IRRAflow CNS System

K171880 · Irras, Inc. · JXG · Jul 13, 2018 · Neurology

Device Facts

• Record ID: K171880
• Device Name: IRRAflow CNS System
• Applicant: Irras, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jul 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The IRRAflow CNS System is an intracranial pressure (ICP) monitoring and drainage system consisting of a control unit, a sterile disposable tube set, and a catheter. The system is used in clinical settings to monitor ICP and drain cerebrospinal fluid (CSF) from the brain ventricles. CSF drainage is uni-directional and gravity-driven; the control unit features a peristaltic pump and pinch valve mechanism to automate drainage control based on user settings. The system includes integrated pressure transducers for real-time ICP measurement and display. A parallel saline infusion line allows for bolus injections to flush the catheter if clogging occurs. The control unit provides a user interface for settings, alarms, and data storage, and includes a battery backup. Healthcare providers use the system to manage intracranial pressure; the automated features and integrated monitoring aim to reduce the risk of faulty connections and provide broader pressure data compared to manual gravity-based systems.

Clinical Evidence

Bench testing only. Testing included biocompatibility (systemic toxicity, pyrogenicity, irritation, hemolysis, cytotoxicity, sensitization), system verification and validation, static software analysis, basic safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), catheter performance (tensile, torsion, shear, drainage flow), shelf life/package integrity, and sterilization validation (E-beam and Ethylene Oxide).

Technological Characteristics

System components: Control unit, sterile disposable tube set, and silicone catheter. Sensing: Integrated pressure transducers. Actuation: Stepper-motor controlled, tube-pinching mechanism. Connectivity: Standalone powered console. Sterilization: E-beam (catheter) and Ethylene Oxide (tube set). Pressure range: -80 mmHg to +100 mmHg.

Indications for Use

Indicated for patients requiring intracranial pressure (ICP) monitoring and external drainage of intracranial fluid to reduce ICP, where an external drainage and monitoring system is needed for ≤ 24 hours.

Regulatory Classification

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.

Predicate Devices

• Medtronic PS Medical External Drainage and Monitoring System (Becker EDMS) (K984053)
• VentriClear II Ventricular Drainage Catheter (K160223)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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 < 24 hours.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|--|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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## IARAS

## 510(k) Summary – K171880

| Submitter: | IRRAS USA, Inc. |
|------------------------------------|-------------------------------------------------------------------------------|
| Address: | 11975 El Camino Real, Suite 304<br>San Diego, CA 92130 |
| Phone Number: | 858-247-7033 |
| Fax number: | 866-575-1002 |
| FDA Registration #: | 3013508628 |
| Contact Personnel | |
| Primary: | Dessi Lyakov<br>Director, Regulatory Affairs and Quality Assurance |
| Phone Number: | 858-336-6236 |
| Fax Number: | 866-575-1002 |
| Email: | [e-mail] |
| Secondary: | Kleanthis G. Xanthopoulos, Ph.D.<br>President and CEO |
| Phone Number: | 858-336-8093 |
| Fax Number: | 866-575-1002 |
| Email: | [e-mail] |
| 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<br>(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.

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| Items | Predicate<br>Medtronic PS Medical External<br>Drainage and Monitoring System<br>(Becker EDMS) (K984053)<br>(JXG), (GWM) | IRRAflow CNS<br>System<br>(K171880)<br>(JXG), (GWM) | Equivalence |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Primary Product Code | JXG | JXG | Same |
| Primary Regulation<br>Number: | 21 CFR 882.5550 | 21 CFR 882.5550 | Same |
| Secondary Product Code | GWM | GWM | Same |
| Secondary Regulation<br>Number: | 21 CFR 882.1620 | 21 CFR 882.1620 | Same |
| Indications for Use | Draining and monitoring of CSF flow<br>from the lateral ventricles or lumbar<br>subarachnoid space is indicated in<br>selected patients to:<br>Reduce intracranial pressure (ICP),<br>e.g., pre, intra- or postoperative.<br>Monitor CSF chemistry, cytology, and<br>physiology.<br>Provide temporary CSF drainage in<br>patients with infected cerebrospinal<br>fluid shunts. Monitoring of intracranial<br>pressure (ICP) is indicated in selected<br>patients with:<br>Severe head injury<br>Subarachnoid hemorrhage graded III,<br>IV, or V preoperatively<br>Reye's syndrome or similar<br>encephalopathies<br>Hydrocephalus Intracranial<br>hemorrhage<br>Miscellaneous problems when drainage<br>is to be used as a therapeutic maneuver<br>Monitoring can also be used to evaluate<br>the status pre- and postoperatively for<br>space-occupying lesions. | The use of IRRAflow<br>CNS System is<br>indicated when<br>intracranial pressure<br>monitoring is required<br>and for externally<br>draining intracranial<br>fluid as a means of<br>reducing intracranial<br>pressure in patients<br>where an external<br>drainage and monitoring<br>system is needed for ≤<br>24 hours. | See discussion<br>below |
| Injection/ CSF Sampling<br>Ports | Yes | Yes | Same |
| Unidirectional<br>Flow of Drained Fluid | Yes | Yes | Same |
| Fluid Injection<br>Capability | Yes | Yes | Same |
| Items | Predicate<br>Medtronic PS Medical External<br>Drainage and Monitoring System<br>(Becker EDMS) (K984053)<br>(JXG), (GWM) | IRRAflow CNS<br>System<br>(K171880)<br>(JXG), (GWM) | Equivalence |
| Attaches to separate,<br>commercially available<br>EVD Catheter | Yes | Yes<br>The IRRAflow system<br>attaches to IRRAflow<br>Catheter which is an<br>EVD Catheter part of the<br>complete system. | Same<br>See discussion<br>below |
| Sterile Disposable tubing<br>set | Yes | Yes | Same |
| CSF Drainage Bag | Yes | Yes | Same |
| Gravity drainage of CSF | Yes | Yes | Same |
| Method to control gravity<br>drainage of CSF | Manual adjustment of the drip chamber<br>either up or down the IV Pole, relative<br>to the patient's head position and<br>ventricular catheter location. | Automated adjustment<br>based on user settings<br>via a stepper-motor<br>controlled, tube-pinching<br>mechanism to either<br>compress or release the<br>compliant drainage<br>tubing contained within<br>the sterile, disposable<br>Cartridge. | See discussion<br>below |
| Pressure Transducer for<br>ICP Measurement | Yes<br>(The Duet System includes a design<br>and instructions for attaching a<br>transducer that allows for ICP<br>measurement and visual display via a | Yes<br>(The IRRAflow system<br>integrates transducers<br>into its design for<br>measurement and visual | Same |
| | connected monitor.) | display of ICP) | |
| Software-based, Powered<br>Console for User<br>Interface, User Settings<br>and Alarm Adjustments,<br>Data Storage and<br>Display, and Alarms for<br>ICP Monitoring | No | Yes | See discussion<br>below |
| Method to account for<br>location of ventricles via<br>patient head position | Laser level must be attached to the<br>system and leveled and then the system<br>"zeroed"; adjustment thereafter may be<br>needed. | Reference marks on the<br>device to allow for the<br>system to be aligned<br>with patient's head<br>positioning. | Equivalent<br>See discussion<br>below |
| Measured Pressure<br>Range | 0 - 31 cm H2O (set ICP range) | -80 mmHg to +100<br>mmHg | See discussion<br>below |
| Displayed ICP | Yes<br>(via drip chamber pressure indicator<br>window or via connected transducer to<br>patient monitor display) | Yes | Equivalent |
| Battery Back-up | No (Manual, non-powered system) | Yes | See discussion<br>below |
| Medtronic PS Medical External Drainage | IRRAflow CNS system | Discussion: | |
| and Monitoring System (Becker EDMS)<br>(K984053) | (K171880) | | |
| Indications for Use: | | | |
| Draining and monitoring of CSF flow from<br>the lateral ventricles or lumbar subarachnoid<br>space is indicated in selected patients to:<br>• Reduce intracranial pressure (ICP), e.g.,<br>pre-, intra- or postoperative.<br>• Monitor CSF chemistry, cytology, and<br>physiology.<br>• Provide temporary CSF drainage in patients<br>with infected cerebrospinal fluid shunts.<br>Monitoring of intracranial pressure (ICP) is<br>indicated in selected patients with:<br>• Severe head injury<br>• Subarachnoid hemorrhage graded III, IV, or<br>V preoperatively<br>• Reyes syndrome or similar encephalopathies<br>• Hydrocephalus<br>• Intracranial hemorrhage<br>• Miscellaneous problems when drainage is to<br>be used as a therapeutic maneuver.<br>Monitoring can also be used to evaluate the<br>status pre- and postoperatively for space-<br>occupying lesions. | The use of IRRAflow CNS<br>System is indicated when<br>intracranial pressure<br>monitoring is required and for<br>externally draining intracranial<br>fluid as a means of reducing<br>intracranial pressure in patients<br>where an external drainage and<br>monitoring system is needed<br>for ≤ 24 hours. | The IRRAflow CNS system is<br>not suitable for lumbar drain.<br><br>The indications both include<br>monitoring of Intracranial<br>Pressure and drainage of<br>intracranial fluid as a means of<br>reducing intracranial pressure.<br><br>Equivalent Indications. | |

## Table 1 – Substantial Equivalence Comparison of the Monitoring Systems

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# IARAS

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## 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.

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#### 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

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| Items | Predicate Device<br>VentriClear II Ventricular<br>Drainage catheter<br>(K160223) | IRRAflow CNS System Catheter<br>(K171880) | Equivalence |
|---------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------|
| Target<br>Population | Any patient needing<br>removal of intracranial<br>fluids from the brain<br>ventricles | Any patient needing removal of<br>intracranial fluids from the brain<br>ventricles | Same |
| Anatomical Sites | Brain ventricles | Brain ventricles | Same |
| Implant<br>Procedure | Designed to be placed<br>through a prepared opening<br>through the skull and into the<br>brain ventricle | Designed to be placed through a<br>prepared opening through the skull<br>and into the brain ventricle | Same |
| Catheter Size | 9Fr | 9Fr | Same |
| Catheter Length | 330mm | 400mm | See discussion<br>below |
| Catheter<br>Sideports | Yes | Yes | Same |
| Catheter End-<br>hole | Closed | Closed | Same |
| Catheter<br>Depth Markers | Yes | Yes | Same |
| Catheter material | Silicone | Silicone | Same |
| Antimicrobial<br>Agents | Minocycline/Rifampin | None | See discussion<br>below |
| Catheter Tip | Radiopaque | Radiopaque | Same |
| Biocompatibility | Tissue contact tested per ISO<br>10993: Biological Evaluation<br>of Medical Devices | Tissue contact tested per ISO 10993:<br>Biological Evaluation of<br>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<br>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.

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#### 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,<br>Mediated Pyrogen | The purpose of the study is to determine if<br>a saline extract of the test article causes a<br>febrile response in rabbits. | PASS Clinical Observations: The test<br>article were determined to be non-<br>pyrogenic. |
| Acute Systemic<br>Toxicity, Injection Test | The purpose of the test was to screen test<br>article extracts for potential toxic effects as<br>a result of a single-dose systemic injection<br>in mice. | PASS Clinical Observations: None of<br>the animals on study were observed with<br>abnormal clinical signs indicative of<br>toxicity during the test period. |
| Irritation/Intracutaneous<br>Reactivity Test | The purpose of the test was to determine if<br>any chemicals that may leach or be<br>extracted from the test article were capable<br>of causing local irritation in the dermal<br>tissues of rabbits. | PASS Clinical Observations:<br>None of the animals on study showed<br>abnormal clinical signs during the<br>observation periods. |
| Indirect Hemolysis<br>(Extract) Test | The test is designed to determine the<br>hemolytic properties of a medical<br>device/material. | PASS Clinical Observations: All test<br>method acceptance criteria were met.…