(61 days)
The AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 – S2), a posterior hook fixation system (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
AnyPlus Spinal Fixation System is made of devices for fixation of the noncervical spine. They include smooth rods, plates, screws, hooks, nut, screws, and transverse links. The purpose of this submission was to add components to the Anyplus Spinal Fixation System.
This document does not describe an AI/ML powered medical device. It pertains to a Spinal Fixation System, which is a physical implant used in spinal surgery.
Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this device.
The "Performance Data" section in the document indicates that the device underwent mechanical testing according to ASTM F1717 standards (static compression bending, static torsion, and dynamic compression bending) to demonstrate its safety and effectiveness. This is typical for physical orthopedic implants, not software algorithms.
The "Substantial Equivalence" section confirms that the device was deemed substantially equivalent to predicate physical devices based on intended use, indications, technological characteristics, principles of operation, and mechanical testing results.
In summary, this document describes the FDA clearance of a medical device (spinal fixation system) that is a physical product, not an AI/ML algorithm.
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October 23, 2017
GS Medical Co., Ltd. % Mr. Barry E. Sands President and Founder ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K172546
Trade/Device Name: AnyPlus® Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: August 22, 2017 Received: August 23, 2017
Dear Mr. Sands:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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 (DICE) 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. 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 (DICE) 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172546
Device Name AnyPlus® Spinal Fixation System
Indications for Use (Describe)
The AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 – S2), a posterior hook fixation system (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
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
GS Medical's AnyPlus Spinal Fixation System
| Submitter: | GS Medical Co., Ltd.Dong Yong, Kim12 F Kolon Digital Tower Aston,505-14 Gasan-DongGeumcheon-gu, Seoul, KoreaPhone: 82-2-2082-7777 |
|---|---|
| Contact Person: | Barry SandsRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307 |
| DatePrepared: | August 10, 2017 |
| Name of Device: | AnyPlus® Spinal Fixation System |
| Common or Usual Name: | Pedicle screw system |
| ClassificationName: | 888.3070 – Thoracolumbosacral Pedicle Screw System888.3050 - Spinal Interlaminal Fixation Orthosis888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Product Codes: | NKBKWPKWQ |
| Predicate Device: | Primary: AnyPlus® Spinal Fixation System (K091717)Secondary: GSS Pedicle Screw System (K053573) |
| Intended Use/Indications for Use: | The AnyPlus Spinal Fixation System are non-cervical spinal fixation devicesintended for use as posterior pedicle screw fixation systems (T1 – S2), aposterior hook fixation system (T1 – L5), or as an anterolateral fixationsystem (T8 - L5). All components are limited to skeletally mature patientsSystem components are to be used for immobilization and stabilization ofthe spine as an adjunct to fusion. These devices are indicated for all of thefollowing indications regardless of the intended use: degenerative disc |
| disease (defined as discogenic back pain with degeneration of the discconfirmed by patient history and radiographic studies), spondylolisthesis,trauma (i.e., fracture or dislocation), deformities or curvatures (i.e.,scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor,stenosis, pseudoarthrosis, and failed previous fusion. | |
| Description: | AnyPlus Spinal Fixation System is made of devices for fixation of thenoncervical spine. They include smooth rods, plates, screws, hooks, nut,screws, and transverse links. The purpose of this submission was to addcomponents to the Anyplus Spinal Fixation System. |
| Performance Data: | Constructs with the subject components were tested using the followingASTM F1717 tests: static compression bending, static torsion, and dynamiccompression bending. |
| Substantial Equivalence: | The AnyPlus Spinal Fixation System is as safe and effective as thepredicates Any Plus Spinal Fixation System (K091717) and GSS PedicleScrew System (K053573). The AnyPlus Spinal Fixation System has thesame intended uses and similar indications, technological characteristics,and principles of operation as its predicate devices. The mechanical testingdemonstrates substantially equivalent mechanical performance to that ofthe predicates. Thus, the AnyPlus Fixation System is substantiallyequivalent. |
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§ 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.