(277 days)
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
The provided text describes a 510(k) premarket notification for a medical device called the "Cleveland Multiport Ventricular Catheter Set." This submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document refers to various tests performed to support this claim, but it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance in the context of AI/ML, nor does it include information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML models.
The information provided relates to the physical and functional aspects of a traditional medical device (a catheter) and its comparison to existing catheters. Therefore, most of the requested fields are not applicable to the given text.
Here's an attempt to answer the applicable parts of your request based on the provided text, while explicitly stating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests and their results, indicating that the device "passed" and "results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices." The specific quantitative acceptance criteria are generally implied rather than explicitly stated as numerical thresholds in this summary, but the results confirm compliance.
| Test | Acceptance Criteria (Implied from "passed") | Reported Device Performance |
|---|---|---|
| Joint and Bond Strength Tests | Withstand minimum pull-off forces; exceed minimum tip loading requirements. | All joints bonds were above the minimum pull-off force requirement. Tip loading exceeded the minimum load requirements. Withstood pull forces based on clinically relevant forces with a safety factor. |
| Viscosity Test | Kinematic viscosity of Cytarabine and saline are comparable (within 2%). | Kinematic viscosity of Cytarabine and saline are similar (within 2%). Bench testing using saline is acceptable. |
| Depth Marking | Depth marks remain legible after swabbing. | Depth gauge marks were not altered. |
| Pressure Testing (Flow Burst, Infusate Pressure, Aspiration Flow Rate) | Withstand pressure spikes; reach specified flow rate within specified time; inject fluid at maximum flow rate; linear pressure profile across all flow rates without leakage or kinking; withstand maximum pressure/spikes; capable of aspirating at clinically acceptable rate. | Reached specified flow rate within specified time; capable of injecting fluid at its maximum flow rate. Reached a linear pressure profile across all flow rates without leakage and no kinking; withstood maximum pressure/spikes. Passed pressure-flow with suture tab attached. Capable of aspirating at its clinically acceptable aspiration rate. |
| Reflux Test | Resists flow in the reverse direction. | Resists flow in the reverse direction. |
| Deployment and Retraction Test | Minimal dimensional changes from deployment/retraction; meet maximum loads for insertion/removal of stylet. | Met specified dimensional and maximum distance insertion and removal forces. |
| Tissue Insertion Test | Withstand insertion and removal from bovine brain tissue. | Passed insertion and removal for bovine tissue. |
| Bend Radius Test | Withstand minimum bend radius without kinking. | Withstands a minimum bend radius without kinking. |
| Dimensional Verification | Manufactured and reproduced to predetermined specifications. | Manufactured and reproduced to predetermined specifications. |
| Micro-Catheter Strength Test | Minimum strength of micro-catheters PTFE material exceeds minimum force requirements. | Micro-catheter material exceeds the minimum force requirements. |
| Syringe Drop Test | Withstand drop without damage to device or operation. | Withstood drop without damage and operation verified. |
| Surface Inspection | Free from voids, cracks, or extraneous matter. | Free from voids, cracks or extraneous matter along the effective length. |
| Particulate Testing | Shedding of particulates below specified limit. | Shedding of particulates are below a specified limit. |
| Leakage under pressure | Free of leaks during infusion and aspiration. | Free of leaks during infusion and aspiration. |
| Cadaver Assessment | Can be placed using conventional techniques and visualized using CT. | Placed using conventional techniques and visualized on axial CT scan with successful infusion of CT dye. |
| Stylet Strength | Withstand excessive loading on stylet handle without fracturing. | Withstood pull forces based on clinically relevant forces with a safety factor. |
| Stylet Corrosion Resistance | Withstand corrosion with extended exposure to sodium chloride. | Withstood corrosion with extended exposure to sodium chloride. |
| Biocompatibility | Compliance with ISO 10993 requirements for tissue contact, limited exposure (<24 hours), non-pyrogenic. | All tissues contacting materials are biocompatible per ISO 10993 (Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Hemocompatibility, Material Mediated Pyrogen tests completed). Non-pyrogenic. |
| Drug Compatibility | Does not leach high concentration levels of identifiable compounds with Cytarabine. | Cytarabine is compatible within the flow path materials with acceptable levels of identifiable compounds. |
| Accelerated Aging | Functions as intended after 1-year equivalent accelerated aging. | Functioned as intended after 1-year equivalent accelerated aging. |
| Sterilization Validation | Minimum sterilization cycle achieves SAL of 10^-6. | Half-cycle EO achieves sterility assurance level (SAL) of 10^-6. |
| LAL Validation | Endotoxin levels <2.15 EU/device per USP guidance. | All devices met an endotoxin level of <2.15 EU/device. |
| Transit Testing - Packaging Qualification | Withstands normal transportation and handling; maintains sterile barrier. | Packaging meets functionality requirements and maintains sterile barrier after exposing to actual and simulated transportation test conditions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are bench tests and cadaver usability testing, not studies on patient data.
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 as the device is a physical medical instrument, not an AI/ML algorithm requiring expert ground truth for interpretation. The "cadaver usability testing" implies a medical professional would have evaluated the device's placement, but details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring adjudication of interpretations.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered interpretive devices, which this catheter is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests was based on engineering specifications, physical measurements, and established medical device testing standards (e.g., ISO standards for biocompatibility, LAL validation). For the cadaver assessment, the "ground truth" was successful placement and visualization on CT, implying a practical assessment against expected physiological outcomes.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or ground truth for one.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2017
Parker Hannifin Corporation % Lisa L. Michels, J.D. Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K161731
Trade/Device Name: Cleveland Multiport Ventricular Catheter Set Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: HCA Dated: February 13, 2017 Received: February 21, 2017
Dear Dr. Lisa Michels:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161731
Device Name
Cleveland Multiport Ventricular Catheter Set
Indications for Use (Describe)
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Parker Hannifin Corporation. Medical Systems Division
3007 Bunsen Avenue. Unit K Ventura CA 93003 Telephone, 805-658-2984 Facsimile: 805-658-6720
| Contact Person: | Lisa L. Michels, J.D., M.S.O.L.Q. |
|---|---|
| Official Correspondent for Parker Hannifin | |
| Regulatory Compliance Associates® Inc. | |
| 10411 Corporate Drive, Suite 102 | |
| Pleasant Prairie, Wisconsin 53158 | |
| Phone: (928)-660-8570 (office) / (520)-704-2700 (mobile) | |
| Email: I.michels@rcainc.com |
Date Prepared: 13-February-2017
| Trade Name: | Cleveland Multiport Ventricular Catheter Set (CMC) |
|---|---|
| Common Name: | Ventricular Catheter |
| Product Code: | HCA |
| Device Classification: | 21 CFR 882.4100 |
| Regulatory Class: | Class II |
Predicate Device: MRI SmartFlow Flex Ventricular Catheter #K123605.
Intended Use / Indications for Use
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
Rx or OTC Device
The Cleveland Multiport Ventricular Catheter Set is an Rx prescription device per 21 CFR Part 801, Subpart D.
Description of Device
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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510(k) Traditional Summary
Parker Hannifin Corporation Cleveland Multiport Ventricular Catheter Set (CMC)
The catheter is available in one size; Ø2.5mm OD x 14.0 cm long, with four micro catheters that deploy at the distal tip.
The Cleveland Multiport Ventricular Catheter Set is supplied sterile. The set includes the insertion stylet which facilitates placement of the catheter into the ventricles of the brain, a suture tab for anchoring the catheter and preventing movement during aspiration of fluids and four female-to-female Luer adapters for connecting each proximal end micro-catheter.
The Cleveland Multiport Ventricular Cather verification activities are included in this 510(k) submission.
Technological Characteristics
The Cleveland Multiport Ventricular Catheter has the same intended use/indications for use along with similar technological characteristics to predicate devices on the market with the same intended use. The following tables show the similarities and differences between the Cleveland Multiport Ventricular Catheter and the predicate devices.
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| Topic | Subject DeviceParker ClevelandMultiport VentricularCatheter Set | Predicate DeviceMRII SmartFlow FlexVentricular Catheter,K123605 | Reference DeviceAlcyone MEMSCannula System,K150660 | Reference DeviceSurgiVisionVentricular Cannula,K102101 | Discussion |
|---|---|---|---|---|---|
| Classification | 21 CFR 882.4100 | 21 CFR 882.4100 | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent to Predicate. |
| Product Code | HCA, Class II | HCA, Class II | HCD, Class I | HCD, Class I | Equivalent to Predicate. |
| Intended Use/Indications for Use | The Cleveland MultiportVentricular CatheterSet is indicated forgaining access to theventricles of the brainfor the removal ofcerebrospinal fluid(CSF) or for injectingCytarabine. | The SmartFlow™ FlexVentricular Catheter isintended for injection ofCytarabine or removalof CSF from theventricles duringintracranial procedures.The device is notintended for implant.This device is intendedfor "single patient useonly." | The Alcyone MEMSCannula (AMC) Systemconsisting of the AMCand the AMC ExtensionLine Set, is intended forinjection of Cytarabine(cytosine arabinoside)or removal ofcerebrospinal fluid(CSF) from theventricles of the brainduring intracranialprocedures. The AMCSystem is not intendedfor implant. The deviceis intended for "singlepatient use only." | The MR CompatibleVentricular Cannula isintended for injection ofCytarabine or removalof CSF from theventricles duringintracranial procedures.The device is notintended for implant.The device is intendedfor "single patient useonly." | Equivalent to Predicate. |
| Single Patient UseOnly | Yes | Yes | Yes | Yes | Equivalent to Predicate. |
| Target PatientPopulation | Patients needinginjection of Cytarabineinto the brain ventricles | Any Pt's needingaspiration of CSF andother fluids of similarphysical characteristics | Pt.s needing injection ofCytarabine into thebrain ventricles or | Pt.s needing injection ofCytarabine to the brainventricles or aspiration | Equivalent to Predicate. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ||
| or removal of CSF fromthe brain ventricles | from the brainventricles | aspiration of CSF fromthe brain ventricles | of CSF from the brainventricles | ||
| Anatomical Sites | Brain ventricle | Brain ventricle | Brain ventricle | Brain ventricle | Equivalent to Predicate. |
| Where used | MRI Suite / SurgicalRoom (OR) | MRI Suite / SurgicalRoom (OR) | MRI Diagnostic/Surgical Room (OR) | MRI Diagnostic/Surgical Room (OR) | Equivalent to Predicate. |
| Human Factors | a) Labeling includessize and length | a) Labeling includessize and length | a) Labeling includessize and length | a) Labeling includessize and length | Equivalent to Predicate. |
| b) Labeling shows flowvs. pressure tables | b) Labeling shows flowvs. pressure tables | b) Labeling shows flowvs. pressure tables | b) Labeling shows flowvs. pressure tables | Equivalent to Predicate. | |
| c) Can be manipulatedwith gloved hand | c) Can be manipulatedwith gloved hand | c) Can be manipulatedwith gloved hand | c) Can be manipulatedwith gloved hand | Equivalent to Predicate. | |
| Design | a) Designed to beplaced through aprepared openingthrough the skull anddura into the brainventricle | a) Designed to beplaced through aprepared openingthrough the skull anddura into the brainventricle | a) Designed to beplaced through aprepared openingthrough the skull anddura into the brainventricle | a) Designed to beplaced through aprepared openingthrough the skull anddura into the brainventricle | Equivalent to Predicate. |
| b) Main cathetersection to enter thebrain. | b) Rigid and straightsection to enter thebrain. | b) Rigid and straightsection to enter thebrain. | b) Rigid and straightsection to enter thebrain. | Equivalent to Predicate. | |
| c) Opening at distal endof micro-catheters forfluid movement | c) Opening at distal endfor fluid movement | c) Opening at distal endfor fluid movement | c) Opening at distal endfor fluid movement | Equivalent to Predicate.One hole per fluid channel. | |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ||
| d) Four openings, noside holes, at distal endfor fluid movement | d) Central hole, no sideholes, at distal end forfluid movement | d) Two holes, no sideholes, at distal end forfluid movement | d) Central hole, no sideholes, at distal end forfluid movement | Equivalent to Predicate.Both devices are movingfluids and their differentinside/outside diametersresult in different flowrates. This is within therange of clearedventricular cannulas andcatheters. | |
| e) Reference sidemarkings on body ofdevice for depthindication | e) No markings ofdevice body | e) Body markingsdesigned to facilitatedetermination of theinsertion depth | e) No markings ofdevice body | Equivalent to Predicate.Length marking on body tohelp user determine depthof insertion. Lengthmarkings are common inthese devices to aid theuser in positioning. | |
| Design | f) Total Length ofCatheter; 5.5" (14.0 cm)long | f) Total length of rigidsection; 10.5" (30 cm)long | f) Total Length ofCatheter; 9" (22.9 cm)long | f) Length of rigidsection; 10.5" (30 cm)long | Equivalent to Predicate.Total length of catheterdoes not impact theintended usage of thedevice. |
| g) Main catheter InsideDiameter: Ø.030"(Ø0.76 mm) ID andmicro-catheters at tipØ.007" (Ø0.177 mm) ID | g) Inside diameter:Ø.008" to .021" (Ø 0.2mm to 0.53 mm) | g) Main catheter InsideDiameter: Ø.010"(Ø0.25 mm) with insidecross-section at tip:.002" x .001" (0.052 x0.03mm) | g) Inside diameter:Ø.008" to .021" (Ø 0.2mm to 0.53 mm) | Equivalent to Predicate.All devices are movingfluids and their differentinside/outside diametersresult in different flowrates. This is within therange of clearedventricular cannulas andcatheters. | |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ventricular cannulas andcatheters. | |
| h) Outside DiameterØ2.5mm | h) Outside Diameter: Ø0.65" (1.6 mm) andØ0.080" (2.0 mm) | h) Outside Diameter: Ø0.65" (1.6 mm) | h) Outside Diameter: Ø0.65" (1.6 mm) andØ0.080" (2.0 mm) | Equivalent to Predicate. | |
| j) Insertion Stylet -Stylet can be removedafter insertion | j) Insertion Stylet | j) No Stylet -Sufficiently rigid to passthrough brain tissuewithout additionalsupport. Rigid sectioncan be removed afterinsertion | j) No Stylet -sufficiently rigid forinsertion | Equivalent to Predicate.Insertion Stylet and rigidsections are removed afterinsertion. | |
| k) Standard Luer | k) Standard Luer | k) Standard Luer | k) Standard Luer | Equivalent to Predicate. | |
| Performance | Flow Rate: 4.93 mL/hr.(1.97 mL/hr. perchannel) at <25 psiinternal pressure perchannel | Flow Rate: 4.0 mL/hr.(0.008"ID) to 56 mL/hr.(0.021"ID) at 0.7 psi | Flow Rate: 3.0 mL/hr.(1.5mL/hr. per channel)to 25mL/hr. at <25 psiinternal pressure perchannel | Flow Rate: 0.6 mL/hr.(0.008"ID) to 34 mL/hr.(0.021"ID) at 0.7 psi | Equivalent to Predicate.All devices are movingfluids, and the differentflow rates results fromtheir different diameters.Pressures listed areinternal to the system. |
| CSF Removal Rate:1.70 mL/hr. (0.47 m/hr.per channel) | Aspiration Rate:Unknown | Aspiration Rate: 2.4mL/hr. (1.2mL/hr. perchannel) using an airvacuum of 10mL from asyringe | Aspiration Rate: 0.1mL/hr. (0.008"ID) to8.7mL/hr. (0.021" ID) | Equivalent to Predicate.All devices are movingfluids, and the differentflow rates results fromtheir different diameters. | |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ||
| Energy Used | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Electrical Safety | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Mechanical Safety | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Chemical safety | Micro-catheter fluidpathway non-reactivefor Cytarabine, Salineand CSF | Lumen materials non-reactive to Cytarabine,Saline, CSF | Lumen materials non-reactive to Cytarabine,Saline, CSF | Silica lumen non-reactive to Cytarabine,Saline, CSF | Equivalent to Predicate.Materials of all devices areusing historically stableand biologically acceptablematerials for ventricularaccess devices. |
| Thermal Safety | MRI Safe. All braincontacting componentstested safe in 1.5T and3.0T environment | MRI Safe. All braincontacting componentstested safe in a 1.5Tenvironment | MRI Safe. All braincontacting componentstested safe in 1.5T and3.0T MRI environment | MRI safe. All braincontacting componentstested safe in a 1.5Tenvironment | Equivalent to Predicate. |
| Materials | a) Main Catheter Body:silicone elastomer; Tip:Siliconeb) Insertion Stylet:PTFE-coated nickelalloy (No fluid/patientcontact) | a) Rigid body: Ceramic;Tip: Polymerb) Stylet: StainlessSteel | a) Rigid body: Ceramic;Tip: Siliconb) Stylet: N/A | a) Rigid body: Ceramic;Tip: Polymer coveredsilicab) Stylet: N/A | Equivalent to Predicate.Materials of all devices areusing historically stableand biologically acceptable |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ||
| materials for ventricularaccess devices. | |||||
| c) Deploying Micro-Catheters: PTFE | c) Through lumen:PEEK | c) Through lumen:Polymer covered silicasilicon | c) Through lumen:Polymer covered silica | Equivalent to Predicate.Materials of all devices areusing historically stableand biologically acceptablematerials for ventricularaccess devices. | |
| d) Non-detachableLumen extension:(outer supportingtubing): Silicone | d) Lumen extension(outer support tubing):PVC extrusion | d) Detachable Lumenextension (outersupport tubing):Polymer | d) Non-detachableLumen extension (outersupport tubing):Polymer coated silica | Equivalent to Predicate.Materials of all devices areusing historically stableand biologically acceptablematerials for ventricularaccess devices. | |
| e) Proximal Connector:Female Luer connector:Translucent | e) Proximal Connector:Female Luer connector:Translucent | e) Proximal Connector:Female Luer connector,Translucent | e) Proximal Connector:Female Luer connector,Translucent | Equivalent to Predicate. | |
| Compatibility withenvironment andother devices | Compatible withstandard syringepumps for infusion. | Compatible withstandard syringepumps for infusion. | Compatible withstandard syringepumps for infusion. | Compatible withstandard syringepumps for infusion. | Equivalent to Predicate. |
| Stereotactic guidancesystem not required | Compatible withstereotactic guidancesystems equipped withadapters possessing a2.6 mm inner diameter | Compatible withStereotactic Frameswith 2.6mm adapter | Compatible with MRIInterventionsStereotactic Frame | Equivalent to Predicate. | |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| Parker ClevelandMultiport VentricularCatheter Set | MRII SmartFlow FlexVentricular Catheter,K123605 | Alcyone MEMSCannula System,K150660 | SurgiVisionVentricular Cannula,K102101 | ||
| Radiation Safety | N/A | N/A | N/A | N/A | Equivalent to Predicate.Device does not containany electronics orRadiation-EmittingElectronics. |
| Packaging | Tray, pouch, SBS boxCatheter, Suture tab,Female-to-Femaleadapters, InsertionStylet in same box | Tray, pouch, boxCatheter with extensionlines in same box | Catheter - Tray, pouch,SBS box; Extensionlines - Pouch, pouch,SBS box | Tray, pouch, boxCatheter with extensionlines in same box | Equivalent to Predicate. |
| Shelf Life | 1 year | Assumed to be 1 year | 1 year | Assumed to be 1 year | Equivalent to Predicate. |
| Sterility | 10-6 SAL | 10-6 SAL | 10-6 SAL | 10-6 SAL | Equivalent to Predicate.New device materials arenot radiation compatible.Both methods ofSterilization maintain asterilization assurancelevel of 10-6 SAL perANSI/AAMI/ISO 11135-1:20072007 - Sterilizationof Healthcare Products-Ethylene Oxide. |
| Topic | Subject DeviceParker ClevelandMultiport VentricularCatheter Set | Predicate DeviceMRII SmartFlow FlexVentricular Catheter,K123605 | Reference DeviceAlcyone MEMSCannula System,K150660 | Reference DeviceSurgiVisionVentricular Cannula,K102101 | Discussion |
| EO Residuals | Limited Exposure -4 mlEO | VDmax25 procedure ofISO 11137-2 | VDmax25 procedure ofISO 11137-2. | VDmax25 procedure ofISO 11137-2. | Equivalent to Predicate.New device materials arenot radiation compatible.EO residuals are belowthe allowable limit. |
| Biocompatibility | Tissue contact | Tissue contact | Tissue contact | Tissue contact | Equivalent to Predicate.Tested per ISO- 10993:Biological Evaluation ofMedical Devices. |
| Limited exposuredevice, <24 hours (Notimplantable). | Limited exposuredevice, <24 hours (Notimplantable). | Limited exposuredevice, <24 hours (Notimplantable). | Limited exposuredevice, <24 hours (Notimplantable). | Equivalent to Predicate. | |
| Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent to Predicate. |
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Image /page/6/Picture/0 description: The image shows the word "Parker" in white text on a black background. To the left of the word "Parker" is a white symbol that looks like a stylized "P" with a horizontal line extending from the left side. The text is in a bold, sans-serif font. The image appears to be a logo or brand name.
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Image /page/7/Picture/0 description: The image shows the word "Parker" in white font on a black background. To the left of the word is a white symbol that looks like a stylized "P" with a horizontal line extending from the left side. The font is bold and sans-serif. The image appears to be a logo or brand name.
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Image /page/8/Picture/0 description: The image shows the word "Parker" in white text on a black background. The word is written in a bold, sans-serif font. To the left of the word is a white horizontal line that extends to the left of the letter "P". The image is a logo for the Parker company.
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Image /page/9/Picture/0 description: The image shows the Parker logo. The logo is white text on a black background. The word "Parker" is written in a bold, sans-serif font.
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Image /page/10/Picture/0 description: The image shows the word "Parker" in white text on a black background. To the left of the word is a white horizontal line that extends to the left of the letter "P". The font is bold and sans-serif. The image appears to be a logo.
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Image /page/11/Picture/0 description: The image shows the Parker logo. The logo is white text on a black background. The word "Parker" is written in a bold, sans-serif font.
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Image /page/12/Picture/0 description: The image shows the Parker logo. The logo is white text on a black background. The word "Parker" is written in a bold, sans-serif font.
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Image /page/13/Picture/0 description: The image shows the word "Parker" in white text on a black background. A horizontal line extends from the left side of the image, connecting to the letter "P" in "Parker." The font of the word "Parker" is sans-serif and appears to be bolded. The image is a logo for the Parker company.
Performance Data
Bench testing was conducted to demonstrate that the Cleveland Multiport Ventricular Catheter meets its design requirements and is substantially equivalent when compared to the predicable standards including verification and validation testing, and cadaver usability testing in a simulated clinical use. The following performance testing tables are to support the determination of the substantial equivalence of devices currently on the market for its intended use.
| Test | Test Method Summary | Results |
|---|---|---|
| Joint and Bond Strength TestsTip loading force | Demonstrate the Cleveland MultiportVentricular Catheter can withstandminimum pull-off forces for eachbond joint. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.All joints bonds were above the minimum pull-off forcerequirement (worst-case usage force plus safety factor).Tip loading exceeded the minimum load requirements.Cleveland Multiport Ventricular Catheter withstood the pullforces based on clinically relevant forces with a safetyfactor. |
| Viscosity Test | Demonstrate kinematic viscosity ofCytarabine and room temperaturesterile saline are comparable. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.The kinematic viscosity of Cytarabine and saline are similar,(within 2%) therefore, bench testing using saline isacceptable. |
| Depth Marking | Demonstrate Cleveland MultiportVentricular Catheter depth markersare legible after swabbing. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Testing for depth gauge marks were not altered. |
| Test | Test Method Summary | Results |
| Pressure TestingFlow Burst Infusate Pressure TestWith suture tabAspiration Flow Rate Test | Demonstrate the Cleveland MultiportVentricular Catheter can withstandpressure spikes and infusion andaspiration pressure with and withoutthe suture tab installed using bodytemperature water. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Cleveland Multiport Ventricular Catheter reached specifiedflow rate within the specified time and was capable ofinjecting fluid at it maximum flow rate.Cleveland Multiport Ventricular Catheter reached a linearpressure profile across all flow rates without leakage and nokinking of catheter and withstood the maximumpressure/spikes. Testing passed pressure-flow with suturetab attached.The Cleveland Multiport Ventricular Catheter was capableaspirating at its clinically acceptable aspiration rate. |
| Pressure Test | Demonstrate the Cleveland MultiportVentricular Catheter resists airleakage when pressurized to aconstant water column. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Reflux Test | Demonstrate the Cleveland MultiportVentricular Catheter resists flow inthe reverse direction. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Deployment and RetractionTest | Demonstrate the Cleveland MultiportVentricular Catheter minimaldimensional changes from thedeployment and retraction processand the maximum loads for insertionand removal of stylet. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Test results met the specified dimensional and maximumdistance insertion and removal forces. |
| Test | Test Method Summary | Results |
| Tissue Insertion Test | Demonstrate the Cleveland MultiportVentricular Catheter can withstandinsertion and removal from bovinebrain tissue. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Testing passed insertion and removal for bovine tissue. |
| Bend Radius Test | Demonstrate the Cleveland MultiportVentricular Catheter withstands aminimum bend radius withoutkinking. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Dimensional Verification | Demonstrate the Cleveland MultiportVentricular Catheter can bemanufactured and reproduced topredetermined specifications. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Micro-Catheter Strength Test | Demonstrate the minimum strengthof micro-catheters PTFE materialexceeds the minimum forcerequirements. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Testing passed demonstrating the micro-catheter materialexceeds the minimum force requirements. |
| Syringe Drop Test | Demonstrate the Cleveland MultiportVentricular Catheter connected to aliquid-filled standard syringe that isanchored and drop syringe. Checkfor damage and operation. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Surface Inspection | Demonstrate the Cleveland MultiportVentricular Catheter is free fromvoids, cracks or extraneous matteralong the effective length of thedevice. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Test | Test Method Summary | Results |
| Particulate Testing | Demonstrate the Cleveland MultiportVentricular Catheter shedding ofparticulates are below a specifiedlimit. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Leakage under pressure | Demonstrate the Cleveland MultiportVentricular Catheter is free of leaksduring infusion and aspiration. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Cadaver Assessment | Demonstrate the Cleveland MultiportVentricular Catheter can be placedusing conventional techniques andvisualized using CT. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Testing passed using conventional techniques and wasvisualized on axial CT scan with successful infusion of CTdye. | ||
| Stylet Strength | Demonstrate the Cleveland MultiportVentricular Catheter can withstandexcessive loading on the stylethandle without fracturing. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Cleveland Multiport Ventricular Catheter withstood the pullforces based on clinically relevant forces with a safetyfactor. | ||
| Stylet Corrosion Resistance | Demonstrate the Cleveland MultiportVentricular Catheter can withstandcorrosion with extended exposure tosodium chloride. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Test | Test Method Summary | Results |
| Biocompatibility | Testing was conducted todemonstrate compliance of theCleveland Multiport VentricularCatheter with ISO 10993biocompatibility requirements. | All tissues contacting materials used in the ClevelandMultiport Ventricular Catheter set are biocompatible per ISO10993- Biological evaluation of Medical Devices, ExternallyCommunicating Device - Tissue contact, limited exposureduration A < 24 hours.The following tests were completed demonstratingsubstantial equivalence to the predicate devices:• Cytotoxicity• Systemic Toxicity• Intracutaneous Reactivity• Sensitization• Hemocompatibility• Material Mediated Pyrogen |
| Drug Compatibility | Testing was conducted todemonstrate compliance of theCleveland Multiport VentricularCatheter with does not leach highconcentration levels of identifiablecompounds per ISO 10993requirements. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices.Test passed showing Cytarabine is compatible within theflow path materials with acceptable levels of identifiablecompounds. |
| Accelerated Aging | Demonstrate the Cleveland MultiportVentricular Catheter functions asintended after 1-year equivalentaccelerated aging using its intended | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter is substantially equivalent tothe predicate devices. |
| Sterilization Validation | Demonstrate the Cleveland MultiportVentricular Catheter minimumsterilization cycle sterilizes theproduct are met. | Testing substantiates the use of the half-cycle (minimumexposure) EO cycle to achieve sterility assurance level, SALof 10 $-6$ , which is required for its intended use and issubstantially equivalent to the predicate devices. |
| Test | Test Method Summary | Results |
| LAL Validation | Testing was conducted todemonstrate compliance of theCleveland Multiport VentricularCatheter set with the LALrequirements per the USP guidancefor CNS contacting devices. | Testing demonstrated that all devices met an endotoxinlevels of <2.15 EU/device required for its intended use perFDA Guidance Guideline on Validation of the LimulusAmebocyte Lysate Test As An End-Product Endotoxin Testfor Human And Animal Parenteral Drugs, BiologicalProducts, and Medical Devices – 1997, and is substantiallyequivalent to the predicate devices. |
| Transit Testing -PackagingQualification | Demonstrate the Cleveland MultiportVentricular Catheter can withstandnormal transportation and handlingof the packaging materials per ISTA-2A. | Testing passed and results demonstrate the ClevelandMultiport Ventricular Catheter packaging meets itsfunctionality requirements and the integrity of the packagemaintains the sterile barrier after exposing it to actual andsimulated transportation test conditions, and is substantiallyequivalent to the predicate devices. |
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Image /page/14/Picture/0 description: The image shows the word "Parker" in white font on a black background. To the left of the word is a white horizontal line that extends to the left of the letter "P". The font is bold and sans-serif. The image appears to be a logo.
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Image /page/15/Picture/0 description: The image shows the word "Parker" in white font on a black background. To the left of the word is a white symbol that looks like a line with a square on the end. The word "Parker" is in a bold, sans-serif font. The image is likely a logo for the Parker company.
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Image /page/16/Picture/0 description: The image shows the word "Parker" in white font on a black background. To the left of the word is a white horizontal line that extends to the left of the letter "P". The font is sans-serif and appears to be bolded. The logo is simple and modern.
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Image /page/17/Picture/0 description: The image shows the Parker logo. The logo consists of a horizontal line extending to the left, followed by the word "Parker" in a bold, sans-serif font. The logo is white and is set against a black background.
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Image /page/18/Picture/0 description: The image shows the Parker logo. The logo consists of a horizontal line extending to the left, followed by the word "Parker" in a bold, sans-serif font. The logo is white and is set against a black background.
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Image /page/19/Picture/0 description: The image shows the word "Parker" in white font on a black background. To the left of the word "Parker" is a white horizontal line that extends to the left of the letter "P". The font is sans-serif and appears to be bolded. The image is a logo for the Parker company.
Substantial Equivalence
The Cleveland Multiport Ventricular Catheter has the same intended use/indications for use along with similar design, materials of construction, and similar technological characteristics as its predicate devices. While there are technological differences between the Cleveland Multiport Ventricular Catheter and the predicate devices (such as the Alcyone MEMS Cannula has two fluid channels versus one in the other predicate devices, different exit hole configurations, and dimensional differences); these differences do not raise new types of safety and effectiveness questions when all listed warnings and cautions are followed.
The results from comparative testing, bench animal testing and usability studies in a simulated clinical use; demonstrate that the technological and performance characteristics of the Cleveland Multiport Ventricular Catheter meet defined design requirements and can perform in a manner equivalent to devices currently on the market for its intended/indicated use. Performance data demonstrate that the Cleveland Multiport Ventricular Catheter performs as intended and is substantially equivalent to its predicates; Alcyone MEMS Cannula, the MRI SmartFlow Flex Ventricular Catheter and the SurgiVision MR Compatible Ventricular Cannula.
Conclusions
The data and information presented within this submission support a determination of substantial equivalence to the predicates listed above, and therefore market clearance of the subject Cleveland Multiport Ventricular Catheter for its intended use. This conclusion is based upon the device equivalence in design, technological characteristics, principles of operation, and indications for use.
The Cleveland Multiport Ventricular Catheter has the same intended uses and identical indications, technological characteristics, and principles of operation as its predicate device.
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).