(609 days)
Not Found
No
The device description and performance studies indicate a purely mechanical, gravity-driven system for CSF drainage and monitoring. There is no mention of any computational analysis, algorithms, or learning processes.
Yes.
The device's intended use is to temporarily drain and monitor cerebrospinal fluid from the lumbar subarachnoid space in patients, particularly those undergoing or recovering from aortic repair surgery, to mitigate neurological deficits such as paraplegia. This direct intervention to alleviate a medical condition and improve patient outcomes qualifies it as a therapeutic device.
No
The device is designed for temporary draining and monitoring of cerebrospinal fluid (CSF) flow and for CSF sampling, which are management and measurement functions, not diagnostic ones. Although it monitors CSF flow, this monitoring is for therapeutic management rather than to diagnose a condition.
No
The device description explicitly lists multiple physical components, including tubing, stopcocks, a drip chamber, a drainage bag, and a pole mount clamp. This indicates it is a hardware device with physical components for draining and monitoring CSF.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space". This is a direct intervention on the patient for therapeutic and monitoring purposes, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a system for collecting and draining CSF, including tubing, stopcocks, a drip chamber, and a drainage bag. These are all components for managing fluid flow within the body or from the body, not for performing diagnostic tests on a sample.
- Mechanism of Action: The device works by gravity-driven drainage of CSF from the patient's lumbar subarachnoid space. This is a physical process of fluid removal and collection, not a diagnostic assay or analysis of a biological sample.
- Performance Studies: The performance studies focus on the clinical outcomes related to CSF drainage in surgical procedures (reducing neurological deficit), not on the accuracy or performance of a diagnostic test.
In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition. The DUET™ EDMS does not fit this definition. It is a device used for managing a physiological process (CSF drainage) in a patient.
N/A
Intended Use / Indications for Use
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.
Product codes
PCB
Device Description
The Medtronic DUET™ External Drainage and Monitoring System (EDMS) that is the subject of this De Novo request is designed to drain and monitor cerebrospinal fluid (CSF) from the lumbar subarachnoid space.
The DUET™ EDMS consists of the following: a green-striped patient connection line (pressure tubing) with an inner diameter of 0.075 ± 0.005 inches, an outer diameter of 0.124 ± 0.003 inches, and a total length of 60 inches (9), a patient line stopcock (10), a main system stopcock (8) that may be attached at two locations on the main panel, a drip chamber (4) with a drip chamber stopcock (5), a rotatable pressure scale (3), three latex-free needleless injection/CSF sampling sites (Figure 1b (IS-5), (IS-10) and (IS-11)) and a removable drainage bag (7) with approximate volumetric graduations and a hydrophobic microbial barrier air vent. There is a pole mount clamp (6) and a cord (12) with a cord lock (13) to enable independent suspension of the system, or to provide additional security when using the pole clamp as identified in Figure 1 below. It should be noted that the numbers in parentheses correspond with the numbers in Figure 1.
The DUET™ EDMS are not long-term implants but are intended for limited external drainage of CSF. The drainage flow of CSF into the DUETTM EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. During use, an external lumbar catheter inserted into the lumbar subarachnoid space is connected to the DUET™ EDMS patient connection line. The CSF drains through the catheter, into the patient connection line and into the graduated drip chamber. CSF collects in the drip chamber, exits the bottom of the chamber via another connection line and is collected in a drainage bag. In the event that the patient may require administration of fluid directly into the lumbar subarachnoid space or CSF sampling is required, the DUET™ EDMS features injection/CSF sampling ports integrated into the patient connection line. The DUET™ EDMS is completely disposable. The DUET™ EDMS is recommended for use with the Clear-Site™ Laser Level (cleared under K984053) that is provided separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
24-hour-a-day availability of trained personnel to supervise monitoring and drainage; hospital setting for surgery.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical/Bench Studies:
Biocompatibility/Materials: Tested components of patient lines for contact with CSF. Classified as external communicating devices of limited contact duration (
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR MEDTRONIC NEUROSURGERY DUET™ EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS)
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Cerebrospinal fluid shunt system. 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.
NEW REGULATION NUMBER: 21 CFR 882.5560
CLASSIFICATION: Class II
PRODUCT CODE: PCB
BACKGROUND
DEVICE NAME: Medtronic Neurosurgery DUETTM External Drainage and Monitoring System (EDMS)
DE NOVO REQUEST: DEN120017
DATE OF DE NOVO REQUEST: December 21, 2012
Medtronic Neurosurgery REQUESTER CONTACT: 125 Cremona Drive Goleta, CA 93117
INDICATIONS FOR USE
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.
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LIMITATIONS
For prescription use only.
The use of a DUET™ EDMS lumbar catheter for drainage and monitoring of cerebrospinal fluid from the lumbar subarachnoid space is contraindicated in a patient with:
- . non-communicating hydrocephalus;
- large intracranial mass lesions, tumors, hematomas, or cysts;
- infections in the area surrounding the lumbar puncture which includes the skin. o subcutaneous tissue, bone and the epidural space; or
- demonstrated blockage of cerebrospinal fluid to the subarachnoid space due to 0 trauma, hematoma, fracture or tumor.
The use of a DUET™ EDMS requires 24-hour-a-day availability of trained personnel to supervise monitoring and drainage.
Literature suggests a maximum CSF drainage duration of 3 days for aneurysm repair patients who do not exhibit symptoms of neurological deficit, with longer durations for those exhibiting symptoms; however, drainage duration should be at the medical discretion of the physician and based on the institution's protocol.
Warnings & Precautions:
- It is possible that the puncture of the ventricle or the opening of the dura will ● result in an intracranial hemorrhage.
- o It is possible that if too much CSF is removed from the ventricles, either during a drainage procedure or when the ventricle is first punctured, the ventricle may collapse and occlude the catheter.
- . It is possible that the monitoring system may give a false pressure reading either due to a pressure line becoming clogged or kinked or from an air bubble lodged in the system. An incorrect pressure reading may lead to the wrong therapy being given to the patient. The irrigation of the catheter or the performance of a Volume Pressure Relationship (VPR) study may induce pressure waves in the patient. For this reason, irrigation or VPR studies should be done only by, or on the order of, a physician.
- o In order to minimize the possibility of infection, meningitis or ventriculitis, several steps should be observed. First, the injection sites should always be cleaned with alcohol and the alcohol allowed to dry before a needle is inserted into them. Second, sterile technique should be observed in setting up the system and in the placement of the catheter. Third, subgaleal tunneling of the ventricular catheter should be approximately one to two inches.
- . Leakage from the system, which can result from damaged system components or improper use of handling, can potentially result in over-drainage, the need to replace the drainage system and/or other complications to the patient.
- o In order to ensure against ventricular collapse and the possible consequences of tentorial herniation, always perform a drainage maneuver against a positive
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pressure head on the order of 20 cm H2O or 15 mmHg. In addition, when the ventricle or lumbar subarachnoid space is first punctured during the insertion of the catheter, care should be taken so as little CSF as possible is lost.
- o Whenever irrigation of the catheter or the performance of the VPR is decided upon, great care must be used so that pressure waves are not initiated. Only a small volume of saline should ever be injected into the ventricular system, and this only done by, or on the order of, a physician. In general, in monitoring intracranial pressure, one should always be aware of the waveform on the oscilloscope. If the waveform begins to dampen out. it is important that the entire monitoring system be examined. Ensure that the line to the patient is not kinked and that all air bubbles or blood or other debris are removed from the system. Ascertain that the transducer is on the same level as the patient's ventricular system to ensure the proper reference level in the manometer tube for use in calibration procedures. Pressure monitoring with the manometer may result in over-drainage of the ventricles.
- Improper vigilance or improper drainage system setup can lead to over- or under-. drainage and potentially serious injury to the patient. Intracranial and lumbar pressure monitoring has been associated with intracranial infection, meningitis and ventriculitis. This hazard has been quoted at less than 1% to more than 5%. The risk of infection is probably influenced both by the number of times a system is opened and by the duration of the monitoring. Prolonged steroid therapy can also increase the risk of infection.
DEVICE DESCRIPTION
The Medtronic DUET™ External Drainage and Monitoring System (EDMS) that is the subject of this De Novo request is designed to drain and monitor cerebrospinal fluid (CSF) from the lumbar subarachnoid space.
The DUET™ EDMS consists of the following: a green-striped patient connection line (pressure tubing) with an inner diameter of 0.075 ± 0.005 inches, an outer diameter of 0.124 ± 0.003 inches, and a total length of 60 inches (9), a patient line stopcock (10), a main system stopcock (8) that may be attached at two locations on the main panel, a drip chamber (4) with a drip chamber stopcock (5), a rotatable pressure scale (3), three latex-free needleless injection/CSF sampling sites (Figure 1b (IS-5), (IS-10) and (IS-11)) and a removable drainage bag (7) with approximate volumetric graduations and a hydrophobic microbial barrier air vent. There is a pole mount clamp (6) and a cord (12) with a cord lock (13) to enable independent suspension of the system, or to provide additional security when using the pole clamp as identified in Figure 1 below. It should be noted that the numbers in parentheses correspond with the numbers in Figure 1.
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Image /page/3/Figure/0 description: The image shows two medical devices labeled 1a and 1b. Both devices have a clear plastic container with volume measurements on the side. The device in 1a has labels pointing to different parts, including a dial (1), a measurement scale (3), a valve (5), a collection bag (8), and a tube (9).
Figure 1: Medtronic DUET EDMS (a) and Location of Injection/CSF Sampling Sites (b)
The DUET™ EDMS are not long-term implants but are intended for limited external drainage of CSF. The drainage flow of CSF into the DUETTM EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. During use, an external lumbar catheter inserted into the lumbar subarachnoid space is connected to the DUET™ EDMS patient connection line. The CSF drains through the catheter, into the patient connection line and into the graduated drip chamber. CSF collects in the drip chamber, exits the bottom of the chamber via another connection line and is collected in a drainage bag. In the event that the patient may require administration of fluid directly into the lumbar subarachnoid space or CSF sampling is required, the DUET™ EDMS features injection/CSF sampling ports integrated into the patient connection line. The DUET™ EDMS is completely disposable. The DUET™ EDMS is recommended for use with the Clear-Site™ Laser Level (cleared under K984053) that is provided separately.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The non-clinical/bench studies conducted on the DUET™ EDMS to demonstrate the safety and effectiveness of the device are summarized in the sections below. The technological characteristics of the DUET™ EDMS for the subject De Novo is identical to the system cleared in K984053.
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BIOCOMPATIBILITY/MATERIALS
The components of the patient lines in the DUET™ EDMS were tested for biocompatibility because these patient lines have the potential for contact with CSF that could be re-introduced to the patient in the case of retrograde flow. The patient lines are classified as external communicating devices of limited contact duration (.
Material-mediated pyrogenicity testing was also conducted on the DUET™ EDMS to detect material-mediated pyrogenic reactions of extracts of the device and/or materials. The testing meets the requirements in ISO 10993-1: 2009/(R)2013. The results show that the extracts of the device and/or its materials are non-pyrogenic.
PERFORMANCE TESTING - BENCH
The DUET™ EDMS was tested and passed the following performance (bench) tests listed in Table 3.
| Test Name | Test Method |
|---|---|
| Dimensional | Measure the dimensions of the scale label vertical and horizontal |
| alignment, pressure scale lengths, patient line tubing inner diameter | |
| (ID) and length, cord length, drainage path ID (from bottom of drip | |
| chamber), and stopcock flow path diameter. | |
| Drip Chamber Graduations |
TABLE 3: DUET™ EDMS PERFORMANCE TESTS
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| Main System Stopcock (MSS)
Assembly Torque Applied to Arm of
Stopcock | Record the peak torque at which the MSS assembly fails or detaches
from the panel. |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MSS Assembly Load Applied to Core
of Stopcock Arm | Record peak load at which MSS assembly failed. |
| Clamp to I.V. Pole Attachment
Strength | Ensure secure attachment of clamp to I.V. pole. |
| Cord to I.V. Pole Attachment Strength | Ensure cord and cord lock maintains secure hanging of system. |
| Drip Chamber to Back Panel
Attachment Strength | Ensure secure attachment of drip chamber/bag subassembly to panel. |
| Strength of Attached Junctions (i.e.,
Tubing to Luer) | Ensure secure attachment of junctions of tubes to luer. |
| Bottom Cap to Stopcock Junction
Torque | Ensure secure bond of stopcock/bottom cap. |
| Drip Assembly and Drainage Bag
Vent Integrity | Ensure that drip assembly and drainage bag vent can withstand
appropriate fluid pressures. |
| Tensile Strength of Drainage Bag
Inlet Port | Evaluate the tensile strength of the drainage bag inlet port to failure. |
| Drainage Bag Seal Weld | Ensure there are no leaks in the drainage bag. |
| Flow Initiation Pressure | Record pressure at which flow initiates, for each drainage bag. |
| Drip Assembly Vent Test (Exposure
of Vent to Blood Solution) | Ensure that the drip assembly vent allows drainage of blood and
provide CSF flow through system with minimal resistance. |
| Drip Assembly Vent Integrity | Test the drip assembly vent to withdraw fluid without compromising its
mechanical integrity. |
| Leakage of UV-Cure Bonds | Record any leakage from the UV-cure bonds between the patient line
and drip chamber subassembly. |
| Leakage of Drainage Bag | The drainage bag must withstand being inverted without leaking. |
| Drip Chamber Volume | Verify fluid weight in the drip chamber. |
| Attachment of I.V. Pole and Position
of Adjustable Drip Chamber | Visually verify that clamping thumbscrews (and cord locks) have not
slipped from initial positions (using visual marks to identify any
slippage). |
| Leakage of UV Cure Bonds | The UV-cure bonds between the patient line and drip chamber
subassembly should withstand air pressure without causing leaks. |
| Attachment of Junctions | Junctions must be able to withstand minimum of 5 pound load in the
axial direction. |
| Bottom Cap to Stopcock Junction
Torque | Test the torque of the stopcock/bottom cap bond. |
| Hydrophobic Microbial Barrier Vent
on the Drainage Bag | The supplier for the material used as the drainage bag vents conducted
microbial barrier testing to demonstrate a 99.9% Bacterial Filtration
Efficiency (BFE) |
SUMMARY OF CLINICAL INFORMATION
Although there was no formal clinical study conducted using the DUET™ EDMS for the expanded indication of temporary draining and monitoring of CSF flow from the lumbar subarachnoid space in patients undergoing open descending TAA/TAAA repair surgeries and patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia. FDA believes that there is sufficient clinical data to support the expanded indication for this device. Given the worldwide clinical experience, the data and information provided support use of the device for the expanded indication as long as it is performed with a clear understanding of the risks associated with the device and clinical procedure. In describing the apparatus set-up, the CSF drains used in the clinical literature had similar characteristics (i.e., gravitational based pole-mounted apparatus with a
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drainage bag) and operating principles as the subject device. The following is a summary of the clinical literature used to support the De Novo Indications for Use for the DUET™ EDMS in general:
-
- Coselli et al. "Cerebrospinal Fluid Drainage Reduces Paraplegia after Thoracoabdominal Aortic Aneurysm Repair: Results of a Randomized Clinical Trial" (J. Vascular Surgery 2002; 35; p. 631-639). In this prospective, randomized study of 145 subjects, the effect of CSF drainage on the incidence of spinal cord injury (SCI) was evaluated in subjects undergoing surgical repair of Type I or II aortic aneurysms. In this study, additional concomitant methods were used for spinal cord protection; however, administration of CSF drainage was the only variable between the two treatment groups. During the procedure, CSF was drained freely with gravity if the CSF pressure exceeded 10 mmHg. The drain was removed two days post-operatively if the subject did not experience SCI, and was maintained bevond two days if SCI occurred. The authors reported a significant difference (p = 0.03) in the SCI rate, which was 2.7% in the CSF drainage group compared to 12.2% in the control group. This difference represents an 80% reduction in the occurrence of SCI and the authors concluded that CSF drainage is beneficial during the repair of Type I and II aortic aneurysms.
-
- Estrera et al. "Descending Thoracic Aortic Aneurysm: Surgical Approach and Treatment using the Adjuncts Cerebrospinal Fluid Drainage and Distal Aortic Perfusion" (Ann. Thorac. Surg. 2001; 72; p. 481-486). A retrospective study was conducted to evaluate the concomitant use of Distal Aortic Perfusion (DAP) and CSF drainage in the prevention of neurological deficit during 148 non-emergent repairs of descending thoracic aortic aneurysms. The authors reported an overall neurological deficit rate of 2.7%.
-
- Estrera et al. "Descending Thoracic Aortic Aneurysm Repair: 12-Year Experience using Distal Aortic Perfusion and Cerebrospinal Fluid Drainage" (Ann. Thorac. Surg. 2005; 80; p. 1290-1296). The authors presented the results of their 12-year experience comparing the rate of neurological deficit in 238 subjects who underwent aortic aneurysm repair in which DAP and CSF drainage were both administered (adjunct group) to 62 subjects with the use of CSF drainage alone (12 subjects). DAP alone (34 subjects). or neither adjunct was used (16 subjects). The results reported a neurological deficit rate of 1.3% for the adjunct group compared to 6.5% for the non-adjunct group (p