(111 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a Zavation Cervical Plate System, which is an implant used for stabilization of the cervical spine, not a therapeutic device in the sense of actively treating or curing disease through non-surgical means. It serves as an adjunct to fusion for structural support.
No
The device description clearly states it is a "Cervical Plate System" used for stabilization and fusion, which are therapeutic interventions, not diagnostic ones. The "Intended Use" section lists conditions it treats, confirming its therapeutic purpose.
No
The device description explicitly states it consists of "self-tapping/self-drilling screws and plates," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Zavation Cervical Plate System is for "anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion." This describes a surgical implant used to stabilize the spine.
- Device Description: The device is described as consisting of "self-tapping/self-drilling screws and plates." These are physical components used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Zavation Cervical Plate System does not involve any such testing or analysis of biological samples.
The device is a surgical implant used for structural support in the spine, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Product codes
KWQ
Device Description
The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available 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-C7)
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)
Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943523, K945700, K071667, K042544, K112533
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
Attachment 4 - 510(k) Summary
APR 2 5 2013
510K Summary
| Date: | March 13, 2013 |
|---|---|
| Submitter: | Zavation LLC |
| 501 Avalon Way | |
| Brandon, MS 39047 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Cervical Plate System |
| Common name: | Anterior Cervical Plate |
| Classification regulation: | 888.3060 |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | KWQ |
| Basis for submission: | Addition of optional screws and plates |
Device Description:
The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Intended Use:
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
1
Materials:
The Zavation Cervical Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
Predicate Device:
ALINE, Smith & Nephew (K943523) CSLP, Synthes (K945700) Vectra-one, Synthes (K071667) Uniplate, Depuy Spine (K042544) Zavation Cervical Plate (K112533)
Technological Characteristics:
The Zavation Cervical Plate System possesses the same technological characteristics as the predicate. These include: basic design (plate designed fixation system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).
Performance Data:
Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate devices.
Conclusion:
The Zavation Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
2
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 stylized eagle with three bars representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 25, 2013
Zavation. LLC % Mr. John Walker Engineering Manager 501-Avalon_Way_ Brandon, Mississippi 39047
Re: K130030
Trade/Device Name: Zavation Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 13, 2013 Received: March 18, 2013
Dear Mr. Walker:
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
Page 2 - Mr. John Walker
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 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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 3 - Indications for Use Statement
Indications for Use
510(k) Number (if known): K130030
Device Name: Zavation Cervical Plate System
Indications For Use:
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1