(197 days)
The Octane-C Interbody Cervical devices are intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with this device.
This submission proposes a new Cervical Interbody Fusion System. The Octane®-C Interbody Fusion System is designed to provide stability during intervertebral body fusion in the cervical spine. Implantable Octane-C devices incorporate a 6° lordotic configuration, are manufactured from PEEK-Optima with 6% barium sulphate, titanium pins, and tantalum beads added for radiographic visibility, are provided sterile, and are designed to be implanted using a direct anterior approach and autogenous bone graft material.
This is not an AI/ML device, therefore, the requested information is not applicable.
This 510(k) submission is for the Exactech® Octane®-C Interbody Fusion System, which is a physical medical device designed for intervertebral fusion in the cervical spine. The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of intended use, materials, dimensions, sterilization processes, and mechanical performance specifications.
The provided text details the device's technical characteristics, indications for use, and a summary of mechanical testing conducted to establish substantial equivalence. It does not involve any artificial intelligence or machine learning components. Therefore, questions related to AI/ML specific acceptance criteria, study designs, ground truth establishment, or human reader performance with/without AI assistance are not relevant to this traditional 510(k) submission.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.