(68 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for treating various spinal instabilities and conditions, indicating its therapeutic purpose.
No
The device is a spinal fixation system, intended to provide immobilization as an adjunct to fusion. This is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it consists of physical components like rods, anchors, screws, and connectors, which are hardware implants.
Based on the provided information, 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 provide information about a person's health.
- Device Description: The Virage OCT Spinal Fixation System is described as a system of rods, anchors, screws, and connectors used to build a spinal construct. These are implants and surgical instruments.
- Intended Use: The intended use is to provide immobilization of spinal segments as an adjunct to fusion for various spinal instabilities and conditions. This is a surgical intervention, not a diagnostic test performed on samples.
The device is a surgical implant system used to treat spinal conditions, not to diagnose them by testing samples.
N/A
Intended Use / Indications for Use
The Virage OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Virage OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, The Virage OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.
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)
NKG, KWP
Device Description
The Zimmer Spine Virage® OCT Spinal Fixation System intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, screws and connectors to build a spinal construct as necessary for the individual patient. The system also includes the instruments necessary for inserting and securing the implants are intended to be removed after solid fusion has occurred.
The Virage System implants are fabricated from medical grade titanium alloy or medical grade cobalt chromium allov. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3, Occipital-Cervical-Thoracic spine (Occiput-T3), posterior cervical or thoracic spine
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)
Published literature and the following non-clinical testing of the Virage open rod connector of the subject Virage OCT Spinal Fixation System demonstrate substantial equivalence:
- Testing conducted per ASTM F1798 for Axial and Torsional Gripping
- . Testing was conducted per ASTM F1717 for Static Torsion, Static and Dynamic Compression Bending.
In addition, sterilization and biocompatibility were assessed and determined that the subject and predicate device systems & components are substantially equivalent for sterilization and biocompatibility.
Performance mechanical testing concluded the Virage open rod connector performed as intended and fundamental scientific technology remains unchanged from the predicate device. The Virage open rod connector is substantially equivalent to the predicate Virage System connectors. The technological characteristics including the basic design and materials, i.e. medical grade titanium alloy, are the same.
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.
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2015
Zimmer Spine, Incorporated Mr. Jonathan Gilbert Director, Regulatory Affairs 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K151031
Trade/Device Name: Virage OCT Spinal Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 5, 2015 Received: May 6, 2015
Dear Mr. Gilbert:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Jonathan Gilbert
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" (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.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
2
Indications for Use
510(k) Number (if known) K151031
Device Name Virage OCT Spinal Fixation System
Indications for Use (Describe)
The Virage OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Virage OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, The Virage OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.
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.
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
|---|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | ] Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Type of Use (Select one or both, as applicable) |
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Image /page/3/Picture/1 description: The image shows the logo for Zimmer Spine. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters, with the word "spine" written in smaller letters underneath and underlined.
510(k) SUMMARY
Virage® OCT Spinal Fixation System
| Date of Summary Preparation: | June 16, 2015 |
|---|---|
| Company: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 USA | |
| Establishment Registration Number: | 2184052 (Minneapolis) |
| Company Contact: | Jon Gilbert |
| Email: jonathan.gilbert@zimmer.com | |
| Office: 952.830.6385 | |
| Email Fax: 952.837.6985 | |
| Device/Trade Name: | Virage®OCT Spinal Fixation System |
| Common Name: | Posterior, Cervical Pedicle Screw Spine Fixation |
| Spinal Interlaminar Fixation Orthosis | |
| Posterior Cervical System | |
| Regulatory Identification/ | |
| Classification: | Orthosis, Cervical Pedicle Screw Spinal Fixation |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code: NKG | |
| Unclassified, Pre-Amendment | |
| Spinal Interlaminar Fixation Orthosis | |
| Regulation Number: 888.3050 | |
| Product Code: KWP | |
| Class II |
General Device Description:
The Zimmer Spine Virage® OCT Spinal Fixation System intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, screws and connectors to build a spinal construct as necessary for the individual patient. The system also includes the instruments necessary for inserting and securing the implants are intended to be removed after solid fusion has occurred.
The Virage System implants are fabricated from medical grade titanium alloy or medical grade cobalt chromium allov. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use 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.
4
Indications for Use:
The Virage OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and deqenerative disease of the facets with instability. The Virage OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation. The Virage OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.
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 technological characteristics for the Zimmer Spine Virage OCT Spinal Fixation System, remain the same as the predicate devices listed above: same system's intended use, same mechanical and functional scientific technology: same materials and the same substantially equivalent performance characteristics.
Performance mechanical testing concluded the Virage open rod connector performed as intended and fundamental scientific technology remains unchanged from the predicate device. The Virage open rod connector is substantially equivalent to the predicate Virage System connectors. The technological characteristics including the basic design and materials, i.e. medical grade titanium alloy, are the same.
Summary of Performance Testing:
Published literature and the following non-clinical testing of the Virage open rod connector of the subject Virage OCT Spinal Fixation System demonstrate substantial equivalence:
- Testing conducted per ASTM F1798 for Axial and Torsional Gripping
- . Testing was conducted per ASTM F1717 for Static Torsion, Static and Dynamic Compression Bending.
In addition, sterilization and biocompatibility were assessed and determined that the subject and predicate device systems & components are substantially equivalent for sterilization and biocompatibility.
Substantial Equivalence:
Zimmer Spine considers the subject Virage OCT Spinal Fixation System to be substantially equivalent to the currently commercialized predicate device listed above because it is similar with respect to technical characteristics, performance, design and intended use.
Identification of Legally Marketed Devices:
The subject Virage OCT Spinal Fixation System is substantially equivalent to the predicate cervical spinal system – the VERTEX® Reconstruction System (primary predicate) cleared by the FDA (K143471 - SE 02/06/15). The subject device is also equivalent to the previously cleared Virage OCT Spinal Fixation System most recently cleared by the agency (K133556 - SE 06/02/14) with respect to the implants used to create the constructs utilized for the indications sought. The earlier Virage OCT Spinal Fixation System clearance is noted for reference purposes only and not as a primary predicate device for this application.