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

Device Name	Indications
Guglielmi Detachable Coils (GDC®)	For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the
patient's general medical condition - are considered by the treating neurosurgical team to be a) very high
risk for management by traditional operative techniques, or b) inoperable; and for embolizing other
vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro
vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral
vasculature.
Occlusion Coils:
Fibered Platinum Coil, .035" Type	For arterial and venous embolizations in the peripheral vasculature
Berenstein Liquid Coil	For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature.
Occlusion Coils (except Fibered
Platinum Coil .035" Type and
Berenstein Liquid Coil)	Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are
intended for use in the interventional radiologic management of arteriovenous malformations and
arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable.
Guidewires	Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion
Catheters to selected vascular sites.
Tracker® Infusion Catheter	Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast
media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and
neurovasculature.
Stealth® Dilation Catheter	The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This
device is not intended for use in the coronary arteries.
Coil Pusher	The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold
marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site.
Guidewire Introducer	The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs
or hemostatic valves.
Guidewire Torquer	The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular
placement.
Rotating Hemostatic Valve	To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the
placement of a therapeutic or diagnostic catheter.
Shaping Mandrel	The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a
catheter tip to suit the requirements of a particular case.
Valve Wire	The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the
balloon section enabling it to be inflated.

Device Description

Please refer to Table 1 (Page 10)

AI/ML Overview

The provided text is a 510(k) summary for various medical devices by Target Therapeutics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional, chemical, biocompatibility, and sterile barrier tests.

This document does not contain information on acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, it details laboratory-based testing for physical and chemical properties and refers to section 6 of the submission for further details on these tests. There is no mention of a study involving human readers, ground truth established by experts, or AI performance metrics.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and studies based on the provided text. The document is for a traditional medical device submission, not an AI/ML-driven one.

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