(146 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML components.
Yes
The device is intended to immobilize spinal segments as an adjunct to fusion in the treatment of various instabilities or deformities, which directly addresses a medical condition or ailment, classifying it as therapeutic.
No
The device is a pedicle screw system intended for immobilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly lists physical components such as pedicle screws, rods, and set screws, indicating it is a hardware-based implant system.
Based on the provided information, the Savannah-T® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Savannah-T® Function: The description clearly states that the Savannah-T® is a surgical implant system (pedicle screws, rods, etc.) intended for the immobilization of spinal segments as an adjunct to fusion. It is a physical device implanted into the body to provide structural support.
- No Specimen Analysis: There is no mention of the Savannah-T® analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the Savannah-T® falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Savannah-T® 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); 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 (15-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 (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The Savannah-T® Pedicle Screw System consists of pedicle screws, mono-axial and poly-axial screw heads, connecting rods, set screws, and transverse crossmembers, called the Savannah-Link. The screws are available in various diameters and lengths, and the rods are available in straight and curved versions in various lengths. The components are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use.
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
thoracic, lumbar, and/or sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
To characterize the strength of the Savannah-T®, the following testing was performed:
- static compression bending, static torsion, and dynamic compression bending in accordance . with ASTM F1717-12
Results of these tests showed the Savannah-T® to be better or equivalent to the predicate device.
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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§ 888.3070 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.
0
Traditional 510(k) Summary
FEB 1 1 2014
- Date Prepared: January 16, 2014 1.
-
- Applicant
Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062
3. Application Correspondent
Kapstone Medical, LLC 100 E. South Main St. PO Box 1458 Waxhaw, NC 28173
Contact Person: John Kapitan, President Tel: (704) 843-7852 Fax: (704) 831-5316 E-mail: jkapitan@kapstonemedical.com
4. Device Name
| Trade Name: | Savannah-T® Pedicle Screw System |
|---|---|
| Classification Name: | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
| Regulation Number: | 21 CFR 888.3070 |
| Regulation Name: | Pedicle screw spinal system |
| Regulation Class: | III |
| Product Code: | NKB, MNI, MNH |
| Panel: | Orthopedic |
5. Predicate Device
The Savannah-T® Pedicle Screw System is substantially equivalent to the following device:
K072116, Savannah Lumbar Percutaneous Stabilization System (SLPSS)
6. Description of the Device
The Savannah-T® Pedicle Screw System consists of pedicle screws, mono-axial and poly-axial screw heads, connecting rods, set screws, and transverse crossmembers, called the Savannah-Link. The screws are available in various diameters and lengths, and the rods are available in straight and curved versions in various lengths. The components are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use.
1
7. Indications for Use
The Savannah-T® 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); 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 (15-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.
8. Summary of Performance Data
To characterize the strength of the Savannah-T®, the following testing was performed:
- static compression bending, static torsion, and dynamic compression bending in accordance . with ASTM F1717-12
Results of these tests showed the Savannah-T® to be better or equivalent to the predicate device.
9. Substantial Equivalence
The Savannah-T® Pedicle Screw system is substantially equivalent to the predicate device, the Savannah Lumbar Percutaneous Stabilization System (SLPSS) (K072116). Both devices have the same "Indications for Use," are available by prescription only, and are provided non-sterile for single-use only. The Savannah-T® differs from the SLPSS in that the Savannah-T® includes additional screw heads, screw, and transverse crossmember, called the Savannah-Link. These differences do not negatively impact the overall safety and effectiveness of the device, and this was verified via mechanical testing. Therefore, it can be concluded that the Savannah-T® is both a safe and effective device and is substantially equivalent to the predicate device.
2
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2014
Amendia, Incorporated % Kapstone Medical, LLC Mr. John Kapitan 100 East South Main Street P.O. Box 1458 Waxhaw, North Carolina 28173
Re: K132925
Trade/Device Name: Savannah-T® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III, or Unclassified Product Code: NKB, MNH, MNI Dated: January 16, 2014 Received: January 24, 2014
Dear Mr. Kapitan:
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. Iisting 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 (reporting of medical
3
Page 2 - Mr. John Kapitan
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Vincent 明@evlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: Savannah-T® Pedicle Screw System
Indications for Use:
The Savannah-T® 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); spondylolisthesis; fracture; dislocation; scoliosis; 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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132925