(33 days)
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 IRRAflow CNS System is an intracranial pressure (ICP) monitoring and drainage system. It 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. A parallel line from the saline infusion bag is used for clearance at the tip of the catheter. 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. CSF or intracranial fluid samples can be taken from the aspiration port. The submission also includes the IRRAflow® Laser Leveler, a reusable accessory to be utilized in conjunction with the IRRAflow® CNS system to assist in setting the height of the control unit by generating a laser mark.
This document describes the design verification and validation for an accessory, the IRRAflow® Laser Leveler, to an existing medical device, the IRRAflow® CNS System. The main device (IRRAflow® CNS System) itself has not undergone any changes, and therefore no new performance data was required for it. The focus of this submission is on the laser leveler accessory.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|
| Dimensional | Units meet dimensional specifications. | Pass |
| Visual (laser) | Units have legible labeling and are free of damage and/or foreign particulate. | Pass |
| Visual (Packaging) | Packaging is free of damage and labels are legible. | Pass |
| Functional Testing | Button press operates correctly, vertical position test passes, laser spot alignment is correct, auto shutoff test passes, trunnion articulation is functional. | Pass |
| IEC 60825-1 (Laser safety) | Wavelength and conformance to IEC 60825-1 standard are met. | Pass |
| IEC 60529 (IP22) (Fluid ingress) | Conformance to the IP2X requirements of IEC 60529 Edition 2.2 is met. | Pass |
| ASTM D4332-14 - Package environmental conditioning | Withstand conditioning at Extreme Cold (-30°C), Tropical (+40°C, 90% RH), and Desert (+60°C, 15% RH) for 24 hours. | Pass |
| ASTM D4169-16, Distribution cycle 13 | Withstand specified air (intercity) and motor freight (local) transportation for single packages up to 150 lb. (61.8 kg). | Pass |
| Schedule A Initial manual handling - ASTM D5276-98 Box | Withstand six impacts (Top, two adjacent bottom edges, two diagonally opposite bottom corners, bottom) at drop heights dependent on weight per procedure. | Pass |
| Schedule C Vehicle stacking - ASTM D642-15 | Package systems withstand compression per the computed load value in section 11.4. | Pass |
| Schedule F Loose load vibration - ASTM D999-08 | Withstand 60 minutes of repetitive shock test (rotary motion) with dwell time distributed as specified (50% bottom, 50% side and end orientations). | Pass |
| Schedule I Low Pressure Test - ASTM D6653-13 | Withstand low pressure equivalent to 14,000 feet (446 torr) for 60 minutes, with specified ramp rates. | Pass |
| Schedule E Vehicle Vibration – ASTM D4729-17 Truck and Air | Withstand Truck Spectrum (Low, Medium, High) and Air Spectrum vibrations at specified frequency ranges and overall intensities for durations outlined per standard. | Pass |
| Schedule J Concentrated Impact - ASTM D6344-04 | Withstand concentrated impact (cylindrical mass at 32 inches drop height, 5.4 J) to all 6 faces of the box (or all wrapped faces excluding base for plastic wrapped loads), unless shipper meets specific Mullen Burst/ECT strength. | Pass |
| Schedule A Final Manual handling – ASTM D5276-99 Box | Withstand six impacts (vertical edge, two adjacent side faces, one top corner, one adjacent top edge, bottom – with the last impact at twice the specified height) at drop heights dependent on weight per procedure. | Pass |
| ASTM F19880-16 Accelerated Aging Testing | Withstand accelerated aging equivalent to 6 months of real-time aging, simulated over 10 days at +65°C (uncontrolled RH), based on a Q10 value of 2 and a real-time room temperature of +23°C. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for each test. It generally refers to "units" or "packages" being tested. For certain tests like "Schedule A Initial manual handling - ASTM D5276-98 Box", it mentions "Six (6)" impacts, which implies a sample size of at least one unit per test setup.
- Data Provenance:
- Development and testing for the laser leveler was performed at a contract manufacturer, Meraqi Medical, Inc. (Freemont, CA).
- Laser testing was performed at a sub-contractor, Intertek (Menlo Park, CA).
- This indicates the data originates from the USA.
- The studies mentioned are verification and validation tests performed during the design and manufacturing process of the laser leveler. These are typically prospective tests aimed at confirming product specifications and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to this submission. The laser leveler is a physical accessory designed to assist with a spatial alignment task. The tests performed are engineering-focused (dimensional, functional, safety, environmental, packaging), not clinical performance evaluations requiring expert assessment for "ground truth". The "ground truth" for these tests is defined by established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. As these are engineering verification and validation tests against established standards and specifications, there is no need for a human adjudication method in the context described (like consensus in image interpretation). The results are objective measurements (e.g., passing a specific temperature range, meeting a safety standard).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable. The device (IRRAflow® CNS System with Laser Leveler) is not an AI-powered diagnostic imaging system or an AI-assisted interpretation tool. It's a medical device system for intracranial pressure monitoring and fluid drainage, with an accessory to aid in physical alignment. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The IRRAflow® CNS System and its laser leveler accessory are physical medical devices, not an algorithm. The laser leveler functions as a tool that assists a human operator in a physical setup task; it is not a standalone algorithm performing automated analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the verification and validation tests listed is based on established engineering standards, safety requirements, and design specifications. For example, for IEC 60825-1, the ground truth is "conformance to the IEC 60825-1 standard for laser safety". For dimensional tests, it's the design specification for the dimensions of the unit. For packaging tests, it's the ability to withstand specific environmental and physical stressors as defined by ASTM standards.
8. The sample size for the training set
- This information is not applicable as the IRRAflow® Laser Leveler is not an AI system that requires a training set. It is a physical device that underwent engineering verification and validation.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as described in point 8.
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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
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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
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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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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.
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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.
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| Items | PREDICATEIRRAflow® CNS System(K171880)(JXG), (GWM) | PREDICATEIRRAflow® CNS System(K192289)(JXG), (GWM) | IRRAflow® CNS SystemSpecial 510(k)(JXG), (GWM)Equivalence |
|---|---|---|---|
| Primary Product Code | JXG | JXG | Same |
| Primary RegulationNumber: | 21 CFR 882.5550 | 21 CFR 882.5550 | Same |
| Secondary Product Code | GWM | GWM | Same |
| Secondary RegulationNumber: | 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 SamplingPorts | Yes | Yes | Same |
| UnidirectionalFlow of Drained Fluid | Yes | Yes | Same |
| Fluid Injection Capability | Yes | Yes | Same |
| Attaches to separate,commercially availableEVD Catheter | YesThe IRRAflow system attaches to IRRAflow Catheter which is an EVD Catheter part of the complete system. | YesThe IRRAflow system attaches to IRRAflow Catheter which is an EVD Catheter part of the complete system. | Same |
| Sterile Disposable tubingset | Yes | Yes | Same |
| CSF Drainage Bag | Yes | Yes | Same |
| Gravity drainage of CSF | Yes | Yes | Same |
| Method to control gravitydrainage 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 | PREDICATEIRRAflow CNS System(K171880)(JXG), (GWM) | PREDICATEIRRAflow CNS System(K192289)(JXG), (GWM) | IRRAflow CNS SystemSpecial 510(k)(JXG), (GWM)Equivalence |
|---|---|---|---|
| Pressure Transducer forICP Measurement | Yes(The IRRAflow systemintegrates transducers into itsdesign for measurement andvisual display of ICP) | Yes(The IRRAflow systemintegrates transducers into itsdesign for measurement andvisual display of ICP) | Same |
| Software-based, PoweredConsole for User Interface,User Settings and AlarmAdjustments, Data Storageand Display, and Alarms forICP Monitoring | Yes | Yes | Same |
| Method to account forlocation of ventricles viapatient head position | Reference marks on the deviceto allow for the system to bealigned with patient's headpositioning. | Reference marks on the deviceto allow for the system to bealigned with patient's headpositioning. | "Same" + Alternative methodto use the Laser Leveleraccessory to position thesystem (control unit) with thepatient'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).
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| Method to account for location of ventricles via patient head position | ||
|---|---|---|
| IRRAflow CNS system(K171880) | IRRAflow CNS system(K192289) | IRRAflow CNS systemSpecial 510(k) |
| Reference marks on the device toallow for the system to be alignedwith patient's head positioning. | Reference marks on the device to allowfor the system to be aligned withpatient's head positioning. | Discussion: Same as forpredicate(s) but also added the useof the Laser Leveler tool to adjustpositioning of IRRAflow CNSsystem so that it is aligned withpatient's head (external auditorymeatus). |
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.
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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/orforeign 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 IP2Xrequirements of IEC 60529 Edition 2.2. | Pass |
| ASTM D4332-14-Packageenvironmentalconditioning | 2014 Version - Standard Practice for ConditioningContainers, Packages, or Packaging Components forTestingConduct the conditioning test per ASTM D4332-14 on thepackages:Extreme Cold: -30°C, uncontrolled RH for 24 hoursTropical: +40°C, 90% RH for 24 hoursDesert: +60°C, 15% RH for 24 hoursChamber Class: 3Notes: Westpak calls out tolerances of ±2°C and ±5% RH. | Pass |
| ASTM D4169-16,Distribution cycle13 | 2016 Version- Air (intercity) and motor freight (local),single package up to 150 lb. (61.8 kg) | Pass |
| Schedule A Initialmanual handling -ASTM D5276-98Box | Impact Quantity: Six (6)Top, Two adjacent bottom edges, two diagonally oppositebottom corners, bottomDrop height: dependent on weight per procedure | Pass |
| Schedule C Vehiclestacking- ASTMD642-15 | The package systems will be compressed per thecomputed load value in section 11.4. | Pass |
| Schedule F Looseload vibration -ASTM D999-08 | Method A2 - Repetitive Shock Test (Rotary Motion)Duration: 60 min (AL I)Dwell time distributed 50% along predetermined bottomorientation facing down and remaining 50% evenly alongside and end orientations. | Pass |
| Test | Test Method Summary | Results |
| Schedule I LowPressure Test-ASTM D6653-13 | 14,000 Feet (446 torr)60 minute dwell, 1,000 to 2,000 feet per minute ramps | Pass |
| Schedule E VehicleVibration – ASTMD4729-17 Truckand Air | Truck Spectrum LowFrequency Range: 1-200 HzOverall Intensity: 0.40 GrmsTruck Spectrum MediumFrequency Range: 1-200 HzOverall Intensity: 0.54 GrmsTruck Spectrum HighFrequency Range: 1-200 HzOverall Intensity: 0.70 GrmsAir SpectrumFrequency Range: 2-300 HzOverall Intensity: 1.49 Grms (Assurance Level I)Durations as outlined per standard. | Pass |
| Schedule JConcentratedImpact - ASTMD6344-04 | Cylindrical massDrop Height: 32 inches (5.4 J)Box: All 6 facesPlastic Wrapped Unitized Loads: All wrapped faces(excluding base)Note: This test will be omitted if the shipper is a doublewallshipper OR a singlewall shipper and has a Mullen BurstStrength equal to or greater than 275 psi/44 ECT. | Pass |
| Schedule A FinalManual handling –ASTM D5276-99Box | BoxImpact Quantity: Six (6)Vertical edge, Two adjacent side faces, one top corner,one adjacent top edge, *bottomDrop height: dependent on weight per procedure*The last impact should be made at twice the specifiedheight. | Pass |
| ASTM F19880-16Accelerated AgingTesting | 2016 Version - Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical DevicesConduct the accelerated aging test per ASTM F1980-16on the packages:6-Month Accelerated Aging (Desired Real Time)Accelerated Aging Duration: 10 (days)Accelerated Aging Temperature (TAA): +65°CAccelerated Aging Relative Humidity (RH): UncontrolledReal Time Room Temperature (TRT): +23°CQ10: 2Volume: 3 cu ft | Pass |
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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.
§ 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).