(573 days)
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio
The Comaneci Embolization Assist Device consists of three device models: Comaneci, Comaneci Petit, and Comaneci 17 (see Table 1). The Comaneci Embolization Assist Device is intended for temporary use and is introduced through an endovascular approach to the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width
The Comaneci Embolization Assist Device is a Class II device (Product Code: PUU, Regulation Number: 21 CFR 882.5955) intended for temporary use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
The acceptance criteria for the Comaneci Embolization Assist Device, as derived from the provided text, are multifaceted, encompassing non-clinical bench testing, animal studies, and a retrospective clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly presented in a single table with numerical targets, but rather are implicitly defined by the successful outcomes of various tests and the conclusions drawn from them. Below is a structured presentation of the implicit acceptance criteria based on the described studies and the reported device performance.
| Acceptance Criterion Category | Specific Acceptance Criterion (Implicit) | Reported Device Performance and Evidence |
|---|---|---|
| Biocompatibility | Device components in contact with the patient (e.g., blood) must be biocompatible according to ISO 10993-1, covering hemocompatibility (complement activation, thrombogenicity, indirect/direct hemolysis), cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. (Ref: Section 'BIOCOMPATIBILITY/MATERIALS') | Evaluated as an external communicating device of limited contact duration ( ( |
§ 882.5955 Temporary coil embolization assist device.
(a)
Identification. A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing of the device must demonstrate the device performs as intended for temporary use as an endovascular device to assist in the coil embolization of intracranial aneurysms and must evaluate all adverse events, including tissue or vessel damage that could lead to dissection, perforation, hemorrhage, or vasospasm, thrombo-embolic events, and coil entanglement.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, compressive, and tip deflection forces;
(ii) Mechanical testing to evaluate the radial forces exerted by the device;
(iii) Simulated use testing to demonstrate the device can be delivered to the target location in the neurovasculature and is compatible with embolic coils;
(iv) Dimensional verification testing;
(v) Radiopacity testing; and
(vi) Performance testing to evaluate the coating integrity and particulates under simulated use conditions.
(4) Animal testing under anticipated use conditions must evaluate all adverse events, including damage to vessels or tissues.
(5) Performance data must support the sterility and pyrogenicity of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(7) The labeling must include:
(i) Instructions for use;
(ii) A detailed summary of the device technical parameters, including compatible delivery catheter dimensions and device sizing information;
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events; and
(iv) A shelf life.