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

The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Device Description

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.

AI/ML Overview

Section 1:

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied by "Pass")	Reported Device Performance
Surface and physical attributes	Device meets established specifications for surface finish and physical characteristics.	Pass
Distal tensile strength	Device can withstand a specified tensile force at its distal end without failure.	Pass
Hub tensile strength	Device can withstand a specified tensile force at its hub without failure.	Pass
Leakage (liquid and air)	Device exhibits no leakage of liquids or air under specified pressure conditions.	Pass
Static and dynamic burst pressure	Device can withstand specified static and dynamic burst pressures without failure.	Pass
Simulated use	Device performs as intended and remains functional during simulated use conditions.	Pass
Compatibility with devices	Device is compatible with other specified medical devices (e.g., guidewires, infusion pumps).	Pass
Flow rate	Device maintains a specified flow rate for diagnostic and therapeutic agents.	Pass
Kink resistance	Device resists kinking under specified bending conditions.	Pass
Catheter flexural fatigue	Device maintains structural integrity and function after a specified number of flex cycles.	Pass
Torque test	Device exhibits appropriate torquability for navigation within vasculature.	Pass
DMSO compatibility	Device material is compatible with Dimethyl sulfoxide (DMSO) without degradation.	Pass
Cytotoxicity (MEM elution assay, Agarose overlay)	Device extracts do not cause toxic effects on cells.	Pass
Sensitization/Irritation (Guinea pig maximization sensitization, Intracutaneous reactivity)	Device materials do not cause skin sensitization or irritation.	Pass
Hemocompatibility (Hemolysis, Prothrombin time assay, Complement activation C3a and SC5b-9, 4 hour thromboresistance in dogs)	Device exhibits acceptable blood compatibility (low hemolysis, no significant impact on coagulation, minimal complement activation, no significant thrombosis).	Pass
Systemic Toxicity (Systemic toxicity, Rabbit pyrogen test)	Device extracts do not cause systemic toxic effects or pyrogenic reactions.	Pass

Note on Acceptance Criteria: The provided document states "Pass" for each test, implying that the device met the pre-defined acceptance criteria for that specific test. The specific numerical or qualitative thresholds for each criterion are not explicitly stated in this summary.

Section 2:

Sample size used for the test set: Not specified. The document summarizes the results of various bench and biocompatibility tests, but does not provide details on the number of units tested for each criterion.
Data provenance: Not specified. This document pertains to pre-market notification (510(k)) for a medical device and describes laboratory and in-vitro testing. There is no indication of clinical trial data or data from human subjects in this summary. Therefore, the concepts of "country of origin" and "retrospective or prospective" do not directly apply to the reported tests.

Section 3:

Number of experts used to establish the ground truth for the test set: Not applicable. The "ground truth" concept is typically associated with clinical studies or diagnostic artificial intelligence, where expert consensus or pathological findings define the true state. The described tests are primarily engineering and biological performance evaluations. These tests rely on established scientific methods and validated measurement techniques rather than expert interpretation of complex clinical cases.
Qualifications of those experts: Not applicable. (See above explanation).

Section 4:

Adjudication method: Not applicable. The tests described are objective, quantitative or qualitative industrial and laboratory tests. They do not involve interpretation of ambiguous data requiring adjudication for ground truth establishment.

Section 5:

If a multi reader multi case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms in clinical settings, often in comparison to human readers. The provided document details the pre-market submission for a physical medical device (microcatheter) and focuses on bench testing and biocompatibility, not diagnostic performance or AI effectiveness.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable. (See above explanation).

Section 6:

If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This document describes the performance of a physical medical device, not an algorithm.

Section 7:

The type of ground truth used: Not applicable in the traditional sense of clinical diagnostic ground truth (e.g., pathology, outcomes data, expert consensus). For the bench and biocompatibility tests, the "ground truth" or reference standard is derived from:
- Validated test methods and specifications: Standards like ISO 10993 for biocompatibility provide the framework for evaluating the device's interaction with biological systems.
- Engineering specifications and design parameters: For bench tests, the device's design requirements define what constitutes a "pass" result (e.g., specific tensile strength thresholds, flow rates, burst pressures).
- Chemical and material analysis: Compatibility tests (like DMSO compatibility) rely on known material properties and reactions.

Section 8:

The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that would require a training set.

Section 9:

How the ground truth for the training set was established: Not applicable. (See above explanation).

Summary

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).