FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ASAHI Precious guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. This Precious guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with either PTFE or Sodium hyaluronate (depending upon the specific model number) to enhance lubricity. The outer surface of the product is coated with Silicone oil.

AI/ML Overview

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it pertains to AI/ML software. This document is a 510(k) summary for a physical medical device (a guide catheter), not an AI/ML algorithm.

Therefore, many of the specific questions about AI/ML algorithm validation cannot be answered from this text.

Here's why and what can be extracted:

Acceptance Criteria/Reported Device Performance (Table): The document states that "mechanical and functional bench testing" was conducted and "demonstrates that the ASAHI Precious guide catheter performs as intended." However, it does not provide specific quantitative acceptance criteria or the numerical results of these tests (e.g., tensile strength, flexibility, lubricity thresholds, and measured values). It only broadly claims equivalence to predicate devices.
Sample size for the test set and data provenance: Not applicable. This is a physical device, not an AI/ML algorithm validated on a dataset. The testing refers to bench testing of the physical catheter.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant here. The ground truth for a physical device is its physical and mechanical properties.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a physical catheter.
Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is not an algorithm.
The type of ground truth used: For a physical device, the "ground truth" would be the expected physical and mechanical properties based on engineering specifications and industry standards. The document implies compliance through "bench testing" and "biocompatibility testing."
Sample size for the training set: Not applicable. This is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a guide catheter) and describes its substantial equivalence to predicate devices based on material composition, dimensional specifications, biocompatibility, and mechanical/functional bench testing. It uses standard device clearance procedures and terminology, which are distinctly different from the validation requirements for AI/ML software.

The requested information about acceptance criteria, test sets, ground truth, expert involvement, and AI-specific studies (MRMC, standalone performance, training sets) is not present in the provided document because it addresses a different type of medical device submission.

Summary

Regulation Number and Section

§ 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).