(68 days)
No
The description focuses on a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to stabilize allograft or autograft as an aid to spinal fusion and provides temporary stabilization, which are therapeutic functions.
No
This device is a surgical implant designed to stabilize the spine and aid in fusion, not to diagnose a condition.
No
The device description clearly states it is a "fixation system" consisting of a "plate shaped to conform to the anatomy" and a "screw fixates the system." This describes a physical, implantable hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Boundary Anterior Lumbar Buttress Plate is a surgical implant intended to stabilize bone grafts in the spine during fusion. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, the Boundary Anterior Lumbar Buttress Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes
KWQ
Device Description
The Boundary Anterior Lumbar Buttress Plate is a fixation system used as a buttress of the interbody, to stabilize the allograft or autograft at one level during the development of a spinal fusion. The device consists in a plate shaped to conform to the anatomy of the anterior lumbar and lumbosacral spine (L1-S1). A screw fixates the system to the anterior surface of the vertebral body, allowing the plate to extend onto the adjacent intervertebral space. The buttress end of the plate may be oriented either caudal or cephalad. The Boundary Anterior Lumbar Buttress Plate may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar and lumbosacral spine (L1-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
No FDA performance standards have been established for the Boundary Anterior Lumbar Buttress Plate. The following tests were performed to demonstrate safety based on current industry standards:
- . Static Cantilever Bending per ASTM F1717-13
- . Dynamic Cantilever Bending per ASTM F1717-13
The results of these tests indicate that the Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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December 6, 2017
Nvision Biomedical Technologies, LLC % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104
Re: K173091
Trade/Device Name: Boundary Anterior Lumbar Buttress Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 28, 2017 Received: September 29, 2017
Dear Dr. Komiyama:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173091
Device Name Boundary Anterior Lumbar Buttress Plate
Indications for Use (Describe)
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DATE PREPARED September 28, 2017
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 350 N Loop 1604 E #103, San Antonio, TX 78232, USA Telephone: Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Boundary Anterior Lumbar Buttress Plate
COMMON NAME
Appliance, Fixation, Spinal Intervertebral Body
DEVICE CLASSIFICATION
Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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DEVICE DESCRIPTION
The Boundary Anterior Lumbar Buttress Plate is a fixation system used as a buttress of the interbody, to stabilize the allograft or autograft at one level during the development of a spinal fusion. The device consists in a plate shaped to conform to the anatomy of the anterior lumbar and lumbosacral spine (L1-S1). A screw fixates the system to the anterior surface of the vertebral body, allowing the plate to extend onto the adjacent intervertebral space. The buttress end of the plate may be oriented either caudal or cephalad. The Boundary Anterior Lumbar Buttress Plate may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
PREDICATE DEVICE IDENTIFICATION
The Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the following predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|----------------------------------------------------------------------|----------------------|
| K092659 | RCS® Anterior Buttress Plate System / Precision Spine, Inc. | ✓ |
| K133911 | Anterior Buttress Plate System / Genesys Spine | |
| K161524 | Tangis Anterior Cervical Plate / Nvision Biomedical Technologies,LLC | |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Boundary Anterior Lumbar Buttress Plate. The following tests were performed to demonstrate safety based on current industry standards:
- . Static Cantilever Bending per ASTM F1717-13
- . Dynamic Cantilever Bending per ASTM F1717-13
The results of these tests indicate that the Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimension as the devices cleared in K092659 and K133911. The subject device uses similar or identical materials as the devices cleared in K092659, K133911, and K161524. The subject device has similar intended use and similar technological characteristics (self-tapping and self-drilling screws) as the devices cleared in K092659 and K133911. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.
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CONCLUSION
Based on the testing performed, including static and dynamic cantilever bending, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Boundary Anterior Lumbar Buttress Plate are assessed to be substantially equivalent to the predicate devices. The device is considered safe and effective for its intended use.