(339 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components, image processing, or data sets for training or testing.
No.
The "Intended Use / Indications for Use" states that the device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, which falls under structural support rather than direct therapeutic healing or treatment of disease.
No
The provided text describes a "Mikron Spinal Fixation System" which is a surgical implant designed to stabilize spinal segments as an "adjunct to fusion." Its function is structural support and stabilization, not to diagnose a medical condition.
No
The device description explicitly states it consists of physical components (polyaxial pedicle screws, rods, and set screws) made from titanium alloy. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "spinal fixation system" intended to "provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details physical components like "polyaxial pedicle screws, rods, and set screws" made from titanium alloy. These are physical devices for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
Therefore, based on the provided information, the MSFX Pedicle Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MSFX Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylothesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylothesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
MNH, MNI
Device Description
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T1 to S2), L5-S1 vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeons
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)
Non-Clinical Performance Testing:
Determining Torsional Properties of Metallic Bone Screws - Standard Applied: ASTM F 543
Flexion-Extension Test of Subassembly - Standard Applied: ASTM F 1798-97(2008)
Axial Torque Gripping Capacity Test for Subassembly - Standard Applied: ASTM F 1798-97(2008)
Axial Gripping Capacity Test - Standard Applied: ASTM F 1798-97(2008)
Static Compression Test for Subassembly - Standard Applied: ASTM F 1717-10
Fatigue Test for Subassembly - Standard Applied: ASTM F 1717-10
Static Torsion Test - Standard Applied: ASTM F 1717-10
Single Cycle Bend Testing of Metallic Spinal Rods - Standard Applied: ASTM F 2193
The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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K130073 Page 1 of 2
DEC 1 6 2013
510 (k) SUMMARY
1 OWNER / SUBMITTER INFORMATION:
Owner: Mikron Makina Sanayi Ticaret Ltd Sti Address: İ.O.S.B. Ağaç İşleri San. Sit. 1372. Sokak No:31 06370 Ivedik / Ankara / Turkey Phone Number: 90 312 3951700 Fax Number: Contact Person: Omar Diker / Ohltech Inc. / 410 885-9978 / omar@ohltech.com Date Prepared: 12/16/2013
2 DEVICE INFORMATION:
Common or Usual Name: Spinal Fixation System Proposed Proprietary or Trade Name: Mikron Spinal Fixation System Classification Name: 21 CFR 888.3070 Pedicle Screw Spinal System . Class Designation: Class II Product Codes : MNH, MNI
3 SUBSTANTIAL EQUIVALENCE:
Mikron Spinal Fixation System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K063708) and Optima Spinal System (K031585).
4 DEVICE DESCRIPTION:
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
5 INDICATION OF USE:
The MSFX Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylothesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylothesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
1
6 STATEMENT OF TECHNICAL COMPARISON:
The summary of the technological characteristics of the Mikron Spinal Fixation System compared to the predicate devices are as follows:
6.1 Material
The Mikron Spinal Fixation System and predicate devices are fabricated of the same material; which is titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11.
6.2 Design
The Mikron Spinal Fixation System and predicate devices have similarly designed and sized components which are polyaxial screws, cylindrical longitudinal rods, and set screws. Also, the Mikron Spinal Fixation System and predicate devices have similar top-loading interconnection mechanism.
6.3 Function
The Mikron Spinal Fixation System and predicate devices have similar functions which are acting as a spinal implant construct to stabilize and promote spinal fusion.
6.4 Level of Attachment
Levels of fixation of the Mikron Spinal Fixation System are for the thoracic, lumbar and sacral spine. Similarly predicate devices are also intended to attach to spinal segment of thoracic, lumbar and sacral.
6.5 Intended Use
The Mikron Spinal Fixation System is indicated for the same intended uses as the predicate devices.
6.6 Sterility
The Mikron Spinal Fixation System is supplied in non-sterile and single use. Similarly the predicate devices are supplied non-sterile and single use.
7 NON-CLINICAL PERFORMANCE TESTING:
| Test Name | Standard Applied |
|---|---|
| Determining Torsional Properties of Metallic Bone Screws | ASTM F 543 |
| Flexion-Extension Test of Subassembly | ASTM F 1798-97(2008) |
| Axial Torque Gripping Capacity Test for Subassembly | ASTM F 1798-97(2008) |
| Axial Gripping Capacity Test | ASTM F 1798-97(2008) |
| Static Compression Test for Subassembly | ASTM F 1717-10 |
| Fatigue Test for Subassembly | ASTM F 1717-10 |
| Static Torsion Test | ASTM F 1717-10 |
| Single Cycle Bend Testing of Metallic Spinal Rods | ASTM F 2193 |
The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices.
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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
Mikron Makina Sanayi Ticaret Ltd Sti % Ohltech Incorporated Mr. Omar Diker 80 Leicester Way Chesapeake City, Maryland 21915
Re: K130073
Trade/Device Name: Mikron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 13, 2013 Received: November 15, 2013
Dear Mr. Diker:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Mr. Omar Diker
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 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.gov/MedicalDevices/ResourcesforYou/industry/default.htm. 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on vour 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 vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130073
Device Name: Mikron Spinal Fixation System
Indications For Use: The MSFX Pedicle Screw 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 the thoracic, lumbar, and sacral spine (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
× 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)
Zane W. Wyatt -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130073
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