Duet External Drainage and Monitoring System (EDMS)

K242034 · Medtronic Neurosurgery · PCB · Oct 24, 2024 · Neurology

Device Facts

• Record ID: K242034
• Device Name: Duet External Drainage and Monitoring System (EDMS)
• Applicant: Medtronic Neurosurgery
• Product Code: PCB · Neurology
• Decision Date: Oct 24, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Device Story

Duet EDMS is a gravity-driven, external drainage and monitoring system for CSF; used for ventricular or lumbar drainage. System consists of a surgically inserted catheter, a sliding graduated 75 ml flow chamber with drip former, and a drainage receptacle. Operates via gravity; uni-directional flow; no recirculation. Used in clinical settings by healthcare professionals to stabilize patients or treat infections until long-term methods are implemented. Output is visual monitoring of CSF flow and intracranial pressure (ICP) via graduated scales (cmH2O and mmHg) on a rotating pole. Clinicians use these measurements to manage patient drainage and monitor neurological status. Benefits include controlled CSF removal and pressure management to prevent or treat neurological complications during or after aortic aneurysm repair.

Clinical Evidence

Bench testing only. Testing included dimensional verification, leakage testing of UV-cure bonds, and axial load testing of junctions. Biocompatibility assessment performed per ISO 10993-1 for prolonged (>24h to 30d) external communicating device with indirect blood path contact; no concerns identified for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, or hemocompatibility.

Technological Characteristics

Gravity-driven external drainage system. Components: catheter, sliding 75 ml flow chamber, drip former, drainage bag. Pressure scales in cmH2O and mmHg. Patient line tubing features green stripe for identification. Sterilization: Ethylene Oxide. Biocompatibility: Prolonged contact (>24h to 30d) external communicating device, indirect blood path.

Indications for Use

Indicated for temporary CSF drainage and monitoring from lumbar subarachnoid space in patients undergoing open TAA/TAAA repair or post-repair patients presenting with symptomatic neurological deficits like paraplegia.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the cerebrospinal fluid shunt system is subject to the following special controls:

*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.

Predicate Devices

• Duet External Drainage and Monitoring (DEN120017)

Reference Devices

• Exacta External Drainage and Monitoring System (K201118)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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### 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:

1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery.

2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Type of Use (Select one or both, as applicable)

| <span> <b> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <b> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> |

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### 510(k) Summary

| I. Company: | Medtronic Neurosurgery<br>4620 N Beach Street,<br>Fort Worth, Texas 79137 USA |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact: | Foram Shukla<br>Regulatory Affairs Specialist<br>[e-mail]<br>Telephone Number: 817-788-6400 |
| Alternate Contact: | Rishi Sinha<br>Senior Regulatory Affairs Director<br>[e-mail]<br>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

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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;
- 2. 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<br>Monitoring | Duet External Drainage and<br>Monitoring |
| 510k Number | K242034 | DEN120017 |
| Indications for Use | The DUET™ EDMS is indicated<br>for temporary draining and<br>monitoring of cerebrospinal fluid<br>(CSF) flow from the lumbar<br>subarachnoid space in:<br>1. Patients undergoing open<br>descending thoracic aortic | The DUET™ EDMS is indicated<br>for temporary draining and<br>monitoring of cerebrospinal fluid<br>(CSF) flow from the lumbar<br>subarachnoid space in:<br>1. Patients undergoing open<br>descending thoracic aortic |
| Characteristic | Subject Device | Predicate Device |
| | aneurysm (open TAA) or<br>open descending thoraco-<br>abdominal aortic aneurysm<br>(open TAAA) repair<br>surgery;<br>2. Patients post TAA/TAAA<br>repair that become<br>symptomatic with<br>neurological deficit such as<br>paraplegia. | aneurysm (open TAA) or<br>open descending thoraco-<br>abdominal aortic aneurysm<br>(open TAAA) repair<br>surgery;<br>2. Patients post TAA/TAAA<br>repair that become<br>symptomatic with<br>neurological deficit such as<br>paraplegia. |
| Patient Line Tubing | Visible Identification: Green stripe<br>downside of tubing to indicate<br>drainage line. | Same |
| Drip Chamber<br>Assembly | • Sliding, graduated 75 ml flow<br>chamber with drip former,<br>tapered bottom, and locking<br>bracket.<br>• “Window” frames desired<br>pressure setting. | • Sliding, graduated 75 ml flow<br>chamber with drip former,<br>tapered bottom, and locking<br>bracket.<br>• “Window” frames desired<br>pressure setting. |
| Pressure Scales | • Unit of Measure: cmH2O and<br>mmHg<br>• Location: 4-way rotating pole<br>scale attached to panel<br>• Scale markings are placed onto<br>Rotating Scale Tube – one<br>pressure scale showing per ¼<br>rotation | • Unit of Measure: cmH2O and<br>mmHg<br>• Location: 4-way rotating pole<br>scale attached to panel<br>• Scale markings are placed onto<br>Rotating Scale Tube – one<br>pressure scale showing per ¼<br>rotation |
| Characteristic | Subject Device | Predicate Device |
| Height Adjustment<br>Cord | Self-adjusting cord with locking<br>mechanism to adjust height of<br>drainage system. | Self-adjusting cord with locking<br>mechanism to adjust height of<br>drainage system. |
| Dimensions | Outer diameter:<br>0.124 inches<br>Inner diameter:<br>0.075 inches | Same |
| Device Accessories | • ClearSite Laser Levels<br>• Replacement Drainage Bag for<br>the Duet External Drainage and<br>Monitoring System | • ClearSite Laser Levels<br>• Replacement Drainage Bag for<br>the Duet External Drainage and<br>Monitoring System |
| Biocompatibility -<br>Patient contact and<br>duration | Prolonged contact (>24hrs to 30<br>days) external communicating<br>device with indirect contact with<br>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<br>Bonds | The UV-cure bonds between the patient line and drip chamber subassembly should withstand air pressure without causing leaks. | Pass |
| Attachment of<br>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).