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The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less

The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use. This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector. The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes. The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass. The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use. The product will be available in both Carmeda coated and uncoated versions.

The provided 510(k) summary (K052524) describes a venous cannula and introducer set, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (K884129) rather than establishing new performance criteria through a standalone clinical study for a novel algorithm or AI.

Therefore, the following information cannot be extracted from the provided text as it typically applies to AI/ML-driven devices or devices requiring extensive clinical trials for efficacy claims beyond substantial equivalence:

• Acceptance Criteria and Reported Device Performance Table: The document states "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." However, it does not provide specific quantitative acceptance criteria or their corresponding reported performance values in a table. The assessment is qualitative, asserting "substantial equivalence" based on "design, test results, and indications for use."
• Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is described. The "test results" refer to engineering validation, not clinical data for AI performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication for AI/ML is described.
• 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: Not applicable. This device is a physical medical instrument, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as understood in AI/ML validation is mentioned. "Test results" likely refer to bench testing or in-vitro performance.
• The sample size for the training set: Not applicable. No AI/ML training set is described.
• How the ground truth for the training set was established: Not applicable. No AI/ML training set is described.

Summary of Acceptance Criteria and Study (based on available information):

The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Bio-Medicus Femoral Cannula and Introducer, K884129) in terms of:

1. Design: The device description details modifications such as a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition, and a 3/8" barbed connector. These design changes were compared to the predicate.
2. Test Results: While specific tests and their outcomes are not detailed, the submission states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implicitly means the device met performance standards (e.g., flow rates, material compatibility, strength, patency, etc.) comparable to or better than the predicate, considering the intended use.
3. Indications for Use: The indications for use for the new device were compared directly to those of the predicate. Both devices are intended "to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment" for cardiopulmonary bypass. The new device specifies "for use by trained physicians only" and "up to six hours or less."

Study Proving Acceptance Criteria:

The study proving the acceptance criteria was a non-clinical validation testing described as "Validation testing" to establish "performance characteristic of the modifications." This type of study demonstrates that the new device's engineering and functional parameters are acceptable and do not raise new questions of safety or effectiveness compared to the predicate. The FDA's clearance letter confirms that based on the submitted information, the device was found to be "substantially equivalent."

In conclusion, for this specific 510(k) summary, the core "study" was the engineering and performance validation comparing the new device's characteristics to those of the legally marketed predicate device, demonstrating that its design and performance were substantially equivalent and supported the same indications for use.

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