(103 days)
No
The device description focuses on gravity-driven drainage and monitoring of CSF and ICP, with no mention of AI or ML technologies for analysis, prediction, or control. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for purposes like reducing intracranial pressure, providing temporary CSF drainage for infections, and managing various intracranial issues, all of which are direct therapeutic interventions.
Yes
The device is indicated for "Monitoring CSF chemistry, cytology, and physiology" and "Monitoring of intracranial pressure (ICP)", which are diagnostic functions. It also helps "evaluate the status pre- and postoperatively for space-occupying lesions" via monitoring, which is a diagnostic activity.
No
The device description explicitly states it is a "complete draining and monitoring cerebrospinal system" that uses gravity to drain fluid and includes a catheter surgically attached to the patient, indicating it is a hardware system with physical components.
Based on the provided information, the Duet EDMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This examination is performed outside of the living body (in vitro).
- Duet EDMS Function: The Duet EDMS is designed to drain cerebrospinal fluid (CSF) directly from the patient's body (lateral ventricles or lumbar subarachnoid space) and monitor intracranial pressure (ICP). While it can be used to monitor CSF chemistry, cytology, and physiology, the primary function described is drainage and pressure monitoring in vivo (within the living body).
- Lack of Specimen Examination Focus: The description focuses on the physical process of drainage and pressure measurement, not on the analysis or examination of collected CSF specimens for diagnostic purposes. While CSF can be collected and potentially analyzed separately, the Duet EDMS itself is not performing the in vitro diagnostic test.
Therefore, the Duet EDMS falls under the category of a medical device used for drainage and monitoring within the patient's body, not an IVD device used for in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to:
- Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative.
- Monitor CSF chemistry, cytology, and physiology.
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- Severe head injury
- Subarachnoid hemorrhage graded III, IV, or V preoperatively
- Reyes syndrome or similar encephalopathies
- Hydrocephalus
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally 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 lumbar region and a catheter is inserted into patient's ventricle or the lumbar or 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
lateral ventricles or lumbar subarachnoid space
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)
"Testing demonstrated the performance of the device for its intended use. The performance testing summarized in Table-2 has been conducted in support of the substantial equivalence determination for the proposed change. Results of verification and validation testing conducted on the Duet EDMS demonstrated that the subject device performed as designed, is suitable for its intended use and is substantially equivalent to the predicate device."
Summary of tests and results:
- Dimensional: Pass
- Drip Chamber Graduations: Pass
- Main System Stopcock (MSS) Assembly Torque Applied to Arm of Stopcock: Pass
- MSS Assembly Load Applied to Core of Stopcock Arm: Pass
- Clamp to I.V. Pole Attachment Strength: Pass
- Cord to I.V. Pole Attachment Strength: Pass
- Drip Chamber to Back Panel Attachment Strength: Pass
- Strength of Attached Junctions (Tubing to Luer): Pass
- Bottom Cap to Stopcock Junction Torque: Pass
- Drip Assembly and Drainage Bag Vent Integrity: Pass
- Tensile Strength of Drainage Bag Inlet Port: Pass
- Drainage Bag Seal Weld: Pass
- Flow Initiation Pressure: Pass
- Drip Assembly Vent Test (Exposure of Vent to Blood Solution): Pass
- Drip Assembly Vent Integrity: Pass
- Leakage of UV-Cure Bonds: Pass
- Leakage of Drainage Bag: Pass
- Drip Chamber Volume: Pass
- Attachment of I.V. Pole and Position of Adjustable Drip Chamber: Pass
- Leakage of UV Cure Bonds: Pass
- Attachment of Junctions: Pass
- Bottom Cap to Stopcock Junction Torque: Pass
- Hydrophobic Microbial Barrier Vent on the Drainage Bag: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to 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 relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
March 10, 2025
Image /page/0/Picture/1 description: The image shows 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 Foram Shukla Regulatory Affairs Specialist 4620 N. Beach Street Fort Worth, Texas 76137
Re: K243676
Trade/Device Name: Duet External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: November 27, 2024 Received: February 6, 2025
Dear Foram Shukla:
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"
1
(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).
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 Rue"). 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-devices/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,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2025.03.10 Pierce -S 13:56:42 -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) K243676
Device Name
Duet External Drainage and Monitoring System (EDMS)
Indications for Use (Describe)
The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to:
- · Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative.
- · Monitor CSF chemistry, cytology, and physiology.
- · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- · Severe head injury
- · Subarachnoid hemorrhage graded III, IV, or V preoperatively
- · Reyes syndrome or similar encephalopathies
- · Hydrocephalus
- · Intracranial hemorrhage
- · Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
March 7, 2025
| 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 |
II. Proprietary Trade Name: Duet™ External Drainage and Monitoring System (EDMS)
Telephone Number: 720-890-2485
III. Regulatory Class: II
IV. Primary Classification:
Name: Central nervous system fluid shunt and components Regulation: 21 CFR 882.5550 Classification Product Code: JXG
V. Identification of Legally Marketed Predicate and Reference Devices
Predicate device: Becker External Drainage and Monitoring System (K200456) Reference device: Duet™ External Drainage and Monitoring System (K242034)
VI. Product Description
The Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage.
5
K243676 Page 2 of 7
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 lumbar region and a catheter is inserted into patient's ventricle or the lumbar or 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 draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. ●
- Monitor CSF chemistry, cytology, and physiology. .
- . Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- . Severe head injury
- . Subarachnoid hemorrhage graded III, IV, or V preoperatively
- . Reyes syndrome or similar encephalopathies
- . Hydrocephalus
- Intracranial hemorrhage .
- . Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
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.
IX. Device Comparison
The tables below provide a summary of the device.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Duet™ External Drainage and Monitoring System | Becker External Drainage and Monitoring System |
| Classification | ||
| Procode | JXG | GWM |
| Characteristic | Subject Device | Predicate Device |
| 510k Number | K243676 | K200456 |
| Intended Use | Draining and monitoring | |
| cerebrospinal fluid (CSF) and | ||
| monitoring intracranial pressure | ||
| (ICP). | Same | |
| Indications for | ||
| Use | The DuetTM EDMS is indicated for | |
| draining and monitoring of CSF flow | ||
| from the lateral ventricles or lumbar | ||
| subarachnoid space in selected | ||
| patients to: | ||
| Reduce intracranial pressure (ICP), | ||
| e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology, | ||
| and physiology. Provide temporary CSF drainage in | ||
| patients with infected CSF shunts. Monitoring of intracranial pressure | ||
| (ICP) is indicated in selected patients | ||
| with: | ||
| Severe head injury Subarachnoid hemorrhage graded | ||
| III, IV, or V preoperatively Reyes syndrome or similar | ||
| encephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems when | ||
| drainage is to be used as a | ||
| therapeutic maneuver. Monitoring can also be used to | ||
| evaluate the status pre- and | ||
| postoperatively for space-occupying | ||
| lesions. | Draining and monitoring of CSF flow | |
| from the lateral ventricles or lumbar | ||
| subarachnoid space is indicated in | ||
| selected patients to: | ||
| Reduce intracranial pressure (ICP), | ||
| e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology, | ||
| and physiology. Provide temporary CSF drainage in | ||
| patients with infected CSF shunts. Monitoring of intracranial pressure | ||
| (ICP) is indicated in selected patients | ||
| with: | ||
| Severe head injury Subarachnoid hemorrhage graded | ||
| III, IV, or V preoperatively Reyes syndrome or similar | ||
| encephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems when | ||
| drainage is to be used as a | ||
| therapeutic maneuver. Monitoring can also be used to | ||
| evaluate the status pre- and | ||
| postoperatively for space-occupying | ||
| lesions. | ||
| Characteristic | Subject Device | Predicate Device |
| Principle of | ||
| Operation | External drainage is temporary | |
| drainage of cerebrospinal fluid (CSF) | ||
| from the lateral ventricles of the | ||
| brain, or the lumbar space of the | ||
| spine, into an external collection bag. | ||
| The Duet™ EDMS drains CSF by | ||
| using a combination of gravity and | ||
| intercerebral pressure. The drainage | ||
| rate depends on the height at which | ||
| the system is placed relative to the | ||
| patient's anatomy. | Same | |
| 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 50 ml flow | |
| chamber with drip former and | ||
| conical bottom and locking bracket. | ||
| • Pressure scale underlines 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 $1/4$ rotation. | • Unit of Measure: cmH2O and | |
| mmHg | ||
| • Location: Printed directly onto | ||
| scale | ||
| • Scales are side by side | ||
| Height | ||
| Adjustment Cord | Self-adjusting cord with locking | |
| mechanism to adjust height of | ||
| drainage system. | Same | |
| Device | ||
| Accessories | • ClearSite Laser Levels | |
| • Replacement Drainage Bag. | • Replacement Laser Level | |
| • Becker Quick-Attach Pole Clamp | ||
| with Laser Level | ||
| • Becker Quick-Attach Pole Clamp | ||
| (without Laser Level) | ||
| • Replacement Drainage Bag. | ||
| Characteristic | Subject Device | Predicate Device |
| Biocompatibility |
- Patient contact
and duration | Prolonged (>24hrs - 24h to 30 d) external communicating device with indirect blood path contact. The biocompatibility evaluation for the cytotoxicity, sensitization or intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, and indirect hemolysis endpoints was completed in accordance with FDA's biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"".
XII. Conclusion
The information provided in this submission demonstrates that the subject device Duet™ EDMS has the same intended use as the predicate devices. Based on the similarities of the device design, principles of operation, technological characteristics and results of the non-clinical performance testing, the subject device Duet™ EDMS is substantially equivalent to the cleared predicate device Becker External Drainage and Monitoring System (K200456).