(183 days)
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainage holes near the catheter's bullet shaped tip. Similar to the predicate, the catheter is barium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cm between 5 cm and 15 cm from the catheter tip to assist the surgeon in catheter placement. Double stripes and numerical markings are located at 10 cm and 15 cm. (All dimensions are nominal).
The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar, Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Stylet facilitates catheter placement for introduction of the catheter into the ventricle or other ventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with each SureFlo EVD Catheter will connect the catheter to external drainage systems. The included Male Luer Cap may be used to close (cap) the barbed luer connector until the catheter is connected to a drainage or monitoring device.
The SureFlo EVD Catheter and its accessories are provided sterile.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Arkis SureFlo EVD Catheter:
The document describes pre-market testing primarily focused on bench performance, sterility, shelf life, package integrity, and biocompatibility. It does not involve a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it present standalone algorithm performance. The device is a physical medical device (catheter), not AI software. Therefore, the questions related to AI-specific criteria (human reader improvement with AI, standalone AI performance, training set details) are not applicable.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with recognized consensus standards (ISO 7197:2006, ASTM F647-94(2014) for performance; ISO 11135:2014, ISO 10993-7:2008, ANSI ST72:2011 for sterility; ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, F88/F88M-15, ASTM F1608-16 for shelf life/package integrity; and ISO 10993-1:2009/(R)2013, ISO 10993-5, -10, -11, -3, -4, -6 for biocompatibility). The reported device performance indicates that the SureFlo EVD Catheter met or exceeded all specified requirements and demonstrated equivalence or superiority to the predicate devices in these areas.
| Acceptance Criteria Category | Specific Test Standard / Requirement | Reported Device Performance |
|---|---|---|
| Bench Performance | ISO 7197:2006 & ASTM F647-94 (General) | Meets all performance specifications. Where no specific standard was given, it had equivalent performance to the predicate. |
| Pressure and Flow Characteristics | Pass: Characterization of pressure and flow successfully completed. | |
| Resistance to Overpressure | Pass: No significant differences in flow rates post-test, no damage/leakage. | |
| Bursting Pressure | Pass: No damage/leakage. Mean flow rate did not change more than allotted value. | |
| Resistance to Leakage (Bench) | Pass: No signs of leakage observed. | |
| Durability (after 28 days submersion/circulation) | Pass: No indication of damage; post-submersion flow rates not statistically different from pre-submersion. | |
| Static Breaking Strength | Pass: Disassembled or failed at higher forces than primary predicate. | |
| Flexibility | Pass: Obstructed when wrapped around a smaller diameter pin than the predicate device. | |
| Dynamic Breaking Strength | Pass: Met prescribed maximum number of cycles without failure. | |
| Radiopacity | Pass: Met or exceeded radiopacity requirements compared to control specimens. | |
| Sterility | Ethylene Oxide Sterilization (ISO 11135:2014) | Pass: Achieved a Sterility Assurance Level (SAL) of <10-6. |
| Ethylene Oxide Residuals (ISO 10993-7:2008) | Pass: EO and ECH levels were less than established limits for prolonged contact devices. | |
| Bacterial Endotoxin (Limulus Amebocyte Lysate (LAL) Assay) (ANSI ST72:2011) | Pass: Bacterial endotoxin levels were less than the established limit; non-pyrogenic. | |
| Shelf Life & Package Integrity | Resistance to Leakage (Aged devices) | Pass: Samples did not show any indication of leakage; no change from non-aged samples. |
| Dynamic Breaking Strength (Aged devices) | Pass: Met prescribed maximum number of cycles without failure; no change from non-aged samples. | |
| Static Breaking Strength (Aged devices) | Pass: Disassembled or failed at higher forces than primary predicate; no change from non-aged samples. | |
| Flexibility (Aged devices) | Pass: Obstructed when wrapped around a smaller diameter pin than the predicate device; no change from non-aged samples. | |
| Accelerated Aging (ASTM F1980-16) | Pass: Accelerated aging completed at specified parameters. | |
| Distribution Simulation (ASTM D4169-16) | Pass: Shipping unit remained intact with no rips, punctures, tears, or crushing; met same specifications as non-aged samples. | |
| Bubble Emission Test (ASTM F2096-11) | Pass: No bubbles emitted; meets same specifications as non-aged/distributed samples. | |
| Pouch Seal Test (ASTM F88/F88M-15) | Pass: Sterile barrier seal strength exceeded minimum specification for non-aged/distributed samples. | |
| Microbial Ranking (ASTM F1608-16) | Pass: Porous sterile barrier material met the same performance specification as non-aged/distributed sterile barrier. | |
| Biocompatibility | ISO 10993-1:2009/(R)2013 (General) | Demonstrated biocompatibility for intended use. |
| Cytotoxicity (ISO 10993-5:2009) | Pass: Non-cytotoxic. | |
| Sensitization (ISO 10993-10:2010) | Pass: Non-sensitizing. | |
| Irritation or Intracutaneous Reactivity (ISO 10993-10:2010) | Pass: Non-irritating. | |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Pass: No acute systemic toxicity. | |
| Material-Mediated Pyrogenicity (ISO 10993-11:2006) | Pass: Non-pyrogenic. | |
| Genotoxicity (Ames Assay, Micronucleus Assay, Mutagenesis Assay) (ISO 10993-3:2014) | Pass: Non-mutagenic, non-clastogenic, increased mutant frequency was less than test criteria. | |
| Hemocompatibility (Complement Activation, Hemolysis, In Vitro, UPTT) (ISO 10993-4:2002) | Pass: Did not activate complement system, non-hemolytic, no effect on selected hematological parameters, no effect on coagulation. | |
| Subacute Toxicity via Brain and Subcutaneous Implantation (ISO 10993-6:2007) | Pass: No local or systemic sign of toxicity. |
Additional Information:
-
Sample sizes used for the test set and data provenance:
- The document describes bench testing, sterility testing, shelf life/package integrity testing, and biocompatibility testing. Specific sample sizes for each test are not explicitly provided in this summary document.
- Data provenance: All testing appears to be prospective laboratory/bench testing conducted by the manufacturer or contract labs, rather than clinical patient data. The origin of the data would be the respective testing facilities.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. This device relies on objective measurements against engineering and biological standards, not expert interpretation of cases or images.
-
Adjudication method for the test set:
- Not applicable. Ground truth is established by objective measurements and standardized test methods, not expert adjudication.
-
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:
- No. This is a physical medical device (catheter) and not an AI/software device. Therefore, MRMC studies and AI assistance metrics are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
-
The type of ground truth used:
- Standardized measurements against industry consensus standards and predicate device performance. For biocompatibility, it involved biological responses measured in in vitro and in vivo (animal) studies compared against established safety limits.
-
The sample size for the training set:
- Not applicable. There is no AI algorithm being "trained" for this physical device.
-
How the ground truth for the training set was established:
- Not applicable. See point 8.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Arkis BioSciences, Inc. Mr. Joseph Howell Ouality and Regulatory Affairs Manager 1059 N. Cedar Bluff Road #157 Knoxville, Tennessee 37923
Re: K170599
Trade/Device Name: SureFlo EVD Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 1, 2017 Received: August 2, 2017
Dear Mr. Howell:
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 device
{1}------------------------------------------------
related 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.
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 (DICE) 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 (DICE) 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,
William J. Heetderks -S 2017.08.31 13:28:40 -04'00'
for 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)
Device Name
SureFlo EVD Catheter Indications for Use (Describe)
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
| 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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510(k) Summary 510(k) Number K170599
| Arkis BioSciences Inc.1059 North Cedar Bluff Rd.Number 157Knoxville, TN 37923(844) 247-5383 | |
|---|---|
| Date Prepared | August 29, 2017 |
| Contact | Joseph HowellQuality and Regulatory Affairs Manager(844) 247-5383 ext. 2 |
| Trade Name | SureFlo™ EVD Catheter |
| Common Name | External Ventricular Drainage Catheter |
| Classification | Class II |
| Regulation Number | 21 CFR 882.5550 |
| FDA Product Code | JXG |
| Classification Name | Shunt, Central Nervous System and Components |
| Predicate Device(s): | Primary Predicate: TraumaCath, Integra NeuroSiciences (K972994)Predicate: Neurocath Ag, Vygon Neuro, (K081942)Reference Device: NMI PICC III, Navilyst Medical (K121089) |
| PerformanceStandards: | Performance standards for external monitoring and drainage systems have not beenestablished by FDA under Section 514 of the Food, Drug and Cosmetic Act. |
| Device Description | The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheterfor diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainageholes near the catheter's bullet shaped tip. Similar to the predicate, the catheter isbarium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cmbetween 5 cm and 15 cm from the catheter tip to assist the surgeon in catheterplacement. Double stripes and numerical markings are located at 10 cm and 15 cm. (Alldimensions are nominal).The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar,Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Styletfacilitates catheter placement for introduction of the catheter into the ventricle or otherventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneoustunneling away from the burr hole. The external portion of the catheter may be secured tothe scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with eachSureFlo EVD Catheter will connect the catheter to external drainage systems. The includedMale Luer Cap may be used to close (cap) the barbed luer connector until the catheter isconnected to a drainage or monitoring device.The SureFlo EVD Catheter and its accessories are provided sterile. |
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The SureFlo EVD Catheter is constructed of a thermoplastic polyurethane (TPU) elastomer, just as the predicate device, Vygon Neurocath Ag (K081942). The SureFlo EVD Catheter polymer contains barium sulfate for radiopacity.
The SureFlo EVD Catheter additionally contains Endexo polymer; a polymer which is blended into the SureFlo EVD Catheter. The Endexo polymer is present throughout the polyurethane matrix including the bulk of the catheter body, and at any molded / extruded surfaces. The same Endexo polymer technology is used in several class II medical devices, including the cited reference device, Navilyst Medical NMI PICC III (K121089), Navilyst Medical Bioflo Midline Catheter (K150407), and the Navilyst Medical NMI Dialysis Catheter (K131260). Additionally, the same Endexo formulation is used in the cited reference device, Navilyst Medical NMI PICC III (K121089).
The Endexo polymer in polyurethane has been shown to be effective in reducing platelet adhesion in-vitro and thrombus accumulation in vitro [1, 2], and reducing the clinical incidence of thrombus formation as reported in medical literature [3, 4, 5, 6]. Please note:
- . In vitro evaluations and in vivo animal evaluations do not necessarily predict the clinical performance of the SureFlo EVD Catheter with respect to thrombus formation.
- . The incidence of thrombus formation on polyurethane containing Endexo polymer in other medical devices and/or tissues systems does not necessarily predict the clinical performance of the SureFlo EVD Catheter for the intended use of CSF external drainage and monitoring.
REFERENCES:
[1] R. Lareau and F. Facchini, "A New Option for Short- or Long-Term Peripheral Access to the Central Venous System: A product technology overview of the BioFlo PICC with Endexo Technology, with and without PASV Valve Technology," AngioDynamics, Inc., 2014.
[2] See test reports in the FDA cleared 510(k) application K121089 "Navilyst Medical NMI PICC III".
[3] L. Sustar and M. Kertesz, "Anti-Thrombogenic Non-Eluting Polyurethane PICC vs. Conventional Polyurethane PICC Upper Extremity DVT Rate," in Association for Vascular Access 2013 Annual Scientific Meeting, Nashville, TN, 2013.
[4] J. Webb and S. Rineair, "Changing the Outcome for the Pediatric Peripherally Inserted Central Catheter Patient: Decreasing Occlusion Complications with the Implementation of the BioFlo Peripherally Inserted Central Catheter with Pressure Activated Safety Valve," in Association For Vascular Access 2013 Annual Scientific Meeting, Nashville, TN, 2013.
[5] H. Polenakovik, A. Patton and J. Jenkins, "Incidence Rates of Symptomatic Peripherally Inserted Central Catheter - Related Deep Vein Thrombosis in Hospitalized Non-trauma Patients – Comparison Study of Two PICC Designs," in Association For Vascular Access 2014 Annual Scientific Meeting, National Harbor, MD, 2014.
[6] L. Crites, "Reducing Catheter-Related Complications with New Anti-Thrombogenic PICC," Journal of the Association for Vascular Acess, vol. 30, no. 4, p. 256, 2015.
Indication for Use The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
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Comparison of Technological Characteristics with the Predicate Devices
At a high level, the SureFlo EVD Catheter (subject device), the primary predicate (Integra TraumaCath (K972994)), and the predicate device (Neurocath Ag Vygon (K081942)), are based on the following same technological elements:
- . The subject device, primary predicate, and predicate device utilize the same mode of action.
- Dimensions between the subject device and the primary predicate device are identical.
- The number of flow holes between the subject device, primary predicate, and predicate device are the same.
- The catheter from the subject device, primary predicate device, and predicate device have depth markings applied to the exterior of the catheter.
- The subject device and the primary predicate utilize the same type and number of accessories.
The following technological differences exist between the subject device (Arkis SureFlo EVD Catheter), primary predicate (Integra TraumaCath (K972994)), and the predicate (Vygon Neurocath Ag (K081942)):
- The catheter material utilized in the subject device (SureFlo EVD Catheter), the primary predicate Integra TraumaCath (K972994), and the predicate device Vygon Neurocath Ag (K081942) are different. Consequently, the SureFlo EVD Catheter was evaluated for biocompatibility and bench-top performance and was found to be biocompatible for its intended use.
Table 1 contains a summary of technological similarities and differences for the SureFlo EVD Catheter, the primary predicate, and the predicate device.
| TechnologicalCharacteristic | SureFlo EVD Catheter SetArkis Biosciences(Subject Device) | TraumaCathIntegra NeuroSicences(K972994)Primary Predicate Device | Neurocath AgVygon 8835.239(K081942)Predicate Device |
|---|---|---|---|
| CatheterDimensions | |||
| OuterDiameter: | 3.3 mm | 3.3 mm | 2.9 mm |
| InnerDiameter: | 1.9 mm | 1.9 mm | 1.8 mm |
| Length: | 35 cm | 35 cm | 32 cm |
| Flow Holes | 16 | 16 | 16 |
| Set Contents | One Each of the FollowingCatheterStainless Steel StyletteStainless Steel TrocarBarbed Luer ConnectorMale Luer CapSilicone Suture Clip | One Each of the FollowingCatheterStainless Steel StyletteStainless Steel TrocarBarbed Luer ConnectorMale Luer CapSilicone Suture Collar | One Each of the FollowingCatheterStainless Steel StyletteStainless Steel TrocarMale Luer ConnectorSlitted WingCompression Hub |
Table 1: Comparison and Differences of Technological Characteristics.
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| TechnologicalCharacteristic | SureFlo EVD Catheter SetArkis Biosciences(Subject Device) | TraumaCathIntegra NeuroSicences(K972994)Primary Predicate Device | Neurocath AgVygon 8835.239(K081942)Predicate Device |
|---|---|---|---|
| CatheterMarkings(listed asdistance fromthe tip) | Black stripes are locatedevery cm between 5 cm and15 cm from the catheter tip.Double stripes andnumerical markings arelocated at 10 cm and 15 cm. | Markings every cm from 3 to15 cm ± 1.5 mm with numberlocated at odd markings, anddots located at even markings. | Markings at 3, 4, 5, 6, 7, 8, 9, 10,15, and 20 cm. A specific markingis added 7.5 cm from the tip |
| CatheterMaterials | Polyurethane withBarium SulfateEndexo polymerBlue colorant | Barium Striped SiliconeTantalum impregnated tip | PolyurethaneSilver ions (for radiopacity) |
Bench testing of the Arkis SureFlo EVD Catheter per ISO 7197:2006 and ASTM F647-94(2014), and biocompatibility testing per ISO 10993-1:2009/(R)2013 demonstrate that the difference in material does not raise any new or different questions of safety or effectiveness compared to the primary predicate Integra TraumaCath (K972994).
Performance Data
Performance Testing - Bench
The SureFlo EVD Catheter was tested per the FDA- recognized consensus standards ISO 7197(2006) and ASTM F647-94(2014). The testing was performed to verify the performance specifications of the SureFlo EVD Catheter and to demonstrate equivalence in function to the predicate external ventricular drainage catheters.
The SureFlo EVD Catheter meets all of the performance specifications given in ISO 7197(2006) and ASTM F647-94(20014). Where no specific performance specification was given in the standards, the SureFlo EVD Catheter was found to have equivalent performance to the predicate ventricular drainage catheter to which it is being compared.
Table 2 summarizes the benchtop performance testing of the Arkis SureFlo EVD Catheter.
Performance Testing - Sterility
The SureFlo EVD Catheter is sterilized using ethylene oxide in per ISO 11135:2014. Sterilization validation demonstrated that the selected sterilization process achieves a sterility assurance level (SAL) of <10°. The ethylene oxide residuals on the device were within the limits specified in Section 4.3.3 of ISO 10993-7:2008 for prolonged contact devices. The bacterial endotoxin levels were quantified on sterilized devices per ANSI ST72:2011, and were less than the limits recommended by the FDA for devices in direct contact with CSF.
The SureFlo EVD Catheter meets the requirements for sterility given in the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."
Table 3 summarizes the sterility testing of the Arkis SureFlo EVD Catheter.
Performance Testing - Shelf Life and Package Integrity
The product's shelf life was established through benchtop testing of real-time aged devices and package integrity testing of accelerated aged products. Bench top testing of aged
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devices was performed per ISO 7197(2006) and ASTM F647-94(2014). The integrity of accelerated aged packages (ASTM F1980-16) was evaluated per ASTM D4169-16, ASTM F2096-11, F88/F88M-15, and ASTM F1608-16.
This testing demonstrated that aged SureFlo EVD Catheter devices and packaging have the same performance characteristics as new devices and packaging.
Table 4 summarizes the device performance testing and package integrity testing used to establish the SureFlo EVD Catheter's shelf life.
Performance Testing - Summary
The results of the performance testing (bench, sterility, shelf life and package integrity) demonstrates the SureFlo EVD Catheter is as safe, as effective, and performs as well or better than the primary predicate Integra TraumaCath (K972994) for its intended use.
| Test Description | Test Summary | Results | ||
|---|---|---|---|---|
| Pressure and FlowCharacteristicsISO 7197:2006ASTM F647-94 | Catheter + luer barb assemblies were tested atvarious flow rates and to characterization of thepressure and flow curve for the catheter and luerbarb assembly. | Pass: The characterization of pressureand flow was successfully completed. | ||
| Resistance toOverpressureISO 7197:2006 | Catheter + luer barb assemblies were tested forsignificant differences in flow rates, pre-and-post-test, to being subjected to a pressure equivalent to a1 m water column. Additionally, catheters wereobserved for any signs of damage or leakage. | Pass: There were no significantdifferences in flow rates and there wasno evidence of damage or leakage onthe tested samples. | ||
| Bursting PressureISO 7197:2006 | Catheter + luer barb assemblies were tested to apressure equivalent to a 2m water column, for adefined period of time and reviewed for signs ofdamage or leakage. Additionally, for a differentdefined time-period, flow rates were compared pre-and-post-test to ensure mean pressure at prescribedflow rates had not changed more than the allowedvariance of the mean values. | Pass: There was no evidence of damageor leakage and the mean value flow ratedid not change more than the allottedvalue pre-and-post-testing. | ||
| Resistance toLeakageISO 7197:2006 | An air pressure equivalent to a 1 m water column wasapplied to catheter + luer barb + male luer capassemblies submerged in water for a defined periodof time and observed for any signs of leakage. | |||
| DurabilityASTM F647-94 | Catheter + luer barb assemblies were submerged indeaerated distilled water at 37C for 28 days, andwater was circulated at a prescribed flow ratethrough catheter assemblies for a prescribedduration. At the end of the prescribed duration, thecatheter assemblies were examined for damage. Thepressure and flow characteristic were measured toensure there was no significant difference betweenpre-submersion and post-submersion. | Pass: After submersion and circulationfor 28 days, the samples showed noindication of damage and the post-submersion flow rates were notstatistically different when compared tothe flow rates of the samples pre-submersion. |
Table 2: Bench Testing Summary.
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| Test Description | Test Summary | Results |
|---|---|---|
| Static BreakingStrengthASTM F647-94 | Catheter + luer barb were loaded with an increasinglongitudinal force until the catheter disassembledfrom the luer, or until the catheter or luer fractures. | Pass: The Arkis SureFlo EVD Catheterassemblies tested disassembled or failedat higher forces than the primarypredicate assemblies tested forcomparison. |
| FlexibilityASTM F647-94 | Catheter + luer barb were wrapped around pins and apositive air pressure was applied to the inside of thecatheter. The catheter was wrapped arounddecreasing pin diameters until the catheter becameobstructed. | Pass: Arkis SureFlo EVD Cathetersamples tested were obstructed whenwrapped around a smaller diameter pinthen the predicate device. |
| Dynamic BreakingStrengthISO 7197:2006 | Catheter + luer barb assemblies were subjected to adynamic longitudinal load (up to 5 N or 10% ofelongation) for a prescribed maximum number ofcycles or until failure occurs. | Pass: The samples tested met theprescribed maximum number of cycleswithout failure. |
| RadiopacityISO 7197:2006ASTM F647-94 | X-ray catheter and suture clips alongsidestandardized control specimens of a specifiedthickness and specified alloy. Compare the pixelintensity of the catheter and suture clip tobackground and suture clip-to-background, atmultiple locations. The test articles must be at leastas radiopaque as the control specimens. | Pass: The test articles met or exceededthe radiopacity requirements ascompared with the control specimens. |
Table 3: Sterilization Testing Summary.
| Test Description | Test Summary | Results |
|---|---|---|
| Ethylene OxideSterilization perISO 11135:2014 | The bioburden of non-sterilized packaged catheters wasquantified. Fractional ethylene oxide cycles were used todetermine the relative resistance of the device bioburdencompared to a standard biological indicator. The packagedcatheters were then exposed to a full ethylene oxide cycle toachieve an SAL of <10-6. | Pass: The devices were sterilewith an SAL <10-6. |
| Ethylene OxideResiduals perISO 10993-7:2008 | The ethylene oxide (EO) and ethylene chlorohydrin (ECH)residuals on the catheters were quantified and compared tothe limits specified in Section 4.3.3 of ISO 10993-7:2008 forprolonged contact devices. | Pass: The EO and ECH levelswere less than the establishedlimits for prolonged contactdevices. |
| Bacterial Endotoxin(LimulusAmebocyte Lysate(LAL) Assay)ANSI ST72:2011 | Bacterial endotoxin levels were quantified on packageddevices prior to sterilization compared to the limitestablished by the FDA for devices in direct contact with CSF.The LAL test method was validated by inhibition andenhancement testing. | Pass: The bacterial endotoxinlevels were less than theestablished limit. Non-pyrogenic |
Table 4: Shelf Life: device performance and package integrity testing summary.
| Test Description | Test Summary | Results |
|---|---|---|
| Resistance toLeakageISO 7197:2006 | Real-time aged devices were tested. An air pressureequivalent to a 1 m water column was applied tocatheter + luer barb + male luer cap assembliessubmerged in water for a defined period of time andobserved for any signs of leakage. | Pass: Samples did not show anyindication of leakage. No change fromnon-aged samples. |
| Test Description | Test Summary | Results |
| DynamicBreakingStrengthISO 7197:2006 | Real-time aged devices were tested. Catheter + luerbarb assemblies were subjected to a dynamiclongitudinal load (up to 5 N or 10% of elongation) for aprescribed maximum number of cycles or until failureoccurs. | Pass: The samples tested met theprescribed maximum number of cycleswithout failure. No change from non-aged samples. |
| Static BreakingStrengthASTM F647-94 | Real-time aged devices were tested. Catheter + luerbarb were loaded with an increasing longitudinal forceuntil the catheter disassembled from the luer, or untilthe catheter or luer fractures. | Pass: The Arkis SureFlo EVD Catheterassemblies tested disassembled or failedat higher forces than the primarypredicate assemblies tested forcomparison. No change from non-agedsamples. |
| FlexibilityASTM F647-94 | Real-time aged devices were tested. Catheter + luerbarb were wrapped around pins and a positive airpressure was applied to the inside of the catheter. Thecatheter was wrapped around decreasing pin diametersuntil the catheter became obstructed. | Pass: Arkis SureFlo EVD Cathetersamples tested were obstructed whenwrapped around a smaller diameter pinthan the predicate device. No changefrom non-aged samples. |
| AcceleratedAgingASTM F1980-16 | Accelerated aging conducted prior to distribution andpackage integrity testing. | Pass: Accelerated aging completed atspecified parameters. |
| DistributionSimulationASTM D4169-16 | Testing performed on accelerated aged products.Distribution simulation of shipper boxes containingindividual device packages per ASTM D4169distribution cycle 13 with Schedule I omitted andSchedule J not performed. | Pass: Shipping unit remained intact withno rips, punctures, tears, or crushing.Shipping unit met the samespecifications as non-aged samples. |
| Bubble EmissionTestASTM F2096-11 | Testing performed on accelerated aged and distributedproducts. Detects leaks in sterile barrier pouchesthrough the emission of bubbles when the pouches areinflated and placed underwater. | Pass: No bubbles were emitted from anyof the tested packaging. Meets samespecifications as non-aged/distributedsamples. |
| Pouch Seal TestASTMF88/F88M-15 | Testing performed on accelerated aged and distributedproducts. Determines the strength sterile barrier(pouch) seal by mechanically pulling on sections of thepouch seal. | Pass: The sterile barrier seal strengthexceeded the minimum specification fornon-aged/distributed samples. |
| MicrobialRankingASTM F1608-16 | Testing performed on accelerated aged and distributedproducts. Quantifies the log reduction value in numberof aerosolized bacterial spores passing through poroussterile barrier materials. | Pass: The porous sterile barrier materialmet the same performance specificationas non-aged/distributed sterile barrier. |
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Biocompatability
The Arkis SureFlo EVD Catheter was evaluated following ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" per the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
The biocompatibility assessments demonstrated that the SureFlo EVD Catheter and the accessories included in the set are biocompatible for their intended use.
The biocompatibility testing is summarized in Table 5.
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| Test | Results | Conclusions |
|---|---|---|
| CytotoxicityISO 10993-5:2009 | The viability percentage of the cells exposed to the 100% (neat) test article extract was within acceptable limits. | Pass: Non-cytotoxic |
| SensitizationISO 10993-10:2010 | Extracts of the test articles elicited no reaction at the test challenge (0% sensitization). | Pass: Non-sensitizing |
| Irritation orIntracutaneousReactivityISO 10993-10:2010 | Extracts of the test articles were evaluated for their potential to produce irritation. The test articles did not show a significantly greater biological reaction than the sites injected with the control article. | Pass: Non-irritating |
| Acute Systemic ToxicityISO 10993-11:2006 | Extracts of the test articles did not induce a significantly greater biological reaction than that of the control extracts. | Pass: No Acute System Toxicity |
| Material-MediatedPyrogenicityISO 10993-11:2006 | Extracts of the test articles did not produce a pyrogenic response when tested. | Pass: Non-pyrogenic |
| Genotoxicity(Ames Assay)ISO 10993-3:2014 | Extracts of the test articles did not induce a biologically significant increase in the number of revertant (mutated) bacterial colonies. | Pass: Non-mutagenic |
| Genotoxicity(Micronucleus Assay)ISO 10993-3:2014 | Extracts of the test articles did not induce a statistically significant increase in the percentage of reticulocytes containing micronuclei and test articles did not induce a clastogenic effect in maturing erythrocytes. | Pass: Non-clastogenic |
| Genotoxicity(Mutagenesis Assay)ISO 10993-3:2014 | The increased mutant frequency (IMF) of cells exposed to test article extracts was less than the test criteria for the main and confirmation assays for all concentrations tested. | Pass: Non-mutagenic |
| Hemocompatibility(ComplementActivation)ISO 10993-4:2002 | The concentrations of C3A and SC5B-9 in the plasma exposed to the test article was not significantly increased from the concentrations in the negative and untreated controls. | Pass: Did not activate complement system in plasma |
| Hemocompatibility(Hemolysis)ISO 10993-4:2002ASTM F756-13 | The test article exhibited a hemolysis index of that was not significantly above the negative control for the direct and indirect contact methods. | Pass: Non-hemolytic |
| Hemocompatibility(In Vitro)ISO 10993-4:2002 | The concentration of White Blood Cells (WBC) and Platelets (Plt) exposed to the test article was not significantly decreased in comparison to the negative control article and was not statistically significantly decreased in comparison to the untreated control. | Pass: No effect on selected hematological parameters |
| Hemocompatibility(Unactivated PartialThromboplastin Time)ISO 10993-4:2002 | The Unactivated Partial Thromboplastin Time (UPTT) was not significantly decreased in comparison to the negative and untreated controls. | Pass: No effect on coagulation |
| Subacute Toxicity viaBrain and SubcutaneousImplantationISO 10993-6:2007ISO 10993-11:2006 | For all parameters tested, animals implanted with the test article did not demonstrate any differences considered attributable to the test article compared to those animals implanted with the control article. | Pass: No local or systemic sign of toxicity |
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- Conclusion The SureFlo EVD Catheter is substantially equivalent to the primary predicate Integra TraumaCath (K972994), per the criteria given in FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]".
Note: Trademarks cited for predicates are owned by the respective companies.
§ 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).