(30 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 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.
The Aqueduct Critical Care, Inc. Smart External Drain (SED) System, as described in the provided 510(k) summary, underwent testing to demonstrate its performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria alongside specific numerical performance results. Instead, it lists various performance tests and states that "All acceptance criteria for the test method were met" for each.
Given this, the table below is constructed based on the described tests and the consistent "PASS" outcome:
| Test Category | Test Performed | Acceptance Criteria (Inferred from "PASS" statement) | Reported Device Performance |
|---|---|---|---|
| SED Cartridge Performance | SED Cartridge Button Verification | Button activation force, leak resistance, and fatigue life met specified requirements. | PASS - All acceptance criteria for the test method were met. |
| Drip Chamber Vent Verification | Vent activates as intended and does not leak (in closed state) after worst-case anticipated vent cycles. | PASS - All acceptance criteria for the test method were met. | |
| Dimensional Verification | Cartridge weight met specified weight requirement. | PASS - All acceptance criteria for the test method were met. | |
| Supplemental Verification (Size and Weight) | Size and weight measurements for modified SED Cartridges met specified requirements. | PASS - All acceptance criteria for the test method were met. | |
| Bond Joint Testing, SED Cartridge | The 3 new bond joints met specified strength requirements during destructive pull tests. | PASS - All acceptance criteria for the test method were met. | |
| SED System Performance | Functionality and Pressure Resistance Verification | Performance requirements for functionality, response time, pressure, and leak resistance were met, including fatigue cycling of the membrane assembly. | PASS - All acceptance criteria for the test method were met. |
| Verification of SED System Initialization Cycle | Modified software initialization cycle performed as intended. | PASS - All acceptance criteria for the test method were met. | |
| Verification of SED System Requirements | System-level performance of the SED System software modifications met specified requirements. | PASS - All acceptance criteria for the test method were met. | |
| Verification of the Pressure Measurement Range of the SED System | Device performed to the extremes of the pressure measurement range (-5 to 40 cm H2O). | PASS - All acceptance criteria for the test method were met. | |
| Software Testing | Software Verification and Validation | Code verification and software verification and validation testing met specified requirements. | PASS – modified SED System met all acceptance criteria for verification and validation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test or for the overall test set.
The data provenance is not explicitly stated beyond the tests being performed by the manufacturer, Aqueduct Critical Care, Inc. It does not mention country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a modified device, these would typically be internal engineering and bench tests, not clinical studies involving patient data provenance in the same way.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. The tests are focused on the hardware and software performance of the medical device itself (e.g., button force, leak resistance, software functionality) through bench testing. They do not involve human interpretation of medical images or data requiring clinical expert ground truth in the traditional sense.
4. Adjudication Method for the Test Set
This information is not applicable. As the testing primarily involves objective measurements of device performance parameters against predetermined engineering specifications, an adjudication method for reconciling expert opinions is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This product is a physical device (an external drain system) with automated features, not an AI/CADe (Computer_Assisted Detection) or AI/CADx (Computer_Assisted Diagnosis) system that would typically warrant such a study for human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is an electromechanical system with embedded software. The performance testing outlined (e.g., functionality, pressure resistance, initialization cycle, software verification) inherently represents the "standalone" performance of the algorithm and hardware working together. It's not an "algorithm-only" performance in the sense of an AI model analyzing data, but rather the system's automated functions operating independently as designed.
7. The Type of Ground Truth Used
The ground truth for the performance tests described would be the predefined engineering specifications and design requirements for the device's physical and functional characteristics. For example:
- Bond Joint Testing: Ground truth is the specified minimum tensile strength for the bond joints.
- Dimensional Verification: Ground truth is the specified weight range for the cartridge.
- Pressure Measurement Range: Ground truth is the specified accurate operating range of -5 to 40 cm H2O.
- Software Verification: Ground truth is the validated software requirements and expected outputs.
8. The Sample Size for the Training Set
This information is not applicable. This submission details a physical medical device (External Drain System) with embedded software, not an AI model that undergoes a "training" phase with a dataset. The software development process likely involved various verification and validation activities, but not "training" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of an AI model for this device. The software development followed standard engineering and quality system processes, with ground truth established through design specifications, requirements, and testing protocols.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
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 (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,
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) | |
|---|---|
| ☑ 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: | June 22, 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 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 TechnologicalCharacteristic | Modified Aqueduct Critical Care, Inc.SED System | Predicate Aqueduct Critical Care, Inc.SED System (K161605) |
|---|---|---|
| Device Trade Name | Same | Smart External Drain (SED) 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 | Same | Yes |
| Sterile Disposable Tubing Set | Same | Yes |
| CSF Drainage Bag | Same | Yes |
| Gravity Drainage of CSF | Same | Yes |
| Method to Control GravityDrainage of CSF | Same | Automated adjustment based on user settings(for max/min ICP) via a stepper-motorcontrolled, tube-pinching mechanism toeither compress or release the compliantdrainage tubing contained within the sterile,disposable SED Cartridge. |
| Pressure Transducer for ICPMeasurement | Same | Yes(The SED System integrates transducers intoits design for drain line and reference linepressure measurements that are used tocalculate and regulate ICP.) |
| Software-based, PoweredConsole for User Interface, UserICP and Alarm SettingAdjustments, Data Display, andAlarms for ICP Monitoring | Same(The modified SED System now alsoincorporates an ICP waveform display.) | Yes |
| Method to Account for Locationof Ventricles via Patient HeadPosition | Same | Reference shroud attached to patient behindthe ear (at the level of the External AuditoryMeatus) to account for patient's headpositioning. |
| 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 |
|---|---|---|
| SED Cartridge Performance Testing | ||
| SED Cartridge ButtonVerification | Modified SED Cartridges were tested to show that themodified manual pinch button location on the modifiedSED Cartridge met the following requirements:activation force, leak resistance, and fatigue life. | PASS - All acceptance criteriafor the test method were met. |
| Drip Chamber VentVerification | Modified SED Cartridges were tested to confirm that thevent activates as intended and that the vent does not leak(in its closed state) following exposure to the worst-caseanticipated number of vent cycles. | PASS - All acceptance criteriafor the test method were met. |
| Dimensional Verification | Modified SED Cartridges were weighed to confirm thatthe cartridge weight met the weight requirement. | PASS - All acceptance criteriafor the test method were met. |
| Supplemental Verification | The only supplemental verification which requiredverification based on the modifications was size andweight, which were measured for the modified SEDCartridges. | PASS - All acceptance criteriafor the test method were met. |
| Bond Joint Testing, SEDCartridge | Modified SED Cartridge subassemblies were used todestructively pull the 3 new bond joints. | PASS - All acceptance criteriafor the test method were met. |
| SED System Performance Testing | ||
| Functionality and PressureResistance Verification | The Modified SED System was tested to show thatperformance requirements were met for functionality,response time, and pressure and leak resistance, with theaddition of fatigue cycling of the membrane assembly. | PASS - All acceptance criteriafor the test method were met. |
| Verification of SEDSystem Initialization Cycle | Testing of the modified software initialization cycle forthe modified SED System was performed. | PASS - All acceptance criteriafor the test method were met. |
| Verification of SEDSystem Requirements | Testing was performed to verify the system-levelperformance of the SED System software modifications. | PASS - All acceptance criteriafor the test method were met. |
| Verification of the PressureMeasurement Range of theSED System | The modified SED System was tested to the extremes ofthe pressure measurement range. | PASS - All acceptance criteriafor the test method were met. |
| Software Testing | ||
| Software Verification andValidation | Code verification and software verification andvalidation testing were performed on the modifiedsoftware. | PASS – modified SED Systemmet all acceptance criteria forverification 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).
§ 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).