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

upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
. upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
A-V access conduits > 3.0mm in diameter and o
for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Description

AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

AI/ML Overview

This document (K113428) is a 510(k) premarket notification for a medical device called the AngioJet Ultra DVX Thrombectomy Set. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through extensive clinical studies like those for novel AI/ML devices or entirely new technologies.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission as it relates to a device with limited design changes from its predicate.

Here's an analysis based on the provided document, addressing what is present and noting what is absent:

Acceptance Criteria and Study for AngioJet Ultra DVX Thrombectomy Set (K113428)

The device is a PIVOTAL device in so much that it is a modified version of an existing device. The acceptance is based on equivalency to a device that has already established safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not framed as specific performance metrics against an outcome (e.g., disease detection accuracy), but rather as a demonstration of equivalent performance and safety compared to its predicate devices despite a minor design change. The design change involved making the distal section more robust for guide wire use.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary from Submission)
Functional Equivalence (after design modification)	Bench testing was performed to support a determination of substantial equivalence. The device maintains similar functional design, materials, indications for use, and principles of operation to the predicate.
Safety - Catheter Operational Characteristics	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Leakage	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Guide Wire Compatibility	Testing performed (directly related to the design modification); results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a key test given the design change.
Safety - Tracking	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Extended Use	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Hemolysis Ratio	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Distal Emboli	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a critical safety consideration for thrombectomy devices.
Safety - Catheter Tip Temperature	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary).
Safety - Mechanical Integrity (tensile, compression, torque)	Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This confirms the new design's mechanical robustness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in this 510(k) summary. The testing refers to "bench testing" which typically involves a set number of units or iterations of the device in a laboratory setting. This is not a clinical study involving patient data.
Data Provenance: N/A. The data comes from internal bench testing (laboratory experiments) conducted by the manufacturer, MEDRAD, Inc. It is not patient data from a specific country, nor is it retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. Since this involves bench testing of a device rather than interpretation of medical images or patient outcomes, there are no "experts" establishing a "ground truth" in the clinical sense. The ground truth for bench tests is typically established by engineering specifications, validated test methods, and measurement against known standards.

4. Adjudication Method for the Test Set

N/A. No adjudication method is applicable as this is bench testing, not an assessment requiring consensus among human interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is compared. This device is a mechanical thrombectomy device, and its performance is evaluated through engineering bench tests, not comparative reading studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a physical medical device (catheter and pump set), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and hydraulic functions.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the bench testing is defined by engineering specifications, physical measurements, and compliance with industry standards relevant to catheter performance, mechanical integrity, and biological interactions (e.g., hemolysis). It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

N/A. There is no "training set" as this is not an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).