(181 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical bench testing.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
This device is an intervertebral fusion cage system, indicated for surgical implantation to treat degenerative disc disease. It is a therapeutic device, not one that gathers or interprets data for diagnostic purposes.
No
The device description explicitly states the device is an implant made of Titanium 6AL-4V Alloy, which is a hardware component. The performance studies also detail mechanical testing of this hardware.
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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The AccelFix Lumbar Expandable Cage System is an implantable device used in spinal fusion surgery. It is a physical structure inserted into the body to aid in spinal fixation. Its function is mechanical and structural, not diagnostic based on analyzing biological samples.
The information clearly describes a surgical implant used for treatment, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
- AccelFix-XL Expandable Cage is to be implanted via lateral approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar 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
Bench testing:
- Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Expandable Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -17
- Static Compression-Shear Test - ASTM F 2077 -17
- Static Torsion Test - ASTM F 2077 -17
- Static Expulsion Test
- Static Subsidence Test - ASTM F 2267 - 04 (Reapproved 2018)/F 2077-17
- Dynamic Axial Compression Test- ASTM F 2077 -17
- Dynamic Compression-Shear Test - ASTM F 2077 -17
Key results: Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.
Key Metrics
Not Found
Predicate Device(s)
K173182, 171425, K110783, K120063, K121096, K151140, K181380
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
September 16, 2019
Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
L&K Biomed Co., Ltd. Kihyang Kim RA Vice President #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Republic of Korea
Re: K190708
Trade/Device Name: AccelFix Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2019 Received: August 15, 2019
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
1
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/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 mediation-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 Melissa Hall 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
Indications for Use
510(k) Number (if known) K190708
Device Name
AccelFix Lumbar Expandable Cage System
Indications for Use (Describe)
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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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3
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 |
2. Device Identification
| Trade Name: | AccelFix Lumbar Expandable Cage System |
|---|---|
| Common Name: | Intervertebral Body Fusion Cage |
| Product Code: | MAX |
| Classification: | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation No. | 21 CFR 888.3080 |
| Classification Pane | Orthopedic |
3. Predicate or legally marketed devices which are substantially equivalent.
The AccelFix Lumbar Expandable Cage System has undergone a comprehensive battery of non-clinical testing, including chemical and physical testing. Testing has shows the device is as safe and effective for its intended use as a predicate device and supports a determination of substantial equivalence.
The AccelFix Lumbar Expandable Cage System met all pre-defined acceptance criteria and, in tests where it was compared to either AccelFix Lumbar Expandable Cage System the predicate devices, 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 Expandable Cage System' is substantially equivalent to the following predicate(s);
- Primary Predicate Device: ProLift® Expandable System (K173182) 1)
4 Materials
AccelFix Lumbar Expandable Cage System is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
4
5. Description of the Device
The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach. ।
- AccelFix-XL Expandable Cage is to be implanted via lateral approach. ।
6. Intended use
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation systems. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
7. Performance -Bench testing
The AccelFix Lumbar Expandable Cage System was tested according to the ASTM F 2077, and ASTM F 2267 as noted below;
Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Expandable Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -17 .
- . Static Compression-Shear Test - ASTM F 2077 -17
- " Static Torsion Test - ASTM F 2077 -17
- . Static Expulsion Test
- . Static Subsidence Test - ASTM F 2267 - 04 (Reapproved 2018)/F 2077-17
- . Dynamic Axial Compression Test- ASTM F 2077 -17
- יי Dynamic Compression-Shear Test - ASTM F 2077 -17
Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.
5
8. Summary of Technology Characteristics
AccelFix Lumbar Expandable Cage System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
9. Substantial Equivalence:
AccelFix Lumbar Expandable Cage 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 Expandable Cage System to the predicate devices.