IRRAflow Active Fluid Exchange System (AFES)

K231664 · Irras USA, Inc. · JXG · Oct 19, 2023 · Neurology

Device Facts

• Record ID: K231664
• Device Name: IRRAflow Active Fluid Exchange System (AFES)
• Applicant: Irras USA, Inc.
• Product Code: JXG · Neurology
• Decision Date: Oct 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The use of IRRAflow Active Fluid Exchange System is 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 Story

The IRRAflow Active Fluid Exchange System (AFES) is a neurosurgical device for intracranial pressure (ICP) monitoring and CSF drainage. It consists of a control unit, a sterile disposable tube set (version 3.0), and a drainage collection system. The system uses a peristaltic pump and a stepper-motor-controlled pinch valve to regulate gravity-driven, unidirectional CSF drainage based on user-defined settings. Integrated pressure transducers measure ICP, which is displayed on the control unit interface. The system allows for bolus injections to clear catheter clogs. It is operated by trained hospital personnel in a clinical setting. The device provides real-time ICP monitoring, automated drainage control, and alarm management. By maintaining controlled drainage and enabling catheter flushing, the device helps manage intracranial pressure, potentially benefiting patients with conditions requiring external ventricular drainage.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity), electrical verification (pressure accuracy), mechanical performance (durability, flow, leakage), life cycle reliability, shelf life/package integrity (ASTM D4332-14, ASTM D4169-22, ASTM F1886-16, ASTM F2096-11, EN 868-5:2009), and sterilization validation (Ethylene Oxide).

Technological Characteristics

System includes a control unit, disposable tube set (316L stainless steel pinch valve ball), and drainage collection system. Features peristaltic pump and stepper-motor pinch valve for flow control. Pressure range: -100 to +300 mmHg. Connectivity: battery-backed control unit with UI for settings/alarms. Sterilization: Ethylene Oxide. Software-based console for data storage and display.

Indications for Use

Indicated for patients requiring intracranial pressure (ICP) monitoring and external drainage of intracranial fluid to reduce ICP.

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

• IRRAflow Active Fluid Exchange System (K222471)

Reference Devices

• IRRAflow CNS System (K200807)

Submission Summary (Full Text)

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October 19, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 ADMINISTRATION" in blue text.

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

Re: K231664

Trade/Device Name: IRRAflow Active Fluid Exchange System (AFES) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG, GWM Dated: September 15, 2023 Received: September 19, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.10.19, and the time is 15:00:38 -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices

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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) K231664

Device Name IRRAflow Active Fluid Exchange System

Indications for Use (Describe)

The use of IRRA/low Active Fluid Exchange System is 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)

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### I. SUBMITTER

IRRAS USA, Inc. 11975 El Camino Real, Suite 304 San Diego, CA 92130 USA Phone Number: 858-220-3761 866-575-1002 Fax number: FDA Registration#: 3013508628

Primary Contact:

| Jeanne S. Warner, RN MS | |
|-----------------------------------|-------------------------|
| VP, Clinical & Regulatory Affairs | |
| Phone Number: | 269-270-2189 |
| Fax Number: | 866-575-1002 |
| Email: | [e-mail] |

Secondary Contact:

| Adam Sampson<br>VP, Product<br>Excellence<br>Phone Number:<br>Email: | 619-992-1861<br>[e-mail] |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Date prepared: | October 18, 2023 |
| II. DEVICE | IRRAflow® Active Fluid |
| Trade name: | Exchange System (AFES) |
| Common Name:<br>Regulatory Class: | CSF Drainage System with ventricular catheter<br>II |
| Primary Product<br>Code: | JXG (21 CFR 882.5550 Central Nervous System Fluid Shunt<br>and Components) |
| Secondary<br>Product Code: | GWM (21 CFR 882.1620 Intracranial Pressure Monitoring Device, per 21 CFR<br>807.92(a)(2)) |
| III. PREDICATE<br>DEVICE | K222471, IRRAflow Active Fluid Exchange System |
| | No reference devices were used in this submission. |

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### IV. DEVICE DESCRIPTION

The IRRAflow® Active Fluid Exchange System (AFES) is an intracranial pressure (ICP) monitoring and drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. 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. The IRRAflow Drainage Collection System is attached to the Control Unit, using the Laser Leveler for defining the height of the Drainage Collection System 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 Drainage Collection System.

#### V. INDICATIONS FOR USE

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.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The IRRAflow® AFES intended use, technological characteristics and principles of operation are the same or similar as those of the predicate device described in K222471 and the earlier device cleared in K200807 as shown for comparison in Table 1.

Comparison of these devices shows that the differences between the subject and predicate devices are the Tube Set and drainage bag components. designated as version 3.0. The currently cleared and marketed Tube Set is designated as version 2.0. Data presented definitively support the IRRAS conclusion that Tube Set version 3.0 continues to be as safe and effective as its cleared predecessor, Tube Set version 2.0.

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## Table 1: Substantial Equivalence (SE) Comparison

| Item | IRRAflow® CNS System<br>(K200807)<br>(JXG), (GWM) | PREDICATE<br>IRRAflow® AFES<br>(K222471)<br>(JXG), (GWM) | IRRAflow® AFES<br>Traditional<br>510(k) K231664<br>(JXG),(GWM)<br>Equivalence |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The use of IRRAflow® CNS<br>System is indicated when<br>intracranial pressure<br>monitoring is required and<br>for externally draining<br>intracranial fluid as a means<br>of reducing intracranial<br>pressure in patients where<br>an external drainage and<br>monitoring system is<br>needed. | The use of the IRRAflow®<br>Active Fluid Exchange<br>System is indicated when<br>intracranial pressure<br>monitoring is required and<br>for externally draining<br>intracranial fluid as a means<br>of reducing intracranial<br>pressure in patients where an<br>external drainage and<br>monitoring system is needed. | Similar<br>The use of IRRAflow®<br>Active Fluid Exchange<br>System is indicated when<br>intracranial pressure<br>monitoring is required, and<br>for externally draining<br>intracranial fluid, as a means<br>of reducing intracranial<br>pressure in patients where an<br>external drainage and<br>monitoring system is needed. |
| Injection/ CSF<br>Sampling<br>Ports | Yes | Yes | Yes |
| Unidirectional<br>Flow of Drained Fluid | Yes | Yes | Yes |
| Fluid Injection<br>Capability | Yes | Yes | Yes |
| Sterile Disposable<br>Tube Set | Tube Set version 2.0 | Tube Set version 2.0 | Tube Set version 3.0 |
| CSF Drainage Bag | Co-packaged with Tube Set<br>version 2.0 | Co-packaged with Tube Set<br>version 2.0 | Drainage Collection System<br>Separately packaged |
| Gravity drainage of<br>CSF | Yes | Yes | Yes |
| Method to control<br>gravity drainage of<br>CSFF | Automated adjustment based<br>on user settings via a<br>stepper-motor controlled,<br>tube pinching mechanism to<br>either compress or release<br>the compliant drainage<br>tubing contained within the<br>sterile, disposable Cartridge. | Automated adjustment based<br>on user settings via a<br>stepper-motor controlled,<br>tube pinching mechanism to<br>either compress or release<br>the compliant drainage<br>tubing contained within the<br>sterile, disposable Cartridge. | Yes, automated adjustment<br>based on user settings via a<br>stepper-motor controlled, tube<br>pinching mechanism to either<br>compress or release the<br>compliant drainage tubing<br>contained within the sterile,<br>disposable Cartridge. |
| Pressure Transducer<br>for ICP Measurement | The IRRAflow®<br>system integrates transducers<br>into its design for<br>measurement and visual<br>display of ICP | The IRRAflow® system<br>integrates transducers into its<br>design for<br>measurement and visual<br>display of ICP | Yes, the IRRAflow® system<br>integrates transducers into its<br>design<br>for measurement and visual<br>display of ICP |
| Item | IRRAflow® CNS System<br>(K200807)<br>(JXG), (GWM) | PREDICATE<br>IRRAflow® AFES<br>(K222471)<br>(JXG), (GWM) | IRRAflow® AFES<br>Traditional 510(k)<br>K231664<br>(JXG),(GWM)<br>Equivalence |
| Software-based,<br>Powered Console for<br>User Interface, User<br>Settings and Alarm<br>Adjustments, Data<br>Storage and Display,<br>and Alarms for ICP<br>monitoring | Yes | Yes | Yes |
| Measured Pressure<br>Range | -80 mmHg to +100 mmHg | -100 to +300 mmHg | -100 to +300 mmHg |
| Displayed ICP | Yes | Yes | Yes |
| Battery Back-up for<br>Control Unit | Yes | Yes | Yes |

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K231664, Page 4 of 8

A review of Table 1 shows that there is no change to the intended use of the IRRAflow® System. Changes made to the Tube Set and Drainage Collection System required additional testing, including verification and validation of continued functionality with material changes. There are no changes to the principles of operation of the IRRA/low® System. Any new safety and effectiveness issues related to the Tube Set and Drainage Collection System modifications are addressed in the FMEA and Risk Analysis. Table 2 provides a comparison of the Tube Set 2.0 characteristics to those of the Tube Set 3.0.

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# Table 2: Tube Set 2.0 and Tube Set 3.0 Comparison

| Device characteristic | Tube Set 2.0<br>Predicate | Tube Set 3.0<br>K231664 | Rationale |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Revision of the internal<br>fluid-contacting pinch<br>valve ball 2.5 mm<br>diameter stainless-steel<br>ball | Stainless Steel 440C | Corrosion resistant<br>Stainless Steel Alloy<br>316L | This material change<br>will prevent component<br>corrosion during the life<br>cycle of the device. |
| 2. Modification of the<br>sensor housing clamp | Wedge to wedge<br>pinch clamp (sensor<br>housing to calibration<br>hub). The two<br>wedges becoming<br>offset will result in<br>failure to achieve<br>appropriate pinch<br>pressure to halt flow,<br>resulting in leakage<br>out of the<br>atmospheric port at<br>clinically relevant<br>temperatures. | Modified Sensor<br>Clamp, Cassette | Improved leak<br>resistance |
| 3. Addition of a<br>protective layer of heat<br>shrink tubing to<br>pressurized manifold<br>barb connections. | No heat shrink<br>protective layer | Heat shrink protective<br>layer, compatible with<br>normal physiological<br>pressure range during<br>use, and designed to<br>withstand -110 to<br>+550mmHg pressure<br>without mechanical<br>damage such as tubing<br>collapse or bursting | Improved device<br>performance at high<br>pressures; heat shrink<br>will act as a secondary<br>protection to prevent<br>leaks when high<br>pressures are<br>inadvertently applied to<br>the device. |
| 4. Improved the fluid<br>flow through the<br>irrigation line by<br>removing the check valve<br>between the irrigation<br>spike and cassette. | In line irrigation<br>tubing check valve | Check valve removed<br>from irrigation line<br>tubing | The head pressure of a<br>full irrigation bag<br>(1000mL) with a fully<br>extended irrigation<br>tubing is 1.15 psi. The<br>cracking pressure of<br>the specified check<br>valve (1.5 - 5psi) is<br>overqualified for this<br>use case, causing<br>turbulent flow past the<br>check valve leading to<br>the formation of small<br>to large air bubbles in<br>the irrigation line. |
| 5. Addition of molded<br>strain reliefs | Non-molded strain<br>relief. | Molded strain relief -<br>the fit, form and | Added to improve the<br>device performance, |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| | | function of the strain<br>relief has not changed.<br>Strain relief will now<br>be molded for ease of<br>manufacturing. | and for ease of<br>manufacturing |
| 6. Removal of luer<br>connections | Luer connections<br>between the Cassette<br>and Catheter on the<br>irrigation line, and the<br>pinch clamp between<br>the irrigation bag and<br>cassette on the<br>irrigation line have<br>been removed | No luer connections | These components<br>are not required for<br>system function or<br>performance |
| 7. Addition of Labels<br>to tubing lines | Irrigation and<br>drainage lines without<br>labels | Labels on tubing lines:<br>identifies irrigation<br>tubing, drainage<br>tubing and drainage<br>bag tubing | Improved usability |
| 8. Addition of a Tyvek<br>sleeve, provided in the<br>tube set assembly | No Tyvek sleeve in<br>tube set assembly | Tyvek sleeve in tube<br>set assembly | To protect the<br>irrigation to drainage<br>line tube connection<br>from accidental<br>sterile field failures<br>during priming |
| 9. Length of tube lines<br>on the catheter side of<br>the cassette | Current length of<br>tubing lines on<br>catheter side of the<br>cassette are 47<br>inches/1195 mm ±<br>20. | Increased length by 12<br>inches; the length of<br>irrigation and drainage<br>tubing on the catheter<br>side of<br>the component is now<br>1500 mm ± 20. | To allow for typical<br>patient care<br>procedures with<br>associated patient<br>position changes |
| 10. Drainage bag | Tube Set 2.0 is co-<br>packaged and<br>sterilized with the<br>drainage bag | Tube Set 3.0is<br>packaged separately<br>from the Drainage<br>Collection System | Allows for<br>independent<br>replacement of these<br>system components<br>when indicated |
| 11. Packaging<br>upgraded to meet brand<br>standards. | Tyvek pouch only | More durable Tyvek<br>pouch with the<br>product mounted on<br>a labeled<br>presentation card. A<br>new 1-up carton,<br>and 5-up shipper<br>will be used for<br>shipping. | The labeled<br>presentation card will<br>help maintain<br>sterility during<br>system set-up and<br>add guidance on how<br>to properly set up the<br>device |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| 12. Increased shelf life | Shelf life set at 18<br>months | Shelf life extended<br>to 36 months | Real time and<br>accelerated aging<br>studies support 36<br>month expiry for<br>sterile packaging |

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K231664, Page 6 of 8

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K231664, Page 7 of 8

## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination (Table 3).

#### Table 3: Testing Summary

| Test | Test Method Summary | Results |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Biocompatiblity Testing | | |
| Cytotoxicity | The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. | PASS |
| Sensitization Test | This test was designed to evaluate the allergenic potential or sensitizing capacity of a test article. | PASS |
| Irritation/Intracutaneous Reactivity Test | The purpose of the test was to determine if any chemicals that may leach or be extracted from the test article were capable of causing local irritation in the dermal tissues of rabbits. | PASS |
| Acute Systemic Toxicity, Injection Test | The purpose of the test was to screen test article extracts for potential toxic effects as a result of a single-dose systemic injection in mice. | PASS |
| Systemic Toxicity, Mediated Pyrogen | The purpose of the study is to determine if a saline extract of the test article causes a febrile response in rabbits. | PASS |
| Genotoxicity | The purpose of the study is to evaluate the potential mutagenicity of the test article extract on various strains of bacteria. | PASS |
| Genotoxicity | The purpose of the study is to evaluate the potential mutagenicity effect of the test article extract on mouse lymphoma cells | PASS |
| Bench and Electrical Testing | | |
| Electrical Requirements Verification | Pressure accuracy per protocol | PASS |
| Mechanical Performance Verification | Durability, flow and freedom from leakage per protocol | PASS |
| Life Cycle Verification Test | Simulated use testing to demonstrate lifecycle reliability | PASS |
| Shelf Life / Package Integrity Testing | | |
| Simulated Distribution Test | ASTM D4332-14<br>ASTM D4169-22 Cycle 13 | PASS |
| Package Integrity Test | ASTM F1886-16<br>ASTM F2096-11 | PASS |
| Package Seal Strength Test | EN 868-5:2009 | PASS |
| Aging Test | Accelerated and real time aging | PASS |
| Sterilization Testing | | |
| Sterilization Process for the IRRAflow Intelligent Cassette and IRRAflow Drainage Collection System | Study conducted to validate the effectiveness of Ethylene Oxide sterilization of IRRAflow Intelligent Cassette and IRRAflow Drainage Collection System | PASS |

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#### Conclusion

The IRRAflow® AFES is substantially equivalent to the predicate device (K222471). The IRRAflow® AFES has the same Indications for Use, similar technological characteristics, and the same principles of operation as the predicate device. Performance testing demonstrates the changes to the Tube Set designated as version 3.0 and Drainage Collection System do not change or adversely impact the operational parameters of the IRRAflow® System.