(263 days)
Not Found
No
The description focuses on the material properties and mechanical performance of the implant, with no mention of AI or ML in the device's function or intended use.
Yes.
The device is described as "intended for spinal fusion procedures" for patients with "disc disease" and "degenerative scoliosis," which are therapeutic interventions.
No
Explanation: The device is an implant for spinal fusion procedures, intended for treatment rather than diagnosis. While "radiographic studies" are mentioned as part of confirming disc degeneration, the device itself "provides radiographic confirmation of the implant location" after implantation, which is a post-treatment assessment, not a diagnostic one.
No
The device description explicitly states that FortiCore® consists of implants and instruments for implantation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. It is used in vivo (within the body) to facilitate bone fusion, not to diagnose a condition by testing samples in vitro (outside the body).
- Device Description: The description details a physical implant made of titanium with specific surface treatments, designed to be placed in the intervertebral space. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The "radiographic studies" mentioned are used to confirm the diagnosis and assess the outcome of the procedure, not as input for the device itself to perform a diagnostic function.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative 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.
Product codes
MAX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 spinal levels
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 of the worst case FortiCore® devices was performed according to ASTM F2077 and included dynamic compression and static and dynamic compression shear. The mechanical test results demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K161485, K140280, K160874, P960025, K160125
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
1
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
2
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) |
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
| Date: | 19 January 2018 |
|---|---|
| Sponsor: | Nanovis, LLC |
| 5865 East State Rd. 14 | |
| Columbia 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 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. | |
| Intended Use: | FortiCore® is intended for spinal fusion procedures in skeletally mature |
| patients with degenerative 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. | |
| Materials: | FortiCore® devices are manufactured from PEEK (OPTIMA® LT1, Invibio®) |
| as described by ASTM F2026. The integrated scaffold (BioSync-Ti, Sites | |
| Medical) 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® (DePuy |
| AcroMed, Inc. - P960025), Cascadia Interbody System (K2M, Inc. - | |
| K160125). | |
| Performance Data: | Mechanical testing of the worst case FortiCore® devices was performed |
| according to ASTM F2077 and included dynamic compression and static | |
| and dynamic compression shear. The mechanical test results demonstrate | |
| that the FortiCore device performance is substantially equivalent to the | |
| predicate devices. | |
| Technological | |
| Characteristics: | FortiCore® possesses the same technological characteristics as the |
| predicate 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 with | |
| descriptive information and/or performance data. Therefore the fundamental | |
| scientific technology of the FortiCore® devices is the same as previously | |
| cleared devices. | |
| Conclusion: | FortiCore® possesses the same intended use and technological |
| characteristics as the predicate devices. Therefore FortiCore® is | |
| substantially equivalent for its intended use. |
4