(65 days)
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LEXUS Cervical Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
LEXUS Cervical Intervertebral body Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of titanium alloy (Ti-6Al-4V ELI).
The provided text describes a 510(k) submission for a medical device called the "LEXUS Cervical Intervertebral body Fusion Cage System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de nouveau clinical trial with detailed acceptance criteria and performance metrics for a novel device.
Therefore, many of the requested categories for a study that proves the device meets acceptance criteria, such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of regulatory submission. The assessment here is primarily based on non-clinical testing and comparison to existing devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily defined by the performance of the predicate devices and the non-clinical testing standards. The device is deemed acceptable if it performs comparably to the predicates and meets relevant ASTM standards.
| Acceptance Criteria (Derived from Substantial Equivalence and Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Material Composition: PEEK-OPTIMA® LTI with titanium alloy (Ti-6Al-4V ELI) marker pins. | The device is made of PEEK-OPTIMA® LTI with marker pins made of titanium alloy (Ti-6Al-4V ELI). |
| Design Characteristics: Similar to predicate devices, including various sizes and configurations. | Shares technological characteristics similar to the predicate devices, including similar design. |
| Intended Use: For skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with radicular symptoms at one disc level (C3 to C7), using autograft bone and supplemental fixation. | Matches the stated intended use. |
| Non-Clinical Testing Performance: Meets ASTM F 2077 (Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear, Static and Dynamic Torsion, Expulsion) and ASTM F 2267 (Static Subsidence under Axial Compression). | The LEXUS Cervical Intervertebral body Fusion Cage devices were tested according to ASTM F 2077 and ASTM F 2267. The submission concludes the device is "safe and effective for its intended use" based on these tests and substantial equivalence. Specific quantitative performance data from these tests are not provided in the summary, but the implication is that they met the respective standard's requirements. |
| Substantial Equivalence: To predicate devices: LDR Spine Cervical Interbody Fusion System (K091088, K113559), Spine Art TRYPTIK CA Anterior Intersomatic Cervical Cage (K091873), Advanced Medical Technologies AG SHELL Cages (K080401), Globus Medical Inc. COALITION TM Spacer (K083389). | The LEXUS Cervical Intervertebral body Fusion Cage System is stated to be "substantially equivalent to the device referenced above." |
2. Sample size used for the test set and the data provenance
Not Applicable in the context of a clinical test set. The submission refers to non-clinical testing according to ASTM standards. The "samples" would be physical units of the device tested under specific lab conditions. No information on the number of physical samples used for these non-clinical tests is provided in the summary, nor is there information on data provenance in terms of country of origin or retrospective/prospective nature for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a 510(k) submission based on non-clinical testing and substantial equivalence, not a clinical study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No clinical test set or adjudication process for clinical outcomes is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the ASTM standards (ASTM F 2077 and ASTM F 2267). The device performance is compared against these engineering and biomechanical criteria. There is no biological "ground truth" in the sense of pathology or outcomes data presented in this summary for the purpose of proving device effectiveness for a new device. The effectiveness and safety are largely based on the established history of the predicate devices and their material/design characteristics.
8. The sample size for the training set
Not Applicable. There is no training set in the context of machine learning or clinical trials for this physical medical device.
9. How the ground truth for the training set was established
Not Applicable. As above, there is no training set for this device.
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L&K BIOMED
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submitter: | L&K BIOMED Co., Ltd.#1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong,Geumcheon-gu, Seoul 153-803 Republic of Korea |
|---|---|
| Contact Person: | KiHyang Kim-Phone. 82-2-2624-1475FAX .82-2-2624-1477E-mail: khkim@Inkbiomed.com |
| Date Prepared | April 30, 2012 |
2. Device Identification
l.
| Trade Name | LEXUS Cervical Intervertebral body Fusion Cage System |
|---|---|
| Common Name | Intervertebral Body Fusion Device |
| Classification Name | intervertebral fusion device with bone graft, cervical |
| Regulation Number | 21 CFR 888.3080 |
| Regulatory Class | Class II |
| Product Code | ODP |
-
- Predicate or Legally Marketed Devices which are Substantially Equivalent The design feature and indications for use for the subject LEXUS Cervical Intervertebral body Fusion Cage System is substantially equivalent to the following predicates:
4. Description of the Device
LEXUS Cervical Intervertebral body Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of titanium alloy (Ti-6Al-4V ELI).
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L8K BIOMED
5. Indications for Use
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LEXUS Cervical Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
6. Discussion of the Non-clinical Testing
The LEXUS Cervical Intervertebral body Fusion Cage devices were tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.
7. Summary of Technology Characteristics
The LEXUS Cervical Intervertebral body Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.
8. Conclusion
The LEXUS Cervical Intervertebral body Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black lines. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
L&K Biomed Co., Ltd. % Ms. Ki Hyang Kim #1104, Ace High-End Tower 3 cha 371-50, Gasan-dong, Geumcheon-gu Seoul, 153-803, Republic of Korea
MAY 2 4 2012
K120840 Re:
Trade/Device Name: LEXUS Cervical Intervertebral Body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 3, 2012 Received: May 4, 2012
Dear Ms. 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.
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Page 2 - Ms. Ki Hyang Kim
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millkern
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
L&K BIOME
510(k) Number (if known):
Device Name: LEXUS Cervical Intervertebral body Fusion Cage System
Indications For Use:
ﺴﺮ
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LEXUS Cervical Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use
AND/OR
Over-The-Counter Use (21 CER801 Subpart C)
(Part 21 CER801 Subpart D)
5106k | Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (OED) | |
|---|---|
| Traditional 510(K)(Division Sign-Off) | |
| Division of Surgical, Orthopedic,and Restorative Devices | |
| Page 26/ 59 |
KI 20840
§ 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.