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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: IRRAflow CNS System

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets. Instead, it details various tests performed and reports the outcome as "PASS" if the acceptance criteria for that specific test were met. The acceptance criteria for each test were implied to be compliance with documented requirements or relevant standards (e.g., ISO 10993, IEC 60601-1-2:2014).

Test Category	Specific Test / Requirement	Test Method Summary	Reported Device Performance
Biocompatibility Testing	Systemic Toxicity, Mediated Pyrogen	Determine if a saline extract causes a febrile response in rabbits.	PASS (Non-pyrogenic)
	Acute Systemic Toxicity, Injection	Screen test article extracts for potential toxic effects from a single-dose systemic injection in mice.	PASS (No abnormal clinical signs indicative of toxicity)
	Irritation/Intracutaneous Reactivity	Determine if chemicals that may leach or be extracted cause local irritation in dermal tissues of rabbits.	PASS (No abnormal clinical signs)
	Indirect Hemolysis (Extract)	Determine the hemolytic properties of a medical device/material.	PASS (All acceptance criteria met)
	Cytotoxicity (MEM Elution)	Determine the cytotoxicity of extractable substances.	PASS (All acceptance criteria met)
	Sensitization	Evaluate the allergenic potential or sensitizing capacity.	PASS (No abnormal clinical signs)
Bench and Electrical Testing	IRRAflow CNS System Verification	Document results of system verification and system regression verification testing.	PASS (Complied with documented requirements)
	IRRAflow CNS System Validation	Ensure the device complies with established requirements through validation test procedures.	PASS (Complied with documented requirements)
	IRRAflow CNS System Static Analysis	Describe the process and results from the static analysis of the IRRAflow CNS system software.	PASS (No errors encountered)
	Basic Safety test	Input Test; Heating Test; Leakage Current Test; Dielectric Voltage Test.	PASS (Acceptance criteria met)
	Electromagnetic Compatibility test	Determine compliance with IEC 60601-1-2:2014 Class B.	PASS (Acceptance criteria met)
	IRRAflow Catheter Performance Test	Describe the tensile test results for the IRRAS catheter.	PASS (Acceptance criteria met)
	IRRAflow Catheter Torsion and Shear	Describe the torsion and shear testing results for the IRRAS catheter.	PASS (Acceptance criteria met)
	IRRAflow Catheter Drainage Flow	Describe the Drainage Flow testing methods for the IRRAS catheter.	PASS (Acceptance criteria met)
Shelf Life / Package Integrity	Validation of sterile barrier	Describe procedures for validating sterile barrier meets design and standards requirements.	PASS (Acceptance criteria met)
	Packaging Peel Test	Describe roll packing seal testing results for the IRRAS catheter and tube set.	PASS (Acceptance criteria met)
	Aging Test	Describe objective evidence that the IRRAS catheter and tube set meet appropriate requirements for transportation and aging.	PASS (Acceptance criteria met)
Sterilization Testing	Sterilization process	Validate the effectiveness of electron beam radiation of IRRAflow Catheter and Ethylene Oxide sterilization of IRRAflow Tube Set.	PASS (Acceptance criteria met)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the various tests described (e.g., number of animals for biocompatibility, number of units for bench testing).

The data provenance is not explicitly stated as country of origin or retrospective/prospective. The description suggests bench testing and laboratory studies (e.g., animal tests for biocompatibility, electrical tests), rather than studies involving human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable as the studies described are primarily laboratory-based verification and validation tests, not studies requiring expert interpretation of clinical data to establish a ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and laboratory validation to demonstrate substantial equivalence to predicate devices, not studies involving human readers or comparative effectiveness in a clinical context. Therefore, there's no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The IRRAflow CNS System is a physical medical device (drainage and monitoring system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The verification and validation described represent the standalone performance of the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is based on:

Standardized Biological Responses: For biocompatibility tests, the ground truth is the expected biological reaction in animal models (e.g., absence of fever, absence of toxic effects, normal cell growth, non-hemolytic properties, no irritation/sensitization) according to established international standards (like ISO 10993).
Engineering Specifications and Requirements: For bench and electrical testing, the ground truth is defined by the device's design specifications, documented requirements, and adherence to international safety and performance standards (e.g., IEC 60601-1-2:2014) and the manufacturer's own internal validated requirements.
Physical and Mechanical Properties: For catheter performance tests (tensile, torsion, shear, drainage flow), the ground truth is the specified physical and mechanical properties and expected performance parameters.
Sterility Assurance Levels: For sterilization and package integrity, the ground truth is the demonstration of sterility and maintenance of a sterile barrier according to validated protocols and standards.

8. The Sample Size for the Training Set:

This information is not applicable. The IRRAflow CNS System is a hardware medical device with integrated software for control and monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for the device would be its design and manufacturing processes, guided by engineering principles and standards.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K171880

Device Name IRRAflow CNS System

Indications for Use (Describe)

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

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IARAS

510(k) Summary – K171880

Submitter:	IRRAS USA, Inc.
Address:	11975 El Camino Real, Suite 304San Diego, CA 92130
Phone Number:	858-247-7033
Fax number:	866-575-1002
FDA Registration #:	3013508628
Contact Personnel
Primary:	Dessi LyakovDirector, 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

INDICATIONS FOR USE

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	PredicateMedtronic PS Medical ExternalDrainage and Monitoring System(Becker EDMS) (K984053)(JXG), (GWM)	IRRAflow CNSSystem(K171880)(JXG), (GWM)	Equivalence
Primary Product Code	JXG	JXG	Same
Primary RegulationNumber:	21 CFR 882.5550	21 CFR 882.5550	Same
Secondary Product Code	GWM	GWM	Same
Secondary RegulationNumber:	21 CFR 882.1620	21 CFR 882.1620	Same
Indications for Use	Draining and monitoring of CSF flowfrom the lateral ventricles or lumbarsubarachnoid space is indicated inselected patients to:Reduce intracranial pressure (ICP),e.g., pre, intra- or postoperative.Monitor CSF chemistry, cytology, andphysiology.Provide temporary CSF drainage inpatients with infected cerebrospinalfluid shunts. Monitoring of intracranialpressure (ICP) is indicated in selectedpatients with:Severe head injurySubarachnoid hemorrhage graded III,IV, or V preoperativelyReye's syndrome or similarencephalopathiesHydrocephalus IntracranialhemorrhageMiscellaneous problems when drainageis to be used as a therapeutic maneuverMonitoring can also be used to evaluatethe status pre- and postoperatively forspace-occupying lesions.	The use of IRRAflowCNS System isindicated whenintracranial pressuremonitoring is requiredand for externallydraining intracranialfluid as a means ofreducing intracranialpressure in patientswhere an externaldrainage and monitoringsystem is needed for ≤24 hours.	See discussionbelow
Injection/ CSF SamplingPorts	Yes	Yes	Same
UnidirectionalFlow of Drained Fluid	Yes	Yes	Same
Fluid InjectionCapability	Yes	Yes	Same
Items	PredicateMedtronic PS Medical ExternalDrainage and Monitoring System(Becker EDMS) (K984053)(JXG), (GWM)	IRRAflow CNSSystem(K171880)(JXG), (GWM)	Equivalence
Attaches to separate,commercially availableEVD Catheter	Yes	YesThe IRRAflow systemattaches to IRRAflowCatheter which is anEVD Catheter part of thecomplete system.	SameSee discussionbelow
Sterile Disposable tubingset	Yes	Yes	Same
CSF Drainage Bag	Yes	Yes	Same
Gravity drainage of CSF	Yes	Yes	Same
Method to control gravitydrainage of CSF	Manual adjustment of the drip chambereither up or down the IV Pole, relativeto the patient's head position andventricular catheter location.	Automated adjustmentbased on user settingsvia a stepper-motorcontrolled, tube-pinchingmechanism to eithercompress or release thecompliant drainagetubing contained withinthe sterile, disposableCartridge.	See discussionbelow
Pressure Transducer forICP Measurement	Yes(The Duet System includes a designand instructions for attaching atransducer that allows for ICPmeasurement and visual display via a	Yes(The IRRAflow systemintegrates transducersinto its design formeasurement and visual	Same
	connected monitor.)	display of ICP)
Software-based, PoweredConsole for UserInterface, User Settingsand Alarm Adjustments,Data Storage andDisplay, and Alarms forICP Monitoring	No	Yes	See discussionbelow
Method to account forlocation of ventricles viapatient head position	Laser level must be attached to thesystem and leveled and then the system"zeroed"; adjustment thereafter may beneeded.	Reference marks on thedevice to allow for thesystem to be alignedwith patient's headpositioning.	EquivalentSee discussionbelow
Measured PressureRange	0 - 31 cm H2O (set ICP range)	-80 mmHg to +100mmHg	See discussionbelow
Displayed ICP	Yes(via drip chamber pressure indicatorwindow or via connected transducer topatient monitor display)	Yes	Equivalent
Battery Back-up	No (Manual, non-powered system)	Yes	See discussionbelow
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 fromthe lateral ventricles or lumbar subarachnoidspace is indicated in selected patients to:• Reduce intracranial pressure (ICP), e.g.,pre-, intra- or postoperative.• Monitor CSF chemistry, cytology, andphysiology.• Provide temporary CSF drainage in patientswith infected cerebrospinal fluid shunts.Monitoring of intracranial pressure (ICP) isindicated in selected patients with:• Severe head injury• Subarachnoid hemorrhage graded III, IV, orV preoperatively• Reyes syndrome or similar encephalopathies• Hydrocephalus• Intracranial hemorrhage• Miscellaneous problems when drainage is tobe used as a therapeutic maneuver.Monitoring can also be used to evaluate thestatus pre- and postoperatively for space-occupying lesions.	The use of IRRAflow CNSSystem is indicated whenintracranial pressuremonitoring is required and forexternally draining intracranialfluid as a means of reducingintracranial pressure in patientswhere an external drainage andmonitoring system is neededfor ≤ 24 hours.	The IRRAflow CNS system isnot suitable for lumbar drain.The indications both includemonitoring of IntracranialPressure and drainage ofintracranial fluid as a means ofreducing intracranial pressure.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.

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 DeviceVentriClear II VentricularDrainage catheter(K160223)	IRRAflow CNS System Catheter(K171880)	Equivalence
TargetPopulation	Any patient needingremoval of intracranialfluids from the brainventricles	Any patient needing removal ofintracranial fluids from the brainventricles	Same
Anatomical Sites	Brain ventricles	Brain ventricles	Same
ImplantProcedure	Designed to be placedthrough a prepared openingthrough the skull and into thebrain ventricle	Designed to be placed through aprepared opening through the skulland into the brain ventricle	Same
Catheter Size	9Fr	9Fr	Same
Catheter Length	330mm	400mm	See discussionbelow
CatheterSideports	Yes	Yes	Same
Catheter End-hole	Closed	Closed	Same
CatheterDepth Markers	Yes	Yes	Same
Catheter material	Silicone	Silicone	Same
AntimicrobialAgents	Minocycline/Rifampin	None	See discussionbelow
Catheter Tip	Radiopaque	Radiopaque	Same
Biocompatibility	Tissue contact tested per ISO10993: Biological Evaluationof Medical Devices	Tissue contact tested per ISO 10993:Biological Evaluation ofMedical 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 discussionbelow

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,Mediated Pyrogen	The purpose of the study is to determine ifa saline extract of the test article causes afebrile response in rabbits.	PASS Clinical Observations: The testarticle were determined to be non-pyrogenic.
Acute SystemicToxicity, Injection Test	The purpose of the test was to screen testarticle extracts for potential toxic effects asa result of a single-dose systemic injectionin mice.	PASS Clinical Observations: None ofthe animals on study were observed withabnormal clinical signs indicative oftoxicity during the test period.
Irritation/IntracutaneousReactivity Test	The purpose of the test was to determine ifany chemicals that may leach or beextracted from the test article were capableof causing local irritation in the dermaltissues of rabbits.	PASS Clinical Observations:None of the animals on study showedabnormal clinical signs during theobservation periods.
Indirect Hemolysis(Extract) Test	The test is designed to determine thehemolytic properties of a medicaldevice/material.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Test	Test Method Summary	Results
Cytotoxicity (MEMElution) Test	The Minimal Essential Media (MEM)Elution test was designed to determine thecytotoxicity of extractable substances.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Sensitization Test	This test was designed to evaluate theallergenic potential or sensitizing capacityof a test article.	PASS Clinical Observations: None ofthe animals in the study showedabnormal clinical signs.
Bench and Electrical Testing
IRRAflow CNS SystemVerification	The purpose of this test is to document theresults of the system verification testingand system regression verification testing.	PASS The system has been shown tocomply with the documentedrequirements for the system.
IRRAflow CNS SystemValidation	The validation test procedures for theIRRAS IRRAflow CNS system weredesigned to ensure that the devicecomplies with established requirements.	PASS The system has been shown tocomply with the documentedrequirements for the system.
IRRAflow CNS SystemStatic Analysis	The purpose of this test is to describe theprocess and results from the static analysisof the IRRAflow CNS system software.	PASS There were no errors encounteredwhen the static analysis was conducted.
Basic Safety test	The following tests were conducted: InputTest; Heating Test; Leakage Current Test;Dielectric Voltage Test.	PASS Acceptance criteria has been met.
ElectromagneticCompatibility test	The objective of the testing is to determinecompliance with IEC 60601-1-2:2014Class B.	PASS Acceptance criteria has been met.
IRRAflow CatheterPerformance Test	The purpose of this test is to describe thetensile test results for the IRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow CatheterTorsion and Shear Test	The purpose of this test is to describe thetorsion and shear testing results for theIRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow CatheterDrainage Flow Test	The purpose of this test is to describe thedrainage testing methods for the IRRAScatheter.	PASS Acceptance criteria has been met.
Test	Test Method Summary	Results
Shelf Life / Package Integrity Testing
Validation of sterilebarrier	The purpose of this test is to describe theprocedures for validating that the sterilebarrier meets design and standardsrequirements.	PASS Acceptance criteria has been met.
Packaging Peel Test	The purpose of this test is to describe theroll packing seal testing results for theIRRAS catheter and tube set.	PASS Acceptance criteria has been met.
Aging Test	The purpose of this test is to describe theobjective evidence that the IRRAS catheterand tube set meet the appropriaterequirements for transportation and aging.	PASS Acceptance criteria has been met.
Sterilization Testing
Sterilization process forthe IRRAflow Catheterand IRRAflow TubeSet	This study was conducted to validate theeffectiveness of electron beam radiation ofIRRAflow Catheter and Ethylene Oxidesterilization of IRRAflow Tube Set.	PASS Acceptance criteria has been met.

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IARAS

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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.

Regulation Number and Section

§ 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).