(280 days)
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No
The document describes a mechanical pedicle screw system and its intended use for spinal fusion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies described are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which is a therapeutic purpose.
No
Explanation: The Savannah-T® Pedicle Screw System is described as a system intended to provide immobilization of spinal segments as an adjunct to fusion. Its components are mechanical (screws, rods, etc.) and it is used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, connecting rods, set screws, and transverse crossmembers, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Savannah-T® Pedicle Screw System is for providing immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details the physical components of the system (screws, rods, etc.) made from Ti-6AI-4V, which are materials used for implants.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Savannah-T® Pedicle Screw System is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Savannah-T® Pedicle Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:
· When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scollosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).
• In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.
Product codes
NKB, MNI, MNH
Device Description
The Savannah-T® Pedicle Screw System provides structural stability in skeletally mature adults requiring fusion of the lumbar and/or sacral spine. The system consists of mono- and poly-axial pedicle screws, connecting rods, set screws, and transverse crossmembers. The screws are available in cancellous and cortical-cancellous thread designs of various diameters and lengths. The rods are available in straight, lordosed and pre-contoured confiqurations in various lengths. They are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
thoracic, lumbar, and/or sacral spine
Indicated Patient Age Range
skeletally mature patients; skeletally mature adults
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
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Summary of Performance Studies
Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device. Testing included static/dynamic axial compression and static torsion (ASTM F1717), as well as secondary bending testing (dynamic compression, ASTM F1717). Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K152920
Trade/Device Name: Savannah-T® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 17, 2016 Received: June 20, 2016
Dear Ms. Allen:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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
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Indications for Use
510(k) Number (if known) K152920
Device Name Savannah-T® Pedicle Screw System
Indications for Use (Describe)
The Savannah-T® Pedicle Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:
· When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scollosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).
• In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.
| 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
Savannah-T® Pedicle Screw System
| Submitter: | Amendia, Inc.
1755 W. Oak Parkway
Marietta, GA 30062 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Sr. Regulatory Affairs Specialist
910-612-4153 (P), 877-420-1213 (F)
kallen@amendia.com (e-mail) |
| Date Prepared: | June 17, 2016 |
| Trade Name: | Savannah-T® Pedicle Screw System |
| Common Name: | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
| Device Product Code
and Classification: | Regulation Number: 21 CFR 888.3070
MNH, Class II, Spondylolisthesis Spinal Fixation Device System
MNI, Class II, Pedicle Screw Spinal System
NKB, Class III, Pedicle Screw Spinal System, For Degenerative
Disc Disease |
| Primary Predicate Device: | Savannah-T® Pedicle Screw System (K132925) |
Talon Spinal System (K102995) Additional Predicate:
Purpose of Submission: This special 510(k) is intended to gain clearance for addition of precontoured fixation rods to the Savannah-T® Pedicle Screw System.
Device Description:
The Savannah-T® Pedicle Screw System provides structural stability in skeletally mature adults requiring fusion of the lumbar and/or sacral spine. The system consists of mono- and poly-axial pedicle screws, connecting rods, set screws, and transverse crossmembers. The screws are available in cancellous and cortical-cancellous thread designs of various diameters and lengths. The rods are available in straight, lordosed and pre-contoured confiqurations in various lengths. They are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for single-use.
Indications and Intended use:
The Savannah-T® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:
- . When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by
4
history and radiographic studies); spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).
- . In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbarfirst sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and who are having the device removed after the development of a solid fusion mass.
Summary of Technological Characteristics:
The subject devices are substantially equivalent to the predicate device as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device is identical to the predicate in regards to technological characteristics including design, intended use, material composition, and function.
Summary of Performance Testing:
Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device. Testing included static/dynamic axial compression and static torsion (ASTM F1717), as well as secondary bending testing (dynamic compression, ASTM F1717). Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.
Conclusion:
Based on the comparison to predicate devices, the Subject Device has been shown to be substantially equivalent to legally marketed predicate devices.