(169 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant (anterior cervical plate system) and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with various medical conditions, indicating a therapeutic purpose.
No
The device is a surgical implant intended for stabilization and fusion of the cervical spine, not for diagnosing a condition.
No
The device description explicitly states it consists of "temporary implants (plates and bone screws)" made from "titanium alloy" and "nitinol (NiTi)", which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ZEVO™ Anterior Cervical Plate System is a surgical implant intended for the temporary stabilization of the anterior spine during cervical spinal fusions. It is a physical device implanted into the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, based on the provided information, the ZEVO™ Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ZEVO™ Anterior Cervical Plate System is interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine.
The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form. The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to T1
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 subject ZEVO™ Anterior Cervical Plate devices were tested in accordance to ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices." The subject device met the pre-determined acceptance criteria for all tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030866, K130640, K081038, K030327, K994239
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2014
Medtronic Sofamor Danek USA, Incorporated Ms. Kristi Frisch Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K141632
Trade/Device Name: ZEVO™ 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: October 16, 2014 Received: October 17, 2014
Dear Ms. Frisch:
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K141632
Device Name ZEVOTM Anterior Cervical Plate System
Indications for Use (Describe)
The ZEVO™ Anterior Cervical Plate System is interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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ZEVO™ Anterior Cervical Plate System 510(k) Summary December, 2014
| I. | Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 |
|------|-------------------------|------------------------------------------------------------------------------------------------|
| II. | Contact: | Kristi Frisch
Senior Regulatory Affairs Specialist |
| III. | Proprietary Trade Name: | ZEVO™ Anterior Cervical Plate System |
| IV. | Common Name: | Spinal Intervertebral Body Fixation
Appliance |
| V. | Classification Name: | 21 CFR 888.3060 - Spinal Intervertebral
Body Fixation Orthosis |
| | Classification: | Class II |
| | Product Codes: | KWO |
VI. Product Description:
The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine.
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The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form. The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).
Indications for Use: VII.
The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.
Summary of Technological Characteristics VIII.
The subject ZEVO™ Anterior Cervical Plate System components have the same fundamental scientific technology as the predicate Cervical Spine Locking Plate (CSLP), ATLANTIS® Anterior Cervical System and ZEPHIR® Anterior Cervical System devices. The subject devices are manufactured from the same titanium alloy and nitinol material as the predicate ATLANTIS® devices. The predicate and subject devices are also anterior screw fixation devices where fixation is provided by bone screws inserted into the vertebral body of the cervical spine.
IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
The subject plate and bone screws are substantially equivalent to the predicates:
Primary Predicate:
- Anterior Cervical Spine Locking Plate (CSLP) System, (K030866, SE . 04/18/2003) [SYNTHES® Spine]
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Additional predicates:
- ATLANTIS® Anterior Cervical Plate System (K130640, SE . 06/04/2013; K081038, SE 08/15/2008) [Medtronic]
- ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003; . K994239, SE 06/19/2000) [Medtronic]
To the best of Medtronic's knowledge, none of the predicates listed here have been subject to a design-related recall.
Brief Discussion of the Non-Clinical Tests Submitted X.
The subject ZEVO™ Anterior Cervical Plate devices were tested in accordance to ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices." The subject device met the pre-determined acceptance criteria for all tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.
Conclusions Drawn from the Non-Clinical Tests XI.
Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the listed predicate devices.