(119 days)
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which are therapeutic actions.
No
The device description clearly states its purpose is to provide immobilization, stabilization, and promote spinal fusion. It is an implantable system for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link." These are physical implants made of titanium and CoCrMo alloy, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Mega Plus MIS Spine System is a system of implants (screws, rods, etc.) designed to be surgically implanted into the spine to provide structural support and stabilization.
- Intended Use: The intended use clearly states that the system is for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mega Plus MIS 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Mega Plus MIS Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link. Various sizes of these implants are available. Mega Plus MIS Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Mega Plus MIS Spine System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously for the Mega Plus Spine System (K173180, K183080).
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
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
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)
The Mega Plus MIS Spine System has been tested in the following test modes:
- Static compression bending per ASTM F1717
- Static torsion per ASTM F1717
- Static tension bending per ASTM F1717
- Dynamic compression bending per ASTM F1717
The results of this non-clinical testing show that the strength of the Mega Plus MIS Spine System is sufficient for its intended use and is substantially equivalent 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.
K183080, K151648, K171421, K110280
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
August 11, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters. Below that is the word "ADMINISTRATION" in smaller, blue letters.
BK Meditech, Co., Ltd % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200981
Trade/Device Name: Mega Plus MIS Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 10, 2020 Received: July 13, 2020
Dear Nathan Wright:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Colin O'Neill, M.B.E. Acting Assistant Director 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K200981 Device Name Mega Plus MIS Spine System
Indications for Use (Describe)
The Mega Plus MIS 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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the time to review instructions, search existing data sources, gather and maintain the data needed and
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unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
5.510(K) SUMMARY
| Submitter's Name: | BK Meditech Co., Ltd. |
|---|---|
| Submitter's Address: | 58, Eunhaengnamu-ro, Yanggam-myeon, |
| Hwaseong-si, Gyeonggi-do 18633, Republic of Korea | |
| Submitter's Telephone: | (82) 313529135 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 13, 2020 |
| Trade or Proprietary Name: | Mega Plus MIS Spine 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 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Mega Plus MIS Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link. Various sizes of these implants are available. Mega Plus MIS Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Mega Plus MIS Spine System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously for the Mega Plus Spine System (K173180, K183080).
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
INDICATIONS FOR USE
The Mega Plus MIS 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.
4
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the 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
- Principles of operation
- Materials of manufacture ●
- Implant sizes
- Surgical technique ●
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|------------------------------------------------|-----------------------|-------------------|
| K183080 | Mega Plus Spine System | BK Meditech Co., Ltd. | Primary |
| K151648 | Valencia MIS Pedicle Screw
System | Altus Partners, LLC | Additional |
| K171421 | VERTICALE® Posterior
Spinal Fixation System | Silony medical GmbH | Additional |
| K110280 | REVLOK™ Fenestrated
Screw System | Globus Medical Inc. | Additional |
Table 5-1 Predicate Devices
Performance Data
The Mega Plus MIS Spine System has been tested in the following test modes:
- Static compression bending per ASTM F1717
- Static torsion per ASTM F1717 ●
- Static tension bending per ASTM F1717 .
- . Dynamic compression bending per ASTM F1717
The results of this non-clinical testing show that the strength of the Mega Plus MIS Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Mega Plus MIS Spine System is substantially equivalent to the predicate device.