(98 days)
The ENABLER-P Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
The ENABLER-P Support Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Support Catheter can provide distal anchoring and support the advancement of the guidewire.
The ENABLER-P Support Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The ENABLER-P Support Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices.
The provided text describes a 510(k) summary for a medical device, the ENABLER-P Support Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device would.
Therefore, the information regarding acceptance criteria, study details like sample size, ground truth, expert involvement, and comparative effectiveness studies (MRMC, standalone) as requested for an AI/ML device is not applicable to this 510(k) submission.
The document indicates that the device's substantial equivalence was established through:
- Biocompatibility testing: Results indicated that the device materials are biocompatible.
- In vitro bench studies: These studies were conducted to evaluate performance characteristics.
- Animal studies: These were also conducted to evaluate performance characteristics.
The conclusion is that "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." However, specific numerical acceptance criteria and reported performance metrics are not detailed in this summary.
In summary, for the ENABLER-P Support Catheter, the following information is not available in the provided text, as it is typical for a 510(k) pathway for a conventional medical device rather than an AI/ML device requiring clinical performance metrics:
- Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence based on material and functional characteristics rather than specific quantifiable performance metrics against pre-defined clinical acceptance criteria.
- Sample size used for the test set and data provenance: No "test set" in the context of an AI/ML algorithm is mentioned. The studies were biocompatibility, in vitro bench, and animal studies, for which sample sizes are not detailed.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI/ML model is not relevant here.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI/ML diagnostic tool meant to assist human readers.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).