Velofix Interbody Fusion System

• K Number: K190067
• Device Name: Velofix Interbody Fusion System
• Manufacturer: U&i Corporation
• Date Cleared: 2019-02-04 ( 20 days)
• Product Code: ODP , MAX
• Regulation Number: 888.3080
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K171749

Intended Use

The Velofix™ PEEK Cervical Cage is intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.

The Velofix™ PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Device Description

The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of autogenous bone graft and consist of:

• 1. Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device (Velofix'™ PEEK Lumbar Cage), which may be implanted.
     The implants are made of radiolucent polymer polyether-ether-ketone(ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560), and they can be supplied either sterile or non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Velofix™ Interbody Fusion System, which is a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI-powered diagnostic/analysis device through a comprehensive clinical study with specific acceptance criteria and performance metrics (like sensitivity, specificity, or AUC).

Therefore, based on the provided text, I cannot extract the information required to populate the bullet points about acceptance criteria and a study proving a device meets them (e.g., performance metrics, sample sizes for test/training sets, expert consensus, MRMC studies) because this document is for a mechanical implant and not an AI/software device that would undergo such testing.

The "study" described in this document is a series of tests to confirm that adding sterilization to the existing device does not introduce new safety or efficacy issues.

Here's what I can definitively state based on the provided text:

• Device Type: The Velofix™ Interbody Fusion System is an intervertebral body fusion device, specifically a PEEK cervical and lumbar cage for spinal fusion. It is a physical implant, not a software or AI diagnostic device.
• Purpose of Submission: The submission's purpose is to introduce sterilized implants of the already established Velofix™ Interbody Fusion System. This indicates that a version of this device already existed and was cleared, and this submission is for a modification (sterilization).
• Basis for Clearance: The device is seeking clearance based on substantial equivalence to a predicate device (Velofix™ Interbody Fusion System, K171749). Substantial equivalence means the device is as safe and effective as a legally marketed device. It does not involve proving new efficacy through clinical trials as an AI diagnostic device would.
• Evaluated Properties due to Sterilization (not "acceptance criteria" for AI performance):
  • Sterility according to ISO11137-2
  • Packaging integrity according to ASTM F1929, ASTM F2096 and etc.
  • Pyrogenicity according to ISO 10993-11
  • Biocompatibility according to ISO 10993-1
  • Shelf-life according to ASTM F1980

In conclusion, the document describes a 510(k) submission for a physical medical device (spinal implant) focusing on demonstrating substantial equivalence, specifically regarding the addition of sterilization. It does not contain the kind of detailed information about acceptance criteria, performance metrics, test/training sets, or expert evaluations that would be present for an AI-powered diagnostic device.

Regulation Number and Section

§ 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.