(114 days)
Not Found
No
The description focuses on mechanical and electronic components (peristaltic pump, pinch valve, Laser Leveler, user interface) for controlling fluid drainage and monitoring ICP. There is no mention of AI/ML terms or functionalities like image processing, data analysis for prediction, or adaptive control based on learned patterns.
Yes
The device is indicated for reducing intracranial pressure (ICP) and for externally draining intracranial fluid, which are therapeutic interventions.
Yes
The device "measures ICP" (intracranial pressure), which is a physiological parameter used to assess a patient's condition, making it a diagnostic function.
No
The device description explicitly details hardware components such as a catheter, tube set, cassette, peristaltic pump, pinch valve, drainage bag, and control unit. The performance studies also mention testing done on the "IRRAflow AFES Control Unit 4.0," indicating a physical device.
Based on the provided text, the IRRAflow Active Fluid Exchange System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "intracranial pressure monitoring" and "externally draining intracranial fluid." This is a direct intervention on the patient's body, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a system that is inserted into the patient's head to drain fluid and monitor pressure. It involves a catheter, tubing, a control unit, and a drainage bag. This is consistent with a medical device used for treatment and monitoring in vivo.
- No mention of analyzing specimens: While the device allows for taking CSF samples, the primary function described is drainage and monitoring, not the analysis of these samples for diagnostic purposes. An IVD would be focused on the analysis of the fluid itself to provide diagnostic information.
Therefore, the IRRAflow Active Fluid Exchange System is a medical device used for direct patient care and monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG, GWM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device underwent verification and validation testing, with a summary provided in a table.
Key Results:
- Verification by Inspection: Acceptable
- BSM Requirements Verification: Pass (algorithmic in nature, with demonstration of passing results one one sample, with repeated tests as defined in the associated protocol, are valid for full requirement coverage)
- Electrical Requirements Verification: Not specified, but likely "Pass" given the column alignment.
- Mechanical Performance Verification: Pass (requirement pertains to the hardware component itself (i.e. pole clamp, drainage bag holder clip, etc.) and not on its interface with the control unit)
- Life Cycle Verification Test: Pass (All testing was completed on capital equipment, with multiple test repeats (as required) were used to demonstrate lifecycle reliability)
- Packaging Verification: Pass (No risk to user since device was found to work based on device functionality checked upon arrival after simulated transit)
The overall conclusion is that the IRRAflow AFES is substantially equivalent to the predicate device (K200807) and its changes do not adversely affect safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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 Sanchez
| Sr. 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
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.
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 | PREDICATE
IRRAflow® CNS
System (K192289)
(JXG), (GWM) | PREDICATE
IRRAflow® CNS
System (K200807)
(JXG), (GWM) | IRRAflow® AFES System
Special 510(k)
K222471
(JXG), (GWM)
Equivalence |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Product
Code | JXG | JXG | JXG |
| Primary Regulation
Number: | 21 CFR 882.5550 | 21 CFR 882.5550 | 21 CFR 882.5550 |
| Secondary
Product Code | GWM | GWM | GWM |
| Secondary
Regulation Number: | 21 CFR 882.1620 | 21 CFR 882.1620 | 21 CFR 882.1620 |
| Indications for Use | The use of IRRAflow®
CNS 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. | Same
The use of IRRAflow®
CNS 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. | Same
The use of IRRAflow® AFES
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. ** |
| Attributes | PREDICATE
IRRAflow® CNS System
(K192289)
(JXG), (GWM) | PREDICATE
IRRAflow® CNS System
(K200807)
(JXG), (GWM) | IRRAflow® AFES System
Special 510(k) K222471
(JXG), (GWM)
Equivalence |
| Injection/ CSF
Sampling
Ports | Yes | Yes | Yes |
| Unidirectional
Flow of Drained Fluid | Yes | Yes | Yes |
| Fluid Injection
Capability | Yes | Yes | Yes |
| Attaches to separate,
commercially
available EVD
Catheter | The IRRAflow® system
attaches to IRRAflow®
Catheter which is an EVD
Catheter part of the complete
system. | Same, the IRRAflow®
system attaches to
IRRAflow® Catheter which
is an EVD Catheter part of
the complete system. | Same, the IRRAflow®
system attaches to
IRRAflow® Catheter which
is an EVD Catheter part of
the complete system |
| Sterile Disposable
tubing set | Yes | Yes | Yes |
| CSF Drainage Bag | Yes | Yes | Yes |
| Gravity drainage of
CSF | Yes | Yes | Yes |
| Method to control
gravity drainage of
CSF | 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, 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, 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. |
| Pressure Transducer
for ICP Measurement | The IRRAflow®
system integrates transducers
into its design for
measurement and visual
display of ICP | Same, the IRRAflow®
system integrates transducers
into its design for
measurement and visual
display of ICP | Same, the IRRAflow®
system integrates
transducers into its design
for measurement and
visual display of ICP. |
| Attributes | PREDICATE
IRRAflow® CNS System
(K192289)
(JXG), (GWM) | PREDICATE
IRRAflow® CNS System (K200807)
(JXG), (GWM) | IRRAflow® AFES System
Special 510(k) (GWM, JXG)
Equivalence |
| Software-based,
Powered Console for
User Interface, User
Settings and Alarm
Adjustments, Data
Storage and Display,
and Alarms for ICP
monitoring | Yes | Yes | Substantially equivalent to
predicate, with addition of:
• Bedside monitoring ability
(BSMA)to export ICP data
stream compatible with
marketed bedside monitors,
with cables
• Increased volume for
system alarms
• Power system changes to
extend shelf life and improve
power shut down sequencing
• Allowance for 'off the
shelf' external power
supply
• Manufacturability
related changes to
board layout
• Bluetooth hardware for
future application
development
• User software enhancements,
including: case-specific
irrigation and drainage
settings, additional data
visualization onscreen
(trending, axis and unit
adjustments), auto priming
cassette functionality,
pressure accuracy
improvement
• Drainage collection system
mounting that allows
enhanced fluid drainage
collection |
| Measured Pressure
Range | -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 the | |
| associated requirements. Coverage was | ||
| demonstrated by analysis and presented in | ||
| a final trace matrix. | Acceptable | |
| BSM Requirements Verification | These testes are algorithmic in nature, with | |
| demonstration of passing results one one | ||
| sample, with repeated tests as defined in | ||
| the associated protocol, are valid for full | ||
| requirement coverage. | Pass | |
| Electrical Requirements Verification | ||
| Mechanical Performance Verification | As defined in the associated protocol, the | |
| requirement pertains to the hardware | ||
| component itself (i.e. pole clamp, drainage | ||
| bag holder clip, etc.) and not on its interface | ||
| with the control unit. | Pass | |
| Life Cycle Verification Test | All testing was completed on capital | |
| equipment, with multiple test repeats (as | ||
| required) were used to demonstrate lifecycle | ||
| reliability. | Pass | |
| Packaging Verification | No risk to user since device was found to | |
| work based on device functionality checked | ||
| upon 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.