(162 days)
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex™ Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Annex™ Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Annex™ Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure® or Sniper® Spine Systems.
The Annex™ Adjacent Level System consists of a selection of non-sterile, single use connectors manufactured from titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537), for attachment to an existing 5.5mm diameter rod construct to extend a rigid spinal construct. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
The Spine Wave Annex™ Adjacent Level System is a medical device, and the provided document details its 510(k) submission to the FDA. For medical devices seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device, primarily through performance testing and comparison of technological characteristics, rather than meeting specific statistical metrics against a ground truth as would be common for AI/ML devices.
Here's an analysis based on the provided text, structured to answer your questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence via Performance Testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: - Static axial compression bending - Dynamic axial compression bending - Static torsion testing | The device underwent static axial compression bending, dynamic axial compression bending, and static torsion testing according to ASTM F1717. These tests were performed to demonstrate that the Annex™ Adjacent Level System is substantially equivalent to the predicate devices. |
| Material Compatibility: - Materials used in the device are suitable for the intended use and similar to predicate devices. | The device consists of connectors manufactured from titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537). These materials are commonly used in spinal implants and are consistent with industry standards and predicate devices. |
| Intended Use Compatibility: - The system's use for extending existing 5.5mm diameter rod constructs is functionally sound. | The system is designed to attach to an existing 5.5mm diameter rod construct to extend a rigid spinal construct. It can link to 5.5mm diameter rod systems, including the CapSure® or Sniper® Spine Systems, demonstrating compatibility with existing spinal fixation systems. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical performance testing (static and dynamic axial compression bending, static torsion) of the device itself, not a clinical study involving human patients or a software algorithm evaluating data. Therefore, there isn't a "test set" of patient data or data provenance in the typical sense for algorithm evaluation.
The "sample size" for the mechanical tests would refer to the number of physical device units tested for each specific test (e.g., how many screws, rods, or connectors were subjected to compression bending). This information is not provided in the summary. The provenance is the testing laboratory that performed the ASTM F1717 tests, but specific details are not given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to this 510(k) submission. The "ground truth" for this device is its mechanical integrity and performance, established through standardized ASTM F1717 testing, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This concept is not applicable. Mechanical testing results are objective measurements (e.g., load at failure, displacement under load) and do not require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) to assess human reader performance with and without AI assistance. The Annex™ Adjacent Level System is a physical spinal implant, not a diagnostic or AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" employed in this submission is the specified mechanical performance standards outlined in ASTM F1717. The device's performance was compared against these objective engineering standards and against the established performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
There is no training set for this device submission. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set.
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JAN 10 2014
SPINE WAVE
510(k) Summary Annex™ Adjacent Level System
1. Submitter Information
| Submitter: | |
|---|---|
| Address: |
Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 203-712-1847 203-944-9493
Telephone: Telefax:
Contact: Joseph Mercado Date Prepared: December 12, 2013
2. Device Information
| Trade Name: | Annex™ Adjacent Level System |
|---|---|
| Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Pedicle Screw Spinal System |
| Classification/Code: | Class II per 21 CFR 888.3070 / MNH, MNI |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new spinal fixation system.
4. Predicate Device Information
The Annex™ Adjacent Level System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| CapSure® PS System | Spine Wave, Inc. | K070245, K132154 |
| Revere® Stabilization System | Globus Medical, Inc. | K122226 |
| Synergy VLS Spine System | Interpore Cross International | K011437 |
5. Device Description
The Annex™ Adjacent Level System consists of a selection of non-sterile, single use connectors manufactured from titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537), for attachment to an existing 5.5mm diameter rod construct to extend a rigid spinal construct. The connectors are provided in a variety of sizes and shapes to
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accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
6. Intended Use
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex™ Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Annex™ Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Annex™ Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure® or Sniper® Spine Systems.
7. Comparison of Technological Characteristics
The substantial equivalence of the subject Annex™ Adjacent Level System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
Static axial compression bending, dynamic axial compression bending, and static torsion testing according to ASTM F1717 were performed to demonstrate that the subject Annex™ Adiacent Level System is substantially equivalent to the predicates.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the subject Annex™ Adjacent Level System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K132403
Trade/Device Name: Annex™ Adjacent Level System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December 12, 2013 Received: December 13, 2013
Dear Mr. Mercado:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Joseph Mercado
forth in the quality systems (OS) 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 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" (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/ReportalProblem/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.
Ronald#19 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132403
Device Name Annex™ Adjacent Level System
Indications for Use (Describe)
When used with pedicle screw fixation systems of the in skeletally mature patients, the Annex™ Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of newologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Annex™ Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint, having fusions with autogenous bone grafi, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Annex™ Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure® Spine Systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.