(120 days)
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.
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.
This report focuses on the Nano FortiFix® System, a thoracolumbosacral pedicle screw system, and assesses its substantial equivalence to predicate devices, particularly concerning its use of nanotechnology.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria for device performance from a clinical trial in the typical sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied through comparative mechanical testing and in vitro evaluations demonstrating substantial equivalence to predicate devices and adherence to specific standards for the nanosurface.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Meet or exceed performance of predicate devices per ASTM F1717 | Mechanical testing of the worst-case construct (static/dynamic compression and static torsion) and polyaxial screw pull-off testing demonstrated that the Nano FortiFix® performance is substantially equivalent to the predicate devices. |
| Nanosurface Properties (Biological) | |
| Enhanced mineralization compared to other surfaces | In vitro evaluations showed that the Nano FortiFix nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces. This addresses the "Points to Consider" in the FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. |
| Biocompatibility (absence of harmful endotoxins) | Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit. |
| Technological Characteristics | |
| Same basic design as predicate devices | Basic design (rod and screw system) is the same. |
| Same implant grade materials as predicate devices | Implant grade materials (titanium alloy, cobalt chrome) are the same. Nano FortiFix® System implants are manufactured from titanium alloy (ASTM F136). Rods are additionally manufactured from cobalt chrome (ASTM F1537). |
| Similar sizes/dimensions as predicate devices | Sizes (dimensions) are within those offered by the predicates. |
| Intended Use | |
| Same as predicate devices | The Nano FortiFix® System has the same intended use as the predicate devices: immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for various indications (DDD, spinal stenosis, spondylolisthesis, spinal deformities, trauma, tumor, pseudarthrosis, failed previous fusion). |
| Regulatory Compliance (Nanotechnology) | |
| Address "Points to Consider" in FDA Nanotechnology Guidance | In vitro evaluations as described above confirm the nanosurface's specific properties and address the guidance for product involving nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties, electrochemically treated to possess a controlled nanotopography composed of nanotube arrays (30-90 nm pore size diameter), with calcium and phosphate incorporated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical imaging. The evaluations are primarily in vitro and mechanical.
- Mechanical Testing: "Worst case construct" and "worst case subconstruct" were tested. The exact number of samples for these tests is not provided, but it implies a representative selection.
- In Vitro Evaluations: Osteoblast (OB) and mesenchymal stem cell (MSC) cultures were used to quantify mineralization. The number of samples/replicates for these cultures is not specified.
- Bacterial Endotoxin Testing: Conducted in accordance with AAMI ST72:2011. The number of samples is not specified.
Data Provenance: All data appears to be from laboratory and bench testing, rather than human clinical data. Therefore, there is no mention of country of origin or whether the data is retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is not a clinical study involving the establishment of ground truth by human experts (e.g., radiologists interpreting images). The "ground truth" for the mechanical and in vitro tests is based on established engineering and biological standards and methodologies.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical PIVOTAL study with a test set requiring adjudication from a panel of experts. The evaluations were laboratory-based (mechanical, in vitro, endotoxin).
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
Not applicable. The Nano FortiFix® System is a medical implant (pedicle screw system), not an AI diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. The Nano FortiFix® System is a medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for the substantial equivalence determination for this device is based on:
- Mechanical Standards: Adherence to ASTM F1717 for static and dynamic mechanical properties.
- Biological Standards: In vitro demonstration of statistically significant enhanced mineralization in osteoblast and mesenchymal stem cell cultures (a functional biological outcome related to bone integration) and meeting bacterial endotoxin limits (safety).
- Material Science Standards: Use of materials compliant with ASTM F136 (titanium alloy) and ASTM F1537 (cobalt chrome).
- Regulatory Guidance: Adherence to FDA's "Points to Consider" for nanotechnology in medical devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
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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
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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.
§ 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.