(90 days)
See table below
| 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. |
Please refer to Table 1 (Page 10)
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.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.