Search Results

The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.

The provided document describes a Special 510(k) Notification for the Medtronic 8F Launcher Guiding Catheter. This type of submission is for modifications to a currently cleared device, demonstrating substantial equivalence to a predicate device. As such, the study focuses on functional and material equivalence rather than clinical performance against specific disease detection criteria.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device, the Medtronic 7F Launcher Guide Catheter (K022764), in terms of materials, manufacturing processes, design, and performance in in-vitro tests.

Study Details

Given this is a 510(k) notification for a guiding catheter, the "study" is primarily an in-vitro testing and comparison assessment rather than a clinical trial with human subjects for diagnostic accuracy.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a numerical sample size for the in-vitro functional and biocompatibility tests. It refers to "tests" being performed.
   • Data Provenance: The tests were conducted internally by Medtronic AVE, Inc. (the submitter). The provenance is therefore considered internal company testing, and by nature, it is prospective with respect to the testing itself (i.e., the tests were performed specifically for this submission). There's no indication of country of origin for the data other than the submitter's location in Danvers, MA, USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this type of device and submission. "Ground truth" in this scenario would refer to the established performance specifications for medical devices of this type (e.g., ISO standards, internal Medtronic specifications). These specifications are typically set by engineering and scientific teams within the company and regulatory bodies, not by "experts" in the sense of clinical reviewers for diagnostic accuracy.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 are used in clinical studies when there are differing opinions from human readers on a diagnostic task. For in-vitro functional and biocompatibility testing, adherence to a specification is typically a pass/fail outcome, not subject to human adjudication of interpretation.

4. 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 (a catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI or human interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. As mentioned, this is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance claims relies on established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and manufacturing quality control parameters. For the claim of substantial equivalence, the "ground truth" is the proven performance of the predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the machine learning sense. The device's design and manufacturing processes are likely derived from years of experience and iterative development, but not a formally defined "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device