(33 days)
No
The device description focuses on mechanical and gravity-driven fluid management, with no mention of AI or ML algorithms for control, analysis, or decision-making. The performance studies are related to the physical accessory and the existing system, not software or algorithmic performance.
Yes.
The device is used for monitoring intracranial pressure and externally draining intracranial fluid to reduce intracranial pressure, which are direct interventions for treating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "intracranial pressure monitoring," which is a diagnostic function. The "Device Description" also confirms it is an "intracranial pressure (ICP) monitoring and drainage system" and "provides drainage and measuring ICP".
No
The device description clearly outlines multiple hardware components including a Control Unit, Tube Set, Catheter, and Laser Leveler accessory, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside of the living body (in vitro).
- IRRAflow CNS System Function: The IRRAflow CNS System is designed to monitor intracranial pressure and drain intracranial fluid directly from the patient's head. This is a therapeutic and monitoring function performed within the living body (in vivo).
- Specimen Analysis: While the system allows for taking CSF or intracranial fluid samples, the device itself is not performing the diagnostic analysis of these samples. The samples would be sent to a laboratory for in vitro testing.
The description clearly outlines a system for managing intracranial pressure and fluid in vivo, not for analyzing specimens in vitro.
N/A
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 (comma separated list FDA assigned to the subject device)
JXG, GWM
Device Description
The IRRAflow CNS System is an intracranial pressure (ICP) monitoring and drainage system, and remains identical, as cleared under predicate 510(k) K192289. 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.
The only difference in the device presented in this Special 510(k) is the inclusion of the Laser Leveler Accessory tool, which supports and augments the IRRAflow CNS system by providing a more accurate and easier method for positioning the control unit (or drainage system) with the patients external auditory meatus (or external ear canal).
The IRRAflow® laser leveler is a reusable accessory to be utilized in conjunction with the IRRAflow® CNS system. The laser leveler generates a laser mark to assist in setting the height of the control unit. The IRRAflow® Laser Leveler device is provided with a mounting screw for use with the The IRRAflow® CNS control unit. The laser leveler has a power button and auto shuts off after approximately 20 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, patient's head (specifically, external auditory meatus / external ear canal, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation testing for the Laser Leveler:
Development and testing for the laser leveler was performed at a contract manufacturer, Meraqi Medical, Inc. (Freemont, CA). The laser testing was performed at a sub-contractor, Intertek (Menlo Park, CA). The design of the laser leveler was performed at IRRAS and transferred to Meraqi Medical for development (including design controls), testing and subsequently, manufacturing.
A full analysis of the laser leveler was performed, and a summary of the testing is presented in Table 2.
The testing includes:
- Dimensional: Verify units meet dimensional specification. Result: Pass.
- Visual (laser): Verify units have legible labeling and are free of damage and/or foreign particulate. Result: Pass.
- Visual (Packaging): Verify packaging is free of damage and labels are legible. Result: Pass.
- Functional Testing: Functional testing includes: button press, vertical position test, laser spot alignment, auto shutoff test, trunnion articulation. Result: Pass.
- IEC 60825-1: Laser safety testing: Wavelength and conformance to IEC 60825-1 standard. Result: Pass.
- IEC 60529 (IP22): Fluid ingress testing: Verify conformance to the IP2X requirements of IEC 60529 Edition 2.2. Result: Pass.
- ASTM D4332-14 - Package environmental conditioning: Conduct the conditioning test per ASTM D4332-14 on the packages: Extreme Cold: -30°C, uncontrolled RH for 24 hours; Tropical: +40°C, 90% RH for 24 hours; Desert: +60°C, 15% RH for 24 hours. Result: Pass.
- ASTM D4169-16, Distribution cycle 13: 2016 Version- Air (intercity) and motor freight (local), single package up to 150 lb. (61.8 kg). Result: Pass.
- Schedule A Initial manual handling - ASTM D5276-98 Box: Impact Quantity: Six (6). Top, Two adjacent bottom edges, two diagonally opposite bottom corners, bottom. Drop height: dependent on weight per procedure. Result: Pass.
- Schedule C Vehicle stacking- ASTM D642-15: The package systems will be compressed per the computed load value in section 11.4. Result: Pass.
- Schedule F Loose load vibration - ASTM D999-08: Method A2 - Repetitive Shock Test (Rotary Motion). Duration: 60 min (AL I). Dwell time distributed 50% along predetermined bottom orientation facing down and remaining 50% evenly along side and end orientations. Result: Pass.
- Schedule I Low Pressure Test- ASTM D6653-13: 14,000 Feet (446 torr). 60 minute dwell, 1,000 to 2,000 feet per minute ramps. Result: Pass.
- Schedule E Vehicle Vibration – ASTM D4729-17 Truck and Air: Truck Spectrum Low, Medium, High and Air Spectrum. Durations as outlined per standard. Result: Pass.
- Schedule J Concentrated Impact - ASTM D6344-04: Cylindrical mass. Drop Height: 32 inches (5.4 J). Box: All 6 faces. Plastic Wrapped Unitized Loads: All wrapped faces (excluding base). Note: This test will be omitted if the shipper is a doublewall shipper OR a singlewall shipper and has a Mullen Burst Strength equal to or greater than 275 psi/44 ECT. Result: Pass.
- Schedule A Final Manual handling – ASTM D5276-99 Box: Box. Impact Quantity: Six (6). Vertical edge, Two adjacent side faces, one top corner, one adjacent top edge, *bottom. Drop height: dependent on weight per procedure. *The last impact should be made at twice the specified height. Result: Pass.
- ASTM F19880-16 Accelerated Aging Testing: 2016 Version - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Conduct the accelerated aging test per ASTM F1980-16 on the packages: 6-Month Accelerated Aging (Desired Real Time). Accelerated Aging Duration: 10 (days). Accelerated Aging Temperature (TAA): +65°C. Accelerated Aging Relative Humidity (RH): Uncontrolled. Real Time Room Temperature (TRT): +23°C. Q10: 2. Volume: 3 cu ft. Result: 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.
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 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.
April 29, 2020
IRRAS USA Inc. Niloufa Insanally, Ph.D., RAC Head of Regulatory Affairs 11975 El Camino Real, Suite 304 San Diego, California 92130
Re: K200807
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: March 28, 2020 Received: March 30, 2020
Dear Dr. 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
1
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 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,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200807
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: 858-220-3761 Fax number: 866-575-1002 FDA Registration #: 3013508628
Primary Contact Personnel:
Niloufa Insanally, Ph.D. RAC Head of Regulatory Affairs Phone Number: 858-220-3761 Fax Number: 866-575-1002 Email: niloufa.insanally@irras.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: | February 07, 2020 |
| Trade name: | IRRAflow® CNS System |
| Common Name: | CSF Drainage System with ventricular catheter |
| Primary Classification: | |
| Name: | Central Nervous System Fluid Shunt and Components |
| 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): |
IRRAflow® CNS System (K171880, K192289)
510(k) Summary
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DEVICE DESCRIPTION – IRRAflow CNS System
The IRRAflow CNS System is an intracranial pressure (ICP) monitoring and drainage system, and remains identical, as cleared under predicate 510(k) K192289. 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® 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.
5
SUBSTANTIAL EQUIVALENCE
The IRRAflow® CNS system's intended use, technological characteristics and principles of operation are the same as the predicate device described in K192289. For ease of reading, both earlier predicate devices described in K171880 and K192289 are shown for comparison in Table 1 below.
Comparison of these Monitoring Systems will show that the only difference in the device presented in this Special 510(k) is the inclusion of the Laser Leveler Accessory tool, which supports and augments the IRRAflow CNS system by providing a more accurate and easier method for positioning the control unit (or drainage system) with the patients external auditory meatus (or external ear canal). Using the laser leveler tool, the drainage system can be raised or lowered until the laser light points horizontally to the correct landmark on the patient's head. The common landmark used is the external auditory canal.
The earlier methods used for this alignment involved the placement of a taut string from the patient's head to the drainage system. This method for alignment may still be used. However, the laser leveler alignment tool presents a better method for this alignment step which is performed when the instrument is set up. The IRRAflow Control Unit was originally designed with a screw connection port which would hold the laser leveler tool, and IRRAS's earlier intention was to submit the laser leveler tool along with the most recent 510(k) submission (K192289) in August 2019, but the testing for the laser leveler tool was not completed at the time of the K192289 submission.
Therefore, this Special 510(k) captures the information related to the laser leveler accessory which is part of the overall IRRAflow CNS System that was originally classified by FDA as a Class II medical device. Traditionally, FDA has been able to classify accessories within the same classification as the parent device and for this reason, IRRAS is submitting this Special 510(k) as a follow up adjunct to the IRRAflow CNS System device described in K192289.
6
| Items | PREDICATE
IRRAflow® CNS System
(K171880)
(JXG), (GWM) | PREDICATE
IRRAflow® CNS System
(K192289)
(JXG), (GWM) | IRRAflow® CNS System
Special 510(k)
(JXG), (GWM)
Equivalence |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Primary Product Code | JXG | JXG | Same |
| Primary Regulation
Number: | 21 CFR 882.5550 | 21 CFR 882.5550 | Same |
| Secondary Product Code | 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. | Same as for K192289 |
| 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 CSF | Yes | Yes | Same |
| 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. | 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 |
| Table 1 - Substantial Equivalence Comparison of the Monitoring Systems | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------------------------ | -- | -- | -- | -- |
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| Items | PREDICATE
IRRAflow CNS System
(K171880)
(JXG), (GWM) | PREDICATE
IRRAflow CNS System
(K192289)
(JXG), (GWM) | IRRAflow CNS System
Special 510(k)
(JXG), (GWM)
Equivalence |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Software-based, Powered
Console for User Interface,
User Settings and Alarm
Adjustments, Data Storage
and Display, and Alarms for
ICP Monitoring | 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" + Alternative method
to use the Laser Leveler
accessory to position the
system (control unit) with the
patient's head. |
| 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 |
An inspection of Table 1 will show that there is no change in the actual IRRAflow CNS System so that no additional testing (or verification and validation testing) on the CNS system was required. There are no changes to the technological characteristics or principles of operation of the drainage system itself; no new safety and effectiveness issues are raised with this new device. The only change was to add a separate tool, the IRRAflow laser leveler, to the overall system to facilitate the alignment of the drainage system with the patient's head at the beginning of the system (refer to redlines in Table 1).
8
| Method to account for location of ventricles via patient head position | ||
|---|---|---|
| IRRAflow CNS system | ||
| (K171880) | IRRAflow CNS system | |
| (K192289) | IRRAflow CNS system | |
| Special 510(k) | ||
| 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. | Discussion: Same as for | |
| predicate(s) but also added the use | ||
| of the Laser Leveler tool to adjust | ||
| positioning of IRRAflow CNS | ||
| system so that it is aligned with | ||
| patient's head (external auditory | ||
| meatus). |
Discussion of differences in Table 1
It should be noted that the earlier methods involving a line level measurement which employs a taut string can still be used for alignment, but the laser leveler tool presents an alternative and better method for alignment of the drainage system with the patient's head.
Therefore, there is no change in the overall IRRAflow CNS system, except for the addition of an accessory to aid in positioning of the drainage system in alignment with the location of the ventricles in the patient's head. The use of the laser leveler is an additional option for location of the ventricles via the patient head position.
Use of the The IRRAflow® Laser Leveler
The IRRAflow® laser leveler is a reusable accessory to be utilized in conjunction with the IRRAflow® CNS system. The laser leveler generates a laser mark to assist in setting the height of the control unit. The IRRAflow® Laser Leveler device is provided with a mounting screw for use with the The IRRAflow® CNS control unit. The laser leveler has a power button and auto shuts off after approximately 20 seconds.
The control unit has a screw connection on the side of the unit and the laser leveler has a shoulder screw which can be screwed into the control unit using an Allen wrench. Once attached to the control unit, the control unit assembly can be moved up and down on an IV pole, and the laser leveler should swing freely (it is weighted down). The laser leveler may then be used to auto align the control unit assembly to the patient's head.
The laser light is turned on and remains on for a maximum of 20 seconds, during which time the emitted light is pointed directly to the patient's external auditory meatus (in order to align with the patient's ventricles). Once the control unit drainage system is aligned horizontally with the patient's auditory meatus, the assembly is locked into position. The laser automatically shuts off after 20 seconds, the laser light will disappear, and the drainage system will be ready to operate.
9
No changes were made to the EVD catheter or the IRRAflow CNS system.
1. EVD Catheter:
The IRRAflow® CNS System's Catheter technological characteristics and principles of operation are identical to the IRRAflow® CNS System Catheter (K192289). There have been no changes to the system catheter. The materials, design and principle of operations remain the same.
2. Verification and Validation Documentation for the IRRAflow CNS System:
Similarly, the addition of the laser leveler accessory does not change or impact any of the verification and validation testing performed earlier on the IRRAflow® CNS System. The verification and validation performance testing which was performed earlier (refer to K192289) has not changed. In conclusion, the IRRAflow® CNS System is substantially equivalent to the predicate device.
3. Verification and Validation testing for the Laser Leveler:
While no changes were made to the IRRAflow CNS System as a whole, and therefore no additional verification and validation testing was required for the system, there was verification and validation testing performed during the design of the laser leveler accessory. Development and testing for the laser leveler was performed at a contract manufacturer, Meraqi Medical, Inc. (Freemont, CA). The laser testing was performed at a sub-contractor, Intertek (Menlo Park, CA). The design of the laser leveler was performed at IRRAS and transferred to Meraqi Medical for development (including design controls), testing and subsequently, manufacturing.
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SUMMARY OF VERIFICATION & VALIDATION FOR THE LASER LEVELER
No additional verification and validation performance testing was done on the IRRAflow® CNS System itself since no new safety and effectiveness issues were raised with the 'new' device. The IRRAflow CNS System remains the same as described in 510(k) K192289. The only change is the addition of the laser leveler accessory. The only new risks to the overall system with the inclusion of the laser leveler accessory, is the introduction of laser energy in the system and the risk posed by exposing the patient to laser light. The risk was evaluated separately, as well as, in conjunction with the laser leveler tool being used in the initial setup of the IRRAflow CNS system. Since no new concerns or risks were identified that could not be mitigated by the actual proper use and function of the laser leveler, and there were built-in fail safes in the laser leveler (i.e. the laser light automatically turns off after 20 seconds), one may conclude that the IRRAflow® CNS System is substantially equivalent to the predicate device (K192289).
However, a full analysis of the laser leveler was performed, and a summary of the testing done at Meraqi Medical and Intertek is presented in Table 2 below.
It is important to note that since no new performance data for the actual IRRAflow CNS system are needed to evaluate the change (i.e. use of the laser leveler accessory with the IRRAflow CNS system), the submission of a Special 510(k) is appropriate in this case. Furthermore, in Table 2 below, IRRAS has identified the various well-established and recognized standards which allow one to evaluate the performance of the laser leveler accessory separately. The data or results are provided in Table 2 in a summary format.
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| Test | Test Method Summary | Results |
|---|---|---|
| Dimensional | Verify units meet dimensional specification. | Pass |
| Visual (laser) | Verify units have legible labeling and are free of damage and/or | |
| foreign particulate. | Pass | |
| Visual (Packaging) | Verify packaging is free of damage and labels are legible | Pass |
| Functional Testing | Functional testing includes: button press, vertical position test, | |
| laser spot alignment, auto shutoff test, trunnion articulation. | Pass | |
| IEC 60825-1 | Laser safety testing: Wavelength and conformance to IEC 60825- | |
| 1 standard | Pass | |
| IEC 60529 (IP22) | Fluid ingress testing: Verify conformance to the IP2X | |
| requirements of IEC 60529 Edition 2.2. | Pass | |
| ASTM D4332-14- | ||
| Package | ||
| environmental | ||
| conditioning | 2014 Version - Standard Practice for Conditioning | |
| Containers, Packages, or Packaging Components for | ||
| Testing | ||
| Conduct the conditioning test per ASTM D4332-14 on the | ||
| packages: | ||
| Extreme Cold: -30°C, uncontrolled RH for 24 hours | ||
| Tropical: +40°C, 90% RH for 24 hours | ||
| Desert: +60°C, 15% RH for 24 hours | ||
| Chamber Class: 3 | ||
| Notes: Westpak calls out tolerances of ±2°C and ±5% RH. | Pass | |
| ASTM D4169-16, | ||
| Distribution cycle | ||
| 13 | 2016 Version- Air (intercity) and motor freight (local), | |
| single package up to 150 lb. (61.8 kg) | Pass | |
| Schedule A Initial | ||
| manual handling - | ||
| ASTM D5276-98 | ||
| Box | Impact Quantity: Six (6) | |
| Top, Two adjacent bottom edges, two diagonally opposite | ||
| bottom corners, bottom | ||
| Drop height: dependent on weight per procedure | Pass | |
| Schedule C Vehicle | ||
| stacking- ASTM | ||
| D642-15 | The package systems will be compressed per the | |
| computed load value in section 11.4. | Pass | |
| Schedule F Loose | ||
| load vibration - | ||
| ASTM D999-08 | Method A2 - Repetitive Shock Test (Rotary Motion) | |
| Duration: 60 min (AL I) | ||
| Dwell time distributed 50% along predetermined bottom | ||
| orientation facing down and remaining 50% evenly along | ||
| side and end orientations. | Pass | |
| Test | Test Method Summary | Results |
| Schedule I Low | ||
| Pressure Test- | ||
| ASTM D6653-13 | 14,000 Feet (446 torr) | |
| 60 minute dwell, 1,000 to 2,000 feet per minute ramps | Pass | |
| Schedule E Vehicle | ||
| Vibration – ASTM | ||
| D4729-17 Truck | ||
| and Air | Truck Spectrum Low | |
| Frequency Range: 1-200 Hz | ||
| Overall Intensity: 0.40 Grms | ||
| Truck Spectrum Medium | ||
| Frequency Range: 1-200 Hz | ||
| Overall Intensity: 0.54 Grms | ||
| Truck Spectrum High | ||
| Frequency Range: 1-200 Hz | ||
| Overall Intensity: 0.70 Grms | ||
| Air Spectrum | ||
| Frequency Range: 2-300 Hz | ||
| Overall Intensity: 1.49 Grms (Assurance Level I) | ||
| Durations as outlined per standard. | Pass | |
| Schedule J | ||
| Concentrated | ||
| Impact - ASTM | ||
| D6344-04 | Cylindrical mass | |
| Drop Height: 32 inches (5.4 J) | ||
| Box: All 6 faces | ||
| Plastic Wrapped Unitized Loads: All wrapped faces | ||
| (excluding base) | ||
| Note: This test will be omitted if the shipper is a doublewall | ||
| shipper OR a singlewall shipper and has a Mullen Burst | ||
| Strength equal to or greater than 275 psi/44 ECT. | Pass | |
| Schedule A Final | ||
| Manual handling – | ||
| ASTM D5276-99 | ||
| Box | Box | |
| Impact Quantity: Six (6) | ||
| Vertical edge, Two adjacent side faces, one top corner, | ||
| one adjacent top edge, *bottom | ||
| Drop height: dependent on weight per procedure | ||
| *The last impact should be made at twice the specified | ||
| height. | Pass | |
| ASTM F19880-16 | ||
| Accelerated Aging | ||
| Testing | 2016 Version - Standard Guide for Accelerated Aging of | |
| Sterile Barrier Systems for Medical Devices | ||
| Conduct the accelerated aging test per ASTM F1980-16 | ||
| on the packages: | ||
| 6-Month Accelerated Aging (Desired Real Time) | ||
| Accelerated Aging Duration: 10 (days) | ||
| Accelerated Aging Temperature (TAA): +65°C | ||
| Accelerated Aging Relative Humidity (RH): Uncontrolled | ||
| Real Time Room Temperature (TRT): +23°C | ||
| Q10: 2 | ||
| Volume: 3 cu ft | Pass |
12
13
Conclusion
The IRRAflow® CNS System is substantially equivalent to the predicate device (K192289). The IRRAflow® CNS System has the same indications for use, technological characteristics, and principles of operation as the predicate device. The addition of the laser leveler accessory does not change or impact the operational parameters of the IRRAflow CNS System, but it does add an additional option to assess the position of the drainage system with the landmark target on the patient's head during initial setup. The positioning of the drainage system with the external auditory meatus of the patient's head is facilitated by use of the laser leveler.