(322 days)
Not Found
No
The device description and intended use focus on a mechanical implant for spinal fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is indicated for the treatment of various spinal instability conditions, including fractures, tumors, and degenerative disc disease, which are therapeutic interventions.
No
The AccelFix Lumbar Plate System is a medical implant used for spinal fixation and fusion, designed to treat instability. It is a therapeutic device, not a device that diagnoses conditions.
No
The device description explicitly states that the AccelFix Lumbar Plate System consists of physical implants (plates and screws) made of Titanium 6AL-4V Alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AccelFix Lumbar Plate System is used in vivo (within the body) as an adjunct to spinal fusion for treating various spinal instabilities. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a system of plates and screws made of titanium, designed for surgical implantation in the spine. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the AccelFix Lumbar Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AccelFix Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The AccelFix Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). The AccelFix Lumbar Plate System consists of a variety of shapes and sizes of plates and screws.
The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar and lumbosacral (L1-S1) spine
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
The AccelFix Lumbar Plate System was tested according to the ASTM F 1717-18.
- Static Compression Bending Test ASTM F1717-18 1)
- Static Tension Bending Test ASTM F1717-18 2)
-
- Static Torsional Test - ASTM F1717-18
-
- Dynamic Compression Bending Test - ASTM F1717-18
Static compression. Static tensile. Static torsion and dynamic compression according to ASTM F 1717-18 was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Plate System to the predicate devices.
Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Plate System showed a higher or similar mechanical value than predicate marketed devices.
Key Metrics
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.
0
Build Correspondence
Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it that says "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in large font and "ADMINISTRATION" in smaller font below.
July 28, 2020
L&K Biomed Co., Ltd. Kihyang Kim Vice President #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do, 17015, Korea
Re: K192481
Trade/Device Name: AccelFix Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 11, 2020 Received: July 14, 2020
Dear Kihyang 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 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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
for
Colin O'Neill, M.B.E. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
AccelFix Lumbar Plate System
Indications for Use (Describe)
The AccelFix Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K192481 - Page 1 of 2
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92:
1 Manufacturer
| Submitter: | Gook Jin Kang |
|---|---|
| L&K BIOMED Co., Ltd. | |
| #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil | |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea | |
| Phone. 82-2-6717-1983/ FAX .82-2-6717-1949 | |
| Contact Person: | KiHyang Kim |
| khkim@lnkbiomed.com/ khkim3747@gmail.com | |
| Date | October 27, 2019 |
2. Device Identification
| Trade Name: | AccelFix Lumbar Plate System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Product Code: | KWQ |
| Classification: | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation No. | 21 CFR 888.3060 |
| Classification Pane: | Orthopedic |
3. Predicate or legally marketed devices which are substantially equivalent.
The AccelFix Lumbar Plate System is undergone a comprehensive battery of non-clinical testing, including chemical, physical. The testing supports a determination of substantial equivalence. The AccelFix Lumbar Plate System met all pre-defined acceptance criteria and, in tests where it was compared to either AccelFix Lumbar Plate System the predicate or reference device, was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device. The design feature and indications for use for the subject device 'AccelFix Lumbar Plate System' is substantially equivalent to the following predicate(s);
-
- Primary Predicate Device: LITe Plate System (Stryker/ K142699)
-
- Additional Predicate Devices: Trinica® Anterior Lumbar Plate System (Zimmer Spine K143626)
4 Materials
AccelFix Lumbar Plate System is manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
4
ട. Description of the Device
The AccelFix Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). The AccelFix Lumbar Plate System consists of a variety of shapes and sizes of plates and screws.
The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
6. Indications for Use
The AccelFix Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
7. Performance -Bench testing
The AccelFix Lumbar Plate System was tested according to the ASTM F 1717-18.
- Static Compression Bending Test ASTM F1717-18 1)
- Static Tension Bending Test ASTM F1717-18 2)
-
- Static Torsional Test - ASTM F1717-18
-
- Dynamic Compression Bending Test - ASTM F1717-18
Static compression. Static tensile. Static torsion and dynamic compression according to ASTM F 1717-18 was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Plate System to the predicate devices.
Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Plate System showed a higher or similar mechanical value than predicate marketed devices.
8. Summary of Technology Characteristics
AccelFix Lumbar Plate System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
9. Substantial Equivalence:
AccelFix Lumbar Plate System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
10. Conclusion
The information presented demonstrates the substantial equivalency of the AccelFix Lumbar Plate System to the predicate devices.