(208 days)
The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The AccelFix Spinal Fixation System is comprised of six different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, AccelFix -SAI Screw, and Accessory.
The provided text describes the 510(k) premarket notification for the AccelFix Spinal Fixation System. This document focuses on the substantial equivalence of and mechanical testing for a medical device (spinal fixation system), not an AI/ML-driven diagnostic or image analysis device.
Therefore, the information required to answer your query about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.
The document states that the additional components for the AccelFix Spinal Fixation System "do not require additional mechanical testing" because none of the additional components is the worst case, and they are substituting mechanical test data from the predicate device (K182544). It cites compliance with ASTM standards for mechanical testing (ASTM F17-15, ASTM F1798-13, ASTM F543-17).
To summarize, for an AI/ML device, your requested information would typically include details on diagnostic performance, reader studies, and dataset characteristics. This document, however, pertains to the mechanical and material equivalence of an implantable medical device.
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October 20, 2020
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L&K BIOMED Co., Ltd. Minju Choi Official Correspondent #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea
Re: K200794
Trade/Device Name: AccelFix Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 21, 2020 Received: September 21, 2020
Dear Ms. Choi:
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
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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. 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
510(k) Number (if known) K200794
Device Name
AccelFix Spinal Fixation System
Indications for Use (Describe)
The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
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
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
-
- Manufacturer
| Submitter: | L&K BIOMED Co., Ltd. |
|---|---|
| #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, | |
| Yongin-si, Gyeonggi-do, 17015, Korea | |
| Phone. +82-10-5477-0325 | |
| Contact Person: | Minju Choi |
| e-mail: jung9844@lnkbiomed.com | |
| Date prepared | March 25, 2020 |
2. Device Identification
| Trade Name | AccelFix Spinal Fixation System |
|---|---|
| Common Name | Pedicle screw spinal system |
| Product Code | NKB, KWP, KWQ |
| Regulatory Class | Class II |
| Classification Name | Thoracolumbosacral pedicle screw systemSpinal interlaminal fixation orthosisSpinal intervertebral body fixation orthosis |
| Regulation No. | 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 |
3. Predicate or legally marketed devices which are substantially equivalent
The additional components of the AccelFix Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have same design, materials, scientific technology, and indications for use.
Primary Predicate: AccelFix Spinal Fixation System (K182544)
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4. Description of the Device
The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The AccelFix Spinal Fixation System is comprised of six different groupings;
| AccelFix-S | 1) Mono Axial Screw |
|---|---|
| 2) Reduction Mono Axial Screw | |
| 3) Poly Axial Screw | |
| 4) Reduction Poly Axial Screw | |
| AccelFix-DS | 1) Mono Axial Screw |
| 2) Reduction Mono Axial Screw | |
| 3) Poly Axial Screw | |
| 4) Reduction Poly Axial Screw | |
| AccelFix-SS | 1) Mono Axial Screw |
| 2) Reduction Mono Axial Screw | |
| 3) Poly Axial Screw | |
| 4) Reduction Poly Axial Screw | |
| AccelFix-MIS | 1) Percutaneous Poly Screw Closed Type |
| 2) Percutaneous Poly Screw Open Type | |
| AccelFix -SAI Screw | 1) Poly Axial Screw |
| (1) Smooth Shank- Non cannulated, cannulated | |
| (2) Full Thread- Non cannulated, cannulated | |
| 2) Reduction Poly Axial Screw | |
| (1) Smooth Shank- Non cannulated, cannulated | |
| (2) Full Thread- Non cannulated, cannulated | |
| Accessory | 1) Rod |
| 2) Crosslink | |
| 3) Set screw | |
| 4) Connector | |
| 5) Hook |
5. Materials
The components of this system are manufactured of Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) or CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537).
6. Indication for use
The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); dislocation); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
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L&K BIOM
7. Performance Testing
The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of AccelFix Spinal Fixation System with the predicate device (K182544).
ASTM F17-15 (Static compression test, Static tension test, Static torsion test, Fatigue test) ASTM F1798-13 (Static cantilever test, axial grip test, static head pullout test) ASTM F543-17 (Axial pullout test)
8. Summary of Technology Characteristics
AccelFix Spinal Fixation System are substantially equivalent to the predicate devices in terms of design, materials and indications for use.
9. Substantial Equivalence
AccelFix Spinal Fixation System were shown to be substantially equivalent to the predicate devices in indications for use, design, function and materials used.
10. Conclusion
The AccelFix Spinal Fixation System is substantially equivalent to the predicate device (K182544).
§ 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.