(134 days)
No reference devices were used in this submission.
No
The description focuses on mechanical and electrical components, fluid dynamics, and user interface controls. There is no mention of AI/ML terms, image processing, or data-driven decision-making beyond basic control logic based on pressure and flow.
No
The device is primarily a monitoring and fluid drainage system, not a device that directly treats a disease or condition itself. While it helps manage intracranial pressure, its function is more supportive and diagnostic (monitoring) than therapeutic in the sense of actively healing or curing.
Yes
The device is explicitly stated to be for "intracranial pressure monitoring," which is a diagnostic function.
No
The device description clearly outlines multiple hardware components including a catheter, tube set with a cassette, peristaltic pump, pinch valve, control unit, drainage collection system, and laser leveler. This is not a software-only device.
Based on the provided information, the IRRAflow Active Fluid Exchange System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is focused on monitoring intracranial pressure and draining intracranial fluid directly from the patient's body. This is a therapeutic and monitoring function performed in vivo (within the living organism).
- Device Description: The description details a system that interacts directly with the patient's intracranial space via a catheter. It involves fluid exchange (infusion and drainage) and pressure measurement within the body.
- 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 system does not perform this function. While it can collect CSF samples, the primary function is not the in vitro analysis of these samples for diagnostic purposes.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG, GWM
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.
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
professional medical hospital personnel, trained and experienced in neurosurgical medical care.
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)
Biocompatiblity Testing:
- Cytotoxicity: The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. Results: PASS
- Sensitization Test: This test was designed to evaluate the allergenic potential or sensitizing capacity of a test article. Results: 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. Results: 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. Results: 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. Results: PASS
- Genotoxicity: The purpose of the study is to evaluate the potential mutagenicity of the test article extract on various strains of bacteria. Results: PASS
- Genotoxicity: The purpose of the study is to evaluate the potential mutagenicity effect of the test article extract on mouse lymphoma cells. Results: PASS
Bench and Electrical Testing:
- Electrical Requirements Verification: Pressure accuracy per protocol. Results: PASS
- Mechanical Performance Verification: Durability, flow and freedom from leakage per protocol. Results: PASS
- Life Cycle Verification Test: Simulated use testing to demonstrate lifecycle reliability. Results: PASS
Shelf Life / Package Integrity Testing:
- Simulated Distribution Test: ASTM D4332-14 ASTM D4169-22 Cycle 13. Results: PASS
- Package Integrity Test: ASTM F1886-16 ASTM F2096-11. Results: PASS
- Package Seal Strength Test: EN 868-5:2009. Results: PASS
- Aging Test: Accelerated and real time aging. Results: 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. Results: PASS
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.
No reference devices were used in this submission.
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
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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: | jeanne.warner@irras.com |
Secondary Contact:
| Adam Sampson
VP, Product
Excellence
Phone Number:
Email: | 619-992-1861
adam.sampson@irras.com |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Date prepared: | October 18, 2023 |
| II. DEVICE | IRRAflow® Active Fluid |
| Trade name: | Exchange System (AFES) |
| Common Name:
Regulatory Class: | CSF Drainage System with ventricular catheter
II |
| Primary Product
Code: | JXG (21 CFR 882.5550 Central Nervous System Fluid Shunt
and Components) |
| Secondary
Product Code: | GWM (21 CFR 882.1620 Intracranial Pressure Monitoring Device, per 21 CFR
807.92(a)(2)) |
| III. PREDICATE
DEVICE | K222471, IRRAflow Active Fluid Exchange System |
| | No reference devices were used in this submission. |
5
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.
6
Table 1: Substantial Equivalence (SE) Comparison
| Item | IRRAflow® CNS System
(K200807)
(JXG), (GWM) | PREDICATE
IRRAflow® AFES
(K222471)
(JXG), (GWM) | IRRAflow® AFES
Traditional
510(k) K231664
(JXG),(GWM)
Equivalence |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Similar
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. |
| Injection/ CSF
Sampling
Ports | Yes | Yes | Yes |
| Unidirectional
Flow of Drained Fluid | Yes | Yes | Yes |
| Fluid Injection
Capability | Yes | Yes | Yes |
| Sterile Disposable
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
version 2.0 | Co-packaged with Tube Set
version 2.0 | Drainage Collection System
Separately packaged |
| Gravity drainage of
CSF | Yes | Yes | Yes |
| Method to control
gravity drainage of
CSFF | 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. | 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. |
| Pressure Transducer
for ICP Measurement | The IRRAflow®
system integrates transducers
into its design for
measurement and visual
display of ICP | 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 |
| Item | IRRAflow® CNS System
(K200807)
(JXG), (GWM) | PREDICATE
IRRAflow® AFES
(K222471)
(JXG), (GWM) | IRRAflow® AFES
Traditional 510(k)
K231664
(JXG),(GWM)
Equivalence |
| Software-based,
Powered Console for
User Interface, User
Settings and Alarm
Adjustments, Data
Storage and Display,
and Alarms for ICP
monitoring | Yes | Yes | Yes |
| Measured Pressure
Range | -80 mmHg to +100 mmHg | -100 to +300 mmHg | -100 to +300 mmHg |
| Displayed ICP | Yes | Yes | Yes |
| Battery Back-up for
Control Unit | Yes | Yes | Yes |
7
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.
8
Table 2: Tube Set 2.0 and Tube Set 3.0 Comparison
| Device characteristic | Tube Set 2.0
Predicate | Tube Set 3.0
K231664 | Rationale |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Revision of the internal
fluid-contacting pinch
valve ball 2.5 mm
diameter stainless-steel
ball | Stainless Steel 440C | Corrosion resistant
Stainless Steel Alloy
316L | This material change
will prevent component
corrosion during the life
cycle of the device. |
| 2. Modification of the
sensor housing clamp | Wedge to wedge
pinch clamp (sensor
housing to calibration
hub). The two
wedges becoming
offset will result in
failure to achieve
appropriate pinch
pressure to halt flow,
resulting in leakage
out of the
atmospheric port at
clinically relevant
temperatures. | Modified Sensor
Clamp, Cassette | Improved leak
resistance |
| 3. Addition of a
protective layer of heat
shrink tubing to
pressurized manifold
barb connections. | No heat shrink
protective layer | Heat shrink protective
layer, compatible with
normal physiological
pressure range during
use, and designed to
withstand -110 to
+550mmHg pressure
without mechanical
damage such as tubing
collapse or bursting | Improved device
performance at high
pressures; heat shrink
will act as a secondary
protection to prevent
leaks when high
pressures are
inadvertently applied to
the device. |
| 4. Improved the fluid
flow through the
irrigation line by
removing the check valve
between the irrigation
spike and cassette. | In line irrigation
tubing check valve | Check valve removed
from irrigation line
tubing | The head pressure of a
full irrigation bag
(1000mL) with a fully
extended irrigation
tubing is 1.15 psi. The
cracking pressure of
the specified check
valve (1.5 - 5psi) is
overqualified for this
use case, causing
turbulent flow past the
check valve leading to
the formation of small
to large air bubbles in
the irrigation line. |
| 5. Addition of molded
strain reliefs | Non-molded strain
relief. | Molded strain relief -
the fit, form and | Added to improve the
device performance, |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| | | function of the strain
relief has not changed.
Strain relief will now
be molded for ease of
manufacturing. | and for ease of
manufacturing |
| 6. Removal of luer
connections | Luer connections
between the Cassette
and Catheter on the
irrigation line, and the
pinch clamp between
the irrigation bag and
cassette on the
irrigation line have
been removed | No luer connections | These components
are not required for
system function or
performance |
| 7. Addition of Labels
to tubing lines | Irrigation and
drainage lines without
labels | Labels on tubing lines:
identifies irrigation
tubing, drainage
tubing and drainage
bag tubing | Improved usability |
| 8. Addition of a Tyvek
sleeve, provided in the
tube set assembly | No Tyvek sleeve in
tube set assembly | Tyvek sleeve in tube
set assembly | To protect the
irrigation to drainage
line tube connection
from accidental
sterile field failures
during priming |
| 9. Length of tube lines
on the catheter side of
the cassette | Current length of
tubing lines on
catheter side of the
cassette are 47
inches/1195 mm ±
20. | Increased length by 12
inches; the length of
irrigation and drainage
tubing on the catheter
side of
the component is now
1500 mm ± 20. | To allow for typical
patient care
procedures with
associated patient
position changes |
| 10. Drainage bag | Tube Set 2.0 is co-
packaged and
sterilized with the
drainage bag | Tube Set 3.0is
packaged separately
from the Drainage
Collection System | Allows for
independent
replacement of these
system components
when indicated |
| 11. Packaging
upgraded to meet brand
standards. | Tyvek pouch only | More durable Tyvek
pouch with the
product mounted on
a labeled
presentation card. A
new 1-up carton,
and 5-up shipper
will be used for
shipping. | The labeled
presentation card will
help maintain
sterility during
system set-up and
add guidance on how
to properly set up the
device |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| 12. Increased shelf life | Shelf life set at 18
months | Shelf life extended
to 36 months | Real time and
accelerated aging
studies support 36
month expiry for
sterile packaging |
9
K231664, Page 6 of 8
10
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 | |
| ASTM D4169-22 Cycle 13 | PASS | |
| Package Integrity Test | ASTM F1886-16 | |
| 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 |
11
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.