(182 days)
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No
The document describes a mechanical spinal implant system and does not mention any software, image processing, or AI/ML capabilities.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for multiple medical conditions, restore spinal column integrity, and treats conditions like traumatic spinal fractures, instability, deformity, and degenerative disease. These are therapeutic actions.
No
Explanation: The G Surgical OCT Spinal System is described as an immobilization device for spinal segments, an adjunct to fusion, and for restoring spinal column integrity. Its purpose is mechanical support and stabilization, not the diagnosis of medical conditions.
No
The device description explicitly states that the G Surgical OCT Spinal System consists of physical components like longitudinal members, anchors, interconnecting devices, and fasteners, which are implants. This indicates it is a hardware-based medical device, not software-only.
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 system designed to provide mechanical support and stabilization to the spine. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of physical components like longitudinal members, anchors, and fasteners, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat spinal instability.
N/A
Intended Use / Indications for Use
The G Surgical OCT Spinal 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, cervical spine (C1 to C7) and the thoracic spine (T1 to 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 G Surgical OCT Spinal 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 G Surgical OCT Spinal System may be connected to the G Surgical Pedicle System (GPS™) using 3.5mm/6.0mm axial connectors, domino connectors and transition rods.
Product codes
NKG, KWP
Device Description
G Surgical OCT Spinal System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.
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
craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3)
Indicated Patient Age Range
Not Found
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
Mechanical testing of worst case G Surgical OCT Spinal System constructs included static and dynamic compression bending and static torsion according to ASTM F1717 and static and dynamic compression bending and torsion according to ASTM F2706. The mechanical test results demonstrate that G Surgical OCT Spinal System performance is substantially equivalent to the predicate devices.
Key Metrics
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Predicate Device(s)
K142838, K153631, K994187, K042544
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2017
G Surgical LLC % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. P.O. Box 566 Chesterland, Ohio 44026-2141
Re: K171834
Trade/Device Name: G Surgical OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: November 24, 2017 Received: November 28, 2017
Dear Dr. Warden:
We have reviewed vour 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 (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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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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171834
Device Name G Surgical OCT Spinal System
Indications for Use (Describe)
The G Surgical OCT Spinal 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, cervical spine (C1 to C7) and the thoracic spine (T1 to 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 G Surgical OCT Spinal 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 G Surgical OCT Spinal System may be connected to the G Surgical Pedicle System (GPS™) using 3.5mm/6.0mm axial connectors, domino connectors and transition rods.
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
| Date: | 16 June 2017 |
|---|---|
| Sponsor: | G Surgical LLC |
| 9433 Bee Cave Road | |
| Building 3, Suite 101-A | |
| Austin, Texas 78733 USA | |
| Tel.: 512.494.4749 | |
| Contact Person: | Don Grafton, Managing Director |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | G Surgical OCT Spinal System |
| Common Name: | Posterior occipital-cervical-thoracic system |
| Device Classification | Class II |
| Classification Name; | |
| Regulation; Device | |
| Product Code: | Orthosis, Cervical Pedicle Screw Spine Fixation; Pre-amendment; NKG |
| Appliance, Fixation, Spinal Interlaminal: 888.3050; KWP | |
| Device Description: | G Surgical OCT Spinal System consists of longitudinal members, anchors, |
| interconnecting devices and fasteners in a variety of sizes to accommodate | |
| differing anatomic requirements. The implants are sold non-sterile. | |
| Intended Use: | The G Surgical OCT Spinal System is intended to provide immobilization |
| and stabilization of spinal segments as an adjunct to fusion for the following | |
| acute and chronic instabilities of the craniocervical junction, cervical spine | |
| (C1 to C7) and the thoracic spine (T1 to 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 G Surgical OCT Spinal 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 G Surgical OCT Spinal | |
| System may be connected to the G Surgical Pedicle System (GPS™) using | |
| 3.5mm/6.0mm axial connectors, domino connectors and transition rods. | |
| Materials: | The G Surgical OCT Spinal System is manufactured from Ti-6Al-4V ELI |
| titanium alloy (ASTM F136). | |
| Primary Predicate | Synapse OCT (DePuy Synthes Spine - K142838) |
| Additional Predicates: | Virage OCT Spinal System (Zimmer Spine Inc. - K153631) |
| CerviFix StarLock System (Synthes USA - K994187) | |
| Uniplate Anterior Cervical Plate (DePuy Spine - K042544) | |
| Performance Data: | Mechanical testing of worst case G Surgical OCT Spinal System constructs |
| included static and dynamic compression bending and static torsion | |
| according to ASTM F1717 and static and dynamic compression bending | |
| and torsion according to ASTM F2706. | |
| The mechanical test results demonstrate that G Surgical OCT Spinal | |
| System performance is substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The G Surgical OCT Spinal System possesses similar technological |
| characteristics as the predicate devices. These include: | |
| performance (as described above), basic design (rod, plate and screw configuration), material (titanium alloy), and sizes (dimensions are comparable to those offered by the predicate | |
| systems). Therefore the fundamental scientific technology of the G Surgical OCT | |
| Spinal System is the same as previously cleared devices. | |
| Conclusion: | The G Surgical OCT Spinal System possess the same intended use and |
| technological characteristics as the predicate devices. Therefore the G | |
| Surgical OCT Spinal System is substantially equivalent for its intended use. |
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