(385 days)
Not Found
No
The description focuses on mechanical and gravity-driven fluid management with a peristaltic pump and pinch valve, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is indicated for "reducing intracranial pressure" by "externally draining intracranial fluid," which are therapeutic actions.
No
The device is primarily an intracranial pressure (ICP) monitoring and fluid drainage system. While it monitors ICP, its main function is therapeutic (reducing pressure by draining fluid) rather than diagnostic (identifying a disease or condition).
No
The device description explicitly states that the system consists of a Control Unit and sterile disposable parts (Tube Set and Catheter), which are hardware components. The performance studies also include testing on these physical components (Biocompatibility, Bench and Electrical, Shelf Life, Sterilization).
Based on the provided information, the IRRAflow CNS System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intracranial pressure monitoring and external drainage of intracranial fluid in patients. This is a direct interaction with the patient's body for therapeutic and monitoring purposes.
- Device Description: The device description details a system that is inserted into the brain ventricles to drain fluid and measure pressure. This is an invasive procedure performed on the patient.
- Lack of In Vitro Activity: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The IRRAflow CNS System does not perform any analysis on specimens outside the body. While samples can be taken from the aspiration port, the device itself is not performing the diagnostic test on those samples.
The IRRAflow CNS System is a medical device used for monitoring and therapeutic intervention directly on the patient.
N/A
Intended Use / Indications for Use
The use of IRRAflow CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where and monitoring system is needed for
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
July 13, 2018
IRRAS Inc. Dessi Lvakov Director, Regulatory Affairs and Quality Assurance 7452 Herschel Avenue La Jolla, California 92037
Re: K171880
Trade/Device Name: IRRAflow CNS 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: June 11, 2018 Received: June 13, 2018
Dear Dessi Lyakov:
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
1
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.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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.
Image /page/1/Picture/6 description: The image contains the name "Xiaolin Zheng" in a large, bold font at the top. Below the name, there is a faint, transparent FDA logo. Underneath the logo, the letters "-SIT" are written in a smaller font size.
Carlos L. Peña, PhD, MS for 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) K171880
Device Name IRRAflow CNS System
Indications for Use (Describe)
The use of IRRAflow CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where and monitoring system is needed for Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
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IARAS
510(k) Summary – K171880
| Submitter: | IRRAS USA, Inc. |
|---|---|
| Address: | 11975 El Camino Real, Suite 304 |
| San Diego, CA 92130 | |
| Phone Number: | 858-247-7033 |
| Fax number: | 866-575-1002 |
| FDA Registration #: | 3013508628 |
| Contact Personnel | |
| Primary: | Dessi Lyakov |
| Director, Regulatory Affairs and Quality Assurance | |
| Phone Number: | 858-336-6236 |
| Fax Number: | 866-575-1002 |
| Email: | Dessi.lyakov@irras.com |
| Secondary: | Kleanthis G. Xanthopoulos, Ph.D. |
| President and CEO | |
| Phone Number: | 858-336-8093 |
| Fax Number: | 866-575-1002 |
| Email: | Kleanthis.xanthopoulos@irras.com |
| Date prepared: | July 11, 2018 |
| Trade name: | IRRAflow® CNS System |
| Common Name: | CSF Drainage System with ventricular catheter |
| Primary Classification: | |
| Name: | Central Nervous System Fluid Shunt and Components |
| Product Code: | JXG |
| Regulation: | 21 CFR 882.5550 |
| Secondary Classification: | |
| Name: | Intracranial Pressure Monitoring Device |
| Product Code: | GWM |
| Regulation: | 21 CFR 882.1620 |
| Predicate and Reference Device(s): | |
| K984053 | Medtronic PS Medical External Drainage and Monitoring System |
| (Becker EDMS) | |
| K160223 | VentriClear II Ventricular Drainage Catheter |
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DEVICE DESCRIPTION
The IRRAflow® CNS System is an intracranial pressure (ICP) monitoring and drainage system. The IRRAflow CNS System consists of an IRRAflow Control Unit and two sterile disposable parts, the IRRAflow Tube Set and the IRRAflow Catheter.
The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. An aspiration bag is attached to the Control Unit tape measure, defining the height of the bag relative to the catheter's tip position in the patient's head and thus controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit.
The default mode provides drainage and measuring ICP, allowing single bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the aspiration port.
INDICATIONS FOR USE
The use of IRRAflow CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed for ≤ 24 hours.
SUBSTANTIAL EQUIVALENCE
The IRRAflow CNS system's intended use, technological characteristics and principles of operation are similar to the Medical External Drainage and Monitoring System (Becker EDMS) (K984053).
Comparison of these Monitoring Systems is provided in table 1 below.
5
| Items | Predicate
Medtronic PS Medical External
Drainage and Monitoring System
(Becker EDMS) (K984053)
(JXG), (GWM) | IRRAflow CNS
System
(K171880)
(JXG), (GWM) | Equivalence |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Primary Product Code | JXG | JXG | Same |
| Primary Regulation
Number: | 21 CFR 882.5550 | 21 CFR 882.5550 | Same |
| Secondary Product Code | GWM | GWM | Same |
| Secondary Regulation
Number: | 21 CFR 882.1620 | 21 CFR 882.1620 | Same |
| 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. | The use of IRRAflow
CNS System is
indicated when
intracranial pressure
monitoring is required
and for externally
draining intracranial
fluid as a means of
reducing intracranial
pressure in patients
where an external
drainage and monitoring
system is needed for ≤
24 hours. | See discussion
below |
| Injection/ CSF Sampling
Ports | Yes | Yes | Same |
| Unidirectional
Flow of Drained Fluid | Yes | Yes | Same |
| Fluid Injection
Capability | Yes | Yes | Same |
| Items | Predicate
Medtronic PS Medical External
Drainage and Monitoring System
(Becker EDMS) (K984053)
(JXG), (GWM) | IRRAflow CNS
System
(K171880)
(JXG), (GWM) | Equivalence |
| Attaches to separate,
commercially available
EVD Catheter | Yes | Yes
The IRRAflow system
attaches to IRRAflow
Catheter which is an
EVD Catheter part of the
complete system. | Same
See discussion
below |
| Sterile Disposable tubing
set | Yes | Yes | Same |
| CSF Drainage Bag | Yes | Yes | Same |
| Gravity drainage of CSF | Yes | Yes | Same |
| Method to control gravity
drainage of CSF | Manual adjustment of the drip chamber
either up or down the IV Pole, relative
to the patient's head position and
ventricular catheter location. | 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
Cartridge. | See discussion
below |
| Pressure Transducer for
ICP Measurement | Yes
(The Duet System includes a design
and instructions for attaching a
transducer that allows for ICP
measurement and visual display via a | Yes
(The IRRAflow system
integrates transducers
into its design for
measurement and visual | Same |
| | connected monitor.) | display of ICP) | |
| Software-based, Powered
Console for User
Interface, User Settings
and Alarm Adjustments,
Data Storage and
Display, and Alarms for
ICP Monitoring | No | Yes | See discussion
below |
| Method to account for
location of ventricles via
patient head position | Laser level must be attached to the
system and leveled and then the system
"zeroed"; adjustment thereafter may be
needed. | Reference marks on the
device to allow for the
system to be aligned
with patient's head
positioning. | Equivalent
See discussion
below |
| Measured Pressure
Range | 0 - 31 cm H2O (set ICP range) | -80 mmHg to +100
mmHg | See discussion
below |
| Displayed ICP | Yes
(via drip chamber pressure indicator
window or via connected transducer to
patient monitor display) | Yes | Equivalent |
| Battery Back-up | No (Manual, non-powered system) | Yes | See discussion
below |
| Medtronic PS Medical External Drainage | IRRAflow CNS system | Discussion: | |
| and Monitoring System (Becker EDMS)
(K984053) | (K171880) | | |
| 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
• Reyes 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 use of IRRAflow CNS
System is indicated when
intracranial pressure
monitoring is required and for
externally draining intracranial
fluid as a means of reducing
intracranial pressure in patients
where an external drainage and
monitoring system is needed
for ≤ 24 hours. | The IRRAflow CNS system is
not suitable for lumbar drain.
The indications both include
monitoring of Intracranial
Pressure and drainage of
intracranial fluid as a means of
reducing intracranial pressure.
Equivalent Indications. | |
Table 1 – Substantial Equivalence Comparison of the Monitoring Systems
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IARAS
7
Discussion of differences in Table 1
IFU:
EVD Catheter:
Both systems attach to a separate commercially available EVD catheter. The IRRAflow CNS system user manual instructs the users to only use approved IRRAflow catheters, which are provided by IRRAS Inc.
This does not impact the functionality or intended use of the system as compared to its predicates.
Method to control gravity drainage of CSF:
The IRRAflow CNS System has built in functionality to control the drainage of CSF which is different than the predicate, which relies on manual methods. This minor difference does not impact the functionality or intended use of the system when compared to its predicate.
Software-based. Powered Console:
For the predicate, a transducer can be attached that allows for ICP measurement and visual display via a connected monitor to provide a display and user interface for ICP monitoring.
The IRRAflow CNS System has this functionality built into the central unit reducing the risk of faulty connections impacting the readings. This minor difference does not impact the functionality or intended use of the system as compared to its predicate.
8
Method to account for location of ventricles via patient head position:
Both systems have methods to account for the location of the ventricles via the patient head position. The predicate uses a laser to align with the patient. The IRRAflow CNS System uses zero-line markings on the unit itself to align with the patient's head position.
This minor difference does not impact the functionality or intended use of the system as compared to its predicate.
Measured Pressure Range:
The predicate range of 0 to 31 cm H20 translates to 0 to 22.8 mmHg. The wider range of the IRRAflow CNS System (-80 to 100 mmHz) does not impact the functionality or intended use of the system as compared to its predicate. The purpose of the larger ICP range is to provide the physician a broader breadth of data and information during treatment.
Any differences between the IRRAflow CNS System and the predicate systems do not alter the substantial equivalence or intended use of the IRRAflow CNS System. The substantial equivalence of the IRRAflow CNS System as compared to the predicate devices has been demonstrated via bench testing.
Battery Back-up:
The IRRAflow CNS System is designed with a battery backup which is an improvement over the predicate device. This minor difference does not impact the functionality or intended use of the system as compared to its predicate.
Any differences between the IRRAflow CNS System and the predicate systems do not alter the substantial equivalence or intended use of the IRRAflow CNS System. The substantial equivalence of the IRRAflow CNS System as compared to the predicate device has been demonstrated via bench testing.
SUBSTANTIAL EQUIVALENCE
The IRRAflow CNS System's Catheter technological characteristics and principles of operation are similar to the VentriClear II Ventricular Drainage catheter (K160223).
Comparison of these Catheters is provided in table 2 below
9
| Items | Predicate Device
VentriClear II Ventricular
Drainage catheter
(K160223) | IRRAflow CNS System Catheter
(K171880) | Equivalence |
|---------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------|
| Target
Population | Any patient needing
removal of intracranial
fluids from the brain
ventricles | Any patient needing removal of
intracranial fluids from the brain
ventricles | Same |
| Anatomical Sites | Brain ventricles | Brain ventricles | Same |
| Implant
Procedure | Designed to be placed
through a prepared opening
through the skull and into the
brain ventricle | Designed to be placed through a
prepared opening through the skull
and into the brain ventricle | Same |
| Catheter Size | 9Fr | 9Fr | Same |
| Catheter Length | 330mm | 400mm | See discussion
below |
| Catheter
Sideports | Yes | Yes | Same |
| Catheter End-
hole | Closed | Closed | Same |
| Catheter
Depth Markers | Yes | Yes | Same |
| Catheter material | Silicone | Silicone | Same |
| Antimicrobial
Agents | Minocycline/Rifampin | None | See discussion
below |
| Catheter Tip | Radiopaque | Radiopaque | Same |
| Biocompatibility | Tissue contact tested per ISO
10993: Biological Evaluation
of Medical Devices | Tissue contact tested per ISO 10993:
Biological Evaluation of
Medical Devices | Similar |
| Cytotoxicity | Acceptable | Acceptable | Same |
| Provided Sterile | Yes | Yes | Same |
| Packaging | Tyvek/polyester pouch | Tyvek/polyester pouch | Same |
| Shelf Life | 2 years | 18 months | See discussion
below |
Table 2 - Substantial Equivalence Comparison - Catheters
Discussion of differences in Table 2
Catheter Working Length:
The working length of the VentriClear II Catheter is 330mm; the IRRAflow Catheter working length is 400 cm.
The difference in catheter working length is not significant and does not impact the functionality or intended use of the system as compared to its predicates. The working lengths of both the VentriClear II Catheter reference device and the IRRAflow Catheter are within the range of working lengths of ventricular drainage catheters.
This does not impact the functionality or intended use of the system as compared to its predicates.
10
Antimicrobial Agents:
The VentriClear II Catheter material includes antimicrobial agents (minocycline and rifampin). The IRRAflow Catheter material does not include any antimicrobial agents. The absence of antimicrobial agents in the IRRAflow Catheter does not impact the functionality or intended use of the Catheter.
This does not impact the functionality or intended use of the system as compared to its predicates.
Shelf Life:
The VentriClear II Catheter has a shelf life of 2 years, whereas the IRRAflow Catheter currently has a listed shelf life of 18 months. The current difference in catheter shelf life is not significant and does not impact the functionality or intended use of the system as compared to its predicates.
Verification and Validation Documentation:
The IRRAflow CNS System tests include verification and validation performance testing as well as externals standards testing to demonstrate no new safety and effectiveness issues are raised with this new device. Analyses demonstrate that system accuracy and performance are adequate for the established intended use. In conclusion, the IRRAflow CNS System is substantially equivalent to the predicate device.
Table 3 below, identifies the testing conducted on the IRRAflow CNS System to demonstrate substantial equivalence.
Table 3 - IRRAflow CNS System Testing
| Test | Test Method Summary | Results |
|---|---|---|
| Biocompatibility Testing | ||
| Systemic Toxicity, | ||
| Mediated Pyrogen | The purpose of the study is to determine if | |
| a saline extract of the test article causes a | ||
| febrile response in rabbits. | PASS Clinical Observations: The test | |
| article were determined to be non- | ||
| pyrogenic. | ||
| Acute Systemic | ||
| Toxicity, Injection Test | The purpose of the test was to screen test | |
| article extracts for potential toxic effects as | ||
| a result of a single-dose systemic injection | ||
| in mice. | PASS Clinical Observations: None of | |
| the animals on study were observed with | ||
| abnormal clinical signs indicative of | ||
| toxicity during the test period. | ||
| Irritation/Intracutaneous | ||
| Reactivity Test | The purpose of the test was to determine if | |
| any chemicals that may leach or be | ||
| extracted from the test article were capable | ||
| of causing local irritation in the dermal | ||
| tissues of rabbits. | PASS Clinical Observations: | |
| None of the animals on study showed | ||
| abnormal clinical signs during the | ||
| observation periods. | ||
| Indirect Hemolysis | ||
| (Extract) Test | The test is designed to determine the | |
| hemolytic properties of a medical | ||
| device/material. | PASS Clinical Observations: All test | |
| method acceptance criteria were met. | ||
| Test | Test Method Summary | Results |
| Cytotoxicity (MEM | ||
| Elution) Test | The Minimal Essential Media (MEM) | |
| Elution test was designed to determine the | ||
| cytotoxicity of extractable substances. | PASS Clinical Observations: All test | |
| method acceptance criteria were met. | ||
| Sensitization Test | This test was designed to evaluate the | |
| allergenic potential or sensitizing capacity | ||
| of a test article. | PASS Clinical Observations: None of | |
| the animals in the study showed | ||
| abnormal clinical signs. | ||
| Bench and Electrical Testing | ||
| IRRAflow CNS System | ||
| Verification | The purpose of this test is to document the | |
| results of the system verification testing | ||
| and system regression verification testing. | PASS The system has been shown to | |
| comply with the documented | ||
| requirements for the system. | ||
| IRRAflow CNS System | ||
| Validation | The validation test procedures for the | |
| IRRAS IRRAflow CNS system were | ||
| designed to ensure that the device | ||
| complies with established requirements. | PASS The system has been shown to | |
| comply with the documented | ||
| requirements for the system. | ||
| IRRAflow CNS System | ||
| Static Analysis | The purpose of this test is to describe the | |
| process and results from the static analysis | ||
| of the IRRAflow CNS system software. | PASS There were no errors encountered | |
| when the static analysis was conducted. | ||
| Basic Safety test | The following tests were conducted: Input | |
| Test; Heating Test; Leakage Current Test; | ||
| Dielectric Voltage Test. | PASS Acceptance criteria has been met. | |
| Electromagnetic | ||
| Compatibility test | The objective of the testing is to determine | |
| compliance with IEC 60601-1-2:2014 | ||
| Class B. | PASS Acceptance criteria has been met. | |
| IRRAflow Catheter | ||
| Performance Test | The purpose of this test is to describe the | |
| tensile test results for the IRRAS catheter. | PASS Acceptance criteria has been met. | |
| IRRAflow Catheter | ||
| Torsion and Shear Test | The purpose of this test is to describe the | |
| torsion and shear testing results for the | ||
| IRRAS catheter. | PASS Acceptance criteria has been met. | |
| IRRAflow Catheter | ||
| Drainage Flow Test | The purpose of this test is to describe the | |
| drainage testing methods for the IRRAS | ||
| catheter. | PASS Acceptance criteria has been met. | |
| Test | Test Method Summary | Results |
| Shelf Life / Package Integrity Testing | ||
| Validation of sterile | ||
| barrier | The purpose of this test is to describe the | |
| procedures for validating that the sterile | ||
| barrier meets design and standards | ||
| requirements. | PASS Acceptance criteria has been met. | |
| Packaging Peel Test | The purpose of this test is to describe the | |
| roll packing seal testing results for the | ||
| IRRAS catheter and tube set. | PASS Acceptance criteria has been met. | |
| Aging Test | The purpose of this test is to describe the | |
| objective evidence that the IRRAS catheter | ||
| and tube set meet the appropriate | ||
| requirements for transportation and aging. | PASS Acceptance criteria has been met. | |
| Sterilization Testing | ||
| Sterilization process for | ||
| the IRRAflow Catheter | ||
| and IRRAflow Tube | ||
| Set | This study was conducted to validate the | |
| effectiveness of electron beam radiation of | ||
| IRRAflow Catheter and Ethylene Oxide | ||
| sterilization of IRRAflow Tube Set. | PASS Acceptance criteria has been met. |
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IARAS
12
Substantially equivalent summary:
Performance data demonstrate that the IRRAflow CNS System is substantially equivalent to the predicate devices.
Conclusion:
The IRRAflow CNS System is substantially equivalent to the predicate, the Medtronic PS Medical External Drainage and Monitoring System (Becker EDMS) (K984053) and the VentriClear II Ventricular Catheter (K160223). The IRRAflow CNS System has the same indications for use, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the IRRAflow CNS System and the predicate devices raise no new issues of safety or effectiveness.