(68 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "Boundary Anterior Lumbar Buttress Plate". It is not a study report for an AI/ML powered device, therefore, much of the requested information regarding AI acceptance criteria, training data, and expert review is not applicable.
However, I can extract the information relevant to the non-clinical testing performed and the substantial equivalence argument.
Here's a breakdown of the requested information where applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Test Performed | Reported Device Performance |
|---|---|---|
| ASTM F1717-13 (Static Cantilever Bending) | Static Cantilever Bending | The results indicate substantial equivalence to predicate devices. (Specific quantitative results or acceptance limits are not provided in this document). |
| ASTM F1717-13 (Dynamic Cantilever Bending) | Dynamic Cantilever Bending | The results indicate substantial equivalence to predicate devices. (Specific quantitative results or acceptance limits are not provided in this document). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For non-clinical mechanical testing, "sample size" typically refers to the number of devices tested. The document only states that "the following tests were performed," but does not detail the number of units tested. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert review are concepts relevant to diagnostic or AI-powered devices, not mechanical fixation devices undergoing non-clinical bench testing. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under controlled conditions, measured against established engineering standards like ASTM F1717-13.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation or AI output, not for mechanical testing.
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 not an AI-powered device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is established by the specified test methods and acceptance criteria defined within standards like ASTM F1717-13. The performance of the device is measured directly against these objective, quantitative standards.
8. The sample size for the training set
Not applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name in blue text.
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 | PrimaryPredicate |
|---|---|---|
| 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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Image /page/5/Picture/1 description: The image is a logo for "nVision Biomedical Technologies". The "n" is in gold and the rest of the word is in black. Underneath the word "nVision" is the phrase "BIOMEDICAL TECHNOLOGIES" in gold.
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.
§ 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.