(263 days)
FortiCore® is intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
FortiCore® consists of implants and instruments for implantation. The upper and lower aspects of the implant incorporate a three-dimensional titanium scaffold electrochemically treated to possess a controlled nanotopography composed of nanotube arrays with an average pore size between 60-80 nanometers, which assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. Calcium and phosphate are incorporated into the nanotube surface. Nanovis has not submitted data to show that phenomena, including chemical properties or biological effects are attributable to these features. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text is a 510(k) summary for the FortiCore® intervertebral body fusion device. It does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy or a study proving that the device meets such criteria for an AI/ML device.
Instead, the "Performance Data" section of the 510(k) summary (page 3) discusses mechanical testing related to the physical device itself:
- Acceptance Criteria and Reported Device Performance: This document describes mechanical performance testing, not clinical or diagnostic performance.
- Acceptance Criteria (Implicit): That the device's mechanical performance (dynamic compression, static and dynamic compression shear) is "substantially equivalent to the predicate devices" according to ASTM F2077.
- Reported Device Performance: Mechanical testing was performed on "worst case FortiCore® devices" according to ASTM F2077. The results "demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."
The following points refer to information typically found in studies for AI/ML devices, which are not present in this document as it's for a physical intervertebral fusion device, not a diagnostic AI/ML algorithm.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical FortiCore® devices subjected to mechanical testing, not a dataset of patient images or clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert opinion.
- Adjudication method: Not applicable.
- 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 is for a physical implant, not an AI assistance tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, the "ground truth" for performance is compliance with mechanical testing standards (ASTM F2077) and comparison to predicate devices, demonstrating substantial equivalence in physical performance.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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January 22, 2018
Nanovis LLC % Karen E. Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K171312
Trade/Device Name: FortiCore® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 11, 2017 Received: December 13, 2017
Dear Karen Warden:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -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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510(k) Number (if known) K171312
Device Name FortiCore®
Indications for Use (Describe)
FortiCore® is intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® devices are to be used with autograff and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date: | 19 January 2018 |
|---|---|
| Sponsor: | Nanovis, LLC5865 East State Rd. 14Columbia City, Indiana 46725 USA(877) 907-6266(260) 625-3834 |
| Contact Person: | Matthew Hedrick, CEO & Chief Operating Officer |
| Trade Name: | FortiCore® |
| Common Name: | Interbody fusion device |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX |
| Device Description: | FortiCore® consists of implants and instruments for implantation. The upperand lower aspects of the implant incorporate a three-dimensional titaniumscaffold electrochemically treated to possess a controlled nanotopographycomposed of nanotube arrays with an average pore size between 60-80nanometers, which assists in securing the implant in the intervertebralspace and provides radiographic confirmation of the implant location.Calcium and phosphate are incorporated into the nanotube surface.Nanovis has not submitted data to show that phenomena, includingchemical properties or biological effects are attributable to thesefeatures. The devices are available in a variety of sizes toaccommodate the individual anatomic and clinical circumstances ofeach patient. |
| Intended Use: | FortiCore® is intended for spinal fusion procedures in skeletally maturepatients with degenerative disc disease (defined as discogenic back painwith degeneration of the disc confirmed by history and radiographic studies)at one or two contiguous spinal levels from L2-S1. These patients shouldhave had six months of nonoperative treatment. These patients may havehad a previous non-fusion spinal surgery and/or may have up to Grade 1spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally,FortiCore® can be used as an adjunct to fusion in patients diagnosed withdegenerative scoliosis. FortiCore® devices are to be used with autograftand/or allograft comprised of cancellous and/or corticocancellous bone graftand with supplemental fixation indicated for lumbar spinal fusion procedures. |
| Materials: | FortiCore® devices are manufactured from PEEK (OPTIMA® LT1, Invibio®)as described by ASTM F2026. The integrated scaffold (BioSync-Ti, SitesMedical) is manufactured from CP titanium as described by ASTM F67. |
| Primary Predicate: | FortiCore® (Nanovis LLC, K161485) |
| Additional predicates: | FortiCore® (Nanovis LLC, K140280 & K160874), Lumbar I/F Cage® (DePuyAcroMed, Inc. - P960025), Cascadia Interbody System (K2M, Inc. -K160125). |
| Performance Data: | Mechanical testing of the worst case FortiCore® devices was performedaccording to ASTM F2077 and included dynamic compression and staticand dynamic compression shear. The mechanical test results demonstratethat the FortiCore device performance is substantially equivalent to thepredicate devices. |
| TechnologicalCharacteristics: | FortiCore® possesses the same technological characteristics as thepredicate devices. These include:performance (as described above), basic design (hollow structural frame), implant grade materials (PEEK polymer and titanium), and sizes (widths, lengths and heights are within the range(s) offered by the predicates). Technological characteristics which are different have been supported withdescriptive information and/or performance data. Therefore the fundamentalscientific technology of the FortiCore® devices is the same as previouslycleared devices. |
| Conclusion: | FortiCore® possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore FortiCore® issubstantially equivalent for its intended use. |
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§ 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.