(28 days)
EBI VueLock™ Anterior Cervical Plate System
Not Found
No
The 510(k) summary describes a mechanical spinal fixation device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a 'cervical spinal fixation device' intended for 'temporary stabilization of the anterior spine during the development of cervical spinal fusions' for various medical conditions, which aligns with the definition of a therapeutic device.
No
Explanation: This device is an anterior cervical plate system used for temporary stabilization and fixation of the cervical spine during fusions. It is an implantable medical device, not a diagnostic tool used to identify or determine a disease, condition, or injury.
No
The device description explicitly states it is a system of plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 directly on the patient's body for structural support and stabilization.
- Device Description: The description details "plates and screws" made of titanium, designed to be implanted in the spine. This is consistent with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical support and stabilization within the body.
N/A
Intended Use / Indications for Use
The EBI VueLock™ 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Product codes
KWQ
Device Description
The EBI VueLock™ Anterior Cervical Plate System is a cervical spinal fixation device of plates and screws. The plates contain a locking ring mechanism, which locks the screws into place. The plates are designed to span between one and four levels, and are manufactured from titanium. This submission is for the addition of Self Drilling Screws to the System.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The mechanical testing demonstrated that the device complies with applicable standards and meets all of its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EBI VueLock™ Anterior Cervical Plate System
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
OCT 1 8 2002
023133
page 1 of 2
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI VueLock™ Anterior Cervical Plate System is provided as required per Section 513(D)(3) of the Food, Drug and Cosmetic Act.
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- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa, RAC Telephone: (973) 299-9300
- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
September 19, 2002 Date prepared:
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- Proprietary Name: EBI VueLock™ Anterior Cervical Plate System Spinal Fixation Device Common Name: Classification Names: Spinal Intervertebral Body Fixation Orthosis
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- Predicate or legally marketed devices that are substantially equivalent: · EBI VueLock™ Anterior Cervical Plate System
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- Description of the device: The EBI VueLock™ Anterior Cervical Plate System is a cervical spinal fixation device of plates and screws. The plates contain a locking ring mechanism, which locks the screws into place. The plates are designed to span between one and four levels, and are manufactured from titanium. This submission is for the addition of Self Drilling Screws to the System.
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- Intended Use: The EBI VueLock™ 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
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K623133
page 2 of 2
Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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- Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136.
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- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI VueLock™ Anterior Cervical Plate System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. The mechanical testing demonstrated that the device complies with applicable standards and meets all of its functional requirements.
- Any statement made in conjunction with this submission of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interveted as an admission or any other type of evidence in patent inigation fistablishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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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 of three human profiles facing to the right, arranged in a stacked, overlapping manner.
OCT 1 8 2002
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Frederic Testa, RAC EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K023133 Trade/Device Name: EBI® VueLock™ Anterior Cervical Plate Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: K WQ Dated: September 19, 2002 Received: September 20, 2002
Dear Mr. Testa;
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. Iisting 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 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Frederic Testa, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A Miller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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STATEMENT OF INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known): KOa 3/33
Device Name: EBI VueLock™ Anterior Cervical Plate System
Indications For Use:
The EBI VueLock™ 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements
(pedicles) of the cervical, thoracic, or lumbar spine.
spine.
for
Mark A. Milleson
(Division Sign-
Division of Ger Restorative
්. Restorative and Neurological J
510(k) Number K023133
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)