(122 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is an implant system designed for spinal stabilization to facilitate fusion, not for direct therapeutic treatment of a disease or condition.
No
The device is an implantable plate system designed for temporary stabilization during spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of plates, screws, and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The inViZia™ Anterior Cervical Plate System is a surgical implant designed to be placed inside the body to stabilize the cervical spine during fusion. It is a physical device used in a surgical procedure, not a device that analyzes biological samples outside the body.
The description clearly indicates it's a temporary implant system for spinal fusion, which falls under the category of surgical devices or implants, not IVDs.
N/A
Intended Use / Indications for Use
The inViZia™ Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The inViZia™ Anterior Cervical Plate 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 with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis 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.
Product codes
KWQ
Device Description
The inViZia 10 Anterior Cervical Plate System is a temporary implant system used to facilitate the biological process of spinal fusion. This system consists of plates, screws and instruments and is intended for anterior use in the cervical spine. Surgical instruments are provided to facilitate placement of the implants.
The implants consist of plates of varying length, fixed and variable screws of varying diameter and length. Components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.
This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-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)
Determination of substantially equivalent performance characteristics in regard to the predicate devices was confirmed through static compression bending, dynamic compression bending and static torsion testing in conformance with the requirements of ASTM F-1717:2010. In addition, validated cleaning and sterilization instructions are provided for the non-sterile components of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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OCT 2 7 2011
Image /page/0/Picture/1 description: The image shows a logo with the letter 'Z' inside a circle at the top. Below the circle, the word 'zimmer' is written in a stylized font. Underneath 'zimmer', the word 'spine' is written in a simpler, sans-serif font.
510(k) SUMMARY
Zimmer Spine inViZia™ Anterior Cervical Plate System
510(k) Number_KII 1796
| Date of Summary Preparation: | August 29, 2011 |
|---|---|
| Manufacturer: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| USA | |
| Company Contact: | Elsa Linke |
| Regulatory Affairs | |
| Telephone: 952.832.5600 | |
| Device Name: | inViZia™ Anterior Cervical Plate System |
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Invertebral Body Fixation Orthosis |
| Product Code: | KWQ |
| Regulation Number: | 21 CFR 888.3060 |
| Device Classification: | Class II |
| Predicate Devices: | Zimmer Spine Trinica® Select Anterior Cervical Plate |
| System (K022344) | |
| Synthes® Spine Anterior CSLP System (K030866 and | |
| K971883) |
Description of Device:
The inViZia 10 Anterior Cervical Plate System is a temporary implant system used to facilitate the biological process of spinal fusion. This system consists of plates, screws and instruments and is intended for anterior use in the cervical spine. Surgical instruments are provided to facilitate placement of the implants.
The implants consist of plates of varying length, fixed and variable screws of varying diameter and length. Components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.
Page 1 of 2
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This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion.
Intended Use:
The inViZia™ Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The inViZia™ Anterior Cervical Plate 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 with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis 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.
Comparison of Technological Characteristics:
The inViZia™ Anterior Cervical Plate System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, same range of sizes, substantially equivalent performance characteristics and the same intended use. Determination of substantially equivalent performance characteristics in regard to the predicate devices was confirmed through static compression bending, dynamic compression bending and static torsion testing in conformance with the requirements of ASTM F-1717:2010. In addition, validated cleaning and sterilization instructions are provided for the non-sterile components of the system.
Substantial Equivalence:
The inViZia™ Anterior Cervical Plate System is substantially equivalent to the predicate devices in design, materials, biocompatibility, mechanical performance and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2011
Zimmer Spine, Inc. % Ms. Elsa Linke 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K111796
Trade/Device Name: inViZia" 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 17, 2011 Received: October 18, 2011
Dear Ms. Linke:
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
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Page 2 - Ms. Elsa Linke
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely, yours,
Erinl Keith
ان Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): __
Device Name: inViZia™ Anterior Cervical Plate System
Indications for Use:
The inViZia™ Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The inViZia™ Anterior Cervical Plate 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 with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined' as kyphosis, lordosis or scoliosis), pseudoarthrosis 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.
Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111796