(29 days)
The CastleLoc Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the CastleLoc Spinal Fixation System is intended to provide immobilization 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
The CastleLoc Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism.
The CastleLoc Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. CastleLoc Spinal Fixation System implants components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
The purpose of this submission is to add components of the type2 pedicle screw in CastleLoc Spinal Fixation System. Various sizes of these implants are available.
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them, in the format you specified. The document is an FDA 510(k) premarket notification for a spinal fixation system, primarily focusing on establishing substantial equivalence to a predicate device.
Specifically, the text is a letter from the FDA to L&K Biomed Co., Ltd., regarding their CastleLoc Spinal Fixation System. It confirms that the device is substantially equivalent to a legally marketed predicate device. The "510(k) Summary" section outlines the device's identification, purpose, predicate devices, description, and indications for use.
While it mentions "Performance Testing" by stating: "Additional components of this system are not worst case. To verify worst case, we have performed mechanical test followed below standard. ASTM F 543", this is a very high-level statement indicating that mechanical tests were performed according to a specific ASTM standard.
The document does NOT provide the following crucial details that you requested:
- A table of acceptance criteria and reported device performance: It only generally refers to mechanical testing per ASTM F 543 but doesn't list specific criteria (e.g., pull-out strength, fatigue life) or the actual results achieved.
- Sample size used for the test set and data provenance: No information about the number of devices tested or if the data was retrospective/prospective or geographical origin.
- Number of experts used to establish ground truth and their qualifications: This is irrelevant for a mechanical device test, as "ground truth" typically refers to clinical or diagnostic accuracy, not mechanical performance.
- Adjudication method: Again, not applicable to mechanical testing.
- Multi reader multi case (MRMC) comparative effectiveness study: This type of study is for evaluating diagnostic devices where human readers interpret results, not for mechanical implants.
- Standalone performance: While mechanical tests are standalone in a sense, the document doesn't provide specific performance metrics.
- Type of ground truth used: Not applicable for a mechanical device.
- Sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory communication for a medical device and describes its equivalence to an existing product, but it does not contain the detailed performance study information with the specific criteria you requested.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
L&K Biomed Co., Ltd. Yerim An RA Specialist #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, Gyeonggi-do 17015 KOREA
Re: K162801
Trade/Device Name: CastleLoc Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNH, MNI Dated: October 4, 2016 Received: October 5, 2016
Dear Yerim An:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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/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 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, Vincent J. Devlin -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) K162801
Device Name CastleLoc Spinal Fixation System
Indications for Use (Describe)
The CastleLoc Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the CastleLoc Syinal Fixation System is intended to provide immobilization 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
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):
-
- Submitter: L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone. 82-2-6717-1985 e-mail: yerim2706@Inkbiomed.com Contact Person: Yerim An Date prepared Nov, 02, 2016
Device Identification 2.
| Trade Name | CastleLoc Spinal Fixation System |
|---|---|
| Classification | Class II |
| Pedicle Screw Spinal System | |
| Orthopaedic | |
| 21 CFR 888.3070 | |
| Product Code: MNH, MNI |
Purpose of 510(k) 3.
The L&K BIOMED Co. Ltd., here by submits this special 510(k) for adding new type of screws and adding new brand name.
Predicate or legally marketed devices which are substantially equivalent 4.
- Primary Predicate Device: K103085 VENUS BASIC Spinal Fixation System (LnK Basic Spinal Fixation System)
Description of the Device 5.
The CastleLoc Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism.
The CastleLoc Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. CastleLoc Spinal Fixation System implants components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
The purpose of this submission is to add components of the type2 pedicle screw in CastleLoc Spinal Fixation System. Various sizes of these implants are available.
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6. Indication for Use
The CastleLoc Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the CastleLoc Spinal Fixation 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Comparison of the technological characteristics of the subject and 7. predicate devices
The CastleLoc Spinal Fixation System is considered substantially equivalent to legally marketed devices LnK Basic Spinal Fixation System. They are similar in design, material, scientific technologies and indications for use. The only different thing is shape of bone screw. We have evaluated equivalency of bone screw shape via worst case justification.
Performance Testing 8.
Additional components of this system are not worst case. To verify worst case, we
have performed mechanical test followed below standard.
ASTM F 543
Conclusion 9.
The CastleLoc Spinal Fixation System is substantially equivalent to legally marketed predicates.
§ 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.