(98 days)
Not Found
No
The device description focuses on the mechanical components (plates, screws, lockers) and their material, intended use for spinal fixation, and performance testing based on mechanical standards. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an "Anterior Cervical Plate System" intended for "anterior screw fixation to the cervical spine (C2-C7)" and is indicated for use in the "immobilization of the spine as an adjunct to fusions." It treats various medical conditions such as degenerative disc disease, trauma, tumors, and spinal stenosis, which are all conditions that cause pain or dysfunction and require medical intervention.
No
This device is an implantable system (plates, screws, and lockers) used for anterior screw fixation to the cervical spine as an adjunct to fusions. It is a treatment device, not explicitly performing diagnosis.
No
The device description explicitly states it is composed of plates, screws, and lockers made from titanium alloy, which are physical hardware components.
No, 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, tissue) to provide information about a person's health.
- Device Description: The SMG Anterior Cervical Plate System is a surgical implant made of titanium alloy. It is designed to be physically implanted into the cervical spine to provide structural support and aid in fusion.
- Intended Use: The intended use is for anterior screw fixation to the cervical spine for immobilization and fusion in patients with various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used for structural support and stabilization within the body, not for analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · failed previous fusion (pseudoarthrosis)
- · spinal stenosis.
Product codes
KWQ
Device Description
The SMG Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6Al-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. This device is provided as non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
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)
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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February 11, 2019
Sapphire Medical Group Mr. Anthony Ruggiero President 32565 B Golden Lantern Street, Suite 113 Dana Point, California 92629
Re: K183073
Trade/Device Name: SMG Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2018 Received: November 27, 2018
Dear Mr. Ruggiero:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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) K183073
Device Name
SMG Anterior Cervical Plate System
The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · failed previous fusion (pseudoarthrosis)
- · spinal stenosis.
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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510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| 1. | Submitter: | Sapphire Medical Group
32565 B Golden Lantern Street
Suite 113, Dana Point, CA 92629, United States
Phone. +1-949-939-8502 |
|----|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Anthony Ruggiero |
| | Date prepared: | November 01, 2018 |
Device Identification 2.
| Trade Name | SMG Anterior Cervical Plate System |
|---|---|
| Common Name | Anterior Cervical Plate |
| Product Code | KWQ |
| Regulatory Class | Spinal Intervertebral Body Fixation Orthosis |
| (21 CFR888.3060) | |
| Classification Name | Class II |
Predicate or legally marketed devices which are substantially equivalent 3.
The design feature and indications for use for the subject SMG Anterior Cervical Plate System is exactly the same as the following predicates:
- Primary predicate device: CastleLoc-P Anterior Cervical Plate System (K143271)
- Additional predicate device: LnK Anterior Cervical Plate System (K143279)
Description of the Device 4.
The SMG Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6Al-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. This device is provided as non-sterile.
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5. Indication for use
The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations), •
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis), ●
- failed previous fusion (pseudoarthrosis) ●
- spinal stenosis.
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| No | Item | Subject device | Primary Predicate device | Additional Predicate device |
|---|---|---|---|---|
| 1 | Manufacturer | SMG Anterior Cervical | ||
| Plate System | ||||
| Sapphire Medical Group | ||||
| (Contract manufacturer: L&K | ||||
| BIOMED CO., LTD.) | CastleLoc-P Anterior | |||
| Cervical Plate System | ||||
| L&K BIOMED Co., | ||||
| Ltd. | LnK Anterior Cervical | |||
| Plate System | ||||
| L&K BIOMED Co., | ||||
| Ltd. | ||||
| 2 | Material | Ti-6Al-4V ELI | ||
| (ASTM F136) | Ti-6Al-4V ELI | |||
| (ASTM F136) | Ti-6Al-4V ELI | |||
| (ASTM F136) | ||||
| 3 | 510(K) Number | K143271 | K143279 | |
| 4 | Product Code | KWQ | KWQ | KWQ |
| 5 | Class | Class II | Class II | Class II |
| 6 | Sterility | Non-sterile | Non-sterile | Non-sterile |
| 7 | Intended Use | The SMG Anterior | ||
| Cervical Plate System | ||||
| is intended for anterior | ||||
| screw fixation to the | ||||
| cervical spine (C2-C7). | ||||
| The System is | ||||
| indicated for use in the | ||||
| immobilization and | ||||
| stabilization of the | ||||
| spine as an adjunct to | ||||
| fusions in patients | ||||
| with: | ||||
| -degenerative disc | ||||
| disease (as defined by | ||||
| neck pain of discogenic | ||||
| origin with | ||||
| degeneration of the | ||||
| disc confirmed by | ||||
| patient history and | The CastleLoc-P | |||
| Anterior Cervical Plate | ||||
| System is intended for | ||||
| anterior screw fixation | ||||
| to the cervical spine | ||||
| (C2-C7). The System is | ||||
| indicated for use in the | ||||
| immobilization and | ||||
| stabilization of the | ||||
| spine as an adjunct to | ||||
| fusions in patients with: | ||||
| -degenerative disc | ||||
| disease (as defined by | ||||
| neck pain of discogenic | ||||
| origin with | ||||
| degeneration of the disc | ||||
| confirmed by patient | ||||
| history and | ||||
| radiographic studies), | The LnK Anterior | |||
| Cervical Plate System | ||||
| is intended for anterior | ||||
| screw fixation to the | ||||
| cervical spine (C2-C7). | ||||
| The System is indicated | ||||
| for use in the | ||||
| immobilization and | ||||
| stabilization of the | ||||
| spine as an adjunct to | ||||
| fusions in patients with: | ||||
| -degenerative disc | ||||
| disease (as defined by | ||||
| neck pain of discogenic | ||||
| origin with | ||||
| degeneration of the disc | ||||
| confirmed by patient | ||||
| history and | ||||
| radiographic studies), | ||||
| radiographic studies), | -spondylolisthesis, | -spondylolisthesis, | ||
| -spondylolisthesis, | -trauma (i.e. fractures | -trauma (i.e. fractures | ||
| -trauma (i.e. fractures | or dislocations), | or dislocations), | ||
| or dislocations), | -tumors, | -tumors, | ||
| -tumors, | -deformity (defined as | -deformity (defined as | ||
| -deformity (defined as | kyphosis, lordosis, or | kyphosis, lordosis, or | ||
| kyphosis, lordosis, or | scoliosis), | scoliosis), | ||
| scoliosis), | -failed previous fusion | -failed previous fusion | ||
| -failed previous fusion | (pseudoarthrosis) | (pseudoarthrosis) | ||
| (pseudoarthrosis) | -spinal stenosis. | -spinal stenosis. | ||
| -spinal stenosis. | ||||
6. Comparison of the technology characteristics of the device to predicate and legally marketed devices
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Comparison of the technology characteristics of the device to predicate and 7. legally marketed devices
The subject device 'SMG Anterior Cervical Plate System' is exactly the same device as the predicate device(s): CastleLoc-P Anterior Cervical Plate System (K143271) and LnK Anterior Cervical Plate System (K143279). Therefore, it is substantially equivalent to these devices which are currently being marketed in terms of design, function and intended use.
Performance Data 8.
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing.
Conclusion 9.
The SMG Anterior Cervical Plate System is substantially equivalent to the devices referenced above for the intended use.