(126 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device description and intended use clearly state that it is a fixation device for achieving supplemental fusion in the spine, addressing various medical conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor. These are all therapeutic applications.
No
The InterBRIDGE® System is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine, and not for diagnosing conditions.
No
The device description explicitly states it includes "various sizes of titanium plate constructs" and is "implanted via a posterior approach to the spine," indicating it is a physical implant and not software-only.
No, 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, or tissue) to provide information about a person's health.
- Device Description: The InterBRIDGE® System is a physical implantable device used for spinal fixation. It is surgically implanted into the body.
- Intended Use: The intended use is to provide supplemental fixation to the spine for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- . Tumor
The InterBRIDGE® system is not intended for stand-alone use.
Product codes
PEK
Device Description
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
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 InterBRIDGE has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-12a .
- Static torsion per modified ASTM F1717-12a .
- Dynamic axial compression bending fatigue per modified ASTM F1717-12a .
- Static axial pull-out resistance .
- Static plate dissociation t
The results of this non-clinical testing show that the strength of the InterBRIDGE 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)
K100354, K073278, K131238, K123093
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
510(K) SUMMARY
| Submitter's Name: | LDR Spine USA, Inc. |
|---|---|
| Submitter's Address: | 13785 Research Boulevard, Suite 200 |
| Austin, TX 78750 | |
| Submitter's Telephone: | 512.344.3333 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | 31 October 2013 |
| Trade or Proprietary Name: | InterBRIDGE Interspinous Posterior Fixation System |
| Common or Usual Name: | Appliance, Fixation, Spinal Interlaminal |
| Spinous Process Plate | |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Code: | PEK |
| Classification Panel: | Division of Orthopedic Devices - Posterior Spine Device |
| Branch | |
| Predicate Devices: | OsteoMed Spine PrimaLOK™ Interspinous Fusion |
| System (K100354) | |
| NuVasive Affix Spinous Process Plate (K073278, | |
| K131238) | |
| Southern Spine StabiLink™ MIS Spinal Fixation System | |
| (K123093) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.
1
INDICATIONS FOR USE
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate
fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- . Tumor
The InterBRIDGE® system is not intended for stand-alone use.
TECHNICAL CHARACTERISTICS
Data was provided which demonstrated the InterBridge® System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function. The devices are manufactured from titanium alloy (ASTM F136). The predicate devices are manufactured from the same or similar materials.
PERFORMANCE DATA
The InterBRIDGE has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-12a .
- Static torsion per modified ASTM F1717-12a .
- Dynamic axial compression bending fatigue per modified ASTM F1717-12a .
- Static axial pull-out resistance .
- Static plate dissociation t
The results of this non-clinical testing show that the strength of the InterBRIDGE is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics, indications for use, and mechanical performance data lead to the conclusion that the InterBRIDGE is substantially equivalent to the predicate device.
LDR InterBRIDGE Posterior Fixation System
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
LDR Spine, USA, Incorporated % Ms. Meredith May Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, CO 80918
Re: K133363
Trade/Device Name: InterBRIDGE Interspinous Posterior Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 29, 2014 Received: November 5, 2014
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 your 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 that 1 27 that intatutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing Confight the Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical (21 CFR 801), racements) (21 CFR 803); good manufacturing practice requirements as set de receited adverse overses (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Meredith May
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vincent 原因Avlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: InterBRIDGE Interspinous Posterior Fixation System
510(k) Number: K133363
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- . Tumor
The InterBRIDGE® system is not intended for stand-alone use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zane W.Wyatt -S
(Division Sign-Off) Division of Orthopedic Devices 510{k} Number: K133363