(80 days)
The Kerberos Proximal Solutions Occluding Guide Catheter (OCG) and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.
The Kerberos Proximal Solutions Occluding Guide Catheter (OGC) is a sterile single-use percutaneous catheter consisting of a dual lumen variable stiffness braided shaft catheter incorporating a flush mounted balloon at the distal tip. Guidance and tracking of the catheter through the coronary, neuro or peripheral vasculature is accomplished by torquing of the catheter and/or the use of a guide wire.
The provided text describes a medical device, the Kerberos Occluding Guide Catheter and Accessories, and its pre-market notification (510(k)) to the FDA. This specific document outlines the device's substantial equivalence to existing predicate devices based on design and performance testing. However, it does not contain the specific acceptance criteria or a detailed study report proving the device meets those criteria in the way you've requested for AI/diagnostic devices.
This document is typical for a Class II medical device where substantial equivalence is demonstrated through comparative testing with predicate devices, rather than establishing de novo performance metrics against specific acceptance thresholds like AI/diagnostic tools.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. These elements are not typically part of a 510(k) submission for this type of device.
Instead, the document states:
Acceptance Criteria and Device Performance (Implicit):
The acceptance criteria are implicitly met by demonstrating "substantial equivalence to currently marketed predicate devices" and that "All data fell well within internal specification requirements, as well as external standard requirements and predicate performance expectations."
Study Information:
The study was conducted through "Design analysis, in vitro and in vivo data." The specific types of tests mentioned are:
- In vitro dimensional analysis
- Balloon performance
- Torque and kink resistance
- Leakage
- Bond strengths
- Biocompatibility tests
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance: Not explicitly provided in this summary. The summary states "All data fell well within internal specification requirements, as well as external standard requirements and predicate performance expectations."
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, not an AI/diagnostic tool requiring expert ground truth for interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for a physical catheter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of diagnostic performance. For a physical device, "ground truth" would relate to engineering specifications and performance in various physical tests.
- The sample size for the training set: Not applicable, as this is not an AI/ML algorithm.
- 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).