerated.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The text only mentions "bench testing." There is no information on sample sizes, whether the testing was on real-world data, or its provenance.
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)
- Not applicable / not provided. As this is a medical device (catheter) 510(k) submission and the testing mentioned is "bench testing," it is highly unlikely that "experts" were used to establish a "ground truth" in the clinical imaging or diagnostics sense. The ground truth for bench testing would be defined by the physical properties measured against the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / not provided. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic outputs. For bench testing of a physical device, this concept does not apply.
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. This is a physical medical device (catheter), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to human readers and AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in these terms. For bench testing of a medical device, the "ground truth" would be the established scientific and engineering principles, and the performance requirements outlined in the referenced national and international standards (e.g., ISO, ASTM, AAMI). The physical and functional characteristics of the device itself would be measured against these predefined standards.
8. The sample size for the training set
- Not applicable / not provided. This is a physical medical device. The concept of a "training set" is typically associated with machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable / not provided. See above.
§ 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.”