(105 days)
The DUET EDMS is indicated for temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in:
- Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery.
- Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.
The Medtronic Duet External Drainage and Monitoring System (Duet EDMS) is a complete system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage. The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull or lumbar region and a catheter is inserted into patient's ventricle or the lumbar subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.
Here's a breakdown of the acceptance criteria and study information for the Medtronic Duet External Drainage and Monitoring System (EDMS), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leakage of UV Cure Bonds: The UV-cure bonds between the patient line and drip chamber subassembly should withstand air pressure without causing leaks. | Pass |
| Attachment of Junctions: Junctions must be able to withstand a minimum of 5-pound load in the axial direction. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the leakage and attachment tests. It refers to "the patient line and drip chamber subassembly" and "junctions" without specifying the number of units tested.
- Data Provenance: The document does not specify the country of origin of the data. It appears to be internal verification/validation testing conducted by Medtronic. The study is retrospective in the sense that the testing was conducted on samples of the device to verify design changes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described performance tests (leakage and attachment strength) are objective engineering tests rather than subjective evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable for these objective performance tests. The results (Pass/Fail) are determined by direct measurement against pre-defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described focuses on technical performance of device components rather than human reader accuracy or improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is not an AI/algorithm-based device. The device is a physical external drainage and monitoring system. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used:
The ground truth for the performance tests were engineering specifications and measurable thresholds. For example, the "5-pound load" for junction attachment and the requirement to "withstand air pressure without causing leaks" serve as the objective ground truth against which device performance was measured.
8. The Sample Size for the Training Set:
This information is not applicable as there is no mention of a "training set" for an algorithm in this submission. The device is a physical medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for an algorithm.
§ 882.5560 Cerebrospinal fluid shunt system.
(a)
Identification. A cerebrospinal fluid shunt system is a prescription device used to monitor and divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of preventing spinal cord ischemia or injury during procedures that require reduction in central nervous system pressure. A cerebrospinal fluid shunt system may include catheters, valved catheters, valves, connectors, and pressure monitors intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device description must include a detailed summary of the device technical parameters, including design configuration, dimensions, engineering drawings, and a list of all components with identification of their materials of construction.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated use testing must be conducted to characterize fluid flow and resistance to leakage; and
(ii) Mechanical integrity testing of all connections must be conducted.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf life.
(5) Performance data must demonstrate the sterility and pyrogenicity of patient-contacting components of the device.
(6) The labeling must include:
(i) Contraindications with respect to patients who should not receive a lumbar drain;
(ii) A warning that the device should have 24-hour-a-day availability of trained personnel to supervise monitoring and drainage;
(iii) Instructions on proper device setup, positioning, and monitoring;
(iv) Warnings and precautions to inform the user of serious hazards and special care associated with the use of the device;
(v) A statement that the device is not to be reused, reprocessed, or resterilized when open but unused; and
(vi) Cleaning instructions for the injection sites.