Smart External Drain (SED) System

K172759 · Aqueduct Critical Care, Inc. · JXG · Nov 14, 2017 · Neurology

Device Facts

• Record ID: K172759
• Device Name: Smart External Drain (SED) System
• Applicant: Aqueduct Critical Care, Inc.
• Product Code: JXG · Neurology
• Decision Date: Nov 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 - Reye's 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.

Device Story

SED System is an electromechanical, software-embedded device for automated CSF drainage and ICP monitoring. It consists of a console and a sterile, disposable cartridge. The system connects to an external drainage catheter and a collection bag. It uses pressure transducers (for ventricular use) or a drip counter (for lumbar use) to measure flow/pressure. An automated stepper-motor pinching mechanism compresses or releases compliant tubing to regulate CSF flow, replacing manual gravity-based adjustments. The console displays real-time data and provides alarms for ICP or drainage rate thresholds. Used in clinical settings (e.g., ICU) by hospital staff. Battery backup allows for patient mobility. The system compensates for patient movement, reducing the need for manual interventions and providing continuous monitoring to assist clinical decision-making regarding therapeutic drainage.

Clinical Evidence

Bench testing only. No clinical data. Performance was verified through functional testing of the SED Lumbar Cartridge, 14-day clinical-use simulation, drainage range verification, software verification/validation, and EMC testing per IEC 60601-1-2.

Technological Characteristics

Electromechanical console with disposable tubing cartridge. Uses stepper-motor for flow control via tube-pinching. Pressure transducers for ICP; drip counter for lumbar drainage. Battery-powered. EMC tested per IEC 60601-1-2. Software-embedded for user interface, alarm management, and automated regulation.

Indications for Use

Indicated for patients requiring CSF drainage or ICP monitoring, including those with severe head injury, subarachnoid hemorrhage (grade III-V), Reye's syndrome, hydrocephalus, intracranial hemorrhage, space-occupying lesions, or infected CSF shunts.

Regulatory Classification

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.

Predicate Devices

• Smart External Drain (SED) System (K171586)
• Duet External Drainage and Monitoring System (K984053)

Submission Summary (Full Text)

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November 14, 2017

Aqueduct Critical Care, Inc. Thomas Clement President & CEO 11822 North Creek Parkway North, Suite 110 Bothell, Washington 98011

Re: K172759

Trade/Device Name: Smart External Drain (SED) System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG, GWM Dated: September 12, 2017 Received: September 13, 2017

Dear Mr. Thomas Clement:

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 (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. 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172759

#### Device Name

Smart External Drain (SED) System

#### Indications for Use (Describe)

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
- · Reye's 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) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY - K172759

# General Information:

| Date of Summary Preparation: | September 12, 2017 | |
|-----------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------|
| Name and Address of Manufacturer: | Aqueduct Critical Care, Inc.<br>11822 North Creek Parkway North<br>Suite 110<br>Bothell, WA 98011 | |
| Contact Person: | Tom Clement, President and CEO | |
| | Phone: | 425-985-1571<br>Fax:<br>425-278-9377 |
| Trade Name: | Smart External Drain (SED) System | |
| Common Name: | External CSF Drainage System | |
| Regulation Number: | Primary: § 21 CFR 882.5550<br>Secondary: § 21 CFR 882.1620 | |
| Regulation Description: | Central Nervous System Fluid Shunt and Components<br>Intracranial Pressure Monitor | |
| Regulatory Class: | Class II | |
| Classification Panel: | Neurology | |
| Product Code: | Primary: JXG<br>Secondary: GWM | |

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Device Description: The SED System is based upon traditional gravity-based drainage systems, but is designed to allow for the automated regulation of ICP or CSF drainage volume without the need for continuous manual measurements, adjustments and interventions. The SED System consists of an electromechanical, software embedded SED Console and a sterile, disposable SED Cartridge, which includes all components necessary to attach to the external drainage catheter via a luer-lock connector and to a drainage bag that collects the drained fluid.

The SED System is mounted on an IV pole, with the SED Console positioned by the user at an easy-to-view height, while the drainage bag is positioned below the lowest possible patient head position or lumbar puncture site, which is considered to be below the height of a hospital bed.

The SED System automatically maintains a set drainage rate (for lumbar use) or set ICP (for ventricular use) using a drip counter or pressure sensors (transducers), respectively, and an automated stepper-motor pinching mechanism that compresses or releases the system's compliant drain tubing in order to control the degree of CSF flow (i.e., equivalent to the alteration of CSF flow that happens when a traditional gravity drain is manually raised or lowered). The SED System displays the measured drainage or ICP information, while additionally incorporating multiple alarms provided by its automated functionality.

The SED System can thus automatically compensate for patient movement, allow far greater mobility (via a battery backup) and also alert hospital staff if the ICP exceeds the set maximum or minimum levels for a particular patient, as well as if low or high CSF drainage values are ever exceeded for a particular lumbar patient.

Indications for Use: 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
- Reye's 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.

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Predicate Device: Aqueduct Critical Care, Inc. cites the following as the predicate devices.

| Primary Predicate | Smart External Drain (SED) System | K171586 |
|---------------------|----------------------------------------------|---------|
| Secondary Predicate | Duet External Drainage and Monitoring System | K984053 |

Table 1 below provides a summary of the technological characteristics of the Modified SED System in comparison to the predicate devices.

| Detail or Technological<br>Characteristic | Modified Aqueduct Critical<br>Care, Inc.<br>SED System | Primary Predicate Aqueduct<br>Critical Care, Inc. SED System<br>(NOTE: as presented in K161605<br>relative to original predicate Duet<br>System) | Original K161605 Predicate<br>Medtronic Duet External<br>Drainage and Monitoring System<br>(Secondary Predicate) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Smart External Drain (SED)<br>System | Smart External Drain (SED)<br>System | Medtronic DUET™ External<br>Drainage and Monitoring System |
| Intended Use | Same | Same | To attach to an implanted, external<br>drainage catheter to externally drain<br>cerebrospinal fluid (CSF) and<br>monitor both CSF drainage and<br>intracranial pressure (ICP). |
| Attaches to separate,<br>commercially available EVD<br>Catheter | Yes | Yes | Yes |
| Sterile Disposable tubing set | Yes | Yes | Yes |
| CSF Drainage Bag | Yes | Yes | Yes |
| Gravity drainage of CSF | Yes | Yes | Yes |
| Method to control gravity<br>drainage of CSF | Same as predicate SED System<br>(in both Lumbar and Ventricular<br>Modes) | Automated adjustment based on<br>user settings via a stepper-motor<br>controlled, tube-pinching<br>mechanism to either compress or<br>release the compliant drainage<br>tubing contained within the sterile,<br>disposable SED Cartridge. | Manual adjustment of the drip<br>chamber either up or down the IV<br>Pole, relative to the patient's head<br>position and ventricular catheter<br>location. |
| Pressure Transducer for<br>ICP Measurement | Same as predicate SED System<br>(in Ventricular Mode) | Yes | Yes<br>(The Duet System includes a design<br>and instructions for attaching a<br>transducer that allows for ICP<br>measurement and visual display via<br>a connected monitor.) |
| Software-based, Powered<br>Console for User Interface,<br>User Settings and Alarm<br>Adjustments, Data Storage<br>and Display, and Alarms for<br>ICP Monitoring | Yes | Yes | No<br>(A transducer can be attached [see<br>above] and then used in<br>conjunction with an ICP Monitor to<br>provide a display and user interface<br>for ICP monitoring.) |
| Method to account for<br>location of ventricles via<br>patient head position | Same as predicate SED System<br>(in Ventricular Mode) | Reference shroud attached to<br>patient behind the ear (at the level<br>of the EAM (External Auditory<br>Meatus) to account for patient's<br>head positioning. | Laser level must be attached to the<br>system and leveled and then the<br>system "zeroed"; adjustment<br>thereafter may be needed. |
| Measured Pressure Range | Same as predicate SED System<br>(in Ventricular Mode) | -5 to 40 cm H2O (set ICP range) | 0 - 31 cm H2O (set ICP range) |
| Measured Lumbar Drainage<br>Rate Range | 0 to 45 ml/hr | Not applicable | Controlled by manual adjustment<br>and measured by user over time. |
| Displayed ICP | Same as predicate SED System<br>(in Ventricular Mode) | Yes<br>(via SED Console display) | Yes<br>(via drip chamber pressure<br>indicator window or via connected<br>transducer to patient monitor<br>display) |

Table 1: Comparative Summary of the SED System and Predicate Devices

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Testing Summary: The subject changes to the SED System have no impact on the device's biocompatibility, electrical safety, packaging, sterilization or shelf life. Therefore, to demonstrate intended device performance, as well as to support the substantial equivalence of the subject SED System, other technological and performance characteristics were evaluated as summarized in Table 2 that follows.

| Testing | Testing Summary | Results/Conclusions |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| SED Cartridge Performance Testing | | |
| Functional Testing of the<br>SED Lumbar Cartridge | SED Lumbar Cartridges were tested as part of<br>the SED System to show that requirements for<br>functionality and the ability of the devices to<br>accurately measure and control the lumbar<br>drainage output were met. | PASS – All requirements verified. |
| SED System Performance Testing | | |
| Supplemental<br>Verification of the<br>Modified SED Cartridge,<br>Console, and System | SED Lumbar Cartridges and an SED Console<br>were evaluated to demonstrate that the devices<br>met the supplemental requirements applicable<br>to the modified device. | PASS – All supplemental system<br>requirements verified. |
| Long-Term (14-Day)<br>Stability of Modified<br>SED System | Modified SED Systems were tested under<br>clinical-use simulation for a period of 14<br>continuous days (to match the longest expected<br>use duration of the SED System for lumbar<br>drainage). | PASS – Modified SED System met all<br>requirements under clinical-use<br>simulation. |
| Verification of the<br>Drainage Range of the<br>Modified SED System | SED Lumbar Cartridges were tested on SED<br>Consoles to test the extremes of the drainage<br>setting range and drainage accuracy of the<br>system | PASS – Modified SED System<br>functioned as intended and met all<br>requirements. |
| Software Testing | | |
| Software Verification<br>and Validation | Code verification and software verification and<br>validation testing was performed. | PASS – Modified SED System met all<br>acceptance criteria for software<br>verification and validation |
| Electrical Safety and Electromagnetic Compatibility Testing | | |
| Verify the<br>Electromagnetic<br>Compatibility (EMC) of<br>the Modified SED<br>System | Applicable EMC testing (including emissions<br>and immunity) was completed on the modified<br>SED System in accordance with the following<br>standards.<br>• IEC 60601-1-2 Edition 3: 2007-03 | PASS – Modified SED System met all<br>applicable EMC requirements. |

Table 2: Summary Table for Modified SED System Testing

The results from these testing activities:

- . demonstrate that the technological and performance characteristics of the modified SED System are comparable to the predicate devices, and
- ensure the modified SED System can perform in a manner equivalent to the predicate ● devices with the same intended use as an external drainage and monitoring system.

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Conclusion (Statement of Equivalence): The data and information presented within this submission support a determination of substantial equivalence, and therefore market clearance of the modified SED System via this 510(k) Premarket Notification.