(155 days)
No
The device description and performance studies focus on the mechanical properties and clinical outcomes of a physical device (braided mesh, shaft, wire, handle) used for embolization assistance. There is no mention of software, algorithms, image processing, or data analysis that would suggest the use of AI/ML.
No.
The device is an embolization assist device, used to temporarily assist in the coil embolization of aneurysms. It is a tool for a medical procedure rather than a device that directly provides therapy or treatment itself.
No
The device is described as an "Embolization Assist Device" used to aid in coil embolization of aneurysms. Its function is to provide temporary support during a therapeutic procedure, not to diagnose a condition.
No
The device description explicitly details physical components (nitinol braided mesh, stainless steel shaft, nitinol core wire, handle) and mentions bench and animal studies evaluating physical properties and performance, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for use in the peripheral vasculature as a temporary endovascular device to assist in coil embolization. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) test.
- Device Description: The description details a physical device (braided mesh, shaft, wire, handle) used for mechanical assistance during a surgical procedure. It does not describe reagents, test kits, or equipment used to analyze biological samples.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body during a procedure.
- Anatomical Site: Peripheral vasculature is a part of the body.
- Performance Studies: The studies described involve bench testing, animal studies, and clinical data from patients undergoing a medical procedure. These are not studies related to the performance of a diagnostic test on biological samples.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR BRAIDE EMBOLIZATION ASSIST DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Temporary coil embolization assist device for peripheral vascular use. A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
NEW REGULATION NUMBER: 21 CFR 870.3325
CLASSIFICATION: Class II
PRODUCT CODE: QZU
BACKGROUND
DEVICE NAME: BraidE Embolization Assist Device
SUBMISSION NUMBER: DEN230064
DATE DE NOVO RECEIVED: September 19, 2023
| SPONSOR INFORMATION: | Rapid-Medical Ltd.
Carmel Building, POB 337 |
|----------------------|------------------------------------------------|
| | Yokneam, Yokneam 2069205 |
| | Israel |
INDICATIONS FOR USE
The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio