Smart External Drain (SED) System

K181301 · Aqueduct Critical Care, Inc. · JXG · Jun 14, 2018 · Neurology

Device Facts

• Record ID: K181301
• Device Name: Smart External Drain (SED) System
• Applicant: Aqueduct Critical Care, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jun 14, 2018
• 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 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 console with a sterile, disposable cartridge for automated CSF drainage and ICP monitoring. It connects to an external drainage catheter via luer-lock and a drainage bag. The system uses pressure transducers (ventricular mode) or a drip counter (lumbar mode) to monitor flow/pressure. An automated stepper-motor pinching mechanism compresses or releases compliant tubing to regulate CSF flow, replacing manual gravity-drain adjustments. Used in clinical settings by hospital staff; mounted on IV poles. The console displays real-time ICP/drainage data and triggers alarms if values exceed set limits. Battery backup allows for patient mobility. Benefits include automated compensation for patient movement, reduced manual intervention, and continuous monitoring. Modifications include updated low-drain alarm timing and added user interface prompts for priming verification.

Clinical Evidence

No clinical data. Substantial equivalence is supported by software verification and validation testing.

Technological Characteristics

Electromechanical console with software-embedded control; sterile disposable cartridge with compliant tubing; stepper-motor pinching mechanism for flow regulation; pressure transducers for ICP; drip counter for drainage monitoring; battery backup; IV pole-mounted; luer-lock connectivity.

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/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 (K172759)

Submission Summary (Full Text)

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June 14, 2018

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

Re: K181301

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 16, 2018 Received: May 17, 2018

Dear 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. Iisting 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);

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# Page 2 - Thomas Clement

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng -S

for 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) K181301

#### 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)

| <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: | May 16, 2018 |
|-----------------------------------|---------------------------------------------------------------------------------------------------|
| 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 Monitoring Device |
| 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 (in Ventricular mode) or regulation of drainage (in Lumbar mode) 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, 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 for greater mobility (via a battery backup) and also alert hospital staff if the ICP and/or drainage values exceed the set maximum or minimum levels for a particular patient.

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

- Changed the Low Drain Alarm reactivation from 10 minutes to 60 minutes in the Ventricular Mode when the SED Cartridge has been confirmed to be properly primed
- Added user prompts to the User Interface Screen to provide a user check that the drain ● tubing path within the SED Cartridge is properly primed prior to use

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

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- . 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 | K172759 |
|------------------|-----------------------------------|---------|
|------------------|-----------------------------------|---------|

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 (K172759) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Same as predicate SED System | Smart External Drain (SED) System |
| Intended Use | Same as predicate SED System | To attach to an implanted, external drainage<br>catheter in order to externally drain<br>cerebrospinal fluid (CSF) and monitor both<br>CSF drainage for both Lumbar and<br>Ventricular modes and intracranial pressure<br>(ICP) for Ventricular mode. |
| Attaches to Separate,<br>Commercially Available EVD<br>Catheter | Same as predicate SED System | Yes |
| Sterile Disposable Tubing Set | Same as predicate SED System | Yes |
| CSF Drainage Bag | Same as predicate SED System | Yes |
| Gravity Drainage of CSF | Same as predicate SED System | Yes |
| Method to Control Gravity<br>Drainage of CSF | Same as predicate SED System<br>(in both Lumbar and Ventricular modes) | Automated adjustment based on user settings<br>via a stepper-motor controlled, tube-pinching<br>mechanism to either compress or release the<br>compliant drainage tubing contained within<br>the sterile, disposable SED Cartridge. |
| Pressure Transducer for ICP<br>Measurement | Same as predicate SED System<br>(in Ventricular mode) | Yes |
| Software-based, Powered<br>Console for User Interface, User<br>ICP, drainage output and Alarm<br>Setting Adjustments, Data<br>Display, and Alarms for ICP<br>and drainage output Monitoring | Same as predicate SED System<br>(The modified SED System now also<br>incorporates additional user prompts) | Yes |
| Method to Account for Location<br>of Ventricles via Patient Head<br>Position | Same as predicate SED System<br>(in Ventricular mode) | Reference shroud attached to patient behind<br>the ear (at the level of the EAM) to account<br>for patient's head positioning. |
| Measured Ventricular Pressure<br>Range | Same as predicate SED System<br>(in Ventricular mode) | -5 to 40 cm H2O (set ICP range) |
| Measured Lumbar Drainage<br>Output Range | Same as predicate SED System<br>(in Lumbar mode) | 0 to 45 ml/hr |
| Displayed ICP | Same as predicate SED System<br>(in Ventricular mode) | Yes (via SED Console display) |
| Battery Back-up | Same as predicate SED system | 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 by completion of the following testing:

- . Software Verification and Validation
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.

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