(105 days)
No
The device description focuses on gravity-driven fluid drainage and monitoring, with no mention of AI or ML technologies. The performance studies are related to mechanical properties of the tubing.
No
The device is used for temporary draining and monitoring of cerebrospinal fluid, which is a supportive and diagnostic function, not directly therapeutic.
No
Explanation: The device is described as an external drainage and monitoring system for cerebrospinal fluid (CSF) and intracranial pressure (ICP). While it monitors these parameters, its primary function is to drain CSF and monitor its flow, not to diagnose a medical condition.
No
The device description clearly states it is a "complete system" that includes a catheter surgically attached to the patient and a drainage system, indicating hardware components beyond just software.
Based on the provided information, the DUET EDMS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- DUET EDMS Function: The DUET EDMS is a system for draining and monitoring cerebrospinal fluid from the patient's body. While it handles a bodily fluid (CSF), its primary function is drainage and monitoring of flow and pressure within the body's system, not analyzing the composition or characteristics of the fluid itself for diagnostic purposes.
- Intended Use: The intended use describes draining and monitoring CSF flow in specific surgical and post-surgical scenarios. This is a therapeutic and monitoring function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of drainage and monitoring, such as gravity-driven flow and pressure monitoring. There is no mention of analyzing the CSF for diagnostic markers.
Therefore, the DUET EDMS falls under the category of a medical device used for drainage and monitoring, not an in vitro diagnostic device.
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar subarachnoid space, ventricles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In accordance with the risk assessment of the change it was determined that dimensional verification, and design verification testing of the patient line tubing was necessary. Based on the Design Verification assessment, change in Duet EDMS patient line tubing impacts the requirements mentioned in Table 2. The performance testing mentioned in Table 2 was completed to evaluate a change to the patient line tubing. The successful results of the testing mentioned in Table 2 demonstrated that the change in patient line tubing establishes safety and effectiveness, supporting the substantial equivalence to the predicate device. The performance testing and special controls summarized in DEN120017 are applicable to the subject 510(k) and support safe use of the subiect device.
Table 2: Performance Testing
Test Name: Leakage of UV Cure Bonds; Test Method: The UV-cure bonds between the patient line and drip chamber subassembly should withstand air pressure without causing leaks.; Results: Pass
Test Name: Attachment of Junctions; Test Method: Junctions must be able to withstand minimum of 5-pound load in the axial direction.; Results: Pass
Biocompatibility assessment was conducted based on Appendix A of the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Duet EDMS (including the patient line tubing) is categorized as a prolonged (>24h to 30 d) external communicating device with indirect blood path contact. The patient line tubing material change does not raise biocompatibility concerns for the following endpoints: cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity, subacute/subchronic toxicity and hemocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
October 24, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Neurosurgery Sudeep Nambiar Senior Regulatory Affairs Manager 4620 N. Beach Street Fort Worth, Texas 76137
Re: K242034
Trade/Device Name: Duet External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.5560 Regulation Name: Cerebrospinal Fluid Shunt System Regulatory Class: Class II Product Code: PCB Dated: July 11, 2024 Received: September 27, 2024
Dear Sudeep Nambiar:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is from Adam D. Pierce -S. The date of the signature is 2024.10.24. The time of the signature is 16:52:53 -04'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242034
Device Name
Duet External Drainage and Monitoring System (EDMS)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| I. Company: | Medtronic Neurosurgery
4620 N Beach Street,
Fort Worth, Texas 79137 USA |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact: | Foram Shukla
Regulatory Affairs Specialist
foram.a.shukla@medtronic.com
Telephone Number: 817-788-6400 |
| Alternate Contact: | Rishi Sinha
Senior Regulatory Affairs Director
rishi.k.sinha@medtronic.com
Telephone Number: 720-890-2485 |
II. Proprietary Trade Name: Duet External Drainage and Monitoring System (EDMS)
Regulatory Class: II III.
IV. Primary Classification:
Name: Cerebrospinal Fluid Shunt System Product Code: PCB Regulation: 21 CFR 882.5560
V. Identification of Legally Marketed Predicate Devices
Primary Predicate device: Duet External Drainage and Monitoring (DEN120017) Reference device: Exacta External Drainage and Monitoring System (K201118)
VI. Product Description
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
5
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.
VII. 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.
VIII. Summary of the Technological Characteristics
The subject device and the predicate device have the same indications for use, intended use, fundamental technology and operating principle. The only difference between the subject device and the predicate is in the patient line tubing material. The patient line tubing of the subject device Duet EDMS is same as the reference device, Exacta EDMS that was cleared under K201118.
IX. Device Comparison
The tables below provide a summary of the device.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Duet External Drainage and | |
| Monitoring | Duet External Drainage and | |
| Monitoring | ||
| 510k Number | K242034 | DEN120017 |
| 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 | 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 |
| Characteristic | Subject Device | Predicate Device |
| | 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. | 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. |
| Patient Line Tubing | Visible Identification: Green stripe
downside of tubing to indicate
drainage line. | Same |
| Drip Chamber
Assembly | • Sliding, graduated 75 ml flow
chamber with drip former,
tapered bottom, and locking
bracket.
• “Window” frames desired
pressure setting. | • Sliding, graduated 75 ml flow
chamber with drip former,
tapered bottom, and locking
bracket.
• “Window” frames desired
pressure setting. |
| Pressure Scales | • Unit of Measure: cmH2O and
mmHg
• Location: 4-way rotating pole
scale attached to panel
• Scale markings are placed onto
Rotating Scale Tube – one
pressure scale showing per ¼
rotation | • Unit of Measure: cmH2O and
mmHg
• Location: 4-way rotating pole
scale attached to panel
• Scale markings are placed onto
Rotating Scale Tube – one
pressure scale showing per ¼
rotation |
| Characteristic | Subject Device | Predicate Device |
| Height Adjustment
Cord | Self-adjusting cord with locking
mechanism to adjust height of
drainage system. | Self-adjusting cord with locking
mechanism to adjust height of
drainage system. |
| Dimensions | Outer diameter:
0.124 inches
Inner diameter:
0.075 inches | Same |
| Device Accessories | • ClearSite Laser Levels
• Replacement Drainage Bag for
the Duet External Drainage and
Monitoring System | • ClearSite Laser Levels
• Replacement Drainage Bag for
the Duet External Drainage and
Monitoring System |
| Biocompatibility -
Patient contact and
duration | Prolonged contact (>24hrs to 30
days) external communicating
device with indirect contact with
blood path. | Same |
| Shelf-life | 3 years | 3 years |
| Sterilization method | Ethylene Oxide | Same |
Table 1: Subject to Predicate Device Comparison - Technological Characteristics
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X. Discussion of the Performance Testing
In accordance with the risk assessment of the change it was determined that dimensional verification, and design verification testing of the patient line tubing was necessary. Based on the Design Verification assessment, change in Duet EDMS patient line tubing impacts the requirements mentioned in Table 2. The performance testing mentioned in Table 2 was completed to evaluate a change to the patient line tubing. The successful results of the testing mentioned in Table 2 demonstrated that the change in patient line tubing establishes safety and effectiveness, supporting the substantial equivalence to the predicate device. The performance testing and special controls summarized in DEN120017 are applicable to the subject 510(k) and support safe use of the subiect device.
| Test Name | Test Method | Results |
|---|---|---|
| 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 minimum of 5-pound load in the axial direction. | Pass |
Table 2: Performance Testing
XI. Biocompatibility Testing
Biocompatibility assessment was conducted based on Appendix A of the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Duet EDMS (including the patient line tubing) is categorized as a prolonged (>24h to 30 d) external communicating device with indirect blood path contact. The patient line tubing material change does not raise biocompatibility concerns for the following endpoints: cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity, subacute/subchronic toxicity and hemocompatibility.
XII. Conclusion
The information provided in this submission demonstrates that the subject device Duet EDMS has the same intended use as the predicate device. The differences in technological characteristics introduced by the proposed changes to the patient line tubing do not alter the intended use of the subject device and do not raise different questions of safety or effectiveness. Based on the information provided in this submission and the performance testing, the subject device Duet EDMS is considered substantially equivalent to the cleared predicate device Duet EDMS (DEN120017).