(35 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to stabilize the spine as an aid to fusion for various conditions, indicating a direct therapeutic purpose for treating physical ailments.
No
The device is a system of screws used for spinal fusion and stabilization, not for diagnosing medical conditions. Its purpose is treatment, not diagnosis.
No
The device description clearly states that the FacetBRIDGE® System is a set of screws and optional polyaxial washers, which are physical hardware components used for spinal fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- FacetBRIDGE® System Function: The FacetBRIDGE® System is a set of screws and washers intended for surgical implantation to stabilize the spine and aid in fusion. It is a physical implant used directly on the patient's anatomy.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device is used in the body, not on samples taken from the body.
Therefore, the FacetBRIDGE® System falls under the category of a surgical implant or medical device used for structural support and stabilization, not an in vitro diagnostic device.
N/A
Intended Use / 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MRW
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® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (spine, facet joints, pedicle, spinous process, lamina)
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)
Non-clinical performance bench testing conducted to support substantial equivalence for the FacetBRIDGE® System included:
- Engineering and dimensional analysis
- Functional verification study utilizing sawbones.
- Endotoxin Testing
The results of detailed engineering analyses and functional verifications ensure that the addition of a new washer does not create a new worst case in terms of functionality or mechanical strength and therefore this line extension is substantially equivalent to the predicate system and does not require new testing.
Clinical testing was not required to demonstrate substantial equivalence.
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.
Not Found
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
N/A
0
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
LDR Spine USA, Incorporated Mr. James E. Wilson Regulatory Affairs Specialist 13785 Research Boulevard, Suite 200 Austin, Texas 78750
Re: K161798
Trade/Device Name: FacetBRIDGE® System Regulatory Class: Unclassified Product Code: MRW Dated: July 28, 2016 Received: July 29, 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/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,
Vincent J. Devlin -S
for
- 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) K161798
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 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.
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) |
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Image /page/3/Picture/0 description: The image contains the logo for LDR. The logo consists of a stylized eye graphic in light blue, followed by the letters "LDR" in bold, dark blue font. Below the logo, the text "a passion for innovation" is written in a smaller, light blue font.
| 510(k) Summary | |
|---|---|
| Owner's Name & Address: | LDR Spine USA, Incorporated |
| 13785 Research Blvd. Suite 200 | |
| Austin, TX 78750 | |
| Contact Person: | Mr. Jamie E. Wilson |
| Regulatory Affairs Specialist | |
| Phone: (512) 344-3355 | |
| Fax: (512) 795-8306 | |
| Email: jamie.wilson@ldrspine.com | |
| Date: | July 28, 2016 |
| Trade Name: | FacetBRIDGE® System |
| Common Name: | System, Facet Screw Spinal Device |
| Panel: | Orthopedic |
| Product Code: | MRW |
| Classification: | Unclassified |
| Predicate Devices: | Primary Predicate: |
| FacetBRIDGE® System – Facet Screws (K152137, LDR Spin | |
| 1/25/2016) |
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® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-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.
Indications for Use:
The LDR 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
4
Image /page/4/Picture/0 description: The image is a logo for LDR. The logo features a stylized eye graphic in light blue, 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, lighter font.
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 LDR 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, ●
- o 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,
- o Trauma including spinal fractures and/or dislocations.
Purpose of this submission:
The purpose of this submission is to introduce a line extension which includes an additional washer design for the FacetBRIDGE® System.
Non-Clinical Performance Data:
Non-clinical performance bench testing conducted to support substantial equivalence for the FacetBRIDGE® System included:
- Engineering and dimensional analysis
- Functional verification study utilizing sawbones. .
- o Endotoxin Testing
The results of detailed engineering analyses and functional verifications ensure that the addition of a new washer does not create a new worst case in terms of functionality or mechanical strength and therefore this line extension is substantially equivalent to the predicate system and does not require new testing.
Clinical Performance Data:
Clinical testing was not required to demonstrate substantial equivalence.
Basis of Substantial Equivalence:
The FacetBRIDGE® System is substantially equivalent to the predicate devices based on intended use and indications for use. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness and the scientific data from assessments of these characteristics demonstrate that the subject device is fit for its intended use and comparable to the predicate device. Therefore, the modified FacetBRIDGE® System is overall is substantially equivalent to the predicate FacetBRIDGE® System.