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The ELITE-i Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

Device Description

The Elite-i (RA) Dual Lumen (short lengths), Elite-i (Bi) Dual Lumen (standard) and Elite-i (BiX) Dual Lumen (extra-long lengths) are wire-reinforced catheters with a one-piece, dual lumen construction. The Dual Lumen Catheter is a single catheter with two separate lumens within the catheter body to collect and to return the blood. The product is offered in a range of sizes to address varying patient size requirements. The catheters are intended to be inserted via the internal jugular vein into the superior vena cava, the right atrium and the inferior vena cava (except for the short lengths which only reach the right atrium). The catheter's dual lumen construction allows for both venous drainage and reinfusion of blood during extracorporeal life support procedures. The catheters are designed for use by physicians trained in and experienced with venous catheterization and extracorporeal life support in a hospital setting. Each catheter is supplied with a tapered tip introducer to facilitate placement into the vasculature using a guide wire and following normal access techniques. In addition to the standard introducer, the Elite-i (RA) Dual Lumen Catheter (short lengths) is supplied with an extra, blunt tip introducer to accommodate user preference for placement into the right atrium. Both the catheter and introducers are radiopaque and include depth or location marks. The standard introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) guide wire (which is not included). The blunt tip introducers do not require or accommodate a guide wire. The device is supplied sterile and non-pryogenic in a peel pouch and carton. It is intended for single use.

AI/ML Overview

A table of acceptance criteria and the reported device performance:

The document describes a medical device, the Elite-i Dual Lumen Catheter family, which is a modification of a previously cleared predicate device. Instead of acceptance criteria and reported device performance in the traditional sense of AI/software performance metrics, this submission focuses on demonstrating substantial equivalence through nonclinical testing.

Here's a table based on the provided text, outlining the tests performed and the general performance conclusions:

Acceptance Criteria (Test Performed)	Reported Device Performance
Pressure/Burst	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Simulated Use	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Kink Resistance	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, design verification of spring and reinforcement modifications included kink resistance testing (Implies performance met original and new criteria).
Tensile Strength	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, design verification of spring and reinforcement modifications included tensile strength testing (Implies performance met original and new criteria).
Flow Characteristics (Flow Curves)	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, flow curves for the new configurations were generated. "Flow curves for the modified devices will be consistent with the flow-curves of the predicate devices."
Hemolysis	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Biocompatibility	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, verification of biocompatibility for the colored caps and tantalum dots was performed. "Biocompatibility was confirmed to be acceptable."
Sterilization (for blunt tipped introducers and modified lengths)	Verification of Sterilization for blunt tipped introducers and modified lengths performed. (Implied successful verification).

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a nonclinical testing program, building upon the original 510(k) submission for the predicate device. The core argument for substantial equivalence is that the new devices utilize the "same technological characteristics (design and materials)" as the predicate device.

For modifications, additional testing was conducted:

Flow curves for the new configurations: These were generated to confirm consistency with the predicate device.
Verification of Biocompatibility for the colored caps and tantalum dots: This addressed new materials.
Verification of Sterilization for blunt tipped introducers and modified lengths: This addressed new components and lengths.
Design verification of spring and reinforcement modifications including kink resistance and tensile strength testing: This addressed minor structural changes.

The conclusion is that the modified catheters are "equivalent to the predicate devices in all key areas of features and performance that affect safety and effectiveness based on a Risk Assessment of the modifications made."

The subsequent questions (2-9) are typically relevant for AI/ML device submissions, where statistical performance of an algorithm against a ground truth is evaluated. This document describes a traditional medical device (catheter) and its 510(k) submission based on substantial equivalence to a predicate device, not an AI/ML device. Therefore, questions 2 through 9 are not directly applicable to this particular submission.

Here's why each question is not applicable in this context:

Sample size used for the test set and the data provenance: This relates to data used to test an algorithm's performance. No such "test set" of data (e.g., images, patient records) is mentioned for this physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no diagnostic or interpretive "ground truth" being established by experts for algorithmic performance.
Adjudication method: Not applicable as there's no expert review of algorithmic outputs.
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 is specific to AI-assisted diagnostic devices. There is no AI component mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no algorithmic output to compare against a ground truth. The "ground truth" for the catheter's performance is adherence to engineering specifications and safe physiological function shown through nonclinical tests.
The sample size for the training set: Not applicable as there is no AI model requiring a training set.
How the ground truth for the training set was established: Not applicable as there is no AI model requiring a training set.

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