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    K Number
    K182918
    Device Name
    Ballast 088 Long Sheath
    Manufacturer
    Balt USA LLC
    Date Cleared
    2019-03-21

    (153 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Ballast 088 Long Sheath

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

    The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Device Description

    The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12. The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.

    AI/ML Overview

    This document is a 510(k) summary for the Ballast 088 Long Sheath, a medical device. It aims to demonstrate substantial equivalence to a predicate device, the Neuron MAX™ System. The document focuses on performance and biocompatibility testing.

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Important Note: This document describes a medical device (a catheter) and its mechanical, material, and biological performance, not an AI/ML-based device. Therefore, many of the requested categories related to AI/ML (e.g., ground truth, experts, MRMC studies, training set data) are not applicable to this type of device submission. The acceptance criteria here are typically physical and biological performance metrics for a hardware device.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each test. Instead, it describes general test methods and states that "All test samples passed testing" or "The subject device is comparable to the predicate device." For biocompatibility, it states "Non-cytotoxic," "Did not elicit sensitization response," etc.

    However, based on the "Performance Bench Testing and Animal Testing Summary" (Table 2) and "Biocompatibility Test Summary" (Table 3), we can infer the acceptance criteria and reported performance for key tests:

    Acceptance Criteria Category/TestTest Method SummaryReported Device Performance (Implied Acceptance)
    Mechanical/Physical Performance
    Visual and Dimensional InspectionInspected dimensions (overall length, ID, OD, etc.).All test samples passed testing.
    Surface ContaminationMicroscope inspection for particulates.All test samples passed testing.
    Catheter CompatibilityVerify compatibility with accessory devices, guidewires, dilators, inner guide/diagnostic catheters.All test samples passed testing.
    Simulated UseIn vitro performance in Bovine Aortic Arch vessel model.All test samples passed testing.
    Coating Integrity and AdherenceDyed samples, simulated use, microscopic inspection.All test samples passed testing.
    Lubricity/Durability of Hydrophilic Coating25 friction cycles with max 75g force.All test samples passed testing.
    Dynamic BurstMEDRAD Mark V Plus Injection System.All test samples passed testing.
    Liquid Leakage at 46 psiPer ISO 10555-1 and ISO 594-2.All test samples passed testing.
    Air LeakagePer EN ISO 10555-1 and ISO 594-2.All test samples passed testing.
    Catheter Static Burst TestHydraulic Burst/Leak tester per ISO 10555-1.All test samples passed testing.
    Tensile StrengthInstron tensile tester, per ISO 10555-1.All test samples passed testing.
    Corrosion ResistanceImmersion in NaCl solution, then boiling water; visual inspection.All test samples passed testing.
    Torque StrengthNumber of turns-to-failures, compared to predicate.All test samples passed testing. Subject device comparable to predicate.
    Kink Resistance TestTested against predicate in simulated use; wrapping around pin and microscopic examination.All test samples passed testing. Subject device comparable to predicate.
    Catheter Stiffness TestingInstron tensile tester.All test samples passed testing.
    Fracture Resistance and Flexing TestResistance to damage by flexing/fracture per ISO 11070.All test samples passed testing.
    Particulate Matter CharacterizationQuantified after simulated use.All test samples passed testing.
    Luer Dimensional InspectionPer ISO 80369-7.All test samples passed testing.
    Separation Force (Luer)Per ISO 594-1 and ISO 594-2.All test samples passed testing.
    Unscrewing Torque (Luer)Per ISO 594-1 and ISO 594-2; remained attached.All test samples passed testing.
    Resistance to Overriding (Luer)Per ISO 594-1 and ISO 594-2; no override of threads.All test samples passed testing.
    Stress Cracking (Luer)Per ISO 594-1 and ISO 594-2; no cracks.All test samples passed testing.
    Subatmospheric-pressure Air Leakage (Luer)Per ISO 80369-7.All test samples passed testing.
    Animal Testing (In Vivo Performance)
    Animal Testing (GLP)Evaluate in vivo performance in acute porcine model; assess trackability, handling, radiopacity, catheter compatibility. Compared to predicate device.All test samples passed testing. Trackability, handling, radiopacity, and compatibility comparable to predicate device.
    Biocompatibility (ISO 10993 Series)
    Cytotoxicity – MEM Elution TestISO 10993-5 (48 hours).Non-cytotoxic (average grade of 0).
    Sensitization - Guinea Pig Kligman Maximization TestISO 10993-10.Did not elicit sensitization response (0% sensitization).
    Irritation or Intracutaneous - RabbitsISO 10993-10.Non-irritant (difference between test and control mean score was 0.0).
    Acute Systemic Toxicity - MiceISO 10993-11.Non-toxic (no significant systemic toxicity or mortality).
    Systemic Toxicity - Rabbit PyrogenISO 10993-11.Non-pyrogenic (no temperature rise >0.5℃).
    Genotoxicity: Ames TestISO 10993-3; Salmonella typhimurium and Escherichia coli.Non-mutagenic (no 2x or 3x increase in revertants).
    Genotoxicity: Chromosomal Aberration AssayISO 10993; Chinese Hamster Ovary (CHO) cells.Non-genotoxic.
    Hemocompatibility – Hemolysis (Indirect/Direct)ISO 10993-4 (ASTM Method).Non-Hemolytic.
    Hemocompatibility – Complement ActivationISO 10993-4 (SC5b-9).Passed (comparable to predicate).
    Hemocompatibility – Partial Thromboplastin Time (PTT)ISO 10993-4.Passed (clotting times lengthened compared to predicate).
    Hemocompatibility – Platelet and Leukocyte Count (PLC)ISO 10993-4.Passed (results for leukocyte and platelet counts within acceptable range, not statistically significant vs. reference material).
    Hemocompatibility – Digital Optical Microscopy40x images for surface morphology comparison.Passed (no significant differences in geometry, surface morphology, or particulate contamination vs. predicate).
    Sterilization & Packaging
    Original Sterilization Validation and AdoptionEO sterilization (100% EO) to SAL 10-6, ISO 11135.Validation study demonstrated capability to sterilize to SAL 10-6. Subject device successfully adopted to original validation.
    EO and ECH ResidualsMeasured per ISO 10993-7:2008.Residual traces below specified limits.
    Bacterial Endotoxin LevelsLAL testing per FDA guidance, USP, European Pharmacopeia BET 2.6.14.
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