(42 days)
The Savannah Technologies Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Savannah Technologies Spinal System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.
The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. The rods are available in multiple lengths. The system has cross linkage assemblies to supply torsional stability to the construct.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and ISO 5832-3.
Function:
The Savannah Technologies Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.
The Savannah Technologies Spinal System is a spinal fixation system that was reviewed under K113755.
1. Acceptance Criteria and Device Performance
The acceptance criteria for the Savannah Technologies Spinal System were based on equivalency to predicate devices through non-clinical mechanical testing, specifically static and dynamic compression, and static torsion. Since no clinical studies were performed, there are no reported device performances from clinical trials to present in this table.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | Equivalent to Predicate Devices |
| Static compression per ASTM F1717 | Met |
| Dynamic compression per ASTM F1717 | Met |
| Static torsion per ASTM F1717 | Met |
2. Sample Size and Data Provenance
Given that no clinical studies were performed, there is no information regarding sample size for a test set or data provenance from patient studies. The evaluation relied solely on non-clinical mechanical testing.
3. Number of Experts and Qualifications for Ground Truth
No clinical studies were performed, therefore, no experts were used to establish ground truth for a clinical test set. The evaluation was based on engineering and materials testing.
4. Adjudication Method
As no clinical studies were performed and no human interpretation of data was required for the submission regarding patient outcomes, there was no adjudication method specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as no clinical studies involving human readers or AI assistance were conducted.
6. Standalone Performance
No standalone performance data for an algorithm (i.e., AI without human-in-the-loop) was provided, as this device is a physical pedicle screw system, not an AI/software device.
7. Type of Ground Truth Used
The ground truth used for proving device performance was based on mechanical testing standards (ASTM F1717) and comparison to the mechanical properties of legally marketed predicate devices. No pathology or outcomes data from human subjects were used.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical implant, not an AI/machine learning model, so there is no "training set" in the context of data used for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this device. The "ground truth" for the non-clinical testing was established by following recognized ASTM standards for mechanical testing of spinal fixation devices.
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510(k) Summary for the Savannah Technologies Spinal System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Savannah Technologies Spinal System
GENERAL INFORMATION 1.
| Date Prepared: January 27, 2012 |
|---|
| Trade Name: Savannah Technologies Spinal System |
| Common Name: orthosis, pedicle screw system |
| Classification Name: orthosis, spondylolisthesis spinal fixationorthosis, spinal pedicle fixation |
| Class: II |
| Product Code: MNH/MNI |
| CFR section: 21 CFR section 888.3070 |
| Device panel: Orthopedic |
| KRD-1 ™ - K092420 |
| Legally Marketed ZODIAC™ Polyaxial Spinal Fixation System - K04267. |
| Predicate Device: ISOBAR (Scient'x - K990118/K013444) |
| Submitter: Savannah Technologies, LLC12741 W Lewis AveAvondale, AZ, 85392 |
| Contact: J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199e-mail: jdwebb@orthomedix.net |
2. DEVICE DESCRIPTION
The Savannah Technologies Spinal System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.
The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. The rods are available in multiple lengths. The system has cross linkage assemblies to supply torsional stability to the construct.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and ISO 5832-3.
Function:
The Savannah Technologies Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The Savannah Technologies Spinal System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
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INTENDED USE 4.
The Savannah Technologies Spinal System is intended to provide immobilization and stabilization of r is ourments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
5. NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- Static and dynamic compression per ASTM F1717 .
- Static torsion per ASTM F1717 .
The results of this testing indicate that the Savannah Technologies Spinal System is equivalent to predicate devices.
CLINICAL TEST SUMMARY 6.
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
The Savannah Technologies Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with multiple lines representing wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Savannah Technologies, LLC % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K113755
Trade/Device Name: Savannah Technologies Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: December 16, 2011 Received: December 21, 2011
Dear Mr. Webb:
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
FEB - 1 2012
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Page 2 - Mr. J.D. Webb
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/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 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 yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K113755
Device Name: Savannah Technologies Spinal System
Indications For Use:
The Savannah Technologies Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).
When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 11 375 S 510(k) Number_
Page 1 of 1
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.