Spartan MC 0165

• K Number: K213451
• Device Name: Spartan MC 0165
• Manufacturer: Spartan Micro
• Date Cleared: 2021-11-22 ( 27 days)
• Product Code: QJP , DQY , KRA
• Regulation Number: 870.1250
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K151638
• Predicate For: K201141

Intended Use

The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.

Device Description

The Spartan MC 0165™ is a sterile single-use microcatheter device. On the proximal end is a Luer connector for infusion of diagnostic agents. The microcatheter has a single lumen of 0.0165" ID, has a flexible and variable stiffness composite body, and 2 radiopaque marker bands on the distal tip for visualization under fluoroscopy. It comes with a sterile stainless steel shaping mandrel to shape the distal portion of the catheter.

AI/ML Overview

The Spartan MC 0165™ is a microcatheter device. The provided text describes several performance studies conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Coating Lubricity (Friction Force)	Acceptable friction force under simulated use conditions similar to the predicate device.	The Spartan MC 0165™ was found to have acceptable friction force under simulated use conditions similar to the predicate device.
Hub Functional & Dimensional	Meet ISO 594-1:1986-06-15 and ISO 594-2:1998-09-01 requirements.	The Spartan MC 0165™ met the acceptance criteria for hub functional and dimensional requirements.
Torque Strength	Acceptable torsional strength similar to the predicate device during simulated use.	The Spartan MC 0165™ exhibited acceptable torsional strength similar to the predicate device.
Tensile	Meet ISO 10555-1:2013 Annex B requirements.	The Spartan MC 0165™ met the acceptance criteria for tensile strength.
Air Aspiration	Meet ISO 10555-1:2013(E) Annex D requirements for air leakage.	The Spartan MC 0165™ met the acceptance criteria for air aspiration.
Liquid Leak	Meet ISO 10555-1:2013(E) Annex C requirements for liquid leakage.	The Spartan MC 0165™ met the acceptance criteria for liquid leakage.
Particulate and Coating Integrity	Meet acceptance criteria for particulate generation and coating integrity, and be substantially equivalent to the predicate.	The Spartan MC 0165™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate.
Tip Shape	Retain steam-shaped tip shape and be substantially equivalent to the predicate device.	The Spartan MC 0165™ met the acceptance criteria for tip shapeability and was found substantially equivalent to the predicate.
Stiffness	Meet acceptance criteria for catheter stiffness and be substantially equivalent to the predicate.	The Spartan MC 0165™ met the acceptance criteria for catheter stiffness and was found substantially equivalent to the predicate.
Kink Resistance	Withstand bends and be substantially equivalent to the predicate.	The Spartan MC 0165™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate.
Radiopacity	Be visible under fluoroscopy and be substantially equivalent to the predicate device.	The Spartan MC 0165™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate.
Corrosion	Meet ISO 10555-1:2013(E) Annex A requirements.	The Spartan MC 0165™ met the acceptance criteria for corrosion resistance.
Static Burst Pressure	Meet ISO 10555-1:2013(E) Annex F requirements.	The Spartan MC 0165™ met the acceptance criteria for static burst pressure.
Torque Response	Meet acceptance criteria for torque response and be substantially equivalent to the predicate.	The Spartan MC 0165™ met the acceptance criteria for torque response and was found substantially equivalent to the predicate.
Buckling	Meet acceptance criteria for tip deflection and buckling, and be substantially equivalent to the predicate.	The Spartan MC 0165™ met the acceptance criteria for tip deflection and buckling, and was found substantially equivalent to the predicate.
Design Validation	Meet requirements for which it was designed and tested in a challenging use setting.	The Spartan MC 0165™ met the requirements for which it was designed and tested.
Dimensional Testing	Meet device specifications.	The Spartan MC 0165™ met the dimensional requirements.
Visual Inspection	Meet visual inspection requirements.	The Spartan MC 0165™ met the visual inspection requirements.
Dead Space Volume	Dead space volume to be measured and reported in labeling.	The Spartan MC 0165™ dead space volume was measured and is reported in the labeling.
Pressure Flow Testing with Contrast Media	Flow rates and pressures for various solutions to be evaluated and reported in labeling.	The Spartan MC 0165™TM pressure-flow performance was evaluated, and flow rates and pressures of various saline and contrast media solutions are reported in the labeling.
Sensitization (Kligman Maximization Test)	Classified as a non-sensitizer (0% sensitization).	Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), classified as a non-sensitizer.
Genotoxicity (Mouse Lymphoma Mutagenesis Assay)	Non-mutagenic (IMF of Test Article

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).