(263 days)
No
The device description and performance studies focus on the mechanical properties of the plates and screws, with no mention of AI or ML.
Yes
The device is indicated for use in the treatment of various medical conditions, including fracture, tumor, degenerative disc disease, scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is a surgical implant system (plates and screws) used for stabilization of the spine in the treatment of various conditions, not for diagnosing them.
No
The device description explicitly states it is a "Lateral Plating System" providing "thoracic and thoracolumbar plates and screws" made of "titanium alloy". This indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant system (plates and screws) used to stabilize the spine during surgery. It is a physical device implanted within the body, not used to test samples outside the body.
The description focuses on the materials, dimensions, and mechanical testing of the implant, which are typical characteristics of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Belvedere™ Lateral Plating System provides an assortment of thoracic and thoracolumbar plates and screws. The plates and screws provided are manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. Multiple variations of the screws are provided in lengths of 20-70mm and diameters of 5.0-6.5mm. The plates are provided in lengths of 36-132mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine
Indicated Patient Age Range
Not Found
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)
The Belvedere™ Lateral Plating System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14
- Static torsion per ASTM F1717-14 .
- Static tension per ASTM F1717-14 .
- Dynamic axial compression bending per ASTM F1717-14 .
The results of this non-clinical testing show that the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2016
Neurostructures, Incorporation % Mr. Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K153097
Trade/Device Name: Belvedere™ Lateral Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 9, 2016 Received: June 10, 2016
Dear Mr. Maxwell:
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153097
Device Name Belvedere™ Lateral Plating System
Indications for Use (Describe)
The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
| 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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| Submitter's Name: | Neurostructures, Inc. |
|---|---|
| Submitter's Address: | 16 Technology Dr. Suite 165 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800.352.6103 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Consulting LLC | |
| 719.291.6874 | |
| Date Summary was Prepared: | 11 July 2016 |
| Trade or Proprietary Name: | Belvedere™ Lateral Plating System |
| Common or Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Belvedere™ Lateral Plating System provides an assortment of thoracic and thoracolumbar plates and screws. The plates and screws provided are manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. Multiple variations of the screws are provided in lengths of 20-70mm and diameters of 5.0-6.5mm. The plates are provided in lengths of 36-132mm.
INDICATIONS FOR USE
The NeuroStructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T) - L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The indications for use for the Belvedere™ Lateral Plating System are similar to that of predicate devices listed in Table 5-1 Predicate Devices.
TECHNOLOGICAL CHARACTERISTICS
The Belvedere™ Lateral Plating System and the predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Principles of operation o
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| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K020244 | Thoracolumbar Spine Locking Plate (TSLP) | ||
| System | Synthes | Primary | |
| K133194 | Black/Red Diamond Rattlesnake Lumbar | ||
| Plating System | Eminent Spine | Additional | |
| K143230 | Palladian™ Lumbar Pedicle Screw System | Neurostructures, Inc. | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Belvedere™ Lateral Plating System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14 ●
- Static torsion per ASTM F1717-14 .
- Static tension per ASTM F1717-14 .
- Dynamic axial compression bending per ASTM F1717-14 ●
The results of this non-clinical testing show that the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Belvedere™ Lateral Plating System is substantially equivalent to the predicate device.