(26 days)
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No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as providing immobilization and stabilization of spinal segments as an adjunct to fusion for various medical conditions, indicating a therapeutic purpose.
No
The device is an implantable system designed to immobilize and stabilize spinal segments as an adjunct to fusion, not to diagnose a medical condition.
No
The device description explicitly states the system consists of physical components like rods, hooks, screws, and connecting components made of titanium and cobalt chrome alloys.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic and structural function within the body.
- Device Description: The device description details physical components like rods, hooks, and screws made of titanium and cobalt chrome alloys. These are materials used for surgical implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Innovasis Gibralt Spine System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Innovasis Gibralt Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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 Gibralt Spine 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 advanced 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 Gibralt Spine System may be connected to the Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Innovasis® Gibralt® Spine System is a posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt Spine System components are manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), with rods being available in both titanium alloy and cobalt chrome alloy (CoCr per ASTM F1537) options.
No modifications have been made to the design, materials or principles of operation when compared to the predicate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine (C1-C7) and the thoracic spine from T1-T3
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed on the subject Gibralt Spine System as part of K160697. The results demonstrated in K160697 that the subject Gibralt Spine System was substantially equivalent to the predicate. This information has been provided to Innovasis and no changes have been made to the system components to necessitate additional mechanical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
September 24, 2019
Innovasis, Inc. Mr. Marshall C. McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K192354
Trade/Device Name: Innovasis® Gibralt® Spine System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, KWP Dated: August 28, 2019 Received: August 29, 2019
Dear Mr. McCarty:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
Ronald P. Jean, Ph.D. Director (Acting) 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) K192354
Device Name Innovasis® Gibralt® Spine System
Indications for Use (Describe)
The Innovasis Gibralt Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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 Gibralt Spine 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 advanced 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 Gibralt Spine System may be connected to the Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.
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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510(k) Summary
In accordance with Title 21 of the Code of Federal Requlations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
1. Submitted by:
Marshall C. McCarty Director QA/RA Innovasis, Inc. 614 E. 3900 S. Salt Lake City, Utah 84107 Telephone: (801) 261-2236 Date Prepared: August 28, 2019
2. Device Information
Device Name: Innovasis® Gibralt® Spine System Common Name: Posterior cervical screw system Product Codes: NKG, KWP Classification Name: Posterior cervical screw system (21 CFR 888.3075); Spinal interlaminar fixation orthosis (21 CFR 888,3050) Requlatory Class: Class II
3. Predicate Devices
The primary predicate device is the Exactech, Inc. Gibralt Spine System, (K160697 -June 28, 2016).
Innovasis, Inc. has obtained the right to manufacture and market the Gibralt Spine System as an Innovasis branded product.
4. Device Description
The device description of the Gibralt Spine System is as follows:
The Innovasis® Gibralt® Spine System is a posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt Spine System components are manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), with rods being available in both titanium alloy and cobalt chrome alloy (CoCr per ASTM F1537) options.
No modifications have been made to the design, materials or principles of operation when compared to the predicate.
5. Intended Use
The Innovasis Gibralt Spine System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed
4
previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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 Gibralt Spine 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 advanced 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 Gibralt Spine System may be connected to the Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.
6. Technological Characteristics
The Gibralt Spinal System is a posterior system intended to help provide immobilization and stabilization of spinal seqments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt System components are manufactured from titanium alloy per ASTM F136 and Cobalt Chrome per ASTM F1537. Overall, the subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, function, and packaging.
7. Performance Data
Nonclinical testing was performed on the subject Gibralt Spine System as part of K160697. The results demonstrated in K160697 that the subject Gibralt Spine System was substantially equivalent to the predicate. This information has been provided to Innovasis and no changes have been made to the system components to necessitate additional mechanical testing.
8. Conclusions
The subject Gibralt Spine System has been shown to be substantially equivalent to legally marketed predicate device for its intended use.