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.

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

The provided document (K192289) describes the 510(k) clearance for the IRRAflow® CNS System. This is a medical device and not an AI/ML algorithm. Therefore, many of the specific questions related to AI/ML model performance, such as MRMC studies, ground truth establishment for training data, and expert consensus for test sets, are not applicable.

However, I can extract the acceptance criteria and the claimed performance of the device based on the testing reported for this medical device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated by passing various bench, electrical, and biocompatibility tests. The "Results" column in Table 3 indicates the device's performance against these criteria, which is consistently "PASS."

Table of Acceptance Criteria and Reported Device Performance (Derived from Table 3):

Test Category	Acceptance Criteria Summary	Reported Performance
Biocompatibility Testing
Systemic Toxicity, Mediated Pyrogen	Saline extract of the test article causes no febrile response in rabbits.	PASS: Determined to be non-pyrogenic.
Acute Systemic Toxicity, Injection Test	No toxic effects from single-dose systemic injection in mice.	PASS: No abnormal clinical signs indicative of toxicity.
Irritation/Intracutaneous Reactivity Test	No local irritation in dermal tissues of rabbits from leached chemicals.	PASS: No abnormal clinical signs.
Indirect Hemolysis (Extract) Test	Demonstrate non-hemolytic properties.	PASS: All test method acceptance criteria met.
Cytotoxicity (MEM Elution) Test	No cytotoxicity of extractable substances.	PASS: All test method acceptance criteria met.
Sensitization Test	No allergenic potential or sensitizing capacity.	PASS: No abnormal clinical signs.
Genotoxicity	No structural chromosome aberrations in Chinese Hamster Ovary (CHO) cells.	PASS: All test method acceptance criteria met.
Implant Study	Acceptable local effects after implantation.	PASS: All test method acceptance criteria met.
Subacute Toxicity	Demonstrate no toxicological hazard related to subacute/subchronic and chronic toxicity.	PASS: All test method acceptance criteria met.
Bench and Electrical Testing
IRRAflow® CNS System Verification	Comply with documented system requirements.	PASS: System complies with documented requirements.
IRRAflow® CNS System Validation	Comply with established device requirements.	PASS: System complies with documented requirements.
IRRAflow® CNS System Static Analysis	No errors encountered during static analysis of software.	PASS: No errors encountered.
Basic Safety Test	Meets criteria for Input, Heating, Leakage Current, Dielectric Voltage tests.	PASS: Acceptance criteria has been met.
Electromagnetic Compatibility test	Compliance with IEC 60601-1-2:2014 Class B.	PASS: Acceptance criteria has been met.
IRRAflow Catheter Performance Test	Tensile test results meet requirements.	PASS: Acceptance criteria has been met.
IRRAflow Catheter Torsion and Shear Test	Torsion and shear test results meet requirements.	PASS: Acceptance criteria has been met.
IRRAflow Catheter Drainage Flow Test	Drainage testing methods and results meet requirements.	PASS: Acceptance criteria has been met.
Shelf Life / Package Integrity Testing
Validation of sterile barrier	Meet design and standards requirements for sterile barrier.	PASS: Acceptance criteria has been met.
Packaging Peel Test	Seal testing results for packaging meet requirements.	PASS: Acceptance criteria has been met.
Aging Test	Demonstrate appropriate requirements for transportation and aging are met.	PASS: Acceptance criteria has been met.
Sterilization Testing
Sterilization process for IRRAflow Catheter and Tube Set	Effectiveness of electron beam radiation (Catheter) and Ethylene Oxide (Tube Set) sterilization.	PASS: Acceptance criteria has been met.

Regarding the specific questions that are more relevant to AI/ML studies (and why they are not directly applicable here):

Sample sizes used for the test set and the data provenance: This device is a hardware system, not an AI/ML diagnostic. The "sample size" for testing refers to the number of units or biological samples used in bench, electrical, and biocompatibility tests. For example, biocompatibility tests might involve a certain number of rabbits or mice. The "data provenance" is not specified beyond the tests themselves (e.g., "saline extract of the test article," "dermal tissues of rabbits"). These are laboratory tests, not clinical data sets from patients. All tests listed in Table 3 were conducted to demonstrate substantial equivalence and safety/effectiveness of the device itself, not an algorithm's performance on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic algorithms, refers to a definitive diagnosis or finding. For a physical medical device like the IRRAflow® CNS System, "ground truth" is established through physical, chemical, and biological performance standards (e.g., whether a material is cytotoxic, whether a mechanical component withstands stress, whether electrical safety standards are met). These are determined by established laboratory methods and validated instrumentation, not by human expert consensus on medical images or clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, for the reasons mentioned above. Adjudication is a process for resolving discrepancies in expert interpretations of data (e.g., radiologists reviewing an image). This device's performance is measured against engineering and biological standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are used to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a physical system for intracranial fluid management and pressure monitoring, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's acceptance is based on adherence to established engineering standards (e.g., IEC 60601-1-2 for electromagnetic compatibility, ISO 10993 series for biocompatibility) and direct physical/chemical measurements (e.g., tensile strength, flow rates). These are objective measurements rather than interpretations of clinical data.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary, the provided document details the regulatory clearance of a physical medical device (IRRAflow® CNS System) through a 510(k) submission. The acceptance criteria and performance are demonstrated via a series of non-clinical (bench, electrical, biocompatibility, sterilization, and packaging) tests against predetermined engineering and biological standards, rather than through clinical studies involving human readers or AI algorithms.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2019

IRRAS USA, Inc. Niloufa Insanally Head of Regulatory Affairs 11975 El Camino Real, 3rd Floor San Diego, California 92130

Re: K192289

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: August 21, 2019 Received: August 23, 2019

Dear Niloufa Insanally:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192289

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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510(k) Summary

Applicant: IRRAS USA, Inc. 11975 El Camino Real, Suite 304 San Diego, CA 92130 U.S.A Phone Number: 858-247-7033 Fax number: 866-575-1002 FDA Registration #: 3013508628

Primary Contact Personnel:

Vinny Podichetty VP Clinical, Regulatory Affairs and Quality Phone Number: 949-356-3094 Fax Number: 866-575-1002 Email: Vinny.podichetty@jirras.com

Secondary Contact Personnel:

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:	August 21, 2019
Trade name:	IRRAflow® CNS System
Common Name:	CSF Drainage System with ventricular catheter

Primary Classification:

Name:	Central Nervous System Fluid Shunt and Component
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): IRAflow® CNS System (K171880)

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DEVICE DESCRIPTION

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 0 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.

SUBSTANTIAL EQUIVALENCE

The IRRAflow® CNS system's intended use, technological characteristics and principles of operation are the same as the predicate device.

Comparison of these Monitoring Systems is provided in table 1 below.

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Items	PREDICATE	IRRAflow® CNS System(JXG), (GWM)(New)	Equivalence
	IRRAflow® CNS System (K171880)(JXG), (GWM)
Primary Product	JXG	JXG	Same
Primary RegulationNumber:	21 CFR 882.5550	21 CFR 882.5550	Same
Secondary Product	GWM	GWM	Same
Secondary RegulationNumber:	21 CFR 882.1620	21 CFR 882.1620	Same
Indications for Use	The use of IRRAflow® CNS Systemis indicated when intracranialpressure monitoring is required andfor externally draining intracranialfluid as a means of reducingintracranial pressure in patients wherean external drainage and monitoringsystem is needed for ≤ 24 hours.	The use of IRRAflow® CNS Systemis indicated when intracranialpressure monitoring is required andfor externally draining intracranialfluid as a means of reducingintracranial pressure in patients wherean external drainage and monitoringsystem is needed.	Seediscussionbelow
Injection/ CSFSampling Ports	Yes	Yes	Same
UnidirectionalFlow of Drained Fluid	Yes	Yes	Same
Fluid InjectionCapability	Yes	Yes	Same
Attaches to separate,commerciallyavailable EVDCatheter	YesThe IRRAflow system attaches toIRRAflow Catheter which is an EVDCatheter part of the complete system.	YesThe IRRAflow system attaches toIRRAflow Catheter which is an EVDCatheter part of the complete system.	Same
Sterile Disposabletubing set	Yes	Yes	Same
CSF Drainage Bag	Yes	Yes	Same
Gravity drainage ofMethod to controlgravity drainage ofCSF	YesAutomated adjustment based on usersettings via a stepper-motorcontrolled, tube-pinching mechanismto either compress or release thecompliant drainage tubing containedwithin the sterile, disposableCartridge.	YesAutomated adjustment based on usersettings via a stepper-motorcontrolled, tube-pinching mechanismto either compress or release thecompliant drainage tubing containedwithin the sterile, disposableCartridge.	Same
Pressure Transducerfor ICP Measurement	Yes(The IRRAflow system integratestransducers into its design formeasurement and visual display ofICP)	Yes(The IRRAflow system integratestransducers into its design formeasurement and visual display ofICP)	Same
Items	PREDICATEIRRAflow® CNS System (K171880)(JXG), (GWM)	IRRAflow® CNS System(JXG), (GWM)(New)	Equivalence
Software-based,Powered Console forUser Interface, UserSettings and AlarmAdjustments, DataStorage and Display,and Alarms for ICP	Yes	Yes	Same
Method to account forlocation of ventriclesvia patient headposition	Reference marks on the device toallow for the system to be alignedwith patient's head positioning.	Reference marks on the device toallow for the system to be alignedwith patient's head positioning.	Same
Measured PressureRange	-80 mmHg to +100 mmHg	-80 mmHg to +100 mmHg	Same
Displayed ICP	Yes	Yes	Same
Battery Back-up	Yes	Yes	Same

Table 1 – Substantial Equivalence Comparison of the Monitoring Systems

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Discussion of differences in Table 1 IFU:

PREDICATE	IRRAflow CNS system (New)	Discussion:
IRRAflow CNS system (K171880)
Indications for Use:
The use of IRRAflow® CNS Systemis indicated when intracranialpressure monitoring is required andfor externally draining intracranialfluid as a means of reducingintracranial pressure in patientswhere an external drainage andmonitoring system is needed for ≤ 24hours.	The use of IRRAflow® CNS Systemis indicated when intracranialpressure monitoring is required andfor externally draining intracranialfluid as a means of reducingintracranial pressure in patientswhere an external drainage andmonitoring system is needed.	The difference in the indications forus in the duration of monitoring.The indications for use for thepredicate (K171880) was ≤ 24hours. Biocompatibility testing hasbeen conducted and provided withthis submission that the duration ofuse can be > 24 hours but less than orequal to 5 days.

EVD Catheter:

SUBSTANTIAL EQUIVALENCE

The IRRAflow® CNS System's Catheter technological characteristics and principles of operation are similar to the IRRAflow® CNS System Catheter (K171880). There have been no changes to the system catheter. The materials, design and principle of operations remain the same.

Comparison of these Catheters is provided in table 2 below

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Items	PREDICATEIRRAflow® CNS System Catheter(K171880)	IRRAflow® CNS System Catheter(New)	Equivalence
Target Population	Any patient needing removal ofintracranial fluids from the brainventricles	Any patient needing removal ofintracranial fluids from the brainventricles	Same
Anatomical Sites	Brain ventricles	Brain ventricles	Same
Implant Procedure	Designed to be placed through aprepared opening through the skulland into the brain ventricle	Designed to be placed through aprepared opening through the skulland into the brain ventricle	Same
Catheter Size	9Fr	9Fr	Same
Catheter Length	400mm	400mm	Same
Catheter Sideports	Yes	Yes	Same
Catheter End- hole	Closed	Closed	Same
Catheter DepthMarkers	Yes	Yes	Same
Catheter material	Silicone	Silicone	Same
AntimicrobialAgents	None	None	Same
Catheter Tip	Radiopaque	Radiopaque	Same
Biocompatibility	Tissue contact tested per ISO 10993:Biological Evaluation ofMedical Devices	Tissue contact tested per ISO 10993:Biological Evaluation ofMedical Devices	Same
Cytotoxicity	Acceptable	Acceptable	Same
Provided Sterile	Yes	Yes	Same
Packaging	Tyvek/polyester pouch	Tyvek/polyester pouch	Same
Functional Use	5 days	5 days	Same
Shelf Life	18 months	18 months	Same

Table 2 - Substantial Equivalence Comparison - Catheters

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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.

Test	Test Method Summary	Results
Biocompatibility Testing
Systemic Toxicity,Mediated Pyrogen	The purpose of the study is to determine if asaline extract of the test article causes a febrileresponse in rabbits.	PASS Clinical Observations: The testarticle were determined to be non-pyrogenic.
Acute Systemic Toxicity,Injection Test	The purpose of the test was to screen test articleextracts for potential toxic effects as a result of asingle-dose systemic injection in 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 if anychemicals that may leach or be extracted from thetest article were capable of causing local irritationin the dermal tissues 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 the hemolyticproperties of a medical device/material.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Cytotoxicity (MEMElution) Test	The Minimal Essential Media (MEM) Elution testwas designed to determine the cytotoxicity ofextractable substances.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Sensitization Test	This test was designed to evaluate the allergenicpotential or sensitizing capacity of a test article.	PASS Clinical Observations: None ofthe animals in the study showedabnormal clinical signs.
Genotoxicity	The test was designed to screen the products andmaterials to determine if they cause structuralchromosome aberrations in industry standardChinese Hamster Ovary (CMC) cells.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Implant Study	This study was conducted for test of local effectsafter implantation.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Subacute Toxicity	The purpose of this study is to closely examinethe toxicological hazard and to evaluate andaddress any risks associated with the biologicalendpoints of subacute/subchronic and chronictoxicity.	PASS Clinical Observations: All testmethod acceptance criteria were met.
Test	Test Method Summary	Results
Bench and Electrical Testing
IRRAflow® CNS SystemVerification	The purpose of this test is to document the results of the system verification testing and systemregression verification testing.	PASS The system has been shown tocomply with the documentedrequirements for the system.
IRRAflow® CNS SystemValidation	The validation test procedures for the IRRASIRRAflow CNS system were designed to ensurethat the device complies with establishedrequirements.	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 the process and results from the static analysis of theIRRAflow CNS system software.	PASS There were no errors encounteredwhen the static analysis was conducted.
Basic Safety test	The following tests were conducted: Input Test;Heating Test; Leakage Current Test; DielectricVoltage Test.	PASS Acceptance criteria has been met.
ElectromagneticCompatibility test	The objective of the testing is to determinecompliance with IEC 60601-1-2:2014 Class B.	PASS Acceptance criteria has been met.
IRRAflow CatheterPerformance Test	The purpose of this test is to describe the tensiletest results for the IRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow CatheterTorsion and Shear Test	The purpose of this test is to describe the torsionand shear testing results for the IRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow CatheterDrainage Flow Test	The purpose of this test is to describe the drainagetesting methods for the IRRAS catheter.	PASS Acceptance criteria has been met.
Shelf Life / Package Integrity Testing
Validation of sterile barrier	The purpose of this test is to describe theprocedures for validating that the sterile barriermeets design and standards requirements.	PASS Acceptance criteria has been met.
Packaging Peel Test	The purpose of this test is to describe the rollpacking seal testing results for the IRRAScatheter and tube set.	PASS Acceptance criteria has been met.
Aging Test	The purpose of this test is to describe theobjective evidence that the IRRAS catheter andtube set meet the appropriate requirements fortransportation and aging.	PASS Acceptance criteria has been met.
Sterilization Testing
Sterilization process forthe IRRAflow Catheterand IRRAflow Tube Set	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.

Table 3 - IRRAflow® CNS System Testing

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Previous 510(k) Clearances:

The following are a list of the clearances for the Products discussed in this document:

Product	Clearance Number	Date
IRRAflow® CNS System	K171880	07/13/2018

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Recognized Consensus Standards:

Recognized Consensus Standards:
The IRRAflow® CNS System was developed in compliance with the following standards:
Standard	FR RecognitionList Number	FR RecognitionNumber	Date ofRecognition
ISO 10993-1 Fourth Edition 2009-10-15, BiologicalEvaluation Of Medical Devices - Part 1: EvaluationAnd Testing Within A Risk Management Process[Including: Technical Corrigendum 1 (2010)]	044	2-220	07/26/2016
ISO 10993-3 Third Edition 2014-10-1, BiologicalEvaluation Of Medical Devices - Part 3: Tests ForGenotoxicity, Carcinogenicity And ReproductiveToxicity	044	2-228	07/26/2016
ISO 10993-4 Third Edition 2017-04 BiologicalEvaluation Of Medical Devices--Part 4: SelectionOf Tests For Interactions With Blood	047	2-248	08/21/2017
ISO 10993-5 Third Edition 2009-06-01, BiologicalEvaluation Of Medical Devices - Part 5: Tests For InVitro Cytotoxicity	046	2-245	12/23/2016
ISO 10993-6 Third Edition 2016-12-01, BiologicalEvaluation Of Medical Devices -- Part 6: Tests ForLocal Effects After Implantation	047	2-247	08/21/2017
ISO 10993-10 Third Edition 2010-08-01, BiologicalEvaluation Of Medical Devices - Part 10: Tests ForIrritation And Skin Sensitization	044	2-174	07/26/2016
ISO 10993-11 Second Edition 2006-08-15,Biological Evaluation Of Medical Devices - Part 11:Tests For Systemic Toxicity	044	2-176	07/26/2016
ISO 10993-12 Fourth Edition 2012-07-01,Biological Evaluation Of Medical Devices - Part 12:Sample Preparation And Reference Materials	044	2-191	07/26/2016
ISO 10993-12 Fourth Edition 2012-07-01,Biological Evaluation Of Medical Devices - Part 12:Sample Preparation And Reference Materials	044	2-191	07/26/2016
ISO 11135 Second Edition 2014, Sterilization OfHealth-Care Products - Ethylene Oxide -Requirements For The Development, ValidationAnd Routine Control Of A Sterilization Process ForMedical Devices	041	14-452	04/04/2016
ISO 11137-1 First Edition 2006-04-15, SterilizationOf Health Care Products - Radiation - Part 1:Requirements For Development, Validation AndRoutine Control Of A Sterilization Process ForMedical Devices [Including: Amendment 1 (2013)]	041	14-428	04/04/2016
The IRRAflow® CNS System was developed in compliance with the following standards:
Standard	FR RecognitionList Number	FR RecognitionNumber	Date ofRecognition
ISO 11137-2 Third Edition 2013-06-01, SterilizationOf Health Care Products - Radiation - Part 2:Establishing The Sterilization Dose	041	14-409	04/04/2016
ISO 11607-1 First Edition 2006-04-15, PackagingFor Terminally Sterilized Medical Devices - Part 1:Requirements For Materials, Sterile Barrier SystemsAnd Packaging Systems [Including: Amendment 1(2014)]	038	14-454	01/27/2015
ISO 14971 Second Edition 2007-03-01, MedicalDevices - Application Of Risk Management ToMedical Devices	043	5-40	06/27/2016
60601-1:2012, Medical Electrical Equipment - Part1: General Requirements for Safety and essentialperformance	036	19-4	07-09-2014
60601-1-2 Edition 4.0 2014-02, Medical ElectricalEquipment - Part 1-2: General Requirements ForBasic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances -Requirements And Tests	050	19-8	09/17/2018
60601-1-8:2006 & A1:2012, Medical ElectricalEquipment -- Part 1-8: General Requirements ForBasic Safety And Essential Performance --Collateral Standard: General Requirements, TestsAnd Guidance For Alarm Systems In MedicalElectrical Equip.	031	5-76	08/06/2013

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Conclusion:

The IRRAflow® CNS System is substantially equivalent to the predicate device (K171880). The IRRAflow® CNS System has the same intended use, technological characteristics, and principles of operation as the predicate devices. The minor differences in the indications for use between the IRRAflow® CNS System and the predicate device 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).