(139 days)
Not Found
No
The device description focuses on automated regulation using pressure sensors and a stepper-motor mechanism, which is a form of automated control, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML.
Yes.
The device's intended use includes reducing intracranial pressure and providing temporary CSF drainage, both of which are therapeutic maneuvers aimed at treating a patient's condition.
Yes
The device monitors CSF chemistry, cytology, physiology, and intracranial pressure (ICP), all of which are diagnostic functions. It also displays the measured ICP information and calculates and displays CSF flow volume output.
No
The device description explicitly states that the SED System consists of an "electromechanical software embedded SED Console" and a "sterile, disposable SED Cartridge," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SED System's primary function is to drain and monitor cerebrospinal fluid (CSF) flow and pressure directly from the lateral ventricles within the patient's body. It is a therapeutic and monitoring device that interacts directly with the patient's internal environment.
- Intended Use: The intended uses listed are related to managing intracranial pressure, providing temporary drainage, and monitoring CSF chemistry, cytology, and physiology in situ (within the body). While it monitors CSF chemistry and cytology, it does so by collecting the fluid, not by performing diagnostic tests on a sample outside the body.
- Device Description: The description details a system with pressure sensors, a stepper-motor mechanism, and a drainage bag. These components are designed for direct interaction with the patient's CSF system for drainage and pressure regulation.
- Lack of Diagnostic Testing: There is no mention of the device performing any diagnostic tests on the collected CSF sample itself. The monitoring of chemistry and cytology is likely done by collecting the fluid for later analysis using separate IVD devices or laboratory procedures.
In summary, the SED System is a medical device used for the management and monitoring of CSF within the patient's body, not for performing diagnostic tests on samples in vitro.
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 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.
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)
The testing activities summarized in Table 2 demonstrated that the technological and performance characteristics of the subject SED System are comparable to the predicate external drainage management system and that 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.
SED Console Performance Testing
- SED Console Verification: Simulated use test cases completed with all requirements tested to verify SED Console performance.
- Results: PASS – All requirements verified.
SED Cartridge Performance Testing
- Results: PASS – All requirements verified.
- SED Cartridge Pinch Tubing Force and Fatigue: SED Cartridges were tested to show that the pinch tubing met requirements, including resistance to pinch tubing fatigue and shut off / pinch force.
- Results: PASS - All requirements verified.
- SED Cartridge Button Verification: SED Cartridges were tested to show that the manual pinch button on the cartridge met the following requirements: activation force, leak resistance, and fatigue life.
- Results: PASS – All requirements verified.
- MRI Compatibility: The SED Cartridge was tested in an MRI environment of 1.5-Tesla and 3.0-Tesla.
- Results: PASS – All requirements verified.
- Tubing Kink and Crush Verification: SED Cartridges were tested in a bend radius to assess kink resistance. For crush resistance, fluid flow exhibited no change when a force was applied to the tubing compared to no force applied.
- Results: PASS – All requirements verified.
- Dimensional Verification: SED Cartridges were dimensionally measured.
- Results: PASS - Measurements confirmed that all dimensional requirements were met.
- Drainage Bag Verification: SED Cartridges were tested to show that drainage bags met requirements for: capacity, venting, and wetting.
- Results: PASS – All requirements verified.
- Bond Joint Testing: SED Cartridges were used to destructively pull test the bond joint configurations.
- Results: PASS - All bond joints met or exceeded the minimum pull strength specification.
SED System Performance Testing
- Results: PASS - All bond joints met or exceeded the minimum pull strength specification.
- SED System Mechanical Verification: The SED System was tested to ensure that all applicable mechanical requirements were met.
- Results: PASS - The SED Console was shown to function properly following the maximum anticipated number of latching and unlatching cycles.
- Verification of SED System Environmental Conditions: The SED System was subjected to the extremes of the specified environmental conditions (including temperature, humidity, and altitude) to confirm intended system functionality post-conditioning.
- Results: PASS - SED System functioned as intended post-conditioning.
- Long-Term Stability of SED System: SED Systems were tested under clinical-use simulation for the longest expected use duration of the SED System.
- Results: PASS - SED System met all requirements under clinical-use simulation.
- Verification of the Pressure Measurement Range and Response Time of the SED System: The SED System was tested to the extremes of the pressure measurement range, as well as to measure the response time of the system.
- Results: PASS - All applicable requirements verified.
Packaging Validation Testing
- Results: PASS - All applicable requirements verified.
- Packaging Validation Testing: The packaging configurations for the reusable SED Console and sterile SED Cartridge and Drain Bag were subjected to applicable distribution simulation per ASTM D4169, followed by testing. The SED Console was tested to ensure it maintained proper function via simulated clinical-use. The sterile SED Cartridge and Drain Bag packaging was subjected to seal strength, dye leak testing, and visual inspection, while the SED Cartridge and Drain Bag were subjected to functional testing to confirm proper device function.
- Results: PASS - Package integrity and product functionality met all applicable requirements.
Sterilization Validation Testing
- Results: PASS - Package integrity and product functionality met all applicable requirements.
- Sterilization Validation: Sterilization validation testing was completed to validate that the gamma radiation (min 25 kGy) sterilization process provides a Sterility Assurance Level (SAL) of 10-6, using the following applicable standards and sterilization 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.
- Results: PASS – The gamma radiation sterilization process provides an SAL of 10-6.
Shelf-Life Testing
- Results: PASS – The gamma radiation sterilization process provides an SAL of 10-6.
- Shelf-Life Testing: Accelerated age testing was completed on the SED Cartridge and SED Drain bag components and their respective packaging to support a 6-month shelf life.
- Results: PASS - All packaging and functional requirements were met following 6 months of accelerated aging.
Biocompatibility Testing
- Results: PASS - All packaging and functional requirements were met following 6 months of accelerated aging.
- Biocompatibility Testing: Biocompatibility testing completed on all direct (skin) and indirect (potential limited and brief periods of retrograde drainage fluid flow) contact portions of the SED System. This included cytotoxicity, sensitization, intracutaneous reactivity, LAL pyrogenicity and acute systemic toxicity.
- Results: PASS - SED System met all applicable biocompatibility requirements for its intended use.
Software Testing
- Results: PASS - SED System met all applicable biocompatibility requirements for its intended use.
- Software Verification and Validation: Code verification and software verification and validation testing was performed.
- Results: PASS - SED System met all acceptance criteria for verification and validation.
Electrical Safety and Electromagnetic Compatibility Testing
- Results: PASS - SED System met all acceptance criteria for verification and validation.
- Verify the Electrical Safety and Electromagnetic Compatibility (EMC) of the SED System: Applicable electrical safety and EMC testing (including emissions and immunity) was completed on the SED System in accordance with the following standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, 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.
- Results: PASS - SED System met all applicable electrical safety and EMC requirements.
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/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 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 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 Technological
Characteristic | Subject Aqueduct Critical Care, Inc.
SED System | Predicate Medtronic Duet External
Drainage and Monitoring System |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Smart External Drain (SED) System | Medtronic DUETTM External Drainage and
Monitoring 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 | Yes | Yes |
| Sterile Disposable tubing set | Yes | Yes |
| CSF Drainage Bag | Yes | Yes |
| Gravity drainage of CSF | Yes | Yes |
| Method to control gravity
drainage of CSF | 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. | 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 | 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.) | Yes
(The Duet System includes both a design
and instructions for attachment of a
transducer to the main system stopcock that
then allows for measurement and visual
display of ICP via a connected monitor.) |
| Software-based, Powered
Console for User Interface, User
ICP and Alarm Setting
Adjustments, Data Storage and
Display, and Alarms for ICP
Monitoring | Yes | No
(Note, however, that 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 | Reference shroud attached to patient behind
the ear (at the level of the EMA) to account
for patient's head positioning. | Laser level must be attached to the system
and leveled appropriately and then the
system "zeroed"; adjustment thereafter may
be 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 indicator
window or via connected transducer to
patient 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 Console | ||
| Verification | Simulated use test cases completed with all requirements | |
| tested to verify SED Console performance. | PASS – All requirements verified. | |
| SED Cartridge Performance Testing | ||
| SED Cartridge Pinch | ||
| Tubing Force and | ||
| Fatigue | SED Cartridges were tested to show that the pinch | |
| tubing met requirements, including resistance to pinch | ||
| tubing fatigue and shut off / pinch force. | PASS - All requirements verified. | |
| SED Cartridge Button | ||
| Verification | SED Cartridges were tested to show that the manual | |
| pinch button on the cartridge met the following | ||
| requirements: activation force, leak resistance, and | ||
| fatigue life. | PASS – All requirements verified. | |
| MRI Compatibility | The SED Cartridge was tested in an MRI environment of | |
| 1.5-Tesla and 3.0-Tesla. | PASS – All requirements verified. | |
| Tubing Kink and Crush | ||
| Verification | SED Cartridges were tested in a bend radius to assess | |
| kink resistance. For crush resistance, fluid flow | ||
| exhibited no change when a force was applied to the | ||
| tubing compared to no force applied. | PASS – All requirements verified. | |
| Dimensional | ||
| Verification | SED Cartridges were dimensionally measured. | PASS - Measurements confirmed that all dimensional requirements were |
| met. | ||
| Drainage Bag | ||
| Verification | SED Cartridges were tested to show that drainage bags | |
| met requirements for: capacity, venting, and wetting. | PASS – All requirements verified. | |
| Bond Joint Testing | SED Cartridges were used to destructively pull test the | |
| bond joint configurations. | PASS - All bond joints met or exceeded the minimum pull strength | |
| specification. | ||
| SED System Performance Testing | ||
| SED System | ||
| Mechanical | ||
| Verification | The SED System was tested to ensure that all applicable | |
| mechanical requirements were met. | PASS - The SED Console was shown to function properly following the | |
| maximum anticipated number of latching and unlatching cycles. | ||
| Verification of SED | ||
| System Environmental | ||
| Conditions | The SED System was subjected to the extremes of the | |
| specified environmental conditions (including | ||
| temperature, humidity, and altitude) to confirm intended | ||
| system functionality post-conditioning. | PASS - SED System functioned as intended post-conditioning. | |
| Long-Term Stability of | ||
| SED System | SED Systems were tested under clinical-use simulation | |
| for the longest expected use duration of the SED | ||
| System | PASS - SED System met all requirements under clinical-use simulation. | |
| Testing | Testing Summary | Results/Conclusions |
| Verification of the | ||
| Pressure Measurement | ||
| Range and Response | ||
| Time of the SED | ||
| System | The SED System was tested to the extremes of the | |
| pressure measurement range, as well as to measure the | ||
| response time of the system. | PASS - All applicable requirements verified. | |
| Packaging Validation Testing | ||
| Packaging Validation | ||
| Testing | The packaging configurations for the reusable SED | |
| Console and sterile SED Cartridge and Drain Bag were | ||
| subjected to applicable distribution simulation per | ||
| ASTM D4169, followed by testing: |
The SED Console was tested to ensure it maintained
proper function via simulated clinical-use.
The sterile SED Cartridge and Drain Bag packaging was
subjected to seal strength, dye leak testing, and visual
inspection, while the SED Cartridge and Drain Bag were
subjected to functional testing to confirm proper device
function. | PASS - Package integrity and product functionality met all applicable
requirements. |
| Sterilization Validation Testing | | |
| Sterilization Validation | Sterilization validation testing was completed to validate
that the gamma radiation (min 25 kGy) sterilization
process provides a Sterility Assurance Level (SAL) of
10-6, using the following applicable standards and
sterilization 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 of
10-6. |
| Shelf-Life Testing | | |
| Shelf-Life Testing | Accelerated age testing was completed on the SED
Cartridge and SED Drain bag components and their
respective packaging to support a 6-month shelf life. | PASS - All packaging and functional requirements were met following 6
months of accelerated aging. |
| Testing | Testing Summary | Results/Conclusions |
| Biocompatibility Testing | | |
| Biocompatibility
Testing | Biocompatibility testing completed on all direct (skin) and indirect (potential limited and brief periods of
retrograde drainage fluid flow) contact portions of the
SED System. This included cytotoxicity, sensitization,
intracutaneous reactivity, LAL pyrogenicity and acute
systemic toxicity. | PASS - SED System met all applicable biocompatibility requirements for
its intended use. |
| Software Testing | | |
| Software Verification
and Validation | Code verification and software verification and
validation testing was performed. | PASS - SED System met all acceptance criteria for verification and
validation |
| Electrical Safety and Electromagnetic Compatibility Testing | | |
| Verify the Electrical
Safety and
Electromagnetic
Compatibility (EMC)
of the SED System | Applicable electrical safety and EMC testing (including
emissions and immunity) was completed on the SED
System in accordance with the following standards.
• AAMI / ANSI ES60601-1:2005/(R)2012 and
A1:2012, 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 EMC
requirements. |
Table 2: Summary Table for SED System Testing
8
9