(259 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical implantation techniques, with no mention of AI or ML.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various spinal conditions, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a spinal implant system used for immobilization and fusion, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of Titanium Alloy (Ti-6A1-4V ELI), such as screws, rods, and set screws, which are implanted into the spine. 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:
- Intended Use: The intended use clearly states that the MEGAFIX® Pedicle Screw Spinal System is for providing immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a system of screws, rods, and other components made of titanium alloy, designed to be surgically implanted into the spine. This is a mechanical device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies described are mechanical tests (static compression bending, static torsion, dynamic compression bending) to assess the physical properties and strength of the implant, not diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MEGAFIX® Pedicle Screw Spinal System does not fit this definition.
N/A
Intended Use / Indications for Use
The MEGAFIX(R) Pedicle Screw Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the lumbar and sacral spine for following indications:
Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis (Grade 1 and 2) of the L5-S1; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The MEGAFIX® Pedicle Screw Spinal System is used for posterior, non-cervical pedicle fixation of the lumbar and sacral spine. This system is comprised of monoaxial screws, monoaxial reduction screws, polyaxial screws, polyaxial reduction screws, polyaxial cannulated screws, cannulated reduction screws, straight rods, set screws, and transverse link. All components are supplied non-sterile, single use and made from Titanium Alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various types and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The MEGAFIX® Pedicle Screw Spinal System is delivered non-sterile and sterilization instructions are provided.
The principle of the spinal fixation is based on pedicle screw-rod locking systems, with the rods transversely crosslinked. A combination of pedicle screws and rods creates a solid "brace" that holds spinal segments. Pedicle screws are fixed through the pedicle bone on the posterior spinal column. The pedicle screw is inserted through the pedicle and into the vertebral body, one on each side. The pedicle screws fix to the bone of the vertebral body, giving them a good solid hold on the vertebrae. Once the pedicle screws are implanted, they are attached to rods that connect all the pedicle screws together. When all components are bolted and tightened by set screws, a stiff metal frame that holds vertebrae still is created so that fusion can occur. Bone graft is then placed around the posterior vertebrae at the implant. A transverse link is used to connect two substantially parallel longitudinal rods for improved stability in the surgical treatment and for increased rotational stiffness for the final construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 was performed on the MEGAFIX® Pedicle Screw Spinal System in accordance with ASTM F1717. The following testing was performed:
- Static Compression Bending
- Static Torsion
- Dynamic Compression Bending
The test results support substantial equivalence of the subject to legally marketed predicate devices.
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.
K131878, K111362, K183080, K123164, K141282
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
March 6, 2020
SeohanCare Co., Ltd % Meredith L. May, MS, RAC Vice President - Empirical Consulting Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K191655
Trade/Device Name: MEGAFIX® Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 3, 2020 Received: February 5, 2020
Dear Ms. May:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191655
Device Name MEGAFIX® Pedicle Screw Spinal System
Indications for Use (Describe)
The MEGAFIX(R) Pedicle Screw Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the lumbar and sacral spine for following indications:
Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis (Grade 1 and 2) of the L5-S1; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in according with requirement of 21 CFR Part 807.92.
| Submitter's Name | SeohanCare Co., Ltd. |
|---|---|
| Submitter's Address | 2F, Da-dong, 22, Gimpo-Daero 2918 beon-Gil, |
| Wolgot-myeon, Gimpo-si, Gyeonggi-do, 10020 | |
| Republic of Korea | |
| Submitter's Telephone number | +82-70-8769-6041 |
| Contact Person | Meredith L. May MS, RAC |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared | 20-Jun-2019 |
| Trade or Proprietary Name | MEGAFIX® Pedicle Screw Spinal System |
| Common or Usual Name | Thoracolumbosacral Pedicle Screw System |
| Classification | Class II per 21 CFR §888.3070 |
| Product Code | NKB |
| Classification Panel | Division of Orthopedic Devices |
5.1. Description of the Device Subject to Premarket Notification
The MEGAFIX® Pedicle Screw Spinal System is used for posterior, non-cervical pedicle fixation of the lumbar and sacral spine. This system is comprised of monoaxial screws, monoaxial reduction screws, polyaxial screws, polyaxial reduction screws, polyaxial cannulated screws, cannulated reduction screws, straight rods, set screws, and transverse link. All components are supplied non-sterile, single use and made from Titanium Alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various types and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The MEGAFIX® Pedicle Screw Spinal System is delivered non-sterile and sterilization instructions are provided.
The principle of the spinal fixation is based on pedicle screw-rod locking systems, with the rods transversely crosslinked. A combination of pedicle screws and rods creates a solid "brace" that holds spinal segments. Pedicle screws are fixed through the pedicle bone on the posterior spinal column. The pedicle screw is inserted through the pedicle and into the vertebral body, one on each side. The pedicle screws fix to the bone of the vertebral body, giving them a good solid hold on the vertebrae. Once the pedicle screws are implanted, they are attached to rods that connect all the pedicle screws together. When all components are bolted and tightened by set screws, a stiff metal frame that holds vertebrae still is created so that fusion can occur. Bone graft is then placed around the posterior vertebrae at the implant. A transverse link is used to connect two substantially parallel longitudinal rods for improved
4
MEGAFIX® Pedicle Screw Spinal System Traditional 510(k)
stability in the surgical treatment and for increased rotational stiffness for the final construct.
5.2. Indications for Use
The MEGAFIX® Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the lumbar and sacral spine for following indications:
Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis (Grade 1 and 2) of the L5-S1; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
5.3. Technological Characteristics
The MEGAFIX® Pedicle Screw Spinal System is made from Titanium Alloy (Ti-6A1-4V ELI) per ASTM F136. The subject and predicate devices have nearly identical technological characteristics and minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Principle Operation
- Material of manufacture
- . Basic design
| K numbe
r | Proprietary Name | Manufacturer | Predicate
Type |
|--------------|-----------------------------------------------|----------------------|-------------------|
| K131878 | Zenius Pedicle Screw System | Medyssey Co., Ltd | Primary |
| K111362 | Rexious Spinal Fixation System | DIOMEDICAL Co., Ltd | Additional |
| K183080 | Mega Plus Spine System | BK MEDITECH Co., Ltd | Additional |
| K123164 | SpineFrontier PedFuse
Pedicle Screw System | SpineFrontier, Inc. | Additional |
| K141282 | PSG 5.5mm Cannulated Pedicle
Screw System | Pinnacle Spine Group | Additional |
Table 5-1 Predicate Device
5.4. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
5.4.1 Mechanical testing
Mechanical testing was performed on the MEGAFIX® Pedicle Screw Spinal System in accordance with ASTM F1717. The following testing was performed:
5
MEGAFIX® Pedicle Screw Spinal System Traditional 510(k)
- Static Compression Bending
- . Static Torsion
- Dynamic Compression Bending
The test results support substantial equivalence of the subject to legally marketed predicate devices.
5.5. Summary of Substantial Equivalence
Based on the comparison, we have demonstrated that the MEGAFIX® Pedicle Screw Spinal System has been shown to be substantially equivalent for the proposed Indications for Use as the legally marketed predicate devices. Therefore, we conclude that the proposed MEGAFIX® Pedicle Screw Spinal System is substantially equivalent to those predicate devices.
5.6. Conclusion
As seen above, the MEGAFIX® Pedicle Screw Spinal System is the same or similar to the predicate devices in terms of intended use, material, principle operation, basic design. The technological differences have been addressed in the 510(k) and performance testing demonstrates substantial equivalence to the identified predicate devices. Therefore, the differences do not raise new questions of safety and effectiveness. The MEGAFIX® Pedicle Screw Spinal System is substantially equivalent to legally marketed predicates.