(140 days)
EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
EIT Cellular Titanium® PLIF Cages: The ET Cellular Titanium® PLF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cages: The ETT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogemic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.
The provided text describes a medical device submission (K170503) for various EIT Cellular Titanium® Cages, which are intervertebral body fusion devices. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document states that the devices were subjected to mechanical testing. The acceptance criteria are implicitly the standards outlined in ASTM F2077-14 and F2267-04. The reported device performance is that the "results demonstrate that the devices are substantially equivalent to the predicate devices." No specific numerical results or detailed performance metrics are given in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static compression (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Static compression-shear (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic compression (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic compression-shear (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Torsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic Torsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Expulsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Subsidence (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Bacterial endotoxin testing (as part of sterilization process) | Devices met the standards, demonstrating substantial equivalence to predicate devices. (No specific thresholds are provided for bacterial endotoxin limits in this extract). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size for the mechanical testing (e.g., number of devices tested for each type of cage and test). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as this is a regulatory submission summary focusing on equivalence rather than a clinical trial. The testing is described as "Performance Testing Summary," indicating laboratory mechanical tests rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This document describes mechanical testing of medical implants, not a diagnostic or prognostic device that would require human expert-established ground truth. Therefore, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As this involves mechanical testing of physical devices against material and performance standards (ASTM standards), there is no adjudication method in the context of expert review for ground truth establishment. The evaluation is based on whether the devices physically meet the specified mechanical requirements.
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:
No MRMC study was conducted. This device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was done. This document pertains to a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards, specifically ASTM F2077-14 and F2267-04 for mechanical properties, and bacterial endotoxin testing for sterility. There is no biological or diagnostic "ground truth" as would be established by pathology or clinical outcomes in the context of a diagnostic device.
8. The sample size for the training set:
Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets.
9. How the ground truth for the training set was established:
Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets and ground truth for them.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a head covering.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
EIT Emerging Implant Technologies, GmbH % Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers. LLC 1050 K Street NW. 10th Floor Washington, District of Columbia 20001
Re: K170503
Trade/Device Name: EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: June 8, 2017 Received: June 9, 2017
Dear Mr. 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. 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
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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Vincent J. Devlin -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) K170503
Device Name
EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages
Indications for Use (Describe)
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
EIT Cellular Titanium® PLIF Cages
The ET Cellular Titanium® PLF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD
patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cages
The ETT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogemic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD
patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® ALIF Cages
The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD
patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Device Trade Name: | EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium®PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EITCellular Titanium® ALIF Cages |
|---|---|
| Manufacturer: | EIT Emerging Implant Technologies GmbHEisenbahnstrasse 8478573 Wurmlingen, GermanyPhone: +49 7461 1716900 |
| Contact: | Ms. Barbara WirthEIT Emerging Implant Technologies GmbHEisenbahnstrasse 8478573 Wurmlingen, GermanyBarbara.wirth@eit-spine.de |
| Prepared by: | Mr. Justin EggletonSenior Director, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com |
| Date Prepared: | June 7, 2017 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX, ODP |
Indications For Use:
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
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EIT Cellular Titanium® PLIF Cages
The EIT Cellular Titanium® PLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.
EIT Cellular Titanium® TLIF Cages
The EIT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.
EIT Cellular Titanium® ALIF Cages
The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.
Device Description:
The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
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Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.
Predicate Device:
The EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages are substantially equivalent to the predicates previously cleared with respect to indications, design, function, and materials, as outlined below.
| Table 1: Primary Predicate Device | ||
|---|---|---|
| Manufacturer | Device Name | K-Number |
| OrthoDevelopment | Vusion CS+ | K122588 |
Additional Predicates: Scient'X Tribeca Cage (K080588)
CoAlign AccuLIF (K093669, K112095)
4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) (K143258)
Precision Spine ShurFit® PLIF Interbody Cage (K092193)
Performance Testing Summary:
The worst case devices were subjected to mechanical testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, torsion, dynamic torsion, expulsion, and subsidence per ASTM F2077-14 and F2267-04. Additional bacterial endotoxin testing was performed as part of the sterilization. The results demonstrate that the devices are substantially equivalent to the predicate devices.
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/or performance.
Conclusion:
The EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages are substantially equivalent to previously cleared devices with respect to its indications for use, design, function, materials, and performance.
§ 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.