(238 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of metal components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a spinal fixation system intended to treat various spinal conditions such as degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, and stenosis, by stabilizing and promoting spinal fusion. This directly addresses health issues and aims to improve patient well-being, categorizing it as therapeutic.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization, not to diagnose medical conditions. Its purpose is to aid fusion and treat existing conditions, not to identify them.
No
The device description explicitly states it consists of physical components made of titanium and cobalt alloys (screws, hooks, rods, etc.) and is intended to be implanted in the spine. This is a hardware-based medical device.
Based on the provided information, the JASPER Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The JASPER Spinal Fixation System is a physical implant designed to stabilize the spine. It is surgically implanted into the patient's body.
- The intended use and device description clearly state its purpose is mechanical fixation and stabilization of the spine as an adjunct to fusion. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, the JASPER Spinal Fixation System falls under the category of a medical device, specifically a spinal implant, rather than an IVD.
N/A
Intended Use / Indications for Use
The JASPER 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 indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
The JASPER Spinal Fixation System is indicated for the following:
- 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
- Pseudoarthrosis
- Failed previous fusion
The JASPER 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 JASPER 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 (pseudoarthrosis).
Product codes
NKB
Device Description
The JASPER Spinal Fixation System is a top-loading multiple component, posterior(thoraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
Materials : All products are made of titanium alloy(Ti-6AI-4V ELI, ASTM F136)and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, posterior pedicle screw fixation systems (T1-S2/ilium), anterolateral fixation system (T8-L5), L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), 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)
Bench testing results demonstrate that JASPER Spinal Fixation System performs equivalently to the predicates in static compression bending, static torsion and fatigue compression bending construct testing (in accordance with ASTM F1717-15) and static and torsional gripping capacity and transverse moment testing (in accordance with ASTM F1798)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
July 23, 2018
GBS Commonwealth Co., Ltd. Jimmy Kim Regulatory Affairs #1007-1, WOOLIM Lion's Valley B, 168 Gasan Digital 1-ro Geumcheon-gu, Seoul SOUTH KOREA
Re: K173645
Trade/Device Name: JASPER Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: June 12, 2018 Received: June 18, 2018
Dear Mr. Kim:
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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
2
Indications for Use
510(k) Number (if known) K173645
Device Name JASPER Spinal Fixation System
Indications for Use (Describe)
The JASPER 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 indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
The JASPER Spinal Fixation System is indicated for the following:
- 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
- Pseudoarthrosis
- Failed previous fusion
The JASPER 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 JASPER 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 (pseudoarthrosis).
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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Image /page/3/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters, the word "COMMONWEALTH" is written in a smaller, bold, purple font. The background of the logo is a light gray color.
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Device Identification 1.
| Submitter: | GBS Commonwealth Co., Ltd.
#1007-1, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul,
South Korea
Phone. 82-2-6925-4469
e-mail: Jimmy.kim@gbscommonwealth.com |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jimmy Kim |
| Date prepared | Nov, 22, 2017 |
| Trade Name | JASPER Spinal Fixation System |
|---|---|
| Classification | 21 CFR 888.3070 Thoracolumbosacral pedicle screw |
| system, Class II | |
| Product Code: NKB |
2. Purpose of 510(k)
The GBS Commonwealth Co. Ltd., here by submits this traditional 510(k): for Initial product Introduction of JASPER Spinal Fixation System
Predicate or legally marketed devices which are substantially equivalent 3.
- Primary Predicate Device: K120270 VENUS Spinal Fixation System 1)
- Additional Predicate : K162801 CastleLoc Spinal Fixation System 2)
Description of the Device 4.
The JASPER Spinal Fixation System is a top-loading multiple component, posterior(thoraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
4
Image /page/4/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters, the word "COMMONWEALTH" is written in a smaller, purple font. The background of the logo features a globe-like design.
Materials : All products are made of titanium alloy(Ti-6AI-4V ELI, ASTM F136)and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.
5. Indication for Use
The JASPER 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 indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
The JASPER Spinal Fixation System is indicated for the following:
- · 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
- · Pseudoarthrosis
- Failed previous fusion
The JASPER 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 JASPER 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 deformities of the thoracic, lumbar and sacral spine: degenerative or spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
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Image /page/5/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters, the word "COMMONWEALTH" is written in a smaller, purple font. The background of the logo is a light gray color.
Comparison of the technological characteristics of the subject and predicate 6. devices
The JASPER Spinal Fixation System is considered substantially equivalent to legally marketed devices VENUS Spinal Fixation System and CastleLoc Spinal Fixation System. They are similar in design, material, scientific technologies and indications for use.
7. Performance Testing
Bench testing results demonstrate that JASPER Spinal Fixation System performs equivalently to the predicates in static compression bending, static torsion and fatigue compression bending construct testing (in accordance with ASTM F1717-15) and static and torsional gripping capacity and transverse moment testing (in accordance with ASTM F1798)
8. Conclusion
The JASPER Spinal Fixation System is substantially equivalent to legally marketed predicates.