(210 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusion" to treat various spinal conditions, which directly aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose as "anterior screw fixation of the plate to the cervical spine" for the "temporary stabilization of the anterior spine during the development of cervical spinal fusion." This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly outlines a physical implant (cervical plate, screws) and associated instruments, which are hardware components. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- VELOX Anterior Cervical Plate System Function: The VELOX system is a surgical implant designed for interior screw fixation to the cervical spine. It is used inside the body to stabilize the spine during fusion.
The description clearly indicates a device used for surgical implantation and structural support within the body, not for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The VELOX Anterior Cervical Plate System is anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity,
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
Product codes
KWQ
Device Description
The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary:
ASTM F1717-12, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Envision Anterior Cervical Plate System (K020649), ALTUM Anterior Cervical Plate (K103505), MaxAn Anterior Cervical Plate System (K080646)
Reference Device(s)
K042544, K082273, K100070, K000536
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K131521 Page 1 of 2
DEC 2 4 2013
510(k) Summary for the VELOX Anterior Cervical Plate
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the VELOX Anterior Cervical Plate
Date Prepared: 5/17/2013
Submitter:
SpineCraft, LLC 777 Oakmont Lane Westmont, IL 60559 USA Tel: 1 630-920-7300 Fax: 1630-920-7310
Contact Person: Ami Akallal-Asaad Director of Requlatory Affairs. SpineCraft, LLC a.asaad@spinecraft.com
Establishment Registration No: Trade name: Common Name: Classification Name:
Product Code: Classification Panel: 3004717358 VELOX Anterior Cervical Plate System Anterior Cervical Plate Spinal intervertebral body fixation orthosis Per 21 CFR 888.3060 KWQ Class II 87
Predicate or legally marketed devices which are substantially equivalent:
Envision Anterior Cervical Plate System (K020649) / Ortho Development ALTUM Anterior Cervical Plate (K103505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) / Biomet Spine UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes
Description of the device:
The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.
Materials:
Ti-6Al-4V per ASTM F136 CoCr28Mo6 per ASTM F1537
1
Function:
The VELOX Anterior Cervical Plate system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion.
Substantial equivalence claimed to predicate devices
VELOX Anterior Cervical Plate system is substantially equivalent to the Envision Anterior Cervical Plate System (K020649), ALTUM Anterior Cervical Plate (K103505) and MaxAn Anterior Cervical Plate System (K080646) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the VELOX Anterior Cervical Plate system to these predicate devices.
Intended Use:
The VELOX Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7), The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- . degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- . spondviolisthesis.
- trauma (i.e. fractures or dislocations), ●
- . tumors,
- deformity, .
- pseudarthrosis. .
- failed previous fusion, .
- . spinal stenosis.
Non-clinical Test Summary:
The following tests were conducted:
ASTM F1717-12, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.
Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical
The VELOX Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing another person.
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
SPINECRAFT, LLC Ms. Ami Akallal-Asaad Director of Regulatory Affairs 777 Oakmont Lane Westmont, lilinois 60559
Re: K131521
Trade/Device Name: VELOX Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 21, 2013 Received: November 26, 2013
Dear Ms. Akallal-Asaad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
ﻟﻬﻢ ﻣﻦ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Page 2 - Ms. Ami Akallal-Asaad
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) K131521
-
- ...
- : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Device Name
VELOX Anterior Cervical Plate System
Indications for Use (Describe)
The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
· trauma (i.e. fractures or dislocations),
• tumors,
· deformity,
· pseudarthrosis.
· failed previous fusion,
· spinal stenosis.
Type of Use (Select one or both, as applicable)
P Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
. . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : FOR FDAIUSE ONLY . . . . . . ं : :
: : : : : :
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
on E. Dmitriev.
FORM FDA 3881 (9/13)
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
. . *. *
.....................