(118 days)
Not Found
No
The 510(k) summary describes a mechanical implant (cervical plate system) and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the materials, design, and intended use for spinal fusion stabilization.
Yes
The device is described as a system for temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with various spinal conditions, indicating it is used for therapeutic purposes.
No
The device is described as a system for temporary stabilization of the anterior spine during cervical spinal fusions, not for diagnosing conditions.
No
The device description explicitly states that the system includes titanium alloy plates and screws, which are hardware components.
Based on the provided information, the Spineway Blue Mountain Cervical Plate 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 Spineway Blue Mountain Cervical Plate System is a surgical implant intended for temporary stabilization of the cervical spine during fusion. It is a physical device implanted in the body, not a tool for analyzing biological samples.
The description clearly outlines its use in surgical procedures for spinal stabilization, which falls under the category of medical devices, but not specifically IVD devices.
N/A
Intended Use / Indications for Use
The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
Product codes
KWQ
Device Description
The Spineway Blue Mountain Cervical Plate System that includes titanium alloy (per ASTM F136 and ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available in various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
Risk analysis and validation activities were performed according to Spineway design control procedure. The risk analysis demonstrated that the subject addition to Blue Mountain Cervical Plate System is substantially equivalent to its predicate device. Spineway determined that the changes made to the device did not present a new worst case, and therefore, no new testing was conducted.
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
§ 888.3060 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
May 7, 2015
Spineway % Rich Jansen, Pharm.D. President Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905
Re: K150036
Trade/Device Name: Blue Mountain Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 8, 2015 Received: April 9, 2015
Dear Dr. Jansen:
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
1
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 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/Resourcesfor You/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 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 yours,
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) K150036
Device Name Blue Mountain Cervical Plate System
Indications for Use (Describe)
The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date Prepared: | January 8, 2015 |
|---|---|
| Submitter Contact: | Julien Thao my |
| Spineway S.A. | |
| 7 Allee Moulin Berger | |
| Ecully, France 69130 | |
| Julien Thao my [quality.jtm@spineway.com] | |
| +33 (0)4 72 77 01 52 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | Blue Mountain Cervical Plate System |
| Product Class: | Class II |
| Classification: | 21 CFR 888.3060 Spinal intervertebral body fixation orthosis |
| Common Name: | Spinal Fixation Device |
| Product Codes: | KWQ |
| Panel Code: | 87 |
Indications for Use:
The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
Device Descriptions:
The Spineway Blue Mountain Cervical Plate System that includes titanium alloy (per ASTM F136 and ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available in various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.
Predicate Device(s):
The Spineway Blue Mountain Cervical Plate System is substantially equivalent to the Qualgenix Blue Mountain Cervical Plate System (K112809),
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Technological Characteristics:
The Blue Mountain Cervical Plate System is very similar to the predicate device. The materials, screw type, screw diameters and screw locking mechanism is exactly the same as the predicate device. This submission includes new plate sizes and some new instruments.
Performance Data:
Risk analysis and validation activities were performed according to Spineway design control procedure. The risk analysis demonstrated that the subject addition to Blue Mountain Cervical Plate System is substantially equivalent to its predicate device. Spineway determined that the changes made to the device did not present a new worst case, and therefore, no new testing was conducted.
Conclusion:
Spineway concludes that the Spineway Blue Mountain Cervical Plate System is substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness.