(59 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and focuses on establishing MR Conditional labeling. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is used to stabilize the anterior spine for various medical conditions like degenerative disc disease, trauma, tumors, and deformities, which directly addresses medical conditions and supports healing.
No
The device is an implant system (plates and bone screws) used for temporary stabilization and fixation of the anterior spine to aid in spinal fusions. It does not perform any diagnostic function.
No
The device description explicitly states it consists of "temporary implants (plates and bone screws)" made from "titanium alloy" and "nitinol (NiTi)". This indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ZEVO™ Anterior Cervical Plate System is for "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description confirms it consists of "temporary implants (plates and bone screws)" intended for "anterior screw fixation of the cervical spine." Again, this describes a physical device implanted in the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with biological samples for diagnostic purposes.
The information provided describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZEVO™ Anterior Cervical Plate System is interior 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) turnors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, 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).
The purpose of this submission is to establish MR Conditional labeling for this implant system.
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)
MR safety Testing
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards:
- . RF-Induced heating: ASTM F2182-19e2
- . Magnetically Induced Force: ASTM F2052-21
- . Magnetically Induced Torque: ASTM F2213-17
- . Image Distortion: ASTM F2119-07(2013)
- Labelling: ASTM F2503-20 .
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.
ZEVO Anterior Cervical Plate System K141632
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
Medtronic Sofamor Danek USA, Inc. Scott Baker Sr. Regulatory Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K231090
Trade/Device Name: ZEVOTM 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: April 13, 2023 Received: April 17, 2023
Dear Scott Baker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
June 15, 2023
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name Eileen Cadel in large, bold font. Next to the name, there is a digital signature that reads "Digitally signed by Eileen Cadel - S Date: 2023.06.15 12:59:39 -04'00' for". The signature indicates that the document was signed by Eileen Cadel on June 15, 2023, at 12:59:39 with a time zone offset of -04'00'.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231090
Device Name
ZEVO™ Anterior Cervical Plate System
Indications for Use (Describe)
The ZEVO™ Anterior Cervical Plate System is interior 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) turnors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 April 13, 2023
| I. | Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 |
|------|-------------------------|------------------------------------------------------------------------------------------------|
| II. | Contact: | Scott P. Baker
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.
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.
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The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).
The purpose of this submission is to establish MR Conditional labeling for this implant system.
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.
VIII. Summary of Technological Characteristics
The subject devices do not differ from the technological characteristics of the predicate devices.
Identification of Legally Marketed Predicate Devices Used to Claim IX. Substantial Equivalence
The subject plate and bone screws are substantially equivalent to the primary predicate: ZEVO Anterior Cervical Plate System K141632 (S.E. 12/04/2014)
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X. MR safety Testing
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards:
- . RF-Induced heating: ASTM F2182-19e2
- . Magnetically Induced Force: ASTM F2052-21
- . Magnetically Induced Torque: ASTM F2213-17
- . Image Distortion: ASTM F2119-07(2013)
- Labelling: ASTM F2503-20 .
Conclusions Drawn from the Non-Clinical Tests
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.