(84 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat various spinal conditions, including degenerative disc disease, spondylolisthesis, fracture, and scoliosis, by providing immobilization and stabilization, which aligns with the definition of a therapeutic device.
No.
The Nanovis Spinal System is described as a system for "pedicle and non-pedicle fixation to provide immobilization and stabilization" and consists of components like "rods, hooks, monoaxial and polyaxial screws." Its intended use is for the surgical treatment of spinal instabilities or deformities as an "adjunct to fusion," not for diagnosing conditions.
No
The device description explicitly lists physical components such as rods, hooks, and screws, indicating it 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 describes a surgical implant for spinal fixation. It is used in the body to provide structural support and stabilization.
- Device Description: The device consists of mechanical components like rods, screws, and hooks, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic device used to treat a physical condition.
N/A
Intended Use / Indications for Use
The Nanovis Spinal System is intended for posterior, non-cervical (i.e., T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
NKB, MNI, MNH, KWP
Device Description
The Nanovis Spinal System consists of rods, hooks, monoaxial and polyaxial screws with set screws, and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks are offered in a variety shapes and sizes. Solid and cannulated monoaxial and polyaxial screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical (i.e., T1-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
Static compression bending and torsion, and dynamic compression bending of the worst case Nanovis construct was performed according to ASTM F1717. The mechanical test results demonstrated that the Nanovis Spinal System performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
CD HORIZON® (K031655/K041460), Expedium™ 5.5 Ti Spine System (K041119/K051024) Moss® Miami (K992168/K022623) and the Synergy™ VLS (K950099/K974749).
Reference Device(s)
Not Found
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.
0
JAN 1 9 2012
Image /page/0/Picture/2 description: The image shows the word "NANOVIS" in a stylized font. The letters are black and the font is sans-serif. The "N" is stylized with a curved line on the left side. The word is centered in the image and the background is white.
| 510(k) Summary | |
|---|---|
| Date: | 21 October 2011 |
| 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 |
| Proposed Trade Name: | Nanovis Spinal System |
| Device Classification | Class III, Class II |
| Classification Name: | Pedicle screw and hook spinal system |
| Regulation: | 888.3070, 888.3050 |
| Device Product Code: | NKB, MNI, MNH, KWP |
| Device Description: | The Nanovis Spinal System consists of rods, hooks, monoaxial and |
| polyaxial screws with set screws, and crosslinks with fastening set | |
| screws. Rods are available either straight or pre-contoured in a variety | |
| of lengths. Hooks are offered in a variety shapes and sizes. Solid and | |
| cannulated monoaxial and polyaxial screws are available in standard | |
| and reduction versions in a variety of diameter-length combinations to | |
| accommodate differing patient anatomy. | |
| Intended Use: | The Nanovis Spinal System is intended for posterior, non-cervical (i.e., |
| T1-S1) pedicle and non-pedicle fixation to provide immobilization and | |
| stabilization in skeletally mature patients as an adjunct to fusion for the | |
| treatment of the following acute and chronic instabilities or deformities: | |
| degenerative disc disease (DDD, defined as back pain of discogenic | |
| origin with degeneration of the disc confirmed by history and | |
| radiographic studies), spondylolisthesis, fracture, dislocation, spinal | |
| stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis | |
| and failed previous fusion. | |
| Materials: | The Nanovis Spinal System components are manufactured from |
| titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. | |
| Predicate Devices: | CD HORIZON® (K031655/K041460), |
| Expedium™ 5.5 Ti Spine System (K041119/K051024) | |
| Moss® Miami (K992168/K022623) and the | |
| Synergy™ VLS (K950099/K974749). |
Pag 1 of 2
Page 5
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KII3173'. The characters are written in a simple, clear style, making them easily readable. The image seems to be a close-up of the written sequence.
Technological Characteristics: The Nanovis Spinal System possesses the same technological characteristics as the predicates. These include
- basic design (rod-based fixation system having monoaxial and . polyaxial screws),
- material (titanium alloy), .
- sizes (rod and screw sizes are encompassed by those offered by . the predicate systems) and
- intended use (as described above). .
The fundamental scientific technology of the Nanovis Spinal System is the same as the previously cleared device.
Static compression bending and torsion, and dynamic compression Performance Data: bending of the worst case Nanovis construct was performed according to ASTM F1717. The mechanical test results demonstrated that the Nanovis Spinal System performs as well as or better than the predicate device.
In comparison to the predicate devices, the Nanovis Spinal System Conclusion: has
- . the same intended use (as described above),
- the same technological characteristics (as described above) .
- and so does not raise new questions of safety and effectiveness.
Therefore the Nanovis Spinal System can be found substantially equivalent to the predicate devices.
Pg 1 of 2 Page 6
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2012
Nanovis. LLC % Backroads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141
Re: K113173
Trade/Device Name: Nanovis Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, K WP Dated: October 21, 2011 Received: October 27, 2011
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
3
Page 2 - Karen E. Warden, Ph.D.
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Radiological Health
Mark N. Melkerson
Director
Der LIN
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Enclosure
4
Indications for Use Statement
510(k) Number:_K113133
Device Name: Nanovis Spinal System
Indications for Use:
The Nanovis Spinal System is intended for posterior, non-cervical (i.e., T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as non adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, fracture. pseudarthrosis and failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113173