(190 days)
The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.
The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.
The provided text describes a medical device, "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface" and its substantial equivalence submission to the FDA. The information focuses on regulatory compliance, device characteristics, and performance data from pre-clinical bench studies.
Based on the provided text, the device is a Class II medical device (Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure). The device does not involve AI. Therefore, the questions related to AI-specific performance criteria, test sets, ground truth, experts, and human-in-the-loop performance are not applicable.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from the "Special Controls" identified in 21 CFR 870.4100, as outlined by the FDA Final Order 81 FR 7451, February 12, 2016. The reported device performance is a statement of compliance with these controls, supported by various bench studies.
| Acceptance Criteria (Special Control) | Reported Device Performance |
|---|---|
| Technological Characteristics: The geometry and design parameters of the device are consistent with its intended use in extracorporeal support procedures, and the device is compatible with other devices and accessories in the extracorporeal circuit. | The device's technological characteristics are consistent with its intended use and compatible with other devices in the circuit. |
| Biocompatibility: The device is demonstrated to be biocompatible in accordance with ISO 10993-1:2018 and with FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (4 September 2020)." | Demonstrated to be biocompatible according to ISO 10993-1:2018 and FDA guidance. |
| Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing demonstrate that the device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device. | Sterilization adoption and shelf-life testing confirm the device maintains sterility, integrity, durability, and reliability over its 2-year shelf life. |
| Non-clinical Performance: Substantial equivalence of the performance characteristics is demonstrated on bench, mechanical integrity, durability, and reliability testing. This includes demonstrating performance for the stated intended use and duration, including demonstrating that components maintain performance after exposure to maximum transit temperature. Compatibility with other devices and accessories, and resistance to kinking and compression that would obstruct fluid flow. Also includes evaluation of blood trauma and coating coverage. | Substantial equivalence of performance characteristics was demonstrated through pre-clinical bench testing including: 21-day simulated use durability testing, tensile strength after life conditioning, pressure test after life conditioning, functional testing, kink testing, blood trauma testing, and coating coverage. |
| Labeling: The Instructions for Use include a detailed summary of the non-clinical evaluations pertinent to use of the device in an extracorporeal 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. | Instructions for Use include detailed summaries of non-clinical evaluations, and adequate instructions for anticoagulation, circuit setup, performance characteristics, and maintenance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "pre-clinical bench studies" for performance testing. Specific sample sizes for each bench test are not provided. The testing is conducted by Medtronic, a US-based company, implying the studies were conducted internally or through contracted labs, but the specific country of origin for the data is not explicitly stated. The studies are described as "pre-clinical bench testing," which are inherently controlled laboratory experiments, not reflecting a "retrospective or prospective" study design in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical medical device clearance based on bench testing of its mechanical, material, and functional properties, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to expert adjudication in diagnostic studies, not bench testing of a physical device.
5. 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. The device does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device does not involve AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance evaluation, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications for properties like durability, tensile strength, pressure resistance, kink resistance, blood trauma, and coating coverage. The "truth" is whether the device meets these pre-defined physical and functional requirements.
8. The sample size for the training set
Not applicable. The device does not involve AI, therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable. The device does not involve AI.
§ 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.