(139 days)
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.
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 far 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 provided text describes the Smart External Drain (SED) System, but it does not contain information related to an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth.
The document is a 510(k) premarket notification for a medical device (Smart External Drain System) and focuses on demonstrating substantial equivalence to a predicate device through various types of engineering, performance, and validation testing (e.g., mechanical, electrical, sterilization, biocompatibility, software verification).
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. Specifically, I cannot provide:
- A table of acceptance criteria vs. reported device performance for an AI/ML system.
- Sample sizes used for test sets with data provenance in the context of an AI/ML model.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone AI algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) in the context of an AI/ML model.
- Sample size for a training set (as this is not an AI/ML device).
- How ground truth for a training set was established (as this is not an AI/ML device).
The document details the device's functional performance and safety, which is different from validating an AI/ML model's diagnostic or predictive capabilities.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
Aqueduct Critical Care, Inc. Mr. Thomas Clement President & CEO 11822 North Creek Parkway North, Suite 110 Bothell, Washington 98011
Re: K161605
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 Dated: September 23, 2016 Received: September 26, 2016
Dear Mr. 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 devicerelated 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.
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena - S/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K161605
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
General Information:
| Date of Summary Preparation: | October 21, 2016 |
|---|---|
| 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 |
{4}------------------------------------------------
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 far 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.
Indications for 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.
{5}------------------------------------------------
Predicate Device: Aqueduct Critical Care, Inc. cites the following as the predicate device.
Predicate Device Duet External Drainage and Monitoring System K984053
Table 1 below provides a summary of the technological characteristics of the SED System in comparison to the predicate device.
| Detail or TechnologicalCharacteristic | Subject Aqueduct Critical Care, Inc.SED System | Predicate Medtronic Duet ExternalDrainage and Monitoring System |
|---|---|---|
| Device Trade Name | Smart External Drain (SED) System | Medtronic DUETTM External Drainage andMonitoring System |
| Intended Use | Same | To attach to an implanted, external drainagecatheter in order to externally draincerebrospinal fluid (CSF) and monitor bothCSF drainage and intracranial pressure(ICP) |
| Attaches to separate,commercially available EVDCatheter | Yes | Yes |
| Sterile Disposable tubing set | Yes | Yes |
| CSF Drainage Bag | Yes | Yes |
| Gravity drainage of CSF | Yes | Yes |
| Method to control gravitydrainage of CSF | Automated adjustment based on user settings(for max/min ICP) via a stepper-motorcontrolled, tube-pinching mechanism to eithercompress or release the compliant drainagetubing contained within the sterile, disposableSED Cartridge. | Manual adjustment of the drip chambereither up or down the IV Pole, relative tothe patient's head position and ventricularcatheter location. |
| Pressure Transducer for ICPMeasurement | Yes(The SED System integrates transducers intoits design for drain line and reference linepressure measurements that are used tocalculate and regulate ICP.) | Yes(The Duet System includes both a designand instructions for attachment of atransducer to the main system stopcock thatthen allows for measurement and visualdisplay of ICP via a connected monitor.) |
| Software-based, PoweredConsole for User Interface, UserICP and Alarm SettingAdjustments, Data Storage andDisplay, and Alarms for ICPMonitoring | Yes | No(Note, however, that a transducer can beattached (see above) and then used inconjunction with an ICP Monitor toprovide a display and user interface forICP monitoring.) |
| Method to account for locationof ventricles via patient headposition | Reference shroud attached to patient behindthe ear (at the level of the EMA) to accountfor patient's head positioning. | Laser level must be attached to the systemand leveled appropriately and then thesystem "zeroed"; adjustment thereafter maybe needed. |
| Measured Pressure Range | -5 to 40 cm H2O (set ICP range) | 0 - 31 cm H2O (set ICP range) |
| Displayed ICP | Yes(via SED Console display) | Yes(via drip chamber pressure indicatorwindow or via connected transducer topatient monitor display) |
| Battery Back-up | Yes | No(Manual, non-powered system) |
Table 1: Comparative Summary of the SED System and Predicate Duet System
{6}------------------------------------------------
Testing Summary: To demonstrate intended device performance, as well as to support the substantial equivalence of the subject SED System, the technological and performance characteristics were evaluated as summarized in Table 2 that follows.
The results from these testing activities:
- demonstrate that the technological and performance characteristics of the subject SED . System are comparable to the predicate external drainage management system, and
- . ensure the SED System can perform in a manner equivalent to the predicate device with the same intended use as an external drainage and monitoring system.
Conclusion (Statement of Equivalence): The data and information presented within this submission support a determination of substantial equivalence, and therefore market clearance of the subject SED System via this 510(k) Premarket Notification.
{7}------------------------------------------------
| Testing | Testing Summary | Results/Conclusions |
|---|---|---|
| SED Console Performance Testing | ||
| SED ConsoleVerification | Simulated use test cases completed with all requirementstested to verify SED Console performance. | PASS – All requirements verified. |
| SED Cartridge Performance Testing | ||
| SED Cartridge PinchTubing Force andFatigue | SED Cartridges were tested to show that the pinchtubing met requirements, including resistance to pinchtubing fatigue and shut off / pinch force. | PASS - All requirements verified. |
| SED Cartridge ButtonVerification | SED Cartridges were tested to show that the manualpinch button on the cartridge met the followingrequirements: activation force, leak resistance, andfatigue life. | PASS – All requirements verified. |
| MRI Compatibility | The SED Cartridge was tested in an MRI environment of1.5-Tesla and 3.0-Tesla. | PASS – All requirements verified. |
| Tubing Kink and CrushVerification | SED Cartridges were tested in a bend radius to assesskink resistance. For crush resistance, fluid flowexhibited no change when a force was applied to thetubing compared to no force applied. | PASS – All requirements verified. |
| DimensionalVerification | SED Cartridges were dimensionally measured. | PASS - Measurements confirmed that all dimensional requirements weremet. |
| Drainage BagVerification | SED Cartridges were tested to show that drainage bagsmet requirements for: capacity, venting, and wetting. | PASS – All requirements verified. |
| Bond Joint Testing | SED Cartridges were used to destructively pull test thebond joint configurations. | PASS - All bond joints met or exceeded the minimum pull strengthspecification. |
| SED System Performance Testing | ||
| SED SystemMechanicalVerification | The SED System was tested to ensure that all applicablemechanical requirements were met. | PASS - The SED Console was shown to function properly following themaximum anticipated number of latching and unlatching cycles. |
| Verification of SEDSystem EnvironmentalConditions | The SED System was subjected to the extremes of thespecified environmental conditions (includingtemperature, humidity, and altitude) to confirm intendedsystem functionality post-conditioning. | PASS - SED System functioned as intended post-conditioning. |
| Long-Term Stability ofSED System | SED Systems were tested under clinical-use simulationfor the longest expected use duration of the SEDSystem | PASS - SED System met all requirements under clinical-use simulation. |
| Testing | Testing Summary | Results/Conclusions |
| Verification of thePressure MeasurementRange and ResponseTime of the SEDSystem | The SED System was tested to the extremes of thepressure measurement range, as well as to measure theresponse time of the system. | PASS - All applicable requirements verified. |
| Packaging Validation Testing | ||
| Packaging ValidationTesting | The packaging configurations for the reusable SEDConsole and sterile SED Cartridge and Drain Bag weresubjected to applicable distribution simulation perASTM D4169, followed by testing:The SED Console was tested to ensure it maintainedproper function via simulated clinical-use.The sterile SED Cartridge and Drain Bag packaging wassubjected to seal strength, dye leak testing, and visualinspection, while the SED Cartridge and Drain Bag weresubjected to functional testing to confirm proper devicefunction. | PASS - Package integrity and product functionality met all applicablerequirements. |
| Sterilization Validation Testing | ||
| Sterilization Validation | Sterilization validation testing was completed to validatethat the gamma radiation (min 25 kGy) sterilizationprocess provides a Sterility Assurance Level (SAL) of10-6, using the following applicable standards andsterilization validation methods.• AAMI / ANSI / ISO 11737-1:2006 (R) 2011• AAMI / ANSI / ISO 11737-2:2009/(R) 2014• AAMI / ANSI / ISO 11137-1:2006/(R) 2010,[Including: Amendment 1 (2013)]• AAMI / ANSI / ISO 11137-2:2013 | PASS – The gamma radiation sterilization process provides an SAL of10-6. |
| Shelf-Life Testing | ||
| Shelf-Life Testing | Accelerated age testing was completed on the SEDCartridge and SED Drain bag components and theirrespective packaging to support a 6-month shelf life. | PASS - All packaging and functional requirements were met following 6months of accelerated aging. |
| Testing | Testing Summary | Results/Conclusions |
| Biocompatibility Testing | ||
| BiocompatibilityTesting | Biocompatibility testing completed on all direct (skin) and indirect (potential limited and brief periods ofretrograde drainage fluid flow) contact portions of theSED System. This included cytotoxicity, sensitization,intracutaneous reactivity, LAL pyrogenicity and acutesystemic toxicity. | PASS - SED System met all applicable biocompatibility requirements forits intended use. |
| Software Testing | ||
| Software Verificationand Validation | Code verification and software verification andvalidation testing was performed. | PASS - SED System met all acceptance criteria for verification andvalidation |
| Electrical Safety and Electromagnetic Compatibility Testing | ||
| Verify the ElectricalSafety andElectromagneticCompatibility (EMC)of the SED System | Applicable electrical safety and EMC testing (includingemissions and immunity) was completed on the SEDSystem in accordance with the following standards.• AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) (IEC 60601-1:2005, MOD)• IEC 60601-1-2 Edition 3: 2007-03• IEC 60601-1-8 Edition 2.0 2006-10 | PASS - SED System met all applicable electrical safety and EMCrequirements. |
Table 2: Summary Table for SED System Testing
{8}------------------------------------------------
{9}------------------------------------------------
§ 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).