(62 days)
Not Found
No
The device description focuses on electromechanical components, software for automated regulation based on sensors (drip counter, pressure sensors), and basic control mechanisms (stepper-motor pinching). There is no mention of AI, ML, or any learning or adaptive algorithms. The software testing described is standard verification and validation, not related to AI/ML model training or evaluation.
Yes
The device is used to reduce intracranial pressure (ICP) and provide temporary CSF drainage, both of which are therapeutic maneuvers.
Yes
The device is explicitly indicated to "Monitor CSF chemistry, cytology, and physiology" and "Monitoring of intracranial pressure (ICP) is indicated in selected patients", which are diagnostic functions.
No
The device description explicitly states the 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.
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 intracranial pressure. It mentions monitoring CSF chemistry, cytology, and physiology, but the primary function is the physical management and monitoring of CSF, not the in vitro analysis of biological samples to provide diagnostic information.
- Device Description: The description details an electromechanical system with a disposable cartridge that physically controls and measures CSF flow and pressure. It does not describe components or processes for analyzing biological samples outside the body for diagnostic purposes.
- Lack of IVD Characteristics: The description and testing summary do not mention any aspects typical of IVD devices, such as reagents, assays, sample preparation for analysis, or performance metrics related to diagnostic accuracy (like sensitivity, specificity, etc.).
The device is a therapeutic and monitoring system for managing CSF and ICP in vivo, not a device for performing diagnostic tests on biological samples in vitro.
N/A
Intended Use / Indications for Use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- · Reduce intracranial pressure (ICP), e.g., pre, intra- or postoperative.
- · Monitor CSF chemistry, cytology, and physiology.
- · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- · Severe head injury
- · Subarachnoid hemorrhage graded III, IV, or V preoperatively
- · Reye's syndrome or similar encephalopathies
- Hydrocephalus
- · 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
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles or lumbar subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Testing Summary:
-
SED Cartridge Performance Testing:
- Functional Testing of the SED Lumbar Cartridge: SED Lumbar Cartridges were tested as part of the SED System to show that requirements for functionality and the ability of the devices to accurately measure and control the lumbar drainage output were met.
- Results/Conclusions: PASS – All requirements verified.
-
SED System Performance Testing:
- Supplemental Verification of the Modified SED Cartridge, Console, and System: SED Lumbar Cartridges and an SED Console were evaluated to demonstrate that the devices met the supplemental requirements applicable to the modified device.
- Results/Conclusions: PASS – All supplemental system requirements verified.
- Long-Term (14-Day) Stability of Modified SED System: Modified SED Systems were tested under clinical-use simulation for a period of 14 continuous days (to match the longest expected use duration of the SED System for lumbar drainage).
- Results/Conclusions: PASS – Modified SED System met all requirements under clinical-use simulation.
- Verification of the Drainage Range of the Modified SED System: SED Lumbar Cartridges were tested on SED Consoles to test the extremes of the drainage setting range and drainage accuracy of the system.
- Results/Conclusions: PASS – Modified SED System functioned as intended and met all requirements.
-
Software Testing:
- Software Verification and Validation: Code verification and software verification and validation testing was performed.
- Results/Conclusions: PASS – Modified SED System met all acceptance criteria for software verification and validation.
-
Electrical Safety and Electromagnetic Compatibility Testing:
- Verify the Electromagnetic Compatibility (EMC) of the Modified SED System: Applicable EMC testing (including emissions and immunity) was completed on the modified SED System in accordance with the following standards: IEC 60601-1-2 Edition 3: 2007-03.
- Results/Conclusions: PASS – Modified SED System met all applicable EMC requirements.
Key Results:
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.
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
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/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.
1
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
2
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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3
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 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 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.
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.
5
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 Technological
Characteristic | Modified Aqueduct Critical
Care, Inc.
SED System | Primary Predicate Aqueduct
Critical Care, Inc. SED System
(NOTE: as presented in K161605
relative to original predicate Duet
System) | Original K161605 Predicate
Medtronic Duet External
Drainage and Monitoring System
(Secondary Predicate) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Smart External Drain (SED)
System | Smart External Drain (SED)
System | Medtronic DUET™ External
Drainage and Monitoring System |
| Intended Use | Same | Same | To attach to an implanted, external
drainage catheter to externally drain
cerebrospinal fluid (CSF) and
monitor both CSF drainage and
intracranial pressure (ICP). |
| Attaches to separate,
commercially available EVD
Catheter | 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 gravity
drainage of CSF | Same as predicate SED System
(in both Lumbar and Ventricular
Modes) | Automated adjustment based on
user settings via a stepper-motor
controlled, tube-pinching
mechanism to either compress or
release the compliant drainage
tubing contained within the sterile,
disposable SED Cartridge. | Manual adjustment of the drip
chamber either up or down the IV
Pole, relative to the patient's head
position and ventricular catheter
location. |
| Pressure Transducer for
ICP Measurement | Same as predicate SED System
(in Ventricular Mode) | Yes | Yes
(The Duet System includes a design
and instructions for attaching a
transducer that allows for ICP
measurement and visual display via
a connected monitor.) |
| Software-based, Powered
Console for User Interface,
User Settings and Alarm
Adjustments, Data Storage
and Display, and Alarms for
ICP Monitoring | Yes | Yes | No
(A transducer can be attached [see
above] and then used in
conjunction with an ICP Monitor to
provide a display and user interface
for ICP monitoring.) |
| Method to account for
location of ventricles via
patient head position | Same as predicate SED System
(in Ventricular Mode) | Reference shroud attached to
patient behind the ear (at the level
of the EAM (External Auditory
Meatus) to account for patient's
head positioning. | Laser level must be attached to the
system and leveled and then the
system "zeroed"; adjustment
thereafter 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 Drainage
Rate Range | 0 to 45 ml/hr | Not applicable | Controlled by manual adjustment
and measured by user over time. |
| Displayed ICP | Same as predicate SED System
(in Ventricular Mode) | Yes
(via SED Console display) | Yes
(via drip chamber pressure
indicator window or via connected
transducer to patient monitor
display) |
Table 1: Comparative Summary of the SED System and Predicate Devices
6
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 the | ||
| SED Lumbar Cartridge | SED Lumbar Cartridges were tested as part of | |
| the SED System to show that requirements for | ||
| functionality and the ability of the devices to | ||
| accurately measure and control the lumbar | ||
| drainage output were met. | PASS – All requirements verified. | |
| SED System Performance Testing | ||
| Supplemental | ||
| Verification of the | ||
| Modified SED Cartridge, | ||
| Console, and System | SED Lumbar Cartridges and an SED Console | |
| were evaluated to demonstrate that the devices | ||
| met the supplemental requirements applicable | ||
| to the modified device. | PASS – All supplemental system | |
| requirements verified. | ||
| Long-Term (14-Day) | ||
| Stability of Modified | ||
| SED System | Modified SED Systems were tested under | |
| clinical-use simulation for a period of 14 | ||
| continuous days (to match the longest expected | ||
| use duration of the SED System for lumbar | ||
| drainage). | PASS – Modified SED System met all | |
| requirements under clinical-use | ||
| simulation. | ||
| Verification of the | ||
| Drainage Range of the | ||
| Modified SED System | SED Lumbar Cartridges were tested on SED | |
| Consoles to test the extremes of the drainage | ||
| setting range and drainage accuracy of the | ||
| system | PASS – Modified SED System | |
| functioned as intended and met all | ||
| requirements. | ||
| Software Testing | ||
| Software Verification | ||
| and Validation | Code verification and software verification and | |
| validation testing was performed. | PASS – Modified SED System met all | |
| acceptance criteria for software | ||
| verification and validation | ||
| Electrical Safety and Electromagnetic Compatibility Testing | ||
| Verify the | ||
| Electromagnetic | ||
| Compatibility (EMC) of | ||
| the Modified SED | ||
| System | Applicable EMC testing (including emissions | |
| and immunity) was completed on the modified | ||
| SED System in accordance with the following | ||
| standards. | ||
| • IEC 60601-1-2 Edition 3: 2007-03 | PASS – Modified SED System met all | |
| applicable 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.
7
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.