(238 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide immobilization of the spine as an adjunct to fusion for various medical conditions, which aligns with the definition of a therapeutic intervention.
No
The device description clearly states it is a screw system for spinal immobilization and fusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists hardware components (screws, rods, set screws) made of titanium alloy, indicating it is a physical implant system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the GALAXY MIS Screw System is for the immobilization of the posterior, non-cervical spine as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The device description details physical components like screws, rods, and set screws made of titanium alloy. These are physical implants, not reagents or instruments used to test biological samples.
- 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. This device does not perform any such tests.
The information provided describes a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
Product codes
NKB, MNI, MNH
Device Description
The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical 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)
Static Compression, tension, torsion and dynamic compression bending were performed according to ASTM F1717 and the test results supports that the GALAXY MIS Screw System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYNSTER® Pedicle Screw System, SYNSTER® PLUS Pedicle Screw System by BM KOREA Co., Ltd., K120353, AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717, Focus Spinal System by L&K Biomed, K112643, K120140
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
June 24, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BM Korea Company, Limited % Ms. Priscilla Chung LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831
Re: K143110
Trade/Device Name: GALAXY MIS Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: May 26, 2015 Received: May 28, 2015
Dear Ms. Chung:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Priscilla Chung
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 Industry and Consumer Education 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. 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/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143110
Device Name
GALAXY MIS Screw System
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
| 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) |
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3
Image /page/3/Picture/0 description: The image shows two logos side-by-side. On the left, there is a circular logo with a human figure in white, arms outstretched, against a background of red and blue. The words "DREAM," "PASSION," and "CREATION" are arranged around the circle. To the right, there is a logo with the letters "BMK" in a bold, two-tone design, with the top half of the letters in red and the bottom half in blue. Below "BMK" are the words "Global Medical Company" in a smaller, sans-serif font. A circled "R" trademark symbol is in the upper right corner of the "BMK" logo.
510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date:
-
- 510K Applicant / Submitter: BM KOREA CO., LTD. 325-26, Dangjeong-dong, Gunpo-si, Republic of Korea 435-832 Tel: +82-31-451-9294~5
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Email: juhee.c@lkconsultinggroup.com
3. Device:
- · Proprietary Name GALAXY MIS Screw System
- · Common Name Pedicle Screw Spinal Fixation System
- · Classification Name Orthosis, spinal pedicle fixation
Orthosis, spondylolisthesis spinal fixation Orthosis, spinal pedicle fixation, for degenerative disc disease
4. Product Code, Classification & Regulation Number:
- · NKB (Class III), MNI (Class II), MNH (Class II)
- · 21 CFR 888.3070
5. Predicate Device:
• Primary Predicate Device:
- SYNSTER® Pedicle Screw System, SYNSTER® PLUS Pedicle Screw System by BM KOREA Co., Ltd., K120353
• Additional Predicate Device:
- AnyPlus Spinal Fixation System by GS Medical Co., Ltd., K091717 - Focus Spinal System by L&K Biomed, K112643 and K120140
Description: 6.
The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated
4
Image /page/4/Picture/0 description: The image shows two logos side by side. The logo on the left is a circular design with a human figure inside, surrounded by the words "DREAM CREATION PASSION". The logo on the right features the letters "BMK" in a bold, two-tone color scheme, with the words "Global Medical Company" underneath. A registered trademark symbol is present next to the "K".
polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.
7. Indications for use:
The GALAXY MIS Screw System is intended to provide immobilization and stabilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.
8. Non-Clinical Testing:
Static Compression, tension, torsion and dynamic compression bending were performed according to ASTM F1717 and the test results supports that the GALAXY MIS Screw System is substantially equivalent to the predicate devices.
Substantial Equivalence: 9.
The GALAXY MIS Screw System is substantially equivalent in design, materials, function, and indications for use, and has similar technological characteristics and principles of operation as the predicate devices. The size range of the predicate devices encompasses that of the subject device. All the devices are provided non-sterile.
There might be difference in design details but the performance test results supported that the subject device is substantially equivalent to the predicate devices.
10. Conclusions:
The subject and predicate devices share the same intended use, primary implant design and equivalent material of manufacture. Based on the test data and the information provided in this 510K submission, the subject device is substantially equivalent to the predicate devices.