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 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

AI/ML Overview

The Aqueduct Critical Care, Inc. Smart External Drain (SED) System, as described in the provided document, does not contain information about specific acceptance criteria, device performance, or a study proving its performance against acceptance criteria.

The document is a 510(k) Pre-Market Notification from the FDA, which primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical trial results or performance metrics against defined acceptance criteria.

The submission is specifically a Special 510(k), indicating that the modifications to the device do not affect the intended use or the fundamental scientific technology. The modifications are minor:

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.

Given these minor modifications, the submission emphasizes that the technological and performance characteristics of the modified SED System are comparable to the predicate SED System. The "Testing Summary" section mentions "Software Verification and Validation" as the testing activities performed to demonstrate intended device performance and support substantial equivalence.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, MRMC study, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not present in this document, as they are typically found in clinical study reports or detailed design validation outputs, which are not usually fully disclosed in a 510(k) summary. The 510(k) process for a minor modification like this primarily relies on demonstrating that the changes do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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.11822 North Creek Parkway NorthSuite 110Bothell, WA 98011
Contact Person:	Tom Clement, President and CEO
	Phone: 425-985-1571Fax: 425-278-9377
Trade Name:	Smart External Drain (SED) System
Common Name:	External CSF Drainage System
Regulation Number:	Primary: § 21 CFR 882.5550Secondary: § 21 CFR 882.1620
Regulation Description:	Central Nervous System Fluid Shunt and ComponentsIntracranial Pressure Monitoring Device
Regulatory Class:	Class II
Classification Panel:	Neurology
Product Code:	Primary: JXGSecondary: 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 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 TechnologicalCharacteristic	Modified Aqueduct Critical Care, Inc.SED System	Predicate Aqueduct Critical Care, Inc.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 drainagecatheter in order to externally draincerebrospinal fluid (CSF) and monitor bothCSF drainage for both Lumbar andVentricular modes and intracranial pressure(ICP) for Ventricular mode.
Attaches to Separate,Commercially Available EVDCatheter	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 GravityDrainage of CSF	Same as predicate SED System(in both Lumbar and Ventricular modes)	Automated adjustment based on user settingsvia a stepper-motor controlled, tube-pinchingmechanism to either compress or release thecompliant drainage tubing contained withinthe sterile, disposable SED Cartridge.
Pressure Transducer for ICPMeasurement	Same as predicate SED System(in Ventricular mode)	Yes
Software-based, PoweredConsole for User Interface, UserICP, drainage output and AlarmSetting Adjustments, DataDisplay, and Alarms for ICPand drainage output Monitoring	Same as predicate SED System(The modified SED System now alsoincorporates additional user prompts)	Yes
Method to Account for Locationof Ventricles via Patient HeadPosition	Same as predicate SED System(in Ventricular mode)	Reference shroud attached to patient behindthe ear (at the level of the EAM) to accountfor patient's head positioning.
Measured Ventricular PressureRange	Same as predicate SED System(in Ventricular mode)	-5 to 40 cm H2O (set ICP range)
Measured Lumbar DrainageOutput Range	Same as predicate SED System(in Lumbar mode)	0 to 45 ml/hr
Displayed ICP	Same as predicate SED System(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).

Regulation Number and Section

§ 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).