· 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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Aqueduct Critical Care, Inc. Smart External Drain (SED) System. It describes the device, its indications for use, and a summary of testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria, particularly in the context of an AI-powered diagnostic device. The SED system described is an electromechanical device for draining and monitoring CSF, not an AI-driven diagnostic tool. Therefore, the concepts of "expert consensus," "MRMC studies," "effect size of human readers improving with AI," "standalone algorithm performance," and "training/test set ground truth establishment" (which are typical for AI/ML medical devices) are not applicable to this submission.

The testing summarized in the document is related to the functional performance, stability, software verification, and electrical safety of the physical medical device, not the performance of an AI algorithm based on diagnostic accuracy metrics.

Therefore, I cannot extract the requested information from the provided text because it describes a different class of medical device and type of study than what your prompt implies.

If you have a document describing an AI-powered medical device and its validation studies, I would be happy to analyze it for the requested details.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

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 (1-800-638-2041 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)
☑ 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.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 Monitor
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 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.

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 TechnologicalCharacteristic	Modified Aqueduct CriticalCare, Inc.SED System	Primary Predicate AqueductCritical Care, Inc. SED System(NOTE: as presented in K161605relative to original predicate DuetSystem)	Original K161605 PredicateMedtronic Duet ExternalDrainage and Monitoring System(Secondary Predicate)
Device Trade Name	Smart External Drain (SED)System	Smart External Drain (SED)System	Medtronic DUET™ ExternalDrainage and Monitoring System
Intended Use	Same	Same	To attach to an implanted, externaldrainage catheter to externally draincerebrospinal fluid (CSF) andmonitor both CSF drainage andintracranial pressure (ICP).
Attaches to separate,commercially available EVDCatheter	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 gravitydrainage of CSF	Same as predicate SED System(in both Lumbar and VentricularModes)	Automated adjustment based onuser settings via a stepper-motorcontrolled, tube-pinchingmechanism to either compress orrelease the compliant drainagetubing contained within the sterile,disposable SED Cartridge.	Manual adjustment of the dripchamber either up or down the IVPole, relative to the patient's headposition and ventricular catheterlocation.
Pressure Transducer forICP Measurement	Same as predicate SED System(in Ventricular Mode)	Yes	Yes(The Duet System includes a designand instructions for attaching atransducer that allows for ICPmeasurement and visual display viaa connected monitor.)
Software-based, PoweredConsole for User Interface,User Settings and AlarmAdjustments, Data Storageand Display, and Alarms forICP Monitoring	Yes	Yes	No(A transducer can be attached [seeabove] and then used inconjunction with an ICP Monitor toprovide a display and user interfacefor ICP monitoring.)
Method to account forlocation of ventricles viapatient head position	Same as predicate SED System(in Ventricular Mode)	Reference shroud attached topatient behind the ear (at the levelof the EAM (External AuditoryMeatus) to account for patient'shead positioning.	Laser level must be attached to thesystem and leveled and then thesystem "zeroed"; adjustmentthereafter may be needed.
Measured Pressure Range	Same as predicate SED System(in Ventricular Mode)	-5 to 40 cm H2O (set ICP range)	0 - 31 cm H2O (set ICP range)
Measured Lumbar DrainageRate Range	0 to 45 ml/hr	Not applicable	Controlled by manual adjustmentand measured by user over time.
Displayed ICP	Same as predicate SED System(in Ventricular Mode)	Yes(via SED Console display)	Yes(via drip chamber pressureindicator window or via connectedtransducer to patient monitordisplay)

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 theSED Lumbar Cartridge	SED Lumbar Cartridges were tested as part ofthe SED System to show that requirements forfunctionality and the ability of the devices toaccurately measure and control the lumbardrainage output were met.	PASS – All requirements verified.
SED System Performance Testing
SupplementalVerification of theModified SED Cartridge,Console, and System	SED Lumbar Cartridges and an SED Consolewere evaluated to demonstrate that the devicesmet the supplemental requirements applicableto the modified device.	PASS – All supplemental systemrequirements verified.
Long-Term (14-Day)Stability of ModifiedSED System	Modified SED Systems were tested underclinical-use simulation for a period of 14continuous days (to match the longest expecteduse duration of the SED System for lumbardrainage).	PASS – Modified SED System met allrequirements under clinical-usesimulation.
Verification of theDrainage Range of theModified SED System	SED Lumbar Cartridges were tested on SEDConsoles to test the extremes of the drainagesetting range and drainage accuracy of thesystem	PASS – Modified SED Systemfunctioned as intended and met allrequirements.
Software Testing
Software Verificationand Validation	Code verification and software verification andvalidation testing was performed.	PASS – Modified SED System met allacceptance criteria for softwareverification and validation
Electrical Safety and Electromagnetic Compatibility Testing
Verify theElectromagneticCompatibility (EMC) ofthe Modified SEDSystem	Applicable EMC testing (including emissionsand immunity) was completed on the modifiedSED System in accordance with the followingstandards.• IEC 60601-1-2 Edition 3: 2007-03	PASS – Modified SED System met allapplicable 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.

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).