(124 days)
Not On File
No
The description focuses on mechanical components (plates, screws, allograft) and their structural function in spinal surgery. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a plating system used to hold or buttress an allograft in place after a laminoplasty, which is a structural support function rather than a therapeutic one (e.g., treating a disease or disorder directly).
No
The device, a Laminoplasty Plating System, is intended to hold or buttress an allograft in place after a laminoplasty, preventing expulsion or spinal cord impingement. Its function is to provide structural support, not to diagnose a medical condition.
No
The device description clearly states it is comprised of physical components like miniplates and screws, which are hardware.
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 used to stabilize the spine after a laminoplasty procedure. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details physical components like plates, screws, and allograft spacers, which are all surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies described are mechanical tests on the implant's strength and durability, not studies evaluating diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Product codes
NQW
Device Description
The NeuroVention LamiFix Laminoplasty Plating System is comprised of various sized, pre-bent miniplates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft spacers that are provided in a variety of sizes. The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
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
The NeuroVention LamiFix Laminoplasty Plating System was tested in static axial compression bending, static torsion, and dynamic axial bending compression per modified ASTM F1717–11 Standord Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
Key Metrics
Not Found
Predicate Device(s)
Synthes Arch™ Fixation System (AFS) (K032534)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
5. 510(k) Summary
AUG 2 9 2012
| Submitter's Name: | NeuroVention LLC |
|---|---|
| Submitter's Address: | 311 N. Clyde Morris Blvd |
| Suite 580 | |
| Daytona Beach, FL 32114 | |
| Submitter's Telephone: | (386) 257-5055 |
| Contact Name: | Rohit Khanna |
| Date Summary was Prepared: | 30 March 2012 |
| Trade or Proprietary Name: | NeuroVention LamiFix Laminoplasty Plating System |
| Common or Usual Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Codes: | NQW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Device: | Synthes Arch™ Fixation System (AFS) (K032534) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NeuroVention LamiFix Laminoplasty Plating System is comprised of various sized, pre-bent miniplates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft spacers that are provided in a variety of sizes. The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
INDICATIONS FOR USE
The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The indications for use for the NeuroVention LamiFix Laminoplasty Plating System are similar to that of the Synthes Arch™ Fixation System (AFS).
TECHNICAL CHARACTERISTICS
The NeuroVention LamiFix Laminoplasty Plating System plates and screws are manufactured from titanium alloy (ASTM F136), and the spacers are manufactured from allograft, similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.
NeuroVention LamiFix™ System
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Performance Data
The NeuroVention LamiFix Laminoplasty Plating System was tested in static axial compression bending, static torsion, and dynamic axial bending compression per modified ASTM F1717–11 Standord Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
Conclusion
The overall technology characteristics and mechanical performance data lead to the conclusion that NeuroVention LamiFix Laminoplasty Plating System is substantially equivalent to the predicate devices.
NeuroVention LamiFix™ System
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 9 2012
Neurovention, LLC % Empirical Testing Coporation Ms. Meredith May 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K121276
Trade/Device Name: NeuroVention LamiFix Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: March 30, 2012 Received: August 03, 2012
Dear Ms. May:
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
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Page 2 - Ms. Meredith May
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 (OS) 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/ReportalProblem/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 yours,
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
121276
Device Name: NeuroVention LamiFix Laminoplasty Plating System
The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Prescription Use X_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol-R
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121276
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NeuroVention LamiFix™ System