Smart External Drain (SED) System

K171586 · Aqueduct Critical Care, Inc. · JXG · Jun 30, 2017 · Neurology

Device Facts

• Record ID: K171586
• Device Name: Smart External Drain (SED) System
• Applicant: Aqueduct Critical Care, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jun 30, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Draining and monitoring of CSF flow from the lateral ventricles 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

The Smart External Drain (SED) System is an electromechanical device for automated CSF drainage and ICP monitoring. It consists of a console and a sterile, disposable cartridge that connects to an external ventricular drainage (EVD) catheter. The system uses pressure transducers to measure ICP and an automated stepper-motor pinching mechanism to compress or release compliant drain tubing, regulating CSF flow based on user-defined pressure setpoints. This replaces manual gravity-based adjustments. The console displays real-time ICP, calculated CSF flow volume, and ICP waveforms, while providing alarms for out-of-range values. Used in clinical settings, it allows for patient mobility via battery backup and compensates for patient movement. Healthcare providers use the output to manage intracranial pressure and monitor patient status, potentially reducing the need for continuous manual interventions.

Clinical Evidence

Bench testing only. Testing included SED cartridge performance (activation force, leak resistance, fatigue life, bond joint testing), system-level functionality (pressure resistance, response time, initialization cycle, measurement range), and software verification/validation. All tests met pre-defined acceptance criteria.

Technological Characteristics

Electromechanical system with software-embedded console and sterile disposable cartridge. Uses pressure transducers for ICP measurement and a stepper-motor controlled tube-pinching mechanism for flow regulation. Features include ICP waveform display, USB interface for software loading, and battery backup. Operates within a pressure range of -5 to 40 cm H2O. Connectivity includes USB for software updates.

Indications for Use

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

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 (K161605)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2017

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

Re: K171586

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: May 30, 2017 Received: May 31, 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 (reporting of medical device

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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)

#### K171586

Device Name Smart External Drain (SED) System

#### Indications for Use (Describe)

Draining and monitoring of CSF flow from the lateral ventricles 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) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

## General Information:

| Date of Summary Preparation: | June 22, 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: [phone]<br>Fax: [phone] | |
| 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 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 ventricular 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, which is considered to be below the height of a hospital bed.

The SED System automatically maintains a set ICP using pressure sensors (transducers) 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 ICP information and also calculates and displays CSF flow volume output, while additionally incorporating multiple alarms given its automated functionality.

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

The modifications included under this Special 510(k) include the following:

- Added ICP Waveform Display to User Interface Screen. .
- Software loading via USB interface.
- Optimization of the SED System's initialization sequence. .

Indications for Use: The Indications for Use statement for the subject device is identical to the predicate device, as follows:

Draining and monitoring of CSF flow from the lateral ventricles 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

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- 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.

Predicate Device: Aqueduct Critical Care, Inc. cites the following as the predicate device that is being modified.

| Predicate Device | Smart External Drain (SED) System |
|------------------|-----------------------------------|
| | K161605 |

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

| Detail or Technological<br>Characteristic | Modified Aqueduct Critical Care, Inc.<br>SED System | Predicate Aqueduct Critical Care, Inc.<br>SED System (K161605) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Same | Smart External Drain (SED) System |
| Intended Use | Same | To attach to an implanted, external drainage<br>catheter in order to externally drain<br>cerebrospinal fluid (CSF) and monitor both<br>CSF drainage and intracranial pressure (ICP) |
| Attaches to Separate,<br>Commercially Available EVD<br>Catheter | Same | Yes |
| Sterile Disposable Tubing Set | Same | Yes |
| CSF Drainage Bag | Same | Yes |
| Gravity Drainage of CSF | Same | Yes |
| Method to Control Gravity<br>Drainage of CSF | Same | Automated adjustment based on user settings<br>(for max/min ICP) via a stepper-motor<br>controlled, tube-pinching mechanism to<br>either compress or release the compliant<br>drainage tubing contained within the sterile,<br>disposable SED Cartridge. |
| Pressure Transducer for ICP<br>Measurement | Same | Yes<br>(The SED System integrates transducers into<br>its design for drain line and reference line<br>pressure measurements that are used to<br>calculate and regulate ICP.) |
| Software-based, Powered<br>Console for User Interface, User<br>ICP and Alarm Setting<br>Adjustments, Data Display, and<br>Alarms for ICP Monitoring | Same<br>(The modified SED System now also<br>incorporates an ICP waveform display.) | Yes |
| Method to Account for Location<br>of Ventricles via Patient Head<br>Position | Same | Reference shroud attached to patient behind<br>the ear (at the level of the External Auditory<br>Meatus) to account for patient's head<br>positioning. |
| Measured Pressure Range | Same | -5 to 40 cm H2O (set ICP range) |
| Displayed ICP | Same | Yes (via SED Console display) |
| Battery Back-up | Same | Yes |

## Table 1: Comparative Summary of the Modified SED System and Predicate SED System

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Testing Summary: To demonstrate intended device performance, as well as to support the substantial equivalence of the modified SED System to the predicate SED System, the performance and technological characteristics were evaluated as summarized in Table 2 that follows.

| Testing | Testing Summary | Results/Conclusions |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <b>SED Cartridge Performance Testing</b> | | |
| SED Cartridge Button<br>Verification | Modified SED Cartridges were tested to show that the<br>modified manual pinch button location on the modified<br>SED Cartridge met the following requirements:<br>activation force, leak resistance, and fatigue life. | PASS - All acceptance criteria<br>for the test method were met. |
| Drip Chamber Vent<br>Verification | Modified SED Cartridges were tested to confirm that the<br>vent activates as intended and that the vent does not leak<br>(in its closed state) following exposure to the worst-case<br>anticipated number of vent cycles. | PASS - All acceptance criteria<br>for the test method were met. |
| Dimensional Verification | Modified SED Cartridges were weighed to confirm that<br>the cartridge weight met the weight requirement. | PASS - All acceptance criteria<br>for the test method were met. |
| Supplemental Verification | The only supplemental verification which required<br>verification based on the modifications was size and<br>weight, which were measured for the modified SED<br>Cartridges. | PASS - All acceptance criteria<br>for the test method were met. |
| Bond Joint Testing, SED<br>Cartridge | Modified SED Cartridge subassemblies were used to<br>destructively pull the 3 new bond joints. | PASS - All acceptance criteria<br>for the test method were met. |
| <b>SED System Performance Testing</b> | | |
| Functionality and Pressure<br>Resistance Verification | The Modified SED System was tested to show that<br>performance requirements were met for functionality,<br>response time, and pressure and leak resistance, with the<br>addition of fatigue cycling of the membrane assembly. | PASS - All acceptance criteria<br>for the test method were met. |
| Verification of SED<br>System Initialization Cycle | Testing of the modified software initialization cycle for<br>the modified SED System was performed. | PASS - All acceptance criteria<br>for the test method were met. |
| Verification of SED<br>System Requirements | Testing was performed to verify the system-level<br>performance of the SED System software modifications. | PASS - All acceptance criteria<br>for the test method were met. |
| Verification of the Pressure<br>Measurement Range of the<br>SED System | The modified SED System was tested to the extremes of<br>the pressure measurement range. | PASS - All acceptance criteria<br>for the test method were met. |
| <b>Software Testing</b> | | |
| Software Verification and<br>Validation | Code verification and software verification and<br>validation testing were performed on the modified<br>software. | PASS – modified SED System<br>met all acceptance criteria for<br>verification and validation. |

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 SED System, and
- ensure the modified SED System can perform in a manner equivalent to the predicate ● SED System with the same intended use.

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