(255 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system, with no mention of AI or ML technology.
Yes
Explanation: The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal conditions, which are therapeutic interventions.
No
The device is a spinal fixation system designed to provide immobilization and stabilization, not to diagnose medical conditions.
No
The device description explicitly states it is manufactured from titanium alloy and describes physical components like screws and rods, indicating it is a hardware-based medical device.
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 Syntec OS Spinal Fixation System is for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used directly within the body to provide structural support.
- Device Description: The description details a system of components made from titanium alloy designed for spinal fusion surgery. This aligns with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on such testing. IVDs are typically used to detect, measure, or identify substances or characteristics in biological samples.
Therefore, the Syntec OS Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Syntec OS Spinal Fixation 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 the following:
- . Degenerative disc disease
- . Spondylolisthesis
- Trauma (i.e., fracture or dislocation) ●
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The Syntec OS Spinal Fixation System is manufactured from titanium alloy (as per ASTM F136) and is designed with various sizes to provide stabilization as an adjunct to spinal fusion surgery. Surgeons can use our top loading technique through the screws and rods to fix the components into a U-shaped opening
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing and engineering analysis was performed and submitted to characterize the modified components of the system. Static and dynamic axial compression and static torsion tests in accordance with ASTM F1717 were performed on the modified and predicate systems. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
CD HORIZON Spinal system (K091442)
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.
Not Found
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).
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.
0
510(K) SUMMARY
Syntec Scientific Corporation
K 101971 Page 1/2
MAR 2 5 2011
- Kung San Rd, Address : Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan Tel : 886-4-7987099 Fax: 886-4-7987077 Carol Chang Contact person: Syntec OS Spinal Fixation System Name of the device : Syntec OS : Trade or proprietary name : Spinal Fixation System Common name: Non-cervical, Pedicle System Classification name : MNH, MNI, NKB Produce Code : 21 CFR 888.3070 Regulation Number : III Class : CD HORIZON Spinal system (K091442) / Predicate device: Medtronic Sofamor Danek USA January 10, 2011 Preparation date:
Description of the Device:
Submitter's name :
The Syntec OS Spinal Fixation System is manufactured from titanium alloy (as per ASTM F136) and is designed with various sizes to provide stabilization as an adjunct to spinal fusion surgery. Surgeons can use our top loading technique through the screws and rods to fix the components into a U-shaped opening
Indications for Use:
Syntec OS Spinal Fixation 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 the following:
- Degenerative disc disease .
- Spondylolisthesis .
- Trauma (i.e., fracture or dislocation) .
1
K101971 age 2/2
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ●
- . Tumor
- . Pseudoarthrosis
- . Failed previous fusion
Performance Data
Performance testing and engineering analysis was performed and submitted to characterize the modified components of the system. Static and dynamic axial compression and static torsion tests in accordance with ASTM F1717 were performed on the modified and predicate systems. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.
Conclusion:
The Syntec OS Spinal Fixation System uses established surgical techniques and does not introduce new concerns regarding safety and effectiveness. Therefore, the system may be considered substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syntec Scientific Corporation % Ms. Carol Chang Regulatory Affairs Specialist 2 Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan 509
Re: K101971
Trade Name: Syntec OS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 10, 2011 Received: March 14, 2011
Dear Ms. Chang:
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.
MAR 2 5 2011
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
3
Page 2 - Ms. Carol Chang
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggy/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/Reportal?roblem/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,
Alij B. Rha
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
Indications for Use
510(k) Number (if known): ピノノタフ/ Device Name: Syntec OS Spinal Fixation System Indications for Use:
Syntec OS Spinal Fixation 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 the following:
- . Degenerative disc disease
- . Spondylolisthesis
- Trauma (i.e., fracture or dislocation) ●
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Prescription Use ( Part 21 CFR 801 Subpart D) (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
5 . 02
| 510(k) Number | K 101971 |
|---|---|
| --------------- | ---------- |