(633 days)
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.
These devices are sterile, nonpyrogenic, disposable, intended for single use only. Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Do not store the product above 25°C (77°F).
The provided document is a 510(k) summary for the Medtronic Bio-Medicus Life Support Catheter and Introducer. It describes a medical device, specifically a catheter and introducer for use in ECMO/ECLS, and assesses its substantial equivalence to a predicate device.
Crucially, this document is for a medical device (catheter and introducer), not an AI/ML device or a software device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML devices (e.g., standalone performance, MRMC studies, expert ground truth for image analysis, etc.) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests and regulatory requirements for a physical medical device. They are focused on mechanical properties, biocompatibility, sterility, shelf-life, and in vivo performance in an animal model, rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot populate the requested table and answer the questions in the context of an AI/ML device. The document does not contain information on:
- A table of acceptance criteria and reported device performance related to AI/ML metrics.
- Sample size for a "test set" or "training set" in the AI/ML sense.
- Number of experts for ground truth or adjudication methods for an AI/ML model.
- MRMC studies or effect sizes for human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML context.
- How ground truth for a training set was established for an AI/ML model.
What the document does provide relevant to device acceptance is:
- Acceptance Criteria (Special Controls for the device type): These are outlined under "Comparison to Predicate (Special Controls)" on page 5 and include:
- Technological Characteristics (geometry, design, compatibility)
- Biocompatibility (ISO 10993-1:2009 compliance)
- Sterility and Shelf-life (demonstrates sterility, integrity, durability, reliability)
- Non-clinical Performance (bench, mechanical integrity, durability, reliability testing)
- In vivo Evaluation (performance over 7-day duration of use)
- Labeling (detailed summary of non-clinical and in vivo evaluations, instructions, compatibility, maintenance)
- Study Proving Device Meets Criteria (Summary of Performance Data): This is detailed on pages 5-6 under "Summary of Performance Data" and includes:
- Pre-clinical bench testing: Used to verify performance characteristics.
- 21-day Simulated use durability testing (Tensile strength after life conditioning, Pressure test after life conditioning)
- Blood trauma testing
- Kink testing
- Birds Mouth testing
- ID occlusion due to suture ring
- Suture Collar Slide Force
- Introducer removal and insertion forces
- In vivo animal testing: 7-day GLP in vivo study.
- Pre-clinical bench testing: Used to verify performance characteristics.
In conclusion, the requested information pertains to AI/ML device validation, which is not the subject of this 510(k) submission. This document describes the testing and regulatory compliance for a physical medical device.
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.