Search Results

The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.

The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

The provided text describes a 510(k) submission for the "CardiacAssist-Transseptal Cannula Set". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the device performance data provided is primarily based on bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes bench testing rather than human clinical trials. Therefore, information about human "test sets" or "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for bench testing. The "test set" would consist of multiple units of the manufactured device subjected to various engineering and materials tests. The document does not specify the exact number of units tested for each criterion, but it implies a sufficient number were tested to draw conclusions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable as the data presented is from bench testing, not from human studies requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests are objective measurements against established engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide interpretations that need to be reconciled. Bench tests rely on objective measurements and established protocols.

5. 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 not applicable. The device is a physical medical instrument (a cannula set), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the bench tests described:

• Functional Performance (Flow vs. Pressure Drop, Kink Radius): The ground truth would be established by comparing the device's performance against the predicate device (Elecath cannula) and/or predetermined engineering specifications. The statement "substantially better than that of the Elecath cannula" indicates the predicate's performance served as a baseline or "ground truth" for comparison.
• Mechanical Strength (Tensile Strength) and Integrity (Leak Testing): The ground truth would be predefined engineering design requirements and specifications.
• Biocompatibility: The ground truth is compliance with recognized international standards and FDA guidance documents (FDA Blue Book Memorandum #G95-1 and ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical instrument, and the testing described is bench testing, not machine learning or AI where "training sets" are used.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reasons as #8.

Ask a specific question about this device