FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Device Description

The Micrus Microcatheters consist of 4 major components:

A flexible shaft with a lubricious liner extruded from Teflon. The shaft is reinforced with stainless steel (coiled distally and braided proximally). The outer shaft jacket is made from Pebax and nylon Grilamid L25).
An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
A standard luer hub insert, which is molded onto the flexible shaft.
A hydrophilic coating (Hydromer), which covers the distal 100 centimeters of the Microcatheters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Micrus Courier Microcatheters, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Micrus Courier Microcatheters were based on demonstrating "substantial equivalence" to the predicate device, the Micrus Microcatheter, Concourse-14. This was achieved through a series of non-clinical tests comparing various physical and mechanical characteristics. The table below summarizes these criteria and the reported performance of the Courier Microcatheters.

Study Details

Below are the details of the study as extracted from the provided text:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the "sample size" in terms of number of devices tested for each characteristic. It lists the tests performed and the general performance criteria.
- The data provenance is not explicitly mentioned as a specific country, but the testing was performed by "Micrus Endovascular Corporation," based in Sunnyvale, CA, USA, and later registered from San Jose, CA, USA. This suggests the testing was conducted in the USA.
- The study is a retrospective comparison as it compares the new device's (Courier) characteristics against an existing, legally marketed predicate device (Concourse-14). The testing itself for the Courier device would be considered prospective in its execution, but the comparison framework is retrospective to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is primarily physical and mechanical in nature, usually performed by engineers or technicians according to established standards. Expert clinical judgment for ground truth in the sense of diagnosis or outcomes is not applicable here as this is not a diagnostic device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided and is not typically relevant for the type of non-clinical, physical/mechanical testing described in the document. Such tests generally have objective pass/fail criteria.
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, an MRMC comparative effectiveness study was not done. This document describes the non-clinical (physical and mechanical) performance testing of a microcatheter, which is a medical instrument, not a diagnostic imaging or AI-assisted device. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This pertains to an AI algorithm, and the device in question is a physical microcatheter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests was based on established engineering and material science standards (e.g., ISO 10555-1, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (Micrus Microcatheter, Concourse-14). The aim was to demonstrate that the new device met or exceeded these established standards and was substantially equivalent to the predicate.
The sample size for the training set:
- Not applicable. This term relates to machine learning models. The current document describes a physical medical device.
How the ground truth for the training set was established:
- Not applicable. This term relates to machine learning models.

Summary

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).

Test or Comparison Characteristic	Acceptance Criteria (based on Predicate Concourse-14)	Reported Device Performance (Courier 165, 170, 190, & 210)
Shaft Materials	Pebax with PTFE liner	Pebax and nylon with PTFE liner (Substantially equivalent)
Shaft Design	Flexible single lumen shaft of Pebax with a PTFE liner; atraumatic distal flexible tip with 2 radiopaque markers.	Flexible single lumen shaft of Pebax & nylon with a PTFE liner; atraumatic distal flexible tip with 2 radiopaque markers. (Substantially equivalent)
Distal Shaft Length (dry & hydrated states)	20 to 25 cm	30 to 35 cm (Substantially equivalent)
Proximal ID/OD (dry & hydrated states)	ID: 0.0165" – 175"; OD: 0.031" (2.4 French)	Inner diameters are within specifications: Courier 165 ID is .0165" min, Courier 170 ID is 0.0170" min, Courier 190 ID is 0.0190" min, Courier 210 ID is 0.0210" min; Outer diameters are within specifications: Courier 165 OD is 0.033" max (2.3 Fr.), Courier 170 OD is 0.034" max (2.4 Fr.), Courier 190 OD is 0.042" max (3.0 Fr.), Courier 210 OD is 0.042" max (3.0 Fr.). (Substantially equivalent)
Distal ID/OD (Dimensions unchanged in dry & hydrated states)	ID: 0.0165"; OD: 0.025" (1.9 French)	Inner diameters are within specifications: Courier 165 ID is .0165" min, Courier 170 ID is 0.0170" min, Courier 190 ID is 0.0190" min, Courier 210 ID is 0.0210" min; Outer diameters are within specifications: Courier 165 OD is 0.023" max (1.7 Fr.), Courier 170 OD is 0.024" max (1.8 Fr.), Courier 190 OD is 0.032" max (2.5 Fr.), Courier 210 OD is 0.032" max (2.5 Fr.). (Substantially equivalent)
Shaft Marker	No shaft marker	Shaft marker located at 90 cm from the distal tip. (Substantially equivalent - new feature)
Tip Markers	Two radiopaque marker bands, spaced 3 cm apart.	Two radiopaque marker bands, spaced 3 cm apart. (Substantially equivalent)
Coating	Hydrophilic coating.	Hydrophilic coating. (Substantially equivalent)
Effective Length (dry & hydrated states)	150 cm (59")	150 cm (59") (Substantially equivalent)
MicroCoil Compatibility	Coils: Compatible with 10-System embolic coils; Wires: Compatible with 0.010" and 0.014" guide wires.	Coils: Courier 165 & 170 are compatible with 10-System embolic coils; Courier 190 & 210 are compatible with 18-System coils; Wires: Courier 165 & 170 are compatible with 0.010" and 0.014" guide wires; Courier 190 & 210 are compatible with 0.014" and 0.018" guide wires. (Substantially equivalent)
Tensile strength and tip attachment strength	Shaft to hub junction minimum tensile strength of 1.12 lb (5 Newtons); all transition junctions minimum tensile strength of 0.67 lb (3 Newtons).	Shaft to hub junction minimum tensile strength of 1.12 lb (5 Newtons); all transition junctions minimum tensile strength of 0.67 lb (3 Newtons). (Substantially Equivalent)
Flexibility/Stiffness	Demonstrates adequate flexibility to bend easily when under pressure, such as that exerted by vessel tortuosity.	As compared to the predicate, demonstrates adequate flexibility to bend easily when under pressure, such as that exerted by vessel tortuosity. (Substantially Equivalent)
Burst Pressure	Demonstrates a burst strength greater than 300 PSI.	Demonstrates a burst strength greater than 300 PSI. (Substantially Equivalent)
Biocompatibility	Materials successfully pass all biocompatibility testing per ISO 10993-1.	Materials successfully pass all biocompatibility testing per ISO 10993-1. (Substantially Equivalent)
Air leakage at hub	No air leakage during testing with negative pressure applied to the catheter hub per ISO 10555-1.	No air leakage during testing with negative pressure applied to the catheter hub per ISO 10555-1. (Substantially Equivalent)
Liquid leakage	Demonstrates no liquid leakage during testing at 46.4 PSI (maintained for 30 seconds) per ISO 10555-1.	Demonstrates no liquid leakage during testing at 46.4 PSI (maintained for 30 seconds) per ISO 10555-1. (Substantially Equivalent)
Fatigue tolerance and catheter material integrity	(No specific quantitative criteria mentioned for predicate)	Catheter advanced and retracted 20 times in a tortuous arterial model with a 150-micron filter in a distal location. No catheter particulate or debris resulted. (Substantially Equivalent)
Chemical Integrity/Corrosion Resistance	Demonstrates corrosion resistance per ISO 10555-1 in saline solution and boiling distilled water.	No change to the design of the Courier microcatheters affected corrosion resistance. (Substantially Equivalent)
Material Used	Pebax shaft. PTFE liner. Hydrophilic coating. All materials are biocompatible.	Pebax shaft. PTFE liner. Hydrophilic coating. All materials are biocompatible. (Substantially Equivalent)
Labeling	Label content complies with regulatory requirements; labels contain at least 2 removable stickers with catalog number, lot number, and product name.	Label content complies with regulatory requirements; labels contain at least 2 removable stickers with catalog number, lot number, and product name. (Substantially Equivalent)
Proximal shaft kink radius	Demonstrates a minimum kink resistant radius (no specific value given for predicate)	Demonstrates a minimum kink resistant radius of 0.325" in the proximal shaft. (Substantially Equivalent)
Distal shaft kink radius	Demonstrates a minimum kink resistant radius of 0.07" in the distal shaft.	Demonstrates a minimum kink resistant radius of 0.07" in the distal shaft. (Substantially Equivalent)
Tracking force	Demonstrates the microcatheter is able to track through a tortuous path.	Demonstrates the microcatheter is able to track through a tortuous path with less or equal force (friction) than the predicate. (Substantially Equivalent)
Tip shape retention	Demonstrates the Microcatheter maintains its tip shape when subjected to 3 hours of soaking in a 37°C. bath.	Demonstrates the Microcatheter maintains its tip shape when subjected to 3 hours of soaking in a 37°C. bath. (Substantially Equivalent)
Packaging Integrity	Tyvek Pouch. Sterile and non-pyrogenic in unopened packaging designed to maintain sterility unless opened/damaged. Qualified to prevent microbial recontamination for a minimum of 3-yrs.	Tyvek Pouch. Sterile and non-pyrogenic in unopened packaging designed to maintain sterility unless opened/damaged. Uses same packaging as Concourse microcatheter, qualified to prevent microbial recontamination for a minimum of 3-yrs. (Equivalent)
Shipping/transit testing	Demonstrates the microcatheter successfully withstands the domestic and international distribution environment, per ISO 10555-1.	Demonstrates the microcatheter successfully withstands the domestic and international distribution environment, per ISO 10555-1. (Substantially Equivalent)
Sterility	Sterilized using EtO with a sterility assurance level of 10-6.	Sterilized using EtO with a sterility assurance level of 10-6. (Substantially Equivalent)