Search Results

The Malleable Vent Catheter is intended for use during cardiopulmonary bypass Surgery to vent/drain the left ventricle.

The Malleable Vent Catheter is designed to vent/drain the left ventricular during coronary artery bypass surgery.

It consists of soft polyviny] chloride (PVC) tubing with a radius tip and vent holes 3.5 cm along the distal tip. The soft PVC tubing consists of two lumens; one large lumen for venting/drainage and one smaller lumen which encapsulates the stainless steel wire. The encapuslated stainless steel wire enables preshaping of the catheter prior to insertion and support during catheter placement. The proximal end of the catheter contains a rigid PVC connector and depth markings along the farge lumen.

The provided document is a 510(k) premarket notification for a medical device, the California Medical Laboratories Inc. Malleable Vent Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a de novo submission.

Therefore, the document does not contain the acceptance criteria or reported device performance data from a study that proves the device meets those criteria in the way you've outlined. The information you are requesting is typically found in clinical trial reports or performance testing documentation, which are not usually included in full in a 510(k) summary that focuses on substantial equivalence.

Here's an explanation of why the requested information isn't available in this document and what is typically presented in a 510(k) for devices like this:

• Acceptance Criteria and Reported Performance: For a 510(k), particularly for a Class II device like a catheter, the "acceptance criteria" are primarily related to demonstrating that the new device has the same technological characteristics and same intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" proving this often involves non-clinical testing (e.g., biocompatibility, sterility, material strength, dimensional accuracy) compared to established standards or the predicate device's specifications, rather than clinical efficacy studies with specific outcome metrics. The document explicitly states: "The California Medical Laboratories, Inc devices have technologic characteristics which are substantially equivalent to the predicate device."

• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set, etc.: These concepts (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are highly relevant to complex diagnostic algorithms, AI/ML-based devices, or clinical efficacy trials for novel devices. They are not typically applicable to a mechanical device like a vent catheter seeking 510(k) clearance based on substantial equivalence to existing devices. For such devices, performance is usually assessed through engineering bench testing, material testing, and sometimes simulated-use testing.

In summary, the provided K981601 document does not contain the specific information requested in your bullet points because:

• It is a 510(k) submission focused on proving substantial equivalence to a predicate device, not on presenting novel clinical performance data against predefined acceptance criteria from a comprehensive clinical study.
• The device (a malleable vent catheter) is a mechanical device, and its safety and effectiveness are typically demonstrated through material testing, functional testing, and comparison of characteristics to a predicate, rather than through extensive clinical trials with the types of performance metrics and study designs relevant to AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, training/test sets).

If this were a more complex diagnostic device or an AI-driven device, the 510(k) summary (or the full submission, if available) would contain much more detail on validation studies, potentially including some of the elements you've listed.

Ask a specific question about this device