(146 days)
No
The summary describes a traditional spinal fixation system with mechanical components and instrumentation, with no mention of AI or ML capabilities.
No.
The device is an implantable fixation system intended to stabilize the spine as an adjunct to fusion, not to provide therapy directly.
No
Explanation: The device is a spinal fixation system, which is an implant used for posterior fusion. Its intended use describes treatment for various spinal conditions, not diagnosis. The "Device Description" also refers to it as a "pedicle screw system" and discusses its components for fixation.
No
The device description explicitly lists various hardware components such as screws, rods, connectors, and instrumentation, indicating it is a physical medical device system, not software-only.
Based on the provided text, the Arsenal Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Arsenal Spinal Fixation System is a surgical implant used for posterior spinal fixation. It is a physical device implanted into the body to stabilize the spine.
- The intended use and device description clearly describe a surgical implant and associated instruments, not a diagnostic test.
Therefore, the Arsenal Spinal Fixation System falls under the category of a surgical implant or device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis: curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.
The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.
Product codes
OSH, NKB, MNI, MNH
Device Description
The Arsenal Spinal Fixation System is a Class III non-cervical, posterior approach pedicle screw system. The Arsenal Spinal Fixation System allows surgeons to perform posterior thoracolumbar spine fusion utilizing both implants for fixation and ergonomic instruments to meet the surgeon's needs.
This traditional 510(k) submission adds a new pedicle screw system to Alphatec Spine's current offering and provides the following:
- Polyaxial, Reduction, Sacral, and Cortical non-cannulated, titanium, self-tapping, pedicle . screws
- Cancellous, Sacral, and Cortical dual lead threadforms ●
- Titanium set screws .
- Straight and pre-contoured rods in titanium and cobalt chromium .
- Titanium connectors which include Variable Bridges, Offset Connectors, Revision Connectors, Axial Connectors and Domino Connectors
- . Instrumentation necessary to perform posterior fixation system procedures
- . Connects with other Alphatec systems to provide fixation for the entire spine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, posterior thoracolumbar spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients, adolescent
Intended User / Care Setting
surgeons
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)
Performance testing was conducted in accordance with Static Compression per ASTM F1717. Dynamic Compression per ASTM F1717, Static Torsion per ASTM F1717, Fatigue Run-out per ASTM F1798. Static Interconnection per ASTM F1798. Static Axial Grip per ASTM F1798, Torsional Gripping Capacity per ASTM F1798 and Neutral/Maximum Angulation Pulloff Strength testing.
Test results demonstrate that this new pedicle screw system is substantially equivalent to the predicate Zodiac Spinal Fixation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
MAR 1 3 2014
| Submission Date: | March 13, 2014 |
|---|---|
| Submitter Information: | Alphatec Spine, Inc. |
| 5818 El Camino Real | |
| Carlsbad, CA 92008 | |
| Ph: (760) 431-9286 | |
| Fax: (760) 431-0289 | |
| Contact: | Renée L. Murphy |
| Sr. Regulatory Affairs Specialist | |
| Ph: (760) 494-6739 | |
| Trade/Model Name: | Arsenal Spinal Fixation System™ |
| Common Name: | Pedicle Screw System |
| Classification Regulation: | 21 CFR 888.3070, Pedicle screw spinal system |
| Class III | |
| Product Code(s): | OSH, NKB, MNI, MNH |
Device Description
The Arsenal Spinal Fixation System is a Class III non-cervical, posterior approach pedicle screw system. The Arsenal Spinal Fixation System allows surgeons to perform posterior thoracolumbar spine fusion utilizing both implants for fixation and ergonomic instruments to meet the surgeon's needs.
This traditional 510(k) submission adds a new pedicle screw system to Alphatec Spine's current offering and provides the following:
- Polyaxial, Reduction, Sacral, and Cortical non-cannulated, titanium, self-tapping, pedicle . screws
- Cancellous, Sacral, and Cortical dual lead threadforms ●
- Titanium set screws .
- Straight and pre-contoured rods in titanium and cobalt chromium .
- Titanium connectors which include Variable Bridges, Offset Connectors, Revision Connectors, Axial Connectors and Domino Connectors
- . Instrumentation necessary to perform posterior fixation system procedures
- . Connects with other Alphatec Spine systems to provide fixation for the entire spine
1
Indications for Use
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis: curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.
The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.
Substantial Equivalence Claimed
The Arsenal Spinal Fixation System is substantially equivalent to the Alphatec Spine, Inc., Zodiac® Spinal Fixation System (K100685) for implants, instruments, indications for use, labeling, materials, design, technology and performance. In addition, the Arsenal Spinal Fixation System is substantially equivalent to the Medtronic Sofamor Danek USA, Inc., CD Horizon® Spinal System (K130646) for implants, instruments, and indications for use.
Technical Characteristics
The intended use and technological design features of the Arsenal Spinal Fixation System are similar to the predicate Zodiac Spinal Fixation System. Both are pedicle screw systems intended for posterior non-cervical screw fixation as an adjunct to fusion. In addition, both systems have the same technical characteristics in terms of design and materials.
Non-Clinical Performance Testing
Performance testing was conducted in accordance with Static Compression per ASTM F1717. Dynamic Compression per ASTM F1717, Static Torsion per ASTM F1717, Fatigue Run-out per ASTM F1798. Static Interconnection per ASTM F1798. Static Axial Grip per ASTM F1798, Torsional Gripping Capacity per ASTM F1798 and Neutral/Maximum Angulation Pulloff Strength testing.
Test results demonstrate that this new pedicle screw system is substantially equivalent to the predicate Zodiac Spinal Fixation System.
Conclusion
The Arsenal Spinal Fixation System is substantially equivalent to the predicates in terms of components, indications for use, design, materials, labeling, technology and performance.
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
March 13, 2014
Alphatec Spine, Incorporated Ms. Renée L. Murphy Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K133221
Trade/Device Name: Arsenal Spinal Fixation System™ Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH Dated: February 12, 2014 Received: February 14, 2014
Dear Ms. Murphy:
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 - Ms. Renée L. Murphy
forth in the quality systems (QS) 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" (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,
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K 133221
Device Name
Arsenal Spinal Fixation System
Indications for Use (Describe)
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e. Fracture or dislocation); spinal senosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); turnor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical screw fixation patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.
The Arsenal Spinal Fixation System is intended to be used with with autograft and/or allograft.
Type of Use (Select one or both, as applicable)
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 (9/13)
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