(119 days)
PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.
- The PowerHohn and PowerLine Catheters are open-ended radiopaque polyurethane . catheters.
- Catheter size is 5 Fr SL 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.
- PowerHohn and PowerLine Catheters are provided in sterile tray configurations. .
- Purple colorants were added to the catheter materials to provide the catheter with an ● I urpic colorants were added to arer to differentiate the PowerHohn and PowerLine as power injectable from other central venous catheters.
- The molded hub is labeled to identify the catheter as PowerHohn and PowerLine. .
- The catheter extension leg and clamp are labeled with information to facilitate proper use of . the device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 5 Fr SL PowerHohn™ and PowerLine™ Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary is a high-level summary and does not explicitly list specific numerical acceptance criteria or detailed performance data in a tabular format. Instead, it makes general statements about meeting predetermined criteria and substantial equivalence.
| Acceptance Criterion (Inferred from text) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "met all the predetermined performance criteria of design verification evaluations" (implies safety and effectiveness were considered) |
| Equivalence to Predicate Devices | "substantially equivalent to the predicate devices" |
| Intended Use | "The PowerHohn and PowerLine Catheters met all the acceptance criteria of the testing performed" (specific to their stated intended use) |
| Power Injectability (Max Infusion Rate) | "maximum recommended infusion rate is 5cc/sec" |
| Power Injectability (Max Pressure) | "maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi" |
| Material Biocompatibility | "There are no new materials therefore, no new biocompatibility is required." (Implies predicate devices' biocompatibility is acceptable) |
| Compliance with Standards | "The FDA's Guidance on Premarket Notification [510(k)] Submission... and relevant ISO 10555 Standards were used" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the test set. It mentions "verification testing was performed" but provides no numerical details.
- Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It is a submission for regulatory clearance in the US, so the testing would typically be conducted by or for the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device (catheter) rather than a diagnostic algorithm or imaging system. Therefore, the concept of "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists) is not directly applicable here. The "ground truth" for a device like this would be its physical properties and functional performance, measured through engineering tests against established specifications.
4. Adjudication Method for the Test Set
As this is a device performance study rather than a diagnostic interpretation study, adjudication methods like 2+1 or 3+1 are not relevant. Device performance is typically determined by measurements and physical tests against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a 510(k) submission for a medical device (catheter), not an AI algorithm. Therefore, an MRMC comparative effectiveness study, which is common for AI tools in diagnostics, was not performed. The study aimed to demonstrate substantial equivalence to predicate devices, not improvement over human performance with AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This is a physical medical device, not an algorithm. Therefore, the concept of a "standalone" algorithm performance study does not apply.
7. The Type of Ground Truth Used
For this type of device, the "ground truth" would be established through:
- Engineering specifications and design requirements: These define the physical and functional properties the catheter must possess.
- Performance metrics derived from relevant standards: Such as ISO 10555 for intravascular catheters, which would specify test methods and acceptance limits (e.g., tensile strength, flow rates, pressure limits, material properties).
- Predicate device characteristics: The performance of the predicate devices (PowerPICC™ Catheter and Broviac® Catheter) would serve as a benchmark for substantial equivalence.
The summary states: "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards." This indicates that the "ground truth" was based on a combination of regulatory guidance, industry standards, and the characteristics of the predicate devices.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the sense of data used to train an AI model. The "training" for a physical device involves its design and manufacturing processes, and the verification testing confirms its performance.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no "training set" for an AI model, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and adherence to quality systems and regulatory standards.
§ 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.”