(120 days)
No
The description focuses on the mechanical properties and nanosurface technology of the pedicle screw system, with no mention of AI or ML.
Yes
Explanation: The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various spinal conditions, indicating a therapeutic purpose to treat diseases or injuries.
No
The device is a posterior pedicle screw system intended for spinal immobilization as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description clearly states that the Nano FortiFix® System is a posterior pedicle screw system consisting of physical components like rods, screws, connectors, and fasteners. It also describes a physical nanosurface on the screws. This is a hardware-based medical device.
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 Nano FortiFix® System is for the immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly in the body to provide structural support.
- Device Description: The description details a system of rods, screws, connectors, and fasteners, which are all components of a surgical implant. The mention of a nanosurface on the pedicle screw is related to the material properties and interaction with bone, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical properties and in vitro cell interactions, not diagnostic accuracy.
In summary, the Nano FortiFix® System is a surgical implant used for spinal fusion, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Nano FortiFix® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.
Product codes
NKB
Device Description
Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available with or without a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
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 construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition polyaxial screw tulip/shank pull-off testing was performed on the worst case subconstruct. The mechanical results from these tests demonstrate that the Nano FortiFix® performance is substantially equivalent to the predicate devices.
To address the "Points to Consider" in the FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, in vitro evaluations were performed to quantitate the mineralization of extracellular matrix secreted by osteoblasts (OB) and mesenchymal stem cells (MSC) on surfaces created from a titanium alloy substrate. The in vitro study results demonstrated that the Nano FortiFix nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces. In addition, bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2020
Nanovis Spine LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026
Re: K193211
Trade/Device Name: Nano FortiFix® System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 18, 2020 Received: February 19, 2020
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. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Colin O'Neill, M.B.E. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193211
Device Name Nano FortiFix® System
Indications for Use (Describe)
The Nano FortiFix® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.
| 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) |
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510(k) Summary
| Date: | 18 February 2020 |
|---|---|
| Sponsor: | Nanovis Spine, LLC 5865 East State Rd. 14 Columbia City, Indiana 46725 USA (877) 907-6266 (260) 625-3834 |
| Sponsor Contact: | Matthew Hedrick, CEO & Chief Operating Officer |
| 510(k) Contact: | Karen E. Warden, PhD BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 Office: 440.729.8457 |
| Trade Name: | Nano FortiFix® System |
| Common Name: | Posterior spinal system |
| Device Classification | Class II |
| Classification Name: | Thoracolumbosacral pedicle screw system |
| Regulation: | 888.3070 |
| Device Product Code: | NKB |
| Device Description: | Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available with or without a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. |
| Indications for Use: | The Nano FortiFix® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. |
| Materials: | Nano FortiFix® System implants are manufactured from titanium alloy as described by ASTM F136. Rods are additionally manufactured from cobalt chrome (ASTM F1537). |
| Primary Predicate: | Nanovis Spinal System (Nanovis, LLC - K113173) |
| Additional Predicate: | Tiger® Spine System (CoreLink LLC – K133369) |
| Reference Device: | Nano FortiCore® (Nanovis Spine, LLC – K191822) |
| Performance Data: | Mechanical testing of the worst case construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition polyaxial screw tulip/shank pull-off testing was performed on the worst case subconstruct. The mechanical results from these tests demonstrate that the Nano FortiFix® performance is substantially equivalent |
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to the predicate devices.
Technological Characteristics: To address the "Points to Consider" in the FDA's Guidance for Industry: Considering Whether an FDA-Requlated Product Involves the Application of Nanotechnology, in vitro evaluations were performed to quantitate the mineralization of extracellular matrix secreted by osteoblasts (OB) and mesenchymal stem cells (MSC) on surfaces created from a titanium alloy substrate. The in vitro study results demonstrated that the Nano FortiFix nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces. In addition, bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.
Nano FortiFix® possesses the same technological characteristics as the predicate devices. These include:
- . performance (as described above),
- . basic design (rod and screw system),
- implant grade materials (titanium alloy, cobalt chrome), and ●
- sizes (dimensions are within those offered by the predicates). Therefore the fundamental scientific technology of the Nano FortiFix® devices is the same as previously cleared devices.
The Nano FortiFix® System possesses the same intended use and Conclusion: technological characteristics as the predicate devices. Therefore Nano FortiFix® is substantially equivalent for its intended use.