(195 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Spinal Fixation System" intended to "promote fusion" and "provide stabilization" for a range of spinal conditions, including degenerative disc disease, fractures, and tumors, indicating its use in treating a medical condition.
No
This device is a spinal fixation system, which is an implant used to provide stabilization and promote fusion in the spine. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of "a variety of rods, anchors, transverse connectors, screws, and polyaxial screws" and "instruments necessary for inserting and securing the implants," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Virage OCT Spinal Fixation System is a "posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3)." It consists of implants (rods, screws, etc.) and instruments for insertion.
- Intended Use: The intended use is to "promote fusion of the occipitocervical spine, cervical spine and the thoracic spine" and provide "stabilization to promote fusion following reduction of fracture/dislocation or trauma." This is a surgical implant used in the body, not a device for testing samples from the body.
The device is a surgical implant used for spinal fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:
Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.
Hooks and Rods
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Thoracic Screws
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.
Rod Connectors
The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.
The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Zimmer Spine Virage OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.
The Virage System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium. medical grade titanium alloy, and medical grade cobalt chromium may be used together, Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances. Refer to the product label to determine if instrumentation is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Occipital-Cervical-Thoracic spine (Occiput-T3)
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)
Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.
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.
K070282, K071435, K091689, K991089, K994187, K003780, K123656
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
JUN 0-2-2014
Image /page/0/Picture/2 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized "Z" inside it, above the words "zimmer" and "spine", with "spine" written in a smaller font. The text is in a sans-serif font and appears to be slightly distressed.
510(k) SUMMARY
Virage OCT Spinal Fixation System
Date of Summary Preparation:
Company:
May 8, 2014
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439 USA
2184052 (Minneapolis)
Office: 952.830.6240 Fax: 952.837.6840
Regulatory Affairs Project Manager Email: Holly.Seppanen@zimmer.com
Virage OCT Spinal Fixation System
Holly Seppanen
Establishment Registration Number:
Company Contact:
Trade Name(s):
Device Name (Common Name):
Device Classification:
Regulation Number and Product Code(s):
21 CFR § 888.3050 / KWP
Spinal Fixation System
Requlation Name:
Appliance, Fixation, Spinal Interlaminal
General Device Description:
The Zimmer Spine Virage OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.
Class II
The Virage System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium. medical grade titanium alloy, and medical grade cobalt chromium may be used together, Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances. Refer to the product label to determine if instrumentation is intended for single use.
1
Indications for Use:
When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:
Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.
Hooks and Rods
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Thoracic Screws
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.
Rod Connectors
The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.
The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Summary of Technological Characteristics:
The Virage System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve a spinal implant construct as necessary for the individual case. The Virage System also includes the instruments necessary for inserting and securing the implants.
All implants are single use only and are not to be reused under any circumstances. All instruments are reusable. All implants and instruments are provided clean and nonsterile and must be sterilized by the end user prior to use.
The medical grade titanium alloy utilized in the Virage System implants is Ti-6AI-4V ELI per ASTM F136. The medical grade cobalt chromium alloy utilized in the Virage System implants is Co-28Cr-6Mo per ASTM F1537.
Performance mechanical testing concluded the Virage System performed as intended and fundamental scientific technology remains unchanged from the predicate devices. The Virage System is substantially equivalent to the predicate devices. The technological characteristics including the basic design and materials, i.e. medical grade metallic constructs, are the same.
2
In summary, the subject Virage System utilizes medical grade metallic constructs and does not change the fundamental scientific technology of the device as compared to the predicates, it will continue to operate in the same way.
Summary of Performance Testing:
Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.
ldentification of Legally Marketed Devices:
| Predicate Device Name | FDA 510k Number |
|---|---|
| Endius Minit Posterior Cervical and Upper Thoracic Fixation | |
| System | K070282 |
| NuVasive® OCT System | K071435 |
| Synthes Synapse, Cervifix, Cervifix Starlock | K091689, K991089, K994187 |
| Vertex Reconstructive System | K003780, K123656 |
Substantial Equivalence:
Zimmer Spine considers the subject Virage OCT Spinal Fixation System product performance to be substantially equivalent to the predicate devices because there is no significant difference in intended use, mechanical and functional performance and fundamental scientific technology. No new issues of safety and effectiveness are raised due to the similarities between the subject and the legally marketed predicate devices, as each are used to treat similar clinical conditions and represent a similar basic design concept.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
June 2, 2014
Zimmer Spine, Incorporated Ms. Holly Seppanen Regulatory Affairs Project Manager 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K133556
Trade/Device Name: Virage OCT Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 8, 2014 Received: May 9, 2014
Dear Ms. Seppanen:
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, Tille 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 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 - Ms. Holly Seppanen
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/ResourcesforYou/Industry/default.htm. 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
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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
RonaldiP. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133556
Device Name
Virage OCT Spinal Fixation System
Indications for Use (Describe)
When intended to promote fusion of the occipitocervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:
Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion of Geoureddislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.
Hooks and Rods
Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
Thoracic Screws
The use of thoracic screws is limited to placement in TI-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.
Rod Connectors
The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.
The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
[区] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line – continue on a separate page if needed.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Zane W. Wyatt | |
| Division of Orthopedic Devices | |
| FORM FDA 3881 (6/13) | Page 1 of 2 |
| PSC Publishing Services (301) 411-6740 FF |
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