(56 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
This device is a pedicle screw system, which is a type of implant used to stabilize spinal segments and promote spinal fusion. Fusion is a procedure that aims to alleviate pain and improve function in patients with certain spinal conditions, thus it has a therapeutic purpose.
No
This device is a pedicle screw system used for spinal fixation and fusion, designed to provide mechanical support rather than to diagnose medical conditions.
No
The device description clearly states it consists of physical components like pedicle screws, rods, and locking bolts, fabricated from titanium alloy. It also mentions specialized instruments for application and removal. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description and Intended Use: The Mega 5.5 Spine System is a surgical implant (pedicle screw system) used to stabilize the spine during fusion procedures. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is mechanical stabilization, not diagnostic testing of samples.
Therefore, the Mega 5.5 Spine System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft, having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Mega 5.5 Spine 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Product codes
MNH, MNI
Device Description
The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA 5.5 Spine System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra, lumbar and sacral spine, thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical testing as listed in ATTACHMENT II that was conducted in accordance with ASTM F 1717 demonstrates equivalence to the above predicate devices. This testing included static and dynamic compression bending, static tension bending, and static torsion. The subject spinal implant system is therefore substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072436, K031585, K071857, K030383
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.
0
510(k) Summary
JAN 0 8 2013
New Device: Mega 5.5 Spine System
Submitter and US Official Correspondent 1.
| Submitter: | BK MEDITECH CO., LTD. |
|---|---|
| Address: | 215-5 Yodang-ri, Yanggam-myun, Hwasung-si |
| Gyeonggi-do, 445-930, Korea | |
| Tel: | +82-31-352-9135-8 |
| Fax: | +82-31-352-9134 |
| Contact: | Mr. Byungjun Park, R&D Manager |
| E-mail: | bjpark@bkmeditech.co.kr |
US Official Correspondent:
Shin Kuk Yoo, Consultant LSK BioPartners, Inc. 8 East Broadway, Suite 611 Salt Lake City, UT 84111, USA Telephone No.: 714-313-7442 Fax No.: 801-303-7455 Email: skyone@l SK BioPartners.com
2. DeviceInformation
| Proprietary/Trade Name: | MEGA 5.5 Spine System |
|---|---|
| Common/Usual Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Pedicle screw spinal system |
| Regulation Number: | 21 CFR 888.3070 |
| Device Class: | Class II |
| Product Code: | MNH, MNI |
Identification of Legally Marketed Predicate Devices 3.
Substantial equivalence for the MEGA 5.5 Spine System is based in its similarities in indication for use, design features, operational principles and material composition when compared to the predicate device cleared under the following submissions:
- Mega Spine System (K072436, BK MEDITECH Co., Ltd.)
- · OPTIMATM Spinal System (K031585, U&I Corporation, America)
- · DELTA, Spinal Fusion System (K071857, Jemo Spine, LLC)
- · Moss Miami Spinal System Polyaxial Screws (K030383, DePuy AcroMed, Inc)
1
4. DescriptionofDevice
The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA 5.5 Spine System.
ട. IndicationsforUsc
The Mega 5.5 Spine System is a pedicte screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft, having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Mega 5.5 Spine 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
6. Performance Testing
Mechanical testing as listed in ATTACHMENT II that was conducted in accordance with ASTM F 1717 demonstrates equivalence to the above predicate devices. This testing included static and dynamic compression bending, static tension bending, and static torsion. The subject spinal implant system is therefore substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use, and performance.
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 features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. 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
Letter dated: January 8, 2013
BK Meditech Company, Limited % LSK BioPartners, Incorporated Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City. Utah 84111
Re: K123476
Trade/Device Name: MEGA 5.5 Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: November 9, 2012 Received: November 13. 2012
Dear Mr. Shin Kuk Yoo:
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 vour 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 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.
3
Page 2 - Mr. Shin Kuk Yoo
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.htmfor 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) number (if known): __K123476
Device Name: Mega 5.5 Spine System
Indications for Use:
The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous 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.
In addition, the Mega 5.5 Spine 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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)
Ronald-P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123476