Duet External Drainage and Monitoring System (EDMS) by Medtronic Neurosurgery

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.

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.

AI/ML Overview

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.

Summary

{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).

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

I. Company:	Medtronic Neurosurgery4620 N Beach Street,Fort Worth, Texas 79137 USA
Contact:	Foram ShuklaRegulatory Affairs Specialistforam.a.shukla@medtronic.comTelephone Number: 817-788-6400
Alternate Contact:	Rishi SinhaSenior Regulatory Affairs Directorrishi.k.sinha@medtronic.comTelephone 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

{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:

1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery;
1. 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 andMonitoring	Duet External Drainage andMonitoring
510k Number	K242034	DEN120017
Indications for Use	The DUET™ EDMS is indicatedfor temporary draining andmonitoring of cerebrospinal fluid(CSF) flow from the lumbarsubarachnoid space in:1. Patients undergoing opendescending thoracic aortic	The DUET™ EDMS is indicatedfor temporary draining andmonitoring of cerebrospinal fluid(CSF) flow from the lumbarsubarachnoid space in:1. Patients undergoing opendescending thoracic aortic
Characteristic	Subject Device	Predicate Device
	aneurysm (open TAA) oropen descending thoraco-abdominal aortic aneurysm(open TAAA) repairsurgery;2. Patients post TAA/TAAArepair that becomesymptomatic withneurological deficit such asparaplegia.	aneurysm (open TAA) oropen descending thoraco-abdominal aortic aneurysm(open TAAA) repairsurgery;2. Patients post TAA/TAAArepair that becomesymptomatic withneurological deficit such asparaplegia.
Patient Line Tubing	Visible Identification: Green stripedownside of tubing to indicatedrainage line.	Same
Drip ChamberAssembly	• Sliding, graduated 75 ml flowchamber with drip former,tapered bottom, and lockingbracket.• “Window” frames desiredpressure setting.	• Sliding, graduated 75 ml flowchamber with drip former,tapered bottom, and lockingbracket.• “Window” frames desiredpressure setting.
Pressure Scales	• Unit of Measure: cmH2O andmmHg• Location: 4-way rotating polescale attached to panel• Scale markings are placed ontoRotating Scale Tube – onepressure scale showing per ¼rotation	• Unit of Measure: cmH2O andmmHg• Location: 4-way rotating polescale attached to panel• Scale markings are placed ontoRotating Scale Tube – onepressure scale showing per ¼rotation
Characteristic	Subject Device	Predicate Device
Height AdjustmentCord	Self-adjusting cord with lockingmechanism to adjust height ofdrainage system.	Self-adjusting cord with lockingmechanism to adjust height ofdrainage system.
Dimensions	Outer diameter:0.124 inchesInner diameter:0.075 inches	Same
Device Accessories	• ClearSite Laser Levels• Replacement Drainage Bag forthe Duet External Drainage andMonitoring System	• ClearSite Laser Levels• Replacement Drainage Bag forthe Duet External Drainage andMonitoring System
Biocompatibility -Patient contact andduration	Prolonged contact (>24hrs to 30days) external communicatingdevice with indirect contact withblood path.	Same
Shelf-life	3 years	3 years
Sterilization method	Ethylene Oxide	Same

Table 1: Subject to Predicate Device Comparison - Technological Characteristics

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

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 CureBonds	The UV-cure bonds between the patient line and drip chamber subassembly should withstand air pressure without causing leaks.	Pass
Attachment ofJunctions	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).

Regulation Number and Section

§ 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.