(28 days)
The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.
The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA® HA Enhanced spacers offered in a variety of widths and lengths. The CES-LIF are generally rectangular in shape. The CES-LIF is used in pairs.
The EVOL® Spinal Interbody System implants are available in a range of sizes to accommodate variations in patients' anatomy. In addition, tantalum beads are embedded in the spacers to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The CES-LIF HA implants themselves are made of biocompatible PEEK-Optima® HA Enhanced (LT120) polymer material and provided non-sterile for single-use.
Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).
The purpose of this submission is to add a new sterilization method.
This document is a 510(k) premarket notification for a medical device called the "EVOL® Spinal Interbody System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that a new, novel device would require.
Therefore, the document does not contain the kind of information you are asking for regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices or devices requiring clinical performance studies to establish performance claims.
Here's why the requested information cannot be extracted from this document:
- Device Type: The EVOL® Spinal Interbody System is a spinal implant (a physical medical device), not an independent diagnostic or AI/ML-driven device that would output performance metrics like sensitivity, specificity, or image analysis results.
- Regulatory Pathway (510(k)): A 510(k) simply requires demonstrating that the new device is "substantially equivalent" to an already legally marketed device (predicate device). This is primarily done through a comparison of technological characteristics, materials, intended use, and sometimes non-clinical performance (e.g., mechanical testing, biocompatibility). It generally doesn't involve clinical performance studies with pre-defined acceptance criteria, expert ground truth establishment, or MRMC studies for quantifying human-AI collaboration.
- Purpose of Submission: The specific purpose of this K200991 submission is to add a new sterilization method (steam sterilization) for an already cleared device line (EVOL® Spinal Interbody System). It explicitly states: "No additional testing is required to determine if Steam as a sterilization method will impact the safety or efficacy of this implant."
In summary, this document does not describe a study that proves the device meets specific acceptance criteria related to its diagnostic or performance accuracy, as it is a physical implant and the submission focuses on a change in sterilization method.
If this were an AI/ML device, the detailed information requested would be crucial for its 510(k) clearance or de novo authorization.
§ 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.