(112 days)
Not Found
No
The summary describes a physical implant (lumbar cage) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and facilitate fusion between vertebrae, which are therapeutic actions.
No
Explanation: The device, an intervertebral body fusion cage, is an implant used for treatment (fusion procedures) rather than for diagnosing a condition. Its purpose is to restore height and facilitate fusion, not to detect or identify a disease.
No
The device description clearly states it is a physical lumbar cage made from titanium, intended for surgical implantation. It is a hardware device, not software.
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 device is a lumbar cage used for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical implant used to treat a physical condition.
- Device Description: The description details a physical implant made of titanium, designed to restore intervertebral height and facilitate fusion. It is a mechanical device.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, and MRI safety, which are typical for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
EIT Cellular Titanium® Lumbar Cage LLIF 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). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF 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 (comma separated list FDA assigned to the subject device)
MAX
Device Description
The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).
The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
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)
- Mechanical testing per ASTM F2077 and ASTM F2267: Static compression, static ● compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence
- Biocompatibility rationale comparing the materials used to manufacture the device ● and instruments with confirmed biocompatibility profiles per ISO 10993.
- MRI Safety Testing per ASTM F2052-15, ASTM F2213-06, and ASTM F2182-● 11a
- A comprehensive clinical literature review was performed to show the clinical performance of allograft bone materials for lumbar interbody fusion.
- Pyrogenicity testing has been completed on the "worst case" EIT lumbar cages. Equivalence has been established to these EIT lumbar cages and the EIT Cellular Titanium® Lumbar Cage LLIF subject device cages do not introduce a new "worst case" cage. As a result, the pyrogenicity testing completed for the EIT lumbar cage family is applicable to the EIT Cellular Titanium® Lumbar Cage LLIF devices.
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
§ 888.3080 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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2018
EIT Emerging Implant Technologies GmbH % Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20005
Re: K181644
Trade/Device Name: EIT Cellular Titanium® Lumbar Cage LLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 4, 2018 Received: October 5, 2018
Dear Justin Eggleton:
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/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,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181644
Device Name
EIT Cellular Titanium® Lumbar Cage LLIF
Indications for Use (Describe)
EIT Cellular Titanium® Lumbar Cage LLIF 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). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF 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)
| Permitted Use (Part 21 CFR 201 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) | ☐ |
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
510(k) Summary
| Device Trade Name: | EIT Cellular Titanium® Lumbar Cage LLIF | |||||
|---|---|---|---|---|---|---|
| Manufacturer: | EIT Emerging Implant Technologies GmbH | |||||
| Eisenbahnstrasse 84 | ||||||
| 78573 Wurmlingen, Germany | ||||||
| Phone: +49 7461 1716900 | ||||||
| Contact: | Mrs. Barbara Wirth | |||||
| EIT Emerging Implant Technologies GmbH | ||||||
| Eisenbahnstrasse 84 | ||||||
| 78573 Wurmlingen, Germany | ||||||
| Prepared by: | Mr. Justin Eggleton | |||||
| Senior Director, Spine Regulatory Affairs | ||||||
| Musculoskeletal Clinical Regulatory Advisers, LLC | ||||||
| 1050 K Street NW, Suite 1000 | ||||||
| Washington, DC 20001 | ||||||
| jeggleton@mcra.com | ||||||
| Date Prepared: | October 12, 2018 | |||||
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device | |||||
| Class: | II | |||||
| Product Codes: | MAX |
Indications for Use:
EIT Cellular Titanium® Lumbar Cage LLIF 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 at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height
4
and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).
The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.
Primary Predicate Device:
The EIT Cellular Titanium® Lumbar Cage LLIF is substantially equivalent to the SPINEART JULIET® LL Lateral Lumbar Cage in device indications, surgical approach, design, and performance.
| Table 1: Primary Predicate Devices | ||
|---|---|---|
| Manufacturer | Device Name | K-Number |
| SPINEART | JULIET® LL Lateral Lumbar Cage | K161888 |
Additional Predicate Devices:
The EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages (EIT Emerging Implant Technologies, GmbH) (K172888) are substantially equivalent to the subject device with respect to indications, design, additive manufacturing process, and performance.
Performance Testing Summary:
The testing of the EIT Cellular Titanium® Lumbar Cage LLIF and cage-dedicated instruments includes:
- Mechanical testing per ASTM F2077 and ASTM F2267: Static compression, static ● compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence
- Biocompatibility rationale comparing the materials used to manufacture the device ● and instruments with confirmed biocompatibility profiles per ISO 10993.
- MRI Safety Testing per ASTM F2052-15, ASTM F2213-06, and ASTM F2182-● 11a
The subject device, the EIT Cellular Titanium® Lumbar Cage LLIF, can be used with autogenous bone graft and/or allogenic bone graft materials to facilitate fusion. Both the primary and secondary predicate devices are indicated for use only with autogenous bone graft. As a result of the inclusion of allogenic bone graft materials in this submission, a comprehensive clinical literature review was performed to show the clinical performance of allograft bone materials for lumbar interbody fusion.
5
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance. Pyrogenicity testing has been completed on the "worst case" EIT lumbar cages. Equivalence has been established to these EIT lumbar cages and the EIT Cellular Titanium® Lumbar Cage LLIF subject device cages do not introduce a new "worst case" cage. As a result, the pyrogenicity testing completed for the EIT lumbar cage family is applicable to the EIT Cellular Titanium® Lumbar Cage LLIF devices.
Conclusion:
The EIT Cellular Titanium® Lumbar Cage LLIF is substantially equivalent to the cited predicate devices with respect to its indications for use, design, function, materials, and performance.