(20 days)
EBI® VucLock® Anterior Cervical Plate System, EBI® SpineLink® Anterior Cervical Plate System, Interpore Cross International C-Tek™ Anterior Cervical Plate System, Synthes* Spine Anterior Cervical Vertabrae Plate System (Anterior CSLP)
None
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusions" and is used for conditions like "degenerative disc disease, trauma including fractures, tumors, deformity," which are all therapeutic interventions.
No
Explanation: The device is an anterior cervical plate system used for temporary stabilization during spinal fusions. Its intended use focuses on stabilization and support, not on diagnosing medical conditions.
No
The device description and performance studies clearly indicate a physical implantable device (Anterior Cervical Plate System) and mechanical testing, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used within the body for structural support and stabilization.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform any such testing on specimens.
- Device Description (though not found): Based on the intended use, the device is a physical implant (a plate and screws).
- No Mention of Specimen Testing: The provided information does not mention any testing of biological samples.
Therefore, the EBI® Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EBI® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthroses and/or failed previous fusions.
Product codes
KWO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
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
Mechanical testing of the EBI® Anterior Cervical Plate System was conducted and demonstrates that the proposed system conforms to its design specifications. The design requirements were established based on those of the previously cleared predicate devices. The results of testing conducted demonstrate that the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance.
Key Metrics
Not Found
Predicate Device(s)
EBI® VucLock® Anterior Cervical Plate System, EBI® SpineLink® Anterior Cervical Plate System, Interpore Cross International C-Tek™ Anterior Cervical Plate System, Synthes* Spine Anterior Cervical Vertabrae Plate System (Anterior CSLP)
Reference Device(s)
Not Found
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
1.037
MAR E 2006
EBI, L.P.'s
EBI® Anterior Cervical Plate System
| SUBMITTER: | EBI. L.P. |
|---|---|
| ADDRESS: | 100 Interpace Parkway |
| Parsippany, NJ 07054 | |
| PHONE: | (973) 299-9300 |
| FAX: | (973) 257-0232 |
| CONTACT PERSON: | Jennifer P. Harakal |
| DATE PREPARED: | February 13, 2006 |
| TRADE NAME: | EBI® Anterior Cervical Plate System |
| COMMON NAME: | Spinal Fixation Device |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis, |
| 21 CFR § 888.3060 | |
| CLASSIFICATION #: | Class II |
| PREDICATE DEVICES: | EBI® VucLock® Anterior Cervical Plate System. |
| EBI® SpineLink® Anterior Cervical Plate System, | |
| Interpore Cross International C-Tek™ Anterior Cervical | |
| Plate System, | |
| Synthes* Spine Anterior Cervical Vertabrae Plate System | |
| (Anterior CSLP) |
INTENDED/INDICATIONS FOR USE:
The F.BI® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spinc during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, turners, deformity (defined as kyphosis, lordosis or scoliosis), pscudarthroses and/or failed previous fisions.
・・ ﺭﺍﺀ ﺗﻌﻠ
1
K660379
TECHNOLOGICAL CHARACTERISTICS:
Performance Testing
Mechanical testing of the EBI® Anterior Cervical Plate System was conducted and demonstrates that the proposed system conforms to its design specifications. The design requirements were established based on those of the previously cleared predicate devices. The results of testing conducted demonstrate that the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance.
Substantial Equivalence
The EBI® Anterior Cervical Plate System is substantially equivalent to other legally marketed anterior cervical spinal fixation devices. Specifically, the proposed oystem is substantially equivalent to EBI L.P 's VueLock® and SpineLink® Anterior Cervical Systems, Synthes' Spine Anterior Cervical Vertabrae Plate System (Anterior CSLP), and Interpore Cross International's C-Tek™ Anterior Cervical Plate System with respect to intended use and indications, technological characteristics, and principles of operation. This premarket notification is being submitted to reflect availability of a modified anterior cervical plate system that allows for the use of both constrained and semi-constrained bone screws. As demonstrated hy mechanical testing, these technological differences do not present any new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
mar 6 2006
211b
EBI, LP C/O Ms. Jennifer P. Harakal Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054
$\sim$
Re: K060379
Trade/Device Name: EBI® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: February 13, 2006 Received: February 14, 2006
Dear Ms. Harakal:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 ווייון (אין יונ comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 -- Ms. Jennifer Harakal
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
el.Mell.
Image /page/3/Picture/4 description: The image contains a black and white drawing of a cursive letter. The letter appears to be a lowercase "k" or a similar character with a loop and a stroke. The drawing is simple and lacks shading or texture.
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K060379 |
|---|---|
| --------------------------- | --------- |
Device Name: EBI® Anterior Cervical Plate System
Indications for Use:
The EBI® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthroses and/or failed previous fusions.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
emre
Page _ of _
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number KO60379
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