Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and gravity-driven fluid management with a control unit for settings and monitoring, with no mention of AI/ML terms or capabilities.

Therapeutic

Yes.
The device is used for reducing intracranial pressure through drainage and monitoring, which directly treats a medical condition.

Diagnostic

Yes

The device "measures ICP" (intracranial pressure), which is a physiological parameter used to diagnose and monitor medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a Control Unit, Tube Set, Catheter, peristaltic pump, pinch valve, and aspiration bag, indicating it is a physical medical device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the IRRAflow® CNS System is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for monitoring intracranial pressure and draining intracranial fluid from the patient's body. This is a direct intervention on the patient, not the analysis of a sample taken from the patient.
Device Description: The device describes a system for drainage and monitoring in situ (within the patient's head). While it mentions that CSF samples can be taken from an aspiration port, the primary function is not the analysis of these samples.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The IRRAflow® CNS System does not perform this function.

The device is clearly described as a system for managing intracranial pressure and fluid within the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The use of IRRAflow® CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.

Product codes

JXG, GWM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain ventricles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench and Electrical Testing:

IRRAflow® CNS System Verification: Purpose was to document results of system verification testing and system regression verification testing. Results: PASS, System shown to comply with documented requirements.
IRRAflow® CNS System Validation: Purpose was to ensure compliance with established requirements. Results: PASS, System shown to comply with documented requirements.
IRRAflow® CNS System Static Analysis: Purpose was to describe process and results from static analysis of the IRRAflow CNS system software. Results: PASS, No errors encountered.
Basic Safety test: Tests conducted included Input Test; Heating Test; Leakage Current Test; Dielectric Voltage Test. Results: PASS, Acceptance criteria met.
Electromagnetic Compatibility test: Objective was to determine compliance with IEC 60601-1-2:2014 Class B. Results: PASS, Acceptance criteria met.
IRRAflow Catheter Performance Test: Purpose was to describe tensile test results for the IRRAS catheter. Results: PASS, Acceptance criteria met.
IRRAflow Catheter Torsion and Shear Test: Purpose was to describe torsion and shear testing results for the IRRAS catheter. Results: PASS, Acceptance criteria met.
IRRAflow Catheter Drainage Flow Test: Purpose was to describe drainage testing methods for the IRRAS catheter. Results: PASS, Acceptance criteria met.

Shelf Life / Package Integrity Testing:

Validation of sterile barrier: Purpose was to describe procedures for validating that the sterile barrier meets design and standards requirements. Results: PASS, Acceptance criteria met.
Packaging Peel Test: Purpose was to describe roll packing seal testing results for the IRRAS catheter and tube set. Results: PASS, Acceptance criteria met.
Aging Test: Purpose was to describe objective evidence that the IRRAS catheter and tube set meet the appropriate requirements for transportation and aging. Results: PASS, Acceptance criteria met.

Sterilization Testing:

Sterilization process for the IRRAflow Catheter and IRRAflow Tube Set: This study was conducted to validate the effectiveness of electron beam radiation of IRRAflow Catheter and Ethylene Oxide sterilization of IRRAflow Tube Set. Results: PASS, Acceptance criteria met.

Biocompatibility Testing:

Systemic Toxicity, Mediated Pyrogen: Purpose was to determine if a saline extract causes a febrile response in rabbits. Results: PASS, non-pyrogenic.
Acute Systemic Toxicity, Injection Test: Purpose was to screen test article extracts for potential toxic effects from a single-dose systemic injection in mice. Results: PASS, No abnormal clinical signs.
Irritation/Intracutaneous Reactivity Test: Purpose was to determine if chemicals that may leach or be extracted from the test article were capable of causing local irritation in dermal tissues of rabbits. Results: PASS, No abnormal clinical signs.
Indirect Hemolysis (Extract) Test: Test designed to determine hemolytic properties. Results: PASS, All test method acceptance criteria were met.
Cytotoxicity (MEM Elution) Test: Test designed to determine cytotoxicity of extractable substances. Results: PASS, All test method acceptance criteria were met.
Sensitization Test: Test designed to evaluate allergenic potential or sensitizing capacity. Results: PASS, No abnormal clinical signs.
Genotoxicity: Test designed to screen products and materials for structural chromosome aberrations in Chinese Hamster Ovary (CMC) cells. Results: PASS, All test method acceptance criteria were met.
Implant Study: Study conducted for test of local effects after implantation. Results: PASS, All test method acceptance criteria were met.
Subacute Toxicity: Purpose was to examine toxicological hazard and evaluate risks related to biological endpoints of subacute/subchronic and chronic toxicity. Results: PASS, All test method acceptance criteria were met.

Key Metrics

Not Found

Predicate Device(s)

IRRAflow® CNS System (K171880)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

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 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

2

Indications for Use

510(k) Number (if known) K192289

Device Name IRRAflow® CNS System

Indications for Use (Describe)

The use of IRRAflow® CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.

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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3

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)

4

DEVICE DESCRIPTION

The IRRAflow® CNS System is an intracranial pressure (ICP) monitoring and drainage system. The IRRAflow® CNS System consists of an IRRAflow Control Unit and two sterile disposable parts, the IRRAflow Tube Set and the IRRAflow Catheter.

The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. An aspiration bag is attached to the Control Unit tape measure, defining the height of the bag relative to the catheter's tip position in the patient's head and thus controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit.

The default mode provides drainage and measuring ICP, allowing single bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the aspiration port.

INDICATIONS FOR USE

The use of IRRAflow 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.

5

| Items | PREDICATE | IRRAflow® CNS System
(JXG), (GWM)
(New) | Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | IRRAflow® CNS System (K171880)
(JXG), (GWM) | | |
| Primary Product | JXG | JXG | Same |
| Primary Regulation
Number: | 21 CFR 882.5550 | 21 CFR 882.5550 | Same |
| Secondary Product | GWM | GWM | Same |
| Secondary Regulation
Number: | 21 CFR 882.1620 | 21 CFR 882.1620 | Same |
| Indications for Use | The use of IRRAflow® CNS System
is indicated when intracranial
pressure monitoring is required and
for externally draining intracranial
fluid as a means of reducing
intracranial pressure in patients where
an external drainage and monitoring
system is needed for ≤ 24 hours. | 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. | See
discussion
below |
| Injection/ CSF
Sampling Ports | Yes | Yes | Same |
| Unidirectional
Flow of Drained Fluid | Yes | Yes | Same |
| Fluid Injection
Capability | Yes | Yes | Same |
| Attaches to separate,
commercially
available EVD
Catheter | Yes
The IRRAflow system attaches to
IRRAflow Catheter which is an EVD
Catheter part of the complete system. | Yes
The IRRAflow system attaches to
IRRAflow Catheter which is an EVD
Catheter part of the complete system. | Same |
| Sterile Disposable
tubing set | Yes | Yes | Same |
| CSF Drainage Bag | Yes | Yes | Same |
| Gravity drainage of
Method to control
gravity drainage of
CSF | Yes
Automated adjustment based on user
settings via a stepper-motor
controlled, tube-pinching mechanism
to either compress or release the
compliant drainage tubing contained
within the sterile, disposable
Cartridge. | Yes
Automated adjustment based on user
settings via a stepper-motor
controlled, tube-pinching mechanism
to either compress or release the
compliant drainage tubing contained
within the sterile, disposable
Cartridge. | Same |
| Pressure Transducer
for ICP Measurement | Yes
(The IRRAflow system integrates
transducers into its design for
measurement and visual display of
ICP) | Yes
(The IRRAflow system integrates
transducers into its design for
measurement and visual display of
ICP) | Same |
| Items | PREDICATE
IRRAflow® CNS System (K171880)
(JXG), (GWM) | IRRAflow® CNS System
(JXG), (GWM)
(New) | Equivalence |
| Software-based,
Powered Console for
User Interface, User
Settings and Alarm
Adjustments, Data
Storage and Display,
and Alarms for ICP | Yes | Yes | Same |
| Method to account for
location of ventricles
via patient head
position | Reference marks on the device to
allow for the system to be aligned
with patient's head positioning. | Reference marks on the device to
allow for the system to be aligned
with patient's head positioning. | Same |
| Measured Pressure
Range | -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

6

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 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.	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.	The difference in the indications for
us in the duration of monitoring.
The indications for use for the
predicate (K171880) was ≤ 24
hours. Biocompatibility testing has
been conducted and provided with
this submission that the duration of
use can be > 24 hours but less than or
equal 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

7

| Items | PREDICATE
IRRAflow® CNS System Catheter
(K171880) | IRRAflow® CNS System Catheter
(New) | Equivalence |
|---------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------|
| Target Population | Any patient needing removal of
intracranial fluids from the brain
ventricles | Any patient needing removal of
intracranial fluids from the brain
ventricles | Same |
| Anatomical Sites | Brain ventricles | Brain ventricles | Same |
| Implant Procedure | Designed to be placed through a
prepared opening through the skull
and into the brain ventricle | Designed to be placed through a
prepared opening through the skull
and 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 Depth
Markers | Yes | Yes | Same |
| Catheter material | Silicone | Silicone | Same |
| Antimicrobial
Agents | None | None | Same |
| Catheter Tip | Radiopaque | Radiopaque | Same |
| Biocompatibility | Tissue contact tested per ISO 10993:
Biological Evaluation of
Medical Devices | Tissue contact tested per ISO 10993:
Biological Evaluation of
Medical 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

8

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 a
saline extract of the test article causes a febrile
response in rabbits.	PASS Clinical Observations: The test
article were determined to be non-
pyrogenic.
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 Clinical Observations: None of
the animals on study were observed with
abnormal clinical signs indicative of
toxicity during the test period.
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 Clinical Observations: None of the animals on study showed
abnormal clinical signs during the
observation periods.
Indirect Hemolysis
(Extract) Test	The test is designed to determine the hemolytic
properties of a medical device/material.	PASS Clinical Observations: All test
method acceptance criteria were met.
Cytotoxicity (MEM
Elution) Test	The Minimal Essential Media (MEM) Elution test
was designed to determine the cytotoxicity of
extractable substances.	PASS Clinical Observations: All test
method acceptance criteria were met.
Sensitization Test	This test was designed to evaluate the allergenic
potential or sensitizing capacity of a test article.	PASS Clinical Observations: None of
the animals in the study showed
abnormal clinical signs.
Genotoxicity	The test was designed to screen the products and
materials to determine if they cause structural
chromosome aberrations in industry standard
Chinese Hamster Ovary (CMC) cells.	PASS Clinical Observations: All test
method acceptance criteria were met.
Implant Study	This study was conducted for test of local effects
after implantation.	PASS Clinical Observations: All test
method acceptance criteria were met.
Subacute Toxicity	The purpose of this study is to closely examine
the toxicological hazard and to evaluate and
address any risks associated with the biological
endpoints of subacute/subchronic and chronic
toxicity.	PASS Clinical Observations: All test
method acceptance criteria were met.
Test	Test Method Summary	Results
Bench and Electrical Testing
IRRAflow® CNS System
Verification	The purpose of this test is to document the results of the system verification testing and system
regression verification testing.	PASS The system has been shown to
comply with the documented
requirements for the system.
IRRAflow® CNS System
Validation	The validation test procedures for the IRRAS
IRRAflow CNS system were designed to ensure
that the device complies with established
requirements.	PASS The system has been shown to
comply with the documented
requirements for the system.
IRRAflow® CNS System
Static Analysis	The purpose of this test is to describe the process and results from the static analysis of the
IRRAflow CNS system software.	PASS There were no errors encountered
when the static analysis was conducted.
Basic Safety test	The following tests were conducted: Input Test;
Heating Test; Leakage Current Test; Dielectric
Voltage Test.	PASS Acceptance criteria has been met.
Electromagnetic
Compatibility test	The objective of the testing is to determine
compliance with IEC 60601-1-2:2014 Class B.	PASS Acceptance criteria has been met.
IRRAflow Catheter
Performance Test	The purpose of this test is to describe the tensile
test results for the IRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow Catheter
Torsion and Shear Test	The purpose of this test is to describe the torsion
and shear testing results for the IRRAS catheter.	PASS Acceptance criteria has been met.
IRRAflow Catheter
Drainage Flow Test	The purpose of this test is to describe the drainage
testing 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 the
procedures for validating that the sterile barrier
meets design and standards requirements.	PASS Acceptance criteria has been met.
Packaging Peel Test	The purpose of this test is to describe the roll
packing seal testing results for the IRRAS
catheter and tube set.	PASS Acceptance criteria has been met.
Aging Test	The purpose of this test is to describe the
objective evidence that the IRRAS catheter and
tube set meet the appropriate requirements for
transportation and aging.	PASS Acceptance criteria has been met.
Sterilization Testing
Sterilization process for
the IRRAflow Catheter
and IRRAflow Tube Set	This study was conducted to validate the
effectiveness of electron beam radiation of
IRRAflow Catheter and Ethylene Oxide
sterilization of IRRAflow Tube Set.	PASS Acceptance criteria has been met.

Table 3 - IRRAflow® CNS System Testing

9

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

10

Recognized Consensus Standards:

Recognized Consensus Standards:
The IRRAflow® CNS System was developed in compliance with the following standards:
Standard	FR Recognition
List Number	FR Recognition
Number	Date of
Recognition
ISO 10993-1 Fourth Edition 2009-10-15, Biological
Evaluation Of Medical Devices - Part 1: Evaluation
And 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, Biological
Evaluation Of Medical Devices - Part 3: Tests For
Genotoxicity, Carcinogenicity And Reproductive
Toxicity	044	2-228	07/26/2016
ISO 10993-4 Third Edition 2017-04 Biological
Evaluation Of Medical Devices--Part 4: Selection
Of Tests For Interactions With Blood	047	2-248	08/21/2017
ISO 10993-5 Third Edition 2009-06-01, Biological
Evaluation Of Medical Devices - Part 5: Tests For In
Vitro Cytotoxicity	046	2-245	12/23/2016
ISO 10993-6 Third Edition 2016-12-01, Biological
Evaluation Of Medical Devices -- Part 6: Tests For
Local Effects After Implantation	047	2-247	08/21/2017
ISO 10993-10 Third Edition 2010-08-01, Biological
Evaluation Of Medical Devices - Part 10: Tests For
Irritation 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 Of
Health-Care Products - Ethylene Oxide -
Requirements For The Development, Validation
And Routine Control Of A Sterilization Process For
Medical Devices	041	14-452	04/04/2016
ISO 11137-1 First Edition 2006-04-15, Sterilization
Of Health Care Products - Radiation - Part 1:
Requirements For Development, Validation And
Routine Control Of A Sterilization Process For
Medical 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 Recognition
List Number	FR Recognition
Number	Date of
Recognition
ISO 11137-2 Third Edition 2013-06-01, Sterilization
Of Health Care Products - Radiation - Part 2:
Establishing The Sterilization Dose	041	14-409	04/04/2016
ISO 11607-1 First Edition 2006-04-15, Packaging
For Terminally Sterilized Medical Devices - Part 1:
Requirements For Materials, Sterile Barrier Systems
And Packaging Systems [Including: Amendment 1
(2014)]	038	14-454	01/27/2015
ISO 14971 Second Edition 2007-03-01, Medical
Devices - Application Of Risk Management To
Medical Devices	043	5-40	06/27/2016
60601-1:2012, Medical Electrical Equipment - Part
1: General Requirements for Safety and essential
performance	036	19-4	07-09-2014
60601-1-2 Edition 4.0 2014-02, Medical Electrical
Equipment - Part 1-2: General Requirements For
Basic Safety And Essential Performance - Collateral
Standard: Electromagnetic Disturbances -
Requirements And Tests	050	19-8	09/17/2018
60601-1-8:2006 & A1:2012, Medical Electrical
Equipment -- Part 1-8: General Requirements For
Basic Safety And Essential Performance --
Collateral Standard: General Requirements, Tests
And Guidance For Alarm Systems In Medical
Electrical Equip.	031	5-76	08/06/2013

11

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.