(65 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various spinal conditions, indicating a therapeutic purpose to treat or alleviate a medical condition.
No
The device is described as an implantable spinal system (cannulated poly screws, rods, and set screw components) intended to provide immobilization as an adjunct to fusion, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it consists of physical components made of titanium and CoCrMo alloys (screws, rods, set screws) and is intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Prase MIS Spinal System is a system of implants (screws, rods, set screws) intended for surgical implantation to stabilize the spine. It is a physical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic information derived from such tests.
Therefore, the Prase MIS Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Prase MIS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended 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 for lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
Prase MIS Spinal System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surqical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. 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
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)
The Static compression bending, tension, and fatigue test were performed according to ASTM F1717 on a worst-case, screw construct. The mechanical test results demonstrated that the Pathloc-L MIS Spinal System performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
October 4, 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: K182059
Trade/Device Name: Prase MIS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: October 1, 2018 Received: October 3, 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. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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
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Indications for Use
510(k) Number (if known) K182059
Device Name Prase MIS Spinal System
Indications for Use (Describe)
The Prase MIS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended 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 for lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion in skeletally mature patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X 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/0 description: The image shows the text 'K182059' and 'Page 1 of 3' at the top. Below the text is a logo with the letters 'GBS' in large, bold, and dark blue font. Underneath the letters is the word 'COMMONWEALTH' in a smaller font size. The background of the logo has a light gray color.
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. Device Identification
| 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 | October 4, 2018 |
| Trade Name | Prase MIS Spinal 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 Prase MIS Spinal System
3. Predicate or legally marketed devices which are substantially equivalent
-
Primary Predicate Device: K161766 Pathloc-L MIS Spinal System
-
Additional Predicate Device: K173645 JASPER Spinal Fixation System
Description of the Device 4.
Prase MIS Spinal System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surqical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy. All products are made of
4
titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile.
5. Indication for Use
The Prase MIS Spinal 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. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended 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
- •Pseudoarthrosis
- •Failed previous fusion
6. Comparison of the technological characteristics of the subject and predicate devices
The Prase MIS Spinal System is considered substantially equivalent to legally marketed devices Pathloc-L MIS Spinal 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 mechanical test.
7. Performance Testing
The Static compression bending, tension, and fatigue test were performed according to ASTM F1717 on a worst-case, screw construct. The
5
mechanical test results demonstrated that the Pathloc-L MIS Spinal System performs as well as the predicate device.
8. Conclusion
The Prase MIS spinal system is substantially equivalent to legally marketed predicates.