(134 days)
The use of IRRAflow 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.
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.
The provided text is a 510(k) premarket notification decision letter from the FDA regarding the IRRAflow Active Fluid Exchange System (AFES). The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, specifically regarding changes to the Tube Set and Drainage Collection System. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device's performance is equivalent to, or better than, the predicate device.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria alongside numerical performance results for the device. Instead, it relies on a "PASS" or "FAIL" outcome for various verification and validation tests. The acceptance criteria for these tests are implied to be established by the test protocols and industry standards (e.g., "Pressure accuracy per protocol," "Durability, flow and freedom from leakage per protocol").
Here's a table summarizing the tests performed and their reported outcomes:
| Test Category | Test Performed | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility Testing | Cytotoxicity (MEM Elution) | PASS |
| Sensitization Test | PASS | |
| Irritation/Intracutaneous Reactivity Test | PASS | |
| Acute Systemic Toxicity, Injection Test | PASS | |
| Systemic Toxicity, Mediated Pyrogen | PASS | |
| Genotoxicity (on various strains of bacteria) | PASS | |
| Genotoxicity (on mouse lymphoma cells) | PASS | |
| Bench and Electrical Testing | Electrical Requirements Verification (Pressure accuracy) | PASS |
| Mechanical Performance Verification (Durability, flow, freedom from leakage) | PASS | |
| Life Cycle Verification Test (Simulated use for 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 Validation (Ethylene Oxide for Cassette and Drainage System) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the tests listed in Table 3.
The data provenance is not explicitly stated beyond general descriptions of the tests (e.g., "The Minimal Essential Media (MEM) Elution test," "This test was designed to evaluate the allergenic potential"). There is no mention of country of origin or whether the tests were retrospective or prospective. Given the nature of these tests (bench, electrical, biocompatibility, sterilization validation), they are typically conducted as prospective laboratory studies rather than clinical studies using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, often following standardized protocols. Therefore, the concept of "ground truth" established by clinical experts (like radiologists for imaging devices) would not directly apply to these types of performance tests. The "ground truth" here is implied by adherence to established test methods and acceptable performance limits defined by those methods.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the types of performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus is needed to establish a definitive ground truth.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a physical system for fluid exchange and pressure monitoring, not an AI-powered diagnostic tool for image interpretation or similar tasks that would typically involve human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the IRRAflow AFES is a medical device for intracranial pressure monitoring and fluid drainage, not an algorithm or AI system. Its performance is evaluated through engineering and biological safety tests.
7. The type of ground truth used
For the performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization), the "ground truth" is based on:
- Established Test Standards and Protocols: Such as ASTM D4332-14, ASTM D4169-22 Cycle 13, ASTM F1886-16, ASTM F2096-11, EN 868-5:2009.
- Defined Acceptance Criteria: These criteria are inherent to the test methods and are designed to ensure safety and effectiveness (e.g., pressure accuracy per protocol, freedom from leakage per protocol).
- Laboratory Measurements and Observations: The results are direct measurements or observations within controlled laboratory environments.
It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather adherence to predefined engineering and biological safety specifications.
8. The sample size for the training set
This question is not applicable because the IRRAflow AFES is a hardware medical device with specific Tube Set and Drainage Collection System modifications, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this device.
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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).
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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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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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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 SampsonVP, ProductExcellencePhone Number:Email: | 619-992-1861adam.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 catheterII |
| Primary ProductCode: | JXG (21 CFR 882.5550 Central Nervous System Fluid Shuntand Components) |
| SecondaryProduct Code: | GWM (21 CFR 882.1620 Intracranial Pressure Monitoring Device, per 21 CFR807.92(a)(2)) |
| III. PREDICATEDEVICE | K222471, IRRAflow Active Fluid Exchange System |
| No reference devices were used in this submission. |
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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.
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Table 1: Substantial Equivalence (SE) Comparison
| Item | IRRAflow® CNS System(K200807)(JXG), (GWM) | PREDICATEIRRAflow® AFES(K222471)(JXG), (GWM) | IRRAflow® AFESTraditional510(k) K231664(JXG),(GWM)Equivalence |
|---|---|---|---|
| Indications for Use | The use of IRRAflow® CNSSystem is indicated whenintracranial pressuremonitoring is required andfor externally drainingintracranial fluid as a meansof reducing intracranialpressure in patients wherean external drainage andmonitoring system isneeded. | The use of the IRRAflow®Active Fluid ExchangeSystem is indicated whenintracranial pressuremonitoring is required andfor externally drainingintracranial fluid as a meansof reducing intracranialpressure in patients where anexternal drainage andmonitoring system is needed. | SimilarThe use of IRRAflow®Active Fluid ExchangeSystem is indicated whenintracranial pressuremonitoring is required, andfor externally drainingintracranial fluid, as a meansof reducing intracranialpressure in patients where anexternal drainage andmonitoring system is needed. |
| Injection/ CSFSamplingPorts | Yes | Yes | Yes |
| UnidirectionalFlow of Drained Fluid | Yes | Yes | Yes |
| Fluid InjectionCapability | Yes | Yes | Yes |
| Sterile DisposableTube Set | Tube Set version 2.0 | Tube Set version 2.0 | Tube Set version 3.0 |
| CSF Drainage Bag | Co-packaged with Tube Setversion 2.0 | Co-packaged with Tube Setversion 2.0 | Drainage Collection SystemSeparately packaged |
| Gravity drainage ofCSF | Yes | Yes | Yes |
| Method to controlgravity drainage ofCSFF | Automated adjustment basedon user settings via astepper-motor controlled,tube pinching mechanism toeither compress or releasethe compliant drainagetubing contained within thesterile, disposable Cartridge. | Automated adjustment basedon user settings via astepper-motor controlled,tube pinching mechanism toeither compress or releasethe compliant drainagetubing contained within thesterile, disposable Cartridge. | Yes, automated adjustmentbased on user settings via astepper-motor controlled, tubepinching mechanism to eithercompress or release thecompliant drainage tubingcontained within the sterile,disposable Cartridge. |
| Pressure Transducerfor ICP Measurement | The IRRAflow®system integrates transducersinto its design formeasurement and visualdisplay of ICP | The IRRAflow® systemintegrates transducers into itsdesign formeasurement and visualdisplay of ICP | Yes, the IRRAflow® systemintegrates transducers into itsdesignfor measurement and visualdisplay of ICP |
| Item | IRRAflow® CNS System(K200807)(JXG), (GWM) | PREDICATEIRRAflow® AFES(K222471)(JXG), (GWM) | IRRAflow® AFESTraditional 510(k)K231664(JXG),(GWM)Equivalence |
| Software-based,Powered Console forUser Interface, UserSettings and AlarmAdjustments, DataStorage and Display,and Alarms for ICPmonitoring | Yes | Yes | Yes |
| Measured PressureRange | -80 mmHg to +100 mmHg | -100 to +300 mmHg | -100 to +300 mmHg |
| Displayed ICP | Yes | Yes | Yes |
| Battery Back-up forControl Unit | Yes | Yes | Yes |
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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.
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Table 2: Tube Set 2.0 and Tube Set 3.0 Comparison
| Device characteristic | Tube Set 2.0Predicate | Tube Set 3.0K231664 | Rationale |
|---|---|---|---|
| 1. Revision of the internalfluid-contacting pinchvalve ball 2.5 mmdiameter stainless-steelball | Stainless Steel 440C | Corrosion resistantStainless Steel Alloy316L | This material changewill prevent componentcorrosion during the lifecycle of the device. |
| 2. Modification of thesensor housing clamp | Wedge to wedgepinch clamp (sensorhousing to calibrationhub). The twowedges becomingoffset will result infailure to achieveappropriate pinchpressure to halt flow,resulting in leakageout of theatmospheric port atclinically relevanttemperatures. | Modified SensorClamp, Cassette | Improved leakresistance |
| 3. Addition of aprotective layer of heatshrink tubing topressurized manifoldbarb connections. | No heat shrinkprotective layer | Heat shrink protectivelayer, compatible withnormal physiologicalpressure range duringuse, and designed towithstand -110 to+550mmHg pressurewithout mechanicaldamage such as tubingcollapse or bursting | Improved deviceperformance at highpressures; heat shrinkwill act as a secondaryprotection to preventleaks when highpressures areinadvertently applied tothe device. |
| 4. Improved the fluidflow through theirrigation line byremoving the check valvebetween the irrigationspike and cassette. | In line irrigationtubing check valve | Check valve removedfrom irrigation linetubing | The head pressure of afull irrigation bag(1000mL) with a fullyextended irrigationtubing is 1.15 psi. Thecracking pressure ofthe specified checkvalve (1.5 - 5psi) isoverqualified for thisuse case, causingturbulent flow past thecheck valve leading tothe formation of smallto large air bubbles inthe irrigation line. |
| 5. Addition of moldedstrain reliefs | Non-molded strainrelief. | Molded strain relief -the fit, form and | Added to improve thedevice performance, |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| function of the strainrelief has not changed.Strain relief will nowbe molded for ease ofmanufacturing. | and for ease ofmanufacturing | ||
| 6. Removal of luerconnections | Luer connectionsbetween the Cassetteand Catheter on theirrigation line, and thepinch clamp betweenthe irrigation bag andcassette on theirrigation line havebeen removed | No luer connections | These componentsare not required forsystem function orperformance |
| 7. Addition of Labelsto tubing lines | Irrigation anddrainage lines withoutlabels | Labels on tubing lines:identifies irrigationtubing, drainagetubing and drainagebag tubing | Improved usability |
| 8. Addition of a Tyveksleeve, provided in thetube set assembly | No Tyvek sleeve intube set assembly | Tyvek sleeve in tubeset assembly | To protect theirrigation to drainageline tube connectionfrom accidentalsterile field failuresduring priming |
| 9. Length of tube lineson the catheter side ofthe cassette | Current length oftubing lines oncatheter side of thecassette are 47inches/1195 mm ±20. | Increased length by 12inches; the length ofirrigation and drainagetubing on the catheterside ofthe component is now1500 mm ± 20. | To allow for typicalpatient careprocedures withassociated patientposition changes |
| 10. Drainage bag | Tube Set 2.0 is co-packaged andsterilized with thedrainage bag | Tube Set 3.0ispackaged separatelyfrom the DrainageCollection System | Allows forindependentreplacement of thesesystem componentswhen indicated |
| 11. Packagingupgraded to meet brandstandards. | Tyvek pouch only | More durable Tyvekpouch with theproduct mounted ona labeledpresentation card. Anew 1-up carton,and 5-up shipperwill be used forshipping. | The labeledpresentation card willhelp maintainsterility duringsystem set-up andadd guidance on howto properly set up thedevice |
| Device characteristic | Tube Set 2.0 | Tube Set 3.0 | Rationale |
| 12. Increased shelf life | Shelf life set at 18months | Shelf life extendedto 36 months | Real time andaccelerated agingstudies support 36month expiry forsterile packaging |
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K231664, Page 6 of 8
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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 D4332-14ASTM D4169-22 Cycle 13 | PASS |
| Package Integrity Test | ASTM F1886-16ASTM 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 |
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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.
§ 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).