(178 days)
The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
· Pseudoarthrosis and failed previous which are symptomatic or which may cause secondary instability or deformity,
· Spondylolisthesis,
· Spondylolysis,
· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
· Degeneration of the facets with instability,
· Trauma including spinal fractures and/or dislocations.
The FacetBRIDGE System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion. Each FacetBRIDGE construct consists of a screw and polyaxial washer both manufactured from Ti-6A1-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.
This document describes the regulatory submission for the FacetBRIDGE® System, a spinal facet screw system. It focuses on non-clinical (bench) performance data rather than clinical studies or those involving AI. Therefore, most of the requested information regarding AI-specific criteria, human expert involvement, and ground truth establishment from clinical data is not available in the provided text.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that non-clinical performance bench testing was conducted to support substantial equivalence. The acceptance criterion is that the device "demonstrates the device is substantially equivalent to legally marketed predicate devices." The reported performance is that the FacetBRIDGE® System met this requirement.
| Acceptance Criterion (stated or inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices based on non-clinical performance bench testing | The FacetBRIDGE® System demonstrated substantial equivalence to legally marketed predicate devices through non-clinical testing. |
| Static Three-point Bend per ASTM F1264-14 | Results reported to support substantial equivalence. |
| Dynamic Three-point Bend Fatigue per ASTM F1264-14 | Results reported to support substantial equivalence. |
| Axial Pullout Strength per ASTM F543e1 | Results reported to support substantial equivalence. |
| Torque to Failure per ASTM F543e1 | Results reported to support substantial equivalence. |
| Screw/washer pull-through testing | Results reported to support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided. The study conducted was non-clinical bench testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The "ground truth" in this context would refer to the performance standards set by the ASTM methods for bench testing, not expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are relevant for clinical studies involving human interpretation or outcome assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical spinal implant system, not a software algorithm or AI device.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" or reference standard would be the engineering specifications and performance standards defined by the ASTM (American Society for Testing and Materials) standards referenced (e.g., ASTM F1264-14, ASTM F543e1).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The study conducted was non-clinical bench testing; there was no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There was no training set for an AI model. For the non-clinical testing, the performance standards (ground truth) were established by the relevant ASTM test methods.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, which is a common symbol for health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2016
LDR Spine USA Mr. Jamie E. Wilson Regulatory Affairs Specialist 13785 Research Boulevard, Suite 200 Austin, Texas 78750
Re: K152137 Trade/Device Name: FacetBRIDGE® System Regulatory Class: Unclassified Product Code: MRW Dated: January 4, 2016 Received: January 5, 2016
Dear Mr. Wilson:
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 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/Resourcesfor You/Industry/default.htm. 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
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K152137
Device Name FacetBRIDGE® System
Indications for Use (Describe)
The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
· Pseudoarthrosis and failed previous which are symptomatic or which may cause secondary instability or deformity,
· Spondylolisthesis,
· Spondylolysis,
· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
· Degeneration of the facets with instability,
· Trauma including spinal fractures and/or dislocations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for LDR. The logo consists of a blue oval shape with a white figure inside, followed by the letters "LDR" in bold blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller font.
| 510(k) Summary | |
|---|---|
| Owner's Name & Address: | LDR Spine USA13785 Research Blvd. Suite 200Austin, TX 78750 |
| Contact Person: | Mr. Jamie E. WilsonRegulatory Affairs SpecialistPhone: (512) 344-3355Fax: (512) 795-8306Email: jamie.wilson@ldrspine.com |
| Date: | January 19, 2016 |
| Trade Name: | FacetBRIDGE® System |
| Common Name: | System, Facet Screw Spinal Device |
| Panel: | Orthopedic |
| Product Code: | MRW |
| Classification: | Unclassified |
| Predicate Devices: | Primary Predicate:TranS1 Facet Screw- (K073515)Additional Predicates:Apollo Spine Venus Facet Screw System - (K120340)X-Spine Zyfix - (K123932) |
Device Description:
The FacetBRIDGE System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.
Each FacetBRIDGE construct consists of a screw and polyaxial washer both manufactured from Ti-6A1-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for LDR. The logo features a stylized eye-shaped graphic in light blue on the left, followed by the letters "LDR" in bold, dark blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller font size.
Indications for Use:
The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
- Pseudoarthrosis and failed previous fusions which are symptomatic or which may . cause secondary instability or deformity.
- Spondylolisthesis. ●
- Spondylolysis. ●
- Degenerative disc disease (DDD) as defined by neck and/or back pain of . discogenic origin as confirmed by radiographic studies,
- Degeneration of the facets with instability,
- . Trauma including spinal fractures and/or dislocations.
Purpose of this submission:
The purpose of this submission is to introduce the FacetBRIDGE System of facet screws into the market.
Non-Clinical Performance Data:
Non-clinical performance bench testing conducted to support substantial equivalence for the FacetBRIDGE System included:
- Static Three-point Bend per ASTM F1264-14 ●
- . Dynamic Three-point Bend Fatigue per ASTM F1264-14
- Axial Pullout Strength per ASTM F543e1 ●
- Torque to Failure per ASTM F543e1 .
- Screw/washer pull-through testing ●
The results of this non-clinical testing demonstrate the device is substantially equivalent to legally marketed predicate devices.
Technological Characteristics
The FacetBRIDGE System has similar technological characteristics when compared to the predicate devices. The system is comprised of similar components including screws and washers manufactured from titanium alloy provided in various sizes. The FacetBRIDGE System, like the predicates, is indicated for use at C2 through S1 as an adjunct to fusion. The FacetBRIDGE system also achieves stabilization of the spine by immobilizing the facet joints in a method similar to the predicate devices.
Clinical Performance Data:
Clinical testing was not required to demonstrate substantial equivalence.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for LDR. The logo consists of a blue oval shape with a white figure inside, followed by the letters "LDR" in bold blue font. Below the logo is the text "a passion for innovation" in a smaller font size.
Basis of Substantial Equivalence:
The FacetBRIDGE system is substantially equivalent to the predicate devices based on intended use and indications for use. The scientific data from assessment of technological characteristics of this device demonstrate that the subject device is comparable to predicate devices. Therefore, the FacetBRIDGE System is substantially equivalent to the predicate devices.
N/A