(162 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for various spinal conditions such as degenerative spondylolisthesis with neurologic impairment, fracture, scoliosis, kyphosis, and spinal tumor, which are all medical conditions that would benefit from therapeutic intervention. The device's function to "extend a rigid spinal construct" implies it is used to treat or manage these conditions.
No
Explanation: The device, the Annex™ Adjacent Level System, is described as a system of connectors used to extend a spinal construct with pedicle screw fixation. Its intended use is for treating various spinal conditions and it is a surgical implant designed for mechanical support, not for diagnosis.
No
The device description explicitly states that the Annex™ Adjacent Level System consists of physical connectors manufactured from titanium and cobalt chrome alloys, which are hardware components.
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, or tissue) to provide information about a person's health.
- Device description: The Annex™ Adjacent Level System is described as a system of connectors made from titanium and cobalt chrome alloys used to extend a rigid spinal construct. It is a physical implant used in surgery.
- Intended Use: The intended use describes the conditions for which the device is used in the spine (degenerative spondylolisthesis, fracture, etc.) and how it is used in conjunction with pedicle screw fixation systems. This is a surgical application, not a diagnostic test performed on a sample.
The device is a surgical implant used to treat spinal conditions, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
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 accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, LS-S1 vertebral joint, lumbar and sacral spine (L3-S1)
Indicated Patient Age Range
skeletally mature patients
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)
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.
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.
K070245, K132154, K122226, K011437
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
§ 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.
0
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
1
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.
2
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
3
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