The use of the IRRAflow Active Fluid Exchange 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® Active Fluid Exchange System (formerly branded as the CNS System) is an intracranial pressure (ICP) monitoring and drainage system, substantially equivalent to the predicate 510(k) K200807. Changes described herein were evaluated using design controls. 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. A drainage bag is attached to the Control Unit, using the Laser Leveler for defining the height of the bag relative to the catheter's tip position in the patient's head. This positioning is used for 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 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 text is a 510(k) summary for the IRRAflow® Active Fluid Exchange System (AFES). It details the device's technical specifications and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the information requested regarding acceptance criteria and performance data for an AI/ML powered device.

The document explicitly states that the device is an "intracranial pressure (ICP) monitoring and drainage system" and that "Changes made only to the Control Unit software required additional testing, including verification and validation of new and enhanced functionality." It refers to "Control Unit 4.0," which includes software enhancements.

Despite mentioning "User software enhancements" and "pressure accuracy improvement," the document focuses on engineering verification and validation tests for a hardware/software medical device, not an AI/ML algorithm. The tests listed in "Table 4" (Verification by Inspection, BSM Requirements Verification, Electrical Requirements Verification, Mechanical Performance Verification, Life Cycle Verification Test, Packaging Verification) are standard for medical device hardware and software, but do not align with the typical criteria and studies for proving the performance of an AI/ML-powered algorithm, especially none that would require ground truth from experts, multi-reader studies, or specific AI acceptance metrics like sensitivity/specificity or AUC.

Therefore, I cannot fulfill the request for a table of AI acceptance criteria and performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document. The document describes a conventional medical device clearance, not an AI/ML clearance.

Without further information that explicitly details a clinical study demonstrating the performance of an AI/ML component with human-in-the-loop or standalone, I cannot generate the requested output.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 8, 2022

IRRAS USA, Inc. Jeanne Warner VP, Clinical & Regulatory Affairs 11975 El Camino Real, Suite 304 San Diego, California 92130

Re: K222471

Trade/Device Name: IRRAflow Active Fluid Exchange 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: November 4, 2022 Received: November 7, 2022

Dear Jeanne Warner:

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

{1}------------------------------------------------

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 medical devices and radiation-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,

Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 07:36:05 -05'00'

Adam D. Pierce, Ph.D. Assistant Director 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

{2}------------------------------------------------

Indications for Use

510(k) Number K222471

Device Name IRRAflow Active Fluid Exchange System

Indications for Use (Describe)

The use of IRRAflow Active Fluid Exchange 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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Applicant:

IRRAS USA, Inc. 11975 El Camino Real, Suite 304 San Diego, CA 92130 US.A 858-220-3761 Phone Number: Fax number: 866-575-1002 FDA Registration#:

Primary Contact Personnel:

Jeanne S. Warner, RN MS VP, Clinical & Regulatory Affairs Phone Number: 269-270-2189 866-575-1002 Fax Number: Email: jeanne.warner@irras.com

Secondary Contact Personnel:

Fernando SanchezSr. Director, Quality
Phone Number:	858-212-6660
Email:	fernando.sanchez@irras.com
Date prepared:	December 8, 2022
510(k) Number:	K222471
Trade name:	IRRAflow® Active Fluid Exchange System(AFES, formerly branded as CNS System)
Common Name:	CSF Drainage System with ventricular catheter

{4}------------------------------------------------

Primary Classification:
Name:	Central Nervous System Fluid Shunt and Component
Product Code:	JXG
Regulation:	21 CFR 882.5550

Primary Predicate Device: IRRAflow® CNS System, K200807 Additional Predicate Device: IRRAflow® CNS System, K192289

1.0 DEVICE DESCRIPTION - IRRAflow® Active Fluid Exchange System

The IRRA/low" Active Fluid Exchange System (formerly branded as the CNS System) is an intracranial pressure (ICP) monitoring and drainage system, substantially equivalent to the predicate 510(k) K200807. Changes described herein were evaluated using design controls. 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 IRRA/low Tube Set has a cassette that clicks on to the IRRA/low Control Unit and aligns the tubing against a peristaltic pump and pinch valve. A drainage bag is attached to the Control Unit, using the Laser Leveler for defining the height of the bag relative to the catheter's tip position in the patient's head. This positioning is used for 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 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.

2.0 INDICATIONS FOR USE

{5}------------------------------------------------

3.0 SUBSTANTIAL EQUIVALENCE

The IRRAflow® AFES (formerly branded as CNS System) intended use, technological characteristics and principles of operation are the substantially equivalent to the predicate device described in K200807. Changes present in the Control Unit 4.0 that would have potential to affect the technological characteristics or principles of operation of the IRRAflow® System were evaluated by design controls. Earlier predicate devices described in K192289 and K200807 are shown for comparison in Table 2 below.

Comparison of these Monitoring Systems will show that the only difference in the device presented in this Special 510(k) are the enhanced and new features present in the Control Unit, designated as version 4.0. The currently cleared and marketed Control Unit is designated as version 3.0. Data presented definitively support the conclusion that Control Unit version 4.0 continues to be as safe and effective as the predicate device.

{6}------------------------------------------------

Therefore, this Special 510(k) captures detailed descriptions of changes to the Control Unit which is part of the overall IRRAflow® AFES, classified by FDA as a Class II medical device. IRRAS is submitting this Special 510(k) as substantially equivalent to the IRRA/low® CNS System device described in K192289 and K200807.

Attributes	PREDICATEIRRAflow® CNSSystem (K192289)(JXG), (GWM)	PREDICATEIRRAflow® CNSSystem (K200807)(JXG), (GWM)	IRRAflow® AFES SystemSpecial 510(k)K222471(JXG), (GWM)Equivalence
Primary ProductCode	JXG	JXG	JXG
Primary RegulationNumber:	21 CFR 882.5550	21 CFR 882.5550	21 CFR 882.5550
SecondaryProduct Code	GWM	GWM	GWM
SecondaryRegulation Number:	21 CFR 882.1620	21 CFR 882.1620	21 CFR 882.1620
Indications for Use	The use of IRRAflow®CNS is indicated whenintracranial pressuremonitoring is requiredand for externallydraining intracranial fluidas a means of reducingintracranial pressure inpatients where an externaldrainage and monitoringsystem is needed.	SameThe use of IRRAflow®CNS is indicated whenintracranial pressuremonitoring is required andfor externally drainingintracranial fluid as ameans of reducingintracranial pressure inpatients where an externaldrainage and monitoringsystem is needed.	SameThe use of IRRAflow® AFESis indicated when intracranialpressure monitoring isrequired and for externallydraining intracranial fluid as ameans of reducing intracranialpressure in patients where anexternal drainage andmonitoringsystem is needed. **
Attributes	PREDICATEIRRAflow® CNS System(K192289)(JXG), (GWM)	PREDICATEIRRAflow® CNS System(K200807)(JXG), (GWM)	IRRAflow® AFES SystemSpecial 510(k) K222471(JXG), (GWM)Equivalence
Injection/ CSFSamplingPorts	Yes	Yes	Yes
UnidirectionalFlow of Drained Fluid	Yes	Yes	Yes
Fluid InjectionCapability	Yes	Yes	Yes
Attaches to separate,commerciallyavailable EVDCatheter	The IRRAflow® systemattaches to IRRAflow®Catheter which is an EVDCatheter part of the completesystem.	Same, the IRRAflow®system attaches toIRRAflow® Catheter whichis an EVD Catheter part ofthe complete system.	Same, the IRRAflow®system attaches toIRRAflow® Catheter whichis an EVD Catheter part ofthe complete system
Sterile Disposabletubing set	Yes	Yes	Yes
CSF Drainage Bag	Yes	Yes	Yes
Gravity drainage ofCSF	Yes	Yes	Yes
Method to controlgravity drainage ofCSF	Automated adjustment basedon user settings via astepper-motor controlled,tube pinching mechanism toeither compress or releasethe compliant drainagetubing contained within thesterile, disposable Cartridge.	Same, automated adjustmentbased on user settings via astepper-motor controlled,tube pinching mechanism toeither compress or releasethe compliant drainagetubing contained within thesterile, disposable Cartridge.	Same, automatedadjustment based on usersettings via a stepper-motorcontrolled, tube pinchingmechanism to eithercompress or release thecompliant drainage tubingcontained within the sterile,disposable Cartridge.
Pressure Transducerfor ICP Measurement	The IRRAflow®system integrates transducersinto its design formeasurement and visualdisplay of ICP	Same, the IRRAflow®system integrates transducersinto its design formeasurement and visualdisplay of ICP	Same, the IRRAflow®system integratestransducers into its designfor measurement andvisual display of ICP.
Attributes	PREDICATEIRRAflow® CNS System(K192289)(JXG), (GWM)	PREDICATEIRRAflow® CNS System (K200807)(JXG), (GWM)	IRRAflow® AFES SystemSpecial 510(k) (GWM, JXG)Equivalence
Software-based,Powered Console forUser Interface, UserSettings and AlarmAdjustments, DataStorage and Display,and Alarms for ICPmonitoring	Yes	Yes	Substantially equivalent topredicate, with addition of:• Bedside monitoring ability(BSMA)to export ICP datastream compatible withmarketed bedside monitors,with cables• Increased volume forsystem alarms• Power system changes toextend shelf life and improvepower shut down sequencing• Allowance for 'off theshelf' external powersupply• Manufacturabilityrelated changes toboard layout• Bluetooth hardware forfuture applicationdevelopment• User software enhancements,including: case-specificirrigation and drainagesettings, additional datavisualization onscreen(trending, axis and unitadjustments), auto primingcassette functionality,pressure accuracyimprovement• Drainage collection systemmounting that allowsenhanced fluid drainagecollection
Measured PressureRange	-80 mmHg to +100 mmHg	Same, -80 mmHg to+100 mmHg	Substantially Equivalent-100 to +300 mmHg
Displayed ICP	Yes	Same	Same
Battery Back-up	Yes	Yes	Same

Table 2: Substantial Equivalence (SE)Comparison

{7}------------------------------------------------

{8}------------------------------------------------

K222471, Page 6 of 8

** Equivalent-change from CNS System to Active Fluid Exchange System is a branding change only

{9}------------------------------------------------

A review of Table 2 shows that there is no change to the overall IRRA/low® system. Changes made only to the Control Unit software required additional testing, including verification and validation of new and enhanced functionality. Changes present in the Control Unit 4.0 that would have potential to affect the technological characteristics or principles of operation of the IRRAflow® System were evaluated by design controls. Any new safety and effectiveness issues related to the Control Unit modifications are addressed in the FMEA and Risk Analysis.

Because changes were made only to the Control Unit software (with minor hardware changes to accommodate hanger for drainage bag and Scale), with the required additional testing including verification and validation new and enhanced functionality, the continued safe and effective use of Control Unit 4.0 was confirmed. Changes present in the Control Unit 4.0 that would have potential to affect the technological characteristics or principles of operation of the IRRAflow® System were evaluated by design controls. Any new safety and effectiveness issues related to the Control Unit modifications are addressed in the Control Unit FMEA. No changes were made to the EVD catheter or the remaining components of the IRRA/low® system.

4.0 SUMMARY OF DESIGN CONTROLS

Procedural design controls were followed, and all design elements were satisfied.

5.0 SUMMARY OF VERIFICATION & VALIDATION

Additional verification and validation performance testing was done on the IRRAflow AFES Control Unit 4.0. Any new safety and effectiveness issues related to software and other described changes were addressed in the FMEA and Risk Analysis.

The IRRAflow® AFES is substantially equivalent to the system described in 510(k) K200807. Enhanced and new Control Unit features are described herein. These changes do not adversely affect the safety and effectiveness of the IRRA/low® Control Unit. Any new risks to the overall system were address in the FMEA and Risk Analysis. The risk was evaluated separately, as well as, in conjunction with the system components of the IRRAflow® AFES. Since any new concerns or risks identified were mitigated by the actual proper use and function of Control Unit 4.0, it is appropriate to conclude that the IRRAflow® AFES is Substantially Equivalent to the predicate device (K200807).

A summary of the testing done at IRRAS is presented in the Table below. In Table 4 below, IRRAS has identified the various well-established and recognized Standards for evaluation of the performance of the Control Unit 4.0 separately. Results are provided in a summary format. Complete test reports are available upon request.

{10}------------------------------------------------

Test	Test Method Summary	Results
Verification by Inspection	No physical testing is performed for theassociated requirements. Coverage wasdemonstrated by analysis and presented ina final trace matrix.	Acceptable
BSM Requirements Verification	These testes are algorithmic in nature, withdemonstration of passing results one onesample, with repeated tests as defined inthe associated protocol, are valid for fullrequirement coverage.	Pass
Electrical Requirements Verification
Mechanical Performance Verification	As defined in the associated protocol, therequirement pertains to the hardwarecomponent itself (i.e. pole clamp, drainagebag holder clip, etc.) and not on its interfacewith the control unit.	Pass
Life Cycle Verification Test	All testing was completed on capitalequipment, with multiple test repeats (asrequired) were used to demonstrate lifecyclereliability.	Pass
Packaging Verification	No risk to user since device was found towork based on device functionality checkedupon arrival after simulated transit.	Pass

Conclusions

The IRRAflow® AFES (formerly branded as the CNS system) is Substantially Equivalent to the predicate device (K200807). The IRRAflow® AFES has the same Indications for Use. Changes present in the Control Unit 4.0 that would have potential to affect the technological characteristics or principles of operation of the IRRAflow® System were evaluated by design controls.

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).