(98 days)
No
The document describes a physical implant device and its intended use, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Intervertebral Body Fusion System," intended for spinal fusion procedures to treat degenerative disc disease and discogenic back pain. This clearly indicates a therapeutic purpose.
No
The device is an implant for spinal fusion procedures, not a diagnostic tool. Its purpose is to physically fuse vertebrae, not to diagnose a condition.
No
The device description explicitly states that the systems include "PLIF implants and related instruments for implantation," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is an implantable intervertebral body fusion device used in spinal fusion procedures. It is a physical device surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Nanovis Intervertebral Body Fusion and FortiCore® Systems are medical devices used for surgical treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, 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). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OPD
Device Description
The Nanovis Intervertebral Body Fusion and FortiCore® Systems include PLIF implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The PLIF devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy. The Nanovis Intervertebral Body Fusion System and FortiCore® PLIF implants are offered as sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1, 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)
Static and dynamic compression testing per ASTM F2077 and/or dimensional analyses of the modified Nanovis Intervertebral Body Fusion and FortiCore® devices were performed. The results demonstrated the performance of the modified Nanovis Intervertebral Body Fusion System and modified FortiCore devices are substantially equivalent to the predicate devices. In addition, bacterial endotoxin testing (BET) has been performed. BET as specified in ANSI/AAMI ST-72:2011 confirm an endotoxin limit of 2.15 EU/mL.
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.
Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442), FortiCore® (Nanovis LLC, K140280), Aleutian® IBF System (K2M, Inc., K133614)
Reference Device(s):
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three faces overlapping to create a sense of depth and dimension. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Nanovis, LLC % Karen E. Warden, Ph.D. President Backroads Consulting, Incorporated P.O. Box 566 Chesterland. Ohio 44026
Re: K161485
Trade/Device Name: Nanovis Intervertebral Body Fusion System and Forticore® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OPD Dated: August 8. 2016 Received: August 10, 2016
Dear Dr. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161485
Device Name
Nanovis Intervertebral Body Fusion System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161485
Device Name FortiCore®
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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). FortiCore® devices are to be used with autogenous bone graft and in combination 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
4
| Date: | 1 September 2016 |
|---|---|
| Sponsor: | Nanovis Spine, LLC |
| 5865 East State Rd. 14 | |
| Columbia City, Indiana 46725 USA | |
| (877) 907-6266 | |
| Sponsor Contact: | Matthew Hedrick, CEO & Chief Operating Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | Nanovis Intervertebral Body Fusion System and FortiCore® |
| Common Name: | Interbody fusion device |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX, ODP |
| Submission Purpose: | To add sizes and modify the external shape of the Nanovis Intervertebral |
| Body Fusion and FortiCore® System PLIF implants, and to provide the | |
| Nanovis Intervertebral Body Fusion PLIF implants as sterile packaged. | |
| Device Description: | The Nanovis Intervertebral Body Fusion and FortiCore® Systems include |
| PLIF implants and related instruments for implantation. The upper and lower | |
| aspects of the implants from both systems are open and have a central | |
| column to be packed with autogenous bone graft. The FortiCore® implants | |
| have an integrated titanium scaffold which assists in securing the implant in | |
| the intervertebral space. The PLIF devices from both systems are available in | |
| a variety of shapes and sizes to accommodate the individual patient anatomy. | |
| The Nanovis Intervertebral Body Fusion System and FortiCore® PLIF | |
| implants are offered as sterile. | |
| Intended Use: | When used as a cervical intervertebral body fusion device, the Nanovis |
| Intervertebral Body Fusion System is intended for spinal fusion procedures in | |
| skeletally mature patients with degenerative disc disease (defined as neck | |
| pain of discogenic origin with degeneration of the disc confirmed by history | |
| and radiographic studies) at one spinal level from C2-T1. These patients | |
| should have had at least six weeks of non-operative treatment. Nanovis | |
| Intervertebral Body Fusion System implants are to be used with autogenous | |
| bone graft and in combination with supplemental fixation indicated for cervical | |
| fusion procedures. | |
| When used as a lumbar intervertebral body fusion device, the Nanovis | |
| Intervertebral Body Fusion System 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). | |
| Nanovis Intervertebral Body Fusion System implants are to be used with | |
| autogenous bone graft and in combination with supplemental fixation | |
| indicated for lumbar spinal fusion procedures. | |
| Intended Use: | When used as a cervical intervertebral body fusion device, FortiCore® is |
| intended for spinal fusion procedures in skeletally mature patients with | |
| degenerative disc disease (defined as neck pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic studies) at | |
| one spinal level from C2-T1. These patients should have had at least six | |
| weeks of non-operative treatment. FortiCore® devices are to be used with | |
| autogenous bone graft and in combination with supplemental fixation | |
| indicated for cervical fusion procedures. | |
| When used as a lumbar intervertebral body fusion device, 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). FortiCore® | |
| devices are to be used with autogenous bone graft and in combination with | |
| supplemental fixation indicated for lumbar spinal fusion procedures. | |
| Materials: | The Nanovis Intervertebral Body Fusion System implants are available in |
| polyetheretherketone (PEEK- OPTIMA® LT1, Invibio® as described by ASTM | |
| F2026) and titanium alloy (Ti-6Al-4V ELI as described by ASTM F136). The | |
| PEEK devices incorporate a tantalum marker per ASTM F560. | |
| FortiCore® devices are manufactured from polyetheretherketone (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. The FortiCore® devices also incorporate a tantalum | |
| marker per ASTM F560. | |
| Primary Predicate: | Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442) |
| Additional Predicates: | FortiCore® (Nanovis LLC, K140280) |
| Aleutian® IBF System (K2M, Inc., K133614) | |
| Performance Data: | Static and dynamic compression testing per ASTM F2077 and/or dimensional |
| analyses of the modified Nanovis Intervertebral Body Fusion and FortiCore® | |
| devices were performed. The results demonstrated the performance of the | |
| modified Nanovis Intervertebral Body Fusion System and modified FortiCore | |
| devices are substantially equivalent to the predicate devices. In addition, | |
| bacterial endotoxin testing (BET) has been performed. BET as specified in | |
| ANSI/AAMI ST-72:2011 confirm an endotoxin limit of 2.15 EU/mL. | |
| Technological | |
| Characteristics: | The modified Nanovis Intervertebral Body Fusion System and FortiCore® |
| possess technological characteristics similar to the predicate devices. These | |
| include: | |
| ● performance (as described above), | |
| ● basic design (hollow structural frame), | |
| ● implant grade materials (PEEK polymer, tantalum and/or titanium), and | |
| ● sizes (widths, lengths and heights are within the range(s) offered by the | |
| predicates). | |
| Therefore the fundamental scientific technology of the FortiCore devices is | |
| the similar to previously cleared devices. | |
| Conclusion: | The Nanovis Intervertebral Body Fusion System and FortiCore® possess the |
| same intended use and similar technological characteristics as the predicate | |
| devices. Therefore the Nanovis Intervertebral Body Fusion System and | |
| FortiCore® are substantially equivalent to legally marketed predicates. |
510(k) Summary
5