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510(k) Data Aggregation

    K Number
    K170599
    Device Name
    SureFlo EVD Catheter
    Manufacturer
    Arkis BioSciences Inc.
    Date Cleared
    2017-08-31

    (183 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K121089,K972994,K081942
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arkis BioSciences Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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.

    Device Description

    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.

    AI/ML Overview

    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 CategorySpecific Test Standard / RequirementReported Device Performance
    Bench PerformanceISO 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 CharacteristicsPass: Characterization of pressure and flow successfully completed.
    Resistance to OverpressurePass: No significant differences in flow rates post-test, no damage/leakage.
    Bursting PressurePass: 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 StrengthPass: Disassembled or failed at higher forces than primary predicate.
    FlexibilityPass: Obstructed when wrapped around a smaller diameter pin than the predicate device.
    Dynamic Breaking StrengthPass: Met prescribed maximum number of cycles without failure.
    RadiopacityPass: Met or exceeded radiopacity requirements compared to control specimens.
    SterilityEthylene Oxide Sterilization (ISO 11135:2014)Pass: Achieved a Sterility Assurance Level (SAL) of -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 IntegrityResistance 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.
    BiocompatibilityISO 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:

    1. 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.

    2. 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.

    3. Adjudication method for the test set:

      • Not applicable. Ground truth is established by objective measurements and standardized test methods, not expert adjudication.

    4. 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.

    5. 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.

    6. 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.

    7. The sample size for the training set:

      • Not applicable. There is no AI algorithm being "trained" for this physical device.

    8. How the ground truth for the training set was established:

      • Not applicable. See point 8.
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