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

The deflectable catheter delivery system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Device Description

The 6226DEF system features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and a slitter to remove the deflectable catheter.

The Attain 6226DEF Deflectable Catheter Delivery System combines devices that are either pre-amendment devices, devices that are cleared for market distribution via 510(k), or are exempt from premarket notification because of Class I designation.

The key changes being made to the system versus the predicate 10600 device are a decrease in the length of the deflectable catheter, a reduction in the stiffness of the deflectable catheter tip, and a change in the articulated shape of the catheter. The dilator length is also decreased in line with the catheter. In addition the slitters are replaced by a Universal Slitter and the adjustable hemostasis valve is replaced by an introducer valve. The entire system is packaged in a revised packaging configuration.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the ATTAIN™ 6226DEF Deflectable Catheter Delivery System. It establishes substantial equivalence to existing predicate devices based on design, technology, features, functions, intended use, and in vitro testing, as well as biocompatibility and sterilization validation.

However, the document does not contain specific acceptance criteria tables nor detailed study results that would typically be used to "prove" the device meets such criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device, or specific success rates for a therapeutic device). This type of information is not typically presented in a 510(k) summary focused on substantial equivalence to a predicate device.

Instead, the document states that:"In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements."

Without access to the full submission, which would include the detailed testing reports, it's impossible to extract the specific acceptance criteria and detailed performance data.

Therefore, for the information requested, I can only provide what is explicitly stated or inferable from the document:

A table of acceptance criteria and the reported device performance:
The document states: "The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements." However, specific numerical acceptance criteria (e.g., tensile strength > X, deflection angle > Y) and the corresponding measured performance values are not provided in this summary. The summary refers to in vitro testing and biocompatibility/sterilization testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions in vitro testing and biocompatibility/sterilization testing. It does not specify sample sizes, data provenance, or whether the tests were retrospective or prospective. In vitro tests generally refer to laboratory-based experiments rather than human data.
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):
This information is not applicable or provided. The testing described is in vitro (laboratory) and biocompatibility/sterilization, which does not involve human subjects or expert assessment of "ground truth" in a clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. Adjudication methods are typically used in clinical studies with human assessors, which is not described here.
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:
This information is not applicable or provided. The device is a "Deflectable Catheter Delivery System," a medical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable or provided. The device is a physical catheter delivery system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For in vitro and biocompatibility/sterilization testing, "ground truth" would typically refer to established engineering specifications, material standards, and validated sterilization protocols. The document does not specify the exact "ground truth" used for each specific test, but implies adherence to "design and performance requirements" and ISO10993 for biocompatibility.
The sample size for the training set:
This information is not applicable or provided. The device is a physical medical instrument, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
This information is not applicable or provided for the same reason as point 8.

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).