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.

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.

AI/ML Overview

This submission describes a medical device, the NeuroVention LamiFix Laminoplasty Plating System, which is a spinal implant. The "study" mentioned here refers to the mechanical performance testing conducted to ensure the device's structural integrity and equivalence to predicate devices, not a clinical study involving human or animal subjects in the way an AI/software device would typically be evaluated for diagnostic accuracy.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria (Performance Standard)	Device Performance
Static Axial Compression Bending	Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence to predicate devices, though specific pass/fail thresholds are not explicitly stated.
Static Torsion	Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence.
Dynamic Axial Bending Compression	Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence.

Explanation: The acceptance criteria are implicitly defined by the modified ASTM F1717-11 standard and the need to demonstrate substantial equivalence to the predicate device (Synthes Arch™ Fixation System (AFS)). The reported performance is that the device was tested according to these standards, and the conclusion drawn is that its overall technology characteristics and mechanical performance data lead to the conclusion of substantial equivalence. Specific numerical results or direct comparisons to predicate device data are not provided in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. For mechanical testing of medical devices, samples typically refer to the number of physical device units tested. The ASTM standard would specify minimum test sample sizes.
Data Provenance: The device itself was tested, not patient data. The testing was performed in accordance with modified ASTM F1717-11, which is an industry standard for spinal implant constructs. Since it's mechanical testing, there's no concept of country of origin for "data" or retrospective/prospective. The testing was laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is mechanical testing of a physical device, not an assessment requiring expert interpretation of clinical data. The "ground truth" is established by the physical properties and performance of the material and device under stress, measured using calibrated equipment.

4. Adjudication method for the test set:

Not applicable. As this is mechanical testing, there is no human adjudication of "ground truth" as there would be for, say, image interpretation. Testing results are quantitative measurements against predefined specifications.

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. This is a physical medical device (spinal implant), not an AI/software device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Quantitative Mechanical Properties: The "ground truth" for this type of device is its ability to withstand specified mechanical forces (axial compression bending, torsion, dynamic axial bending compression) as defined by a recognized standard (modified ASTM F1717-11). The measurements obtained from the physical tests represent the objective performance of the device.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for a mechanical device.

Summary

{0}------------------------------------------------

5. 510(k) Summary

AUG 2 9 2012

Submitter's Name:	NeuroVention LLC
Submitter's Address:	311 N. Clyde Morris BlvdSuite 580Daytona 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:

INDICATIONS FOR USE

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

Page 18 of 128

Page 1 of 2

{1}------------------------------------------------

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

.
.

2 of 2

{2}------------------------------------------------

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

{3}------------------------------------------------

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

{4}------------------------------------------------

4. Indications for Use Statement

121276

Device Name: NeuroVention LamiFix Laminoplasty Plating System

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

Page 17 of 128

Page 1 of 1

NeuroVention LamiFix™ System

Regulation Number and Section

§ 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.