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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the MEGAFIX® Pedicle Screw Spinal System. This document focuses on demonstrating the substantial equivalence of a new medical device to existing predicate devices, primarily through mechanical testing and comparison of technological characteristics.

It does not contain information on acceptance criteria for an AI/algorithm-driven device, nor does it describe a study involving human readers or expert ground truth for image analysis.

However, I can extract the relevant information pertaining to the device's performance testing based on the document's content:

1. A table of acceptance criteria and the reported device performance:

The document states that mechanical testing was performed in accordance with ASTM F1717. The acceptance criteria are implicitly met by stating: "The test results support substantial equivalence of the subject to legally marketed predicate devices." Specific numerical acceptance criteria or performance values are not provided in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Meet ASTM F1717 standards for medical implants, supporting substantial equivalence to predicate devices for mechanical properties.	"The test results support substantial equivalence of the subject to legally marketed predicate devices." (Specific numerical results are not provided in this summary document.)

2. Sample size used for the test set and the data provenance:

The document states that "Mechanical testing was performed on the MEGAFIX® Pedicle Screw Spinal System." It falls under pre-market notification (510(k)), implying a laboratory setting for testing the device itself, rather than testing on human subjects or clinical data in the context of device performance. No specific sample sizes for the mechanical tests are given in this summary, nor is there any mention of data provenance in terms of country of origin or retrospective/prospective nature, as this type of information is not relevant to a mechanical component test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for this device's performance (mechanical strength) is established by engineering standards (ASTM F1717) and direct measurement, not by expert interpretation of data.

4. Adjudication method for the test set:

Not applicable. This is a mechanical device, not an AI or diagnostic tool requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This document describes a mechanical medical device, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's mechanical performance is established through adherence to the ASTM F1717 standard for spinal implant constructs, which dictates testing methodologies and performance benchmarks for static and dynamic loading.

8. The sample size for the training set:

Not applicable. There is no "training set" for a mechanical device undergoing physical performance testing.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K191655

Device Name MEGAFIX® Pedicle Screw Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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, 10020Republic of Korea
Submitter's Telephone number	+82-70-8769-6041
Contact Person	Meredith L. May MS, RACEmpirical 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

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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 number	Proprietary Name	Manufacturer	PredicateType
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 PedFusePedicle Screw System	SpineFrontier, Inc.	Additional
K141282	PSG 5.5mm Cannulated PedicleScrew 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:

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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.

Regulation Number and Section

§ 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.