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Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel.
The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.

The provided text describes a medical device's 510(k) submission to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the physical and material characteristics of the catheters and the bench testing performed. However, it does not contain information pertinent to the typical acceptance criteria or study design for AI/ML-based medical devices, such as a test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I am unable to provide the requested information based on the input text.

The document discusses the following:

• Device Name: Python Catheter and Over-the-Wire Latis Graft Cleaning Catheter
• Intended Use: Removal of thromboemboli from the peripheral arterial system/vascular grafts, and for occlusion and infusion of fluids into a vessel/graft.
• Testing Performed:
  • Engineering/Bench Testing: Balloon Pull Force, Inflation & Guidewire Hub Pull Force, Catheter Body Tensile Strength, Catheter Balloon Cycling Test, Balloon Burst Pressure Test, Inflated Balloon Diameter Inspection, Guidewire & Inflation Hub Leak Test, Simulated Use Bend Test, Torsion Test, Kink Test.
  • Biocompatibility Testing: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity, Platelet and Leukocyte Counts, Partial Thromboplastin Time, Complement Activation, Thrombogenicity.
• Standards Referenced: ISO 10555-1:ed2:2017 and EN 13868.

This information relates to the physical and biological safety and performance of the catheter itself, not to the performance of an AI/ML component.

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The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.

The Applied Medical Dual Lumen Graft Cleaning Catheter is a single-use catheter intended for removal of thromboemboli from vascular grafts.

The provided text describes a 510(k) submission for the Applied Medical latis™ Dual Lumen Graft Cleaning Catheter. This regulatory submission process is focused on demonstrating substantial equivalence to a previously marketed device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device might.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone performance with AI, training set details) are not applicable to this type of medical device submission as described in the provided document. The "study" here is primarily a set of mechanical and biocompatibility tests to show the device is safe and performs comparably to its predicates.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Detailed Information (Not all applicable to this type of device submission):

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

   • Sample Size: Not specified for clinical or performance data as this submission relies on demonstrating substantial equivalence through mechanical safety and biocompatibility tests, not a clinical trial with a "test set" of patients in the context of AI/ML evaluation.
   • Data Provenance: Not applicable in the context of human data. The tests were likely conducted in a lab setting by the manufacturer.

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

   • Not Applicable. The "ground truth" for this device's submission is primarily established through engineering tests (mechanical, functional, biocompatibility) and comparison to predicate devices, not through expert consensus on diagnostic images or patient outcomes.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2.

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 is not an AI/ML device, nor is it a device that is intended to assist human readers in interpretation. It's a physical medical catheter.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

   • Not Applicable. This is not an algorithm or AI system.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the successful completion of mechanical safety tests and biocompatibility tests, and the demonstration of comparability to the predicate devices. This is based on engineering specifications and established test methodologies for medical devices.

7. The Sample Size for the Training Set:

   • Not Applicable. This device does not use a "training set" in the context of machine learning.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. See point 7.

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