(30 days)
Not Found
No
The description focuses on automated regulation using pressure sensors and a stepper motor based on set parameters, not learning or adaptive algorithms. The modifications are also related to display, software loading, and initialization, not AI/ML functionality.
Yes
The device is used to reduce intracranial pressure and provide temporary CSF drainage, both of which are therapeutic maneuvers.
Yes
The device "Monitors CSF chemistry, cytology, and physiology" and "Monitors intracranial pressure (ICP)", which are diagnostic functions. It also "displays the measured ICP information and also calculates and displays CSF flow volume output," providing information used for diagnosis or guidance of treatment.
No
The device description explicitly states the SED System consists of an "electromechanical software embedded SED Console" and a "sterile, disposable SED Cartridge," indicating the presence of significant hardware components beyond just software. The performance testing also includes verification of hardware elements like the SED Cartridge and the SED System's functionality and pressure resistance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as draining and monitoring CSF flow and monitoring intracranial pressure. These are direct physiological measurements and interventions performed on the patient.
- Device Description: The device description details a system that physically interacts with the patient's CSF drainage system (via a luer-lock connector) and uses pressure sensors and a mechanical mechanism to control flow.
- Lack of In Vitro Activity: An IVD is designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on patient specimens outside the body. It is directly interacting with and managing a physiological process within the patient.
The device is a therapeutic and monitoring device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG, GWM
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital staff
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SED Cartridge Performance Testing
- SED Cartridge Button Verification: Modified SED Cartridges were tested to show that the modified manual pinch button location on the modified SED Cartridge met the following requirements: activation force, leak resistance, and fatigue life.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Drip Chamber Vent Verification: Modified SED Cartridges were tested to confirm that the vent activates as intended and that the vent does not leak (in its closed state) following exposure to the worst-case anticipated number of vent cycles.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Dimensional Verification: Modified SED Cartridges were weighed to confirm that the cartridge weight met the weight requirement.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Supplemental Verification: The only supplemental verification which required verification based on the modifications was size and weight, which were measured for the modified SED Cartridges.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Bond Joint Testing, SED Cartridge: Modified SED Cartridge subassemblies were used to destructively pull the 3 new bond joints.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
SED System Performance Testing
- Functionality and Pressure Resistance Verification: The Modified SED System was tested to show that performance requirements were met for functionality, response time, and pressure and leak resistance, with the addition of fatigue cycling of the membrane assembly.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Verification of SED System Initialization Cycle: Testing of the modified software initialization cycle for the modified SED System was performed.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Verification of SED System Requirements: Testing was performed to verify the system-level performance of the SED System software modifications.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
- Verification of the Pressure Measurement Range of the SED System: The modified SED System was tested to the extremes of the pressure measurement range.
- Results/Conclusions: PASS - All acceptance criteria for the test method were met.
Software Testing
- Software Verification and Validation: Code verification and software verification and validation testing were performed on the modified software.
- Results/Conclusions: PASS – modified SED System met all acceptance criteria for verification and validation.
Overall Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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 North | ||
| Suite 110 | ||
| Bothell, WA 98011 | ||
| Contact Person: | Tom Clement, President and CEO | |
| Phone: 425-985-1571 | ||
| Fax: 425-278-9377 | ||
| Trade Name: | Smart External Drain (SED) System | |
| Common Name: | External CSF Drainage System | |
| Regulation Number: | Primary: § 21 CFR 882.5550 | |
| Secondary: § 21 CFR 882.1620 | ||
| Regulation Description: | Central Nervous System Fluid Shunt and Components | |
| Intracranial Pressure Monitor | ||
| Regulatory Class: | Class II | |
| Classification Panel: | Neurology | |
| Product Code: | Primary: JXG | |
| Secondary: 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 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
5
- 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 Technological
Characteristic | 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 drainage
catheter in order to externally drain
cerebrospinal fluid (CSF) and monitor both
CSF drainage and intracranial pressure (ICP) |
| Attaches to Separate,
Commercially Available EVD
Catheter | Same | Yes |
| Sterile Disposable Tubing Set | Same | Yes |
| CSF Drainage Bag | Same | Yes |
| Gravity Drainage of CSF | Same | Yes |
| Method to Control Gravity
Drainage of CSF | Same | Automated adjustment based on user settings
(for max/min ICP) via a stepper-motor
controlled, tube-pinching mechanism to
either compress or release the compliant
drainage tubing contained within the sterile,
disposable SED Cartridge. |
| Pressure Transducer for ICP
Measurement | Same | Yes
(The SED System integrates transducers into
its design for drain line and reference line
pressure measurements that are used to
calculate and regulate ICP.) |
| Software-based, Powered
Console for User Interface, User
ICP and Alarm Setting
Adjustments, Data Display, and
Alarms for ICP Monitoring | Same
(The modified SED System now also
incorporates an ICP waveform display.) | Yes |
| Method to Account for Location
of Ventricles via Patient Head
Position | Same | Reference shroud attached to patient behind
the ear (at the level of the External Auditory
Meatus) to account for patient's head
positioning. |
| 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
6
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 Button | ||
| Verification | Modified SED Cartridges were tested to show that the | |
| modified manual pinch button location on the modified | ||
| SED Cartridge met the following requirements: | ||
| activation force, leak resistance, and fatigue life. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Drip Chamber Vent | ||
| Verification | Modified SED Cartridges were tested to confirm that the | |
| vent activates as intended and that the vent does not leak | ||
| (in its closed state) following exposure to the worst-case | ||
| anticipated number of vent cycles. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Dimensional Verification | Modified SED Cartridges were weighed to confirm that | |
| the cartridge weight met the weight requirement. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Supplemental Verification | The only supplemental verification which required | |
| verification based on the modifications was size and | ||
| weight, which were measured for the modified SED | ||
| Cartridges. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Bond Joint Testing, SED | ||
| Cartridge | Modified SED Cartridge subassemblies were used to | |
| destructively pull the 3 new bond joints. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| SED System Performance Testing | ||
| Functionality and Pressure | ||
| Resistance Verification | The Modified SED System was tested to show that | |
| performance requirements were met for functionality, | ||
| response time, and pressure and leak resistance, with the | ||
| addition of fatigue cycling of the membrane assembly. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Verification of SED | ||
| System Initialization Cycle | Testing of the modified software initialization cycle for | |
| the modified SED System was performed. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Verification of SED | ||
| System Requirements | Testing was performed to verify the system-level | |
| performance of the SED System software modifications. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Verification of the Pressure | ||
| Measurement Range of the | ||
| SED System | The modified SED System was tested to the extremes of | |
| the pressure measurement range. | PASS - All acceptance criteria | |
| for the test method were met. | ||
| Software Testing | ||
| Software Verification and | ||
| Validation | Code verification and software verification and | |
| validation testing were performed on the modified | ||
| software. | PASS – modified SED System | |
| met all acceptance criteria for | ||
| verification 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.
7
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).