(97 days)
No
The 510(k) summary describes a mechanical implant (cervical plate system) and its intended use for spinal fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are mechanical tests, not studies evaluating algorithmic performance.
Yes
The device is described as "intended for anterior interbody fixation of the cervical spine" and "indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions," which implies a therapeutic intervention.
No
The device is a cervical plate system for anterior fixation of the cervical spine, used for stabilization and fusion, not for diagnosing conditions.
No
The device description clearly outlines physical components like plates and screws, indicating it is a hardware-based medical device for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior interbody fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "cervical plate" and "bone screws" used for "anterior fixation of the cervical spine." This further confirms it's a physical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with biological specimens outside the body.
- Performance Studies: The performance studies mentioned are related to mechanical testing (compression bending and torsion), which is typical for surgical implants, not IVDs.
Therefore, the Altus Spine Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altus Spine Cervical Plate System is interior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Product codes
KWQ
Device Description
The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, sub-axial cervical spine from the C3 through C7 levels.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and dynamic compression bending and static torsion testing in accordance with ASTM F1717 was performed and demonstrated that the Altus Spine Cervical Plate System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cardo Medical Cervical Plate System from Cardo Medical Corporation (K091396), Accin Cervical Plate System by Accelerated Innovations, LLC (K073530), Vertebron SCP Cervical Plate System (K040003)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2017
Altus Partners, LLC Claudia Hill RA/OA Lead 1340 Enterprise Drive West Chester, Pennsylvania 19380
Re: K163061
Trade/Device Name: Altus Spine Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 10, 2017 Received: January 11, 2017
Dear Ms. Hill:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Mark N. Melkerson -S
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) K163061
Device Name Altus Spine Cervical Plate System
Indications for Use (Describe)
The Altus Spine Cervical Plate System is interior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
| 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) |
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510(k) Summary
| SUBMITTER: | Altus Partners
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-355-4156
Fax: 610-300-3049 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Claudia Hill, MSME, RAC
Regulatory Affairs & Quality Assurance
chill@altus-spine.com |
| DATE PREPARED: | October 3, 2016 |
| COMMON NAME: | Anterior Cervical Plate System |
| PROPRIETARY NAME: | Altus Spine Cervical Plate System |
| PRIMARY PREDICATE DEVICE: | Cardo Medical Cervical Plate System from Cardo Medical Corporation
(K091396) |
| ADDITIONAL PREDICATE DEVICES: | Accin Cervical Plate System by Accelerated Innovations, LLC
(K073530); Vertebron SCP Cervical Plate System (K040003) |
| CLASSIFICATION NAME: | 21 CFR §888.3060 |
| PRODUCT CODES: | KWQ |
| DEVICE CLASS: | Class II |
| MATERIAL: | The material used is Titanium Alloy that conforms to ASTM F136 |
DEVICE DESCRIPTION:
The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.
INDICATIONS FOR USE:
The Altus Spine Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The technological characteristics of the Altus Spine Cervical plate system is equivalent to the predicate device, except for the locking mechanism. The locking mechanism is provided to ensure that the bone screws remain in place.
SUMMARY OF NON-CLINICAL TESTS SUBMITTED:
Static and dynamic compression bending and static torsion testing in accordance with ASTM F1717 was performed and demonstrated that the Altus Spine Cervical Plate System is substantially equivalent to the predicate devices.
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices.