(71 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 "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as stabilizing the spine during the intervertebral fusion process, indicated for temporary stabilization and treatment of various spinal conditions like degenerative disc disease, spinal stenosis, trauma, and tumors. These are therapeutic actions aimed at treating a disease or condition.
No
The device is a cervical plate system intended for temporary stabilization during spinal fusions, not for diagnosing conditions.
No
The device description explicitly states it is comprised of titanium alloy plates and screws, which are hardware components, not software.
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 screw fixation at the vertebral bodies of the cervical spine (C2-C7)" and "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is described as "an assortment of titanium alloy plates and screws." These are physical implants.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or components.
Therefore, the SEEplate Cervical Plate System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate 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.
Product codes (comma separated list FDA assigned to the subject device)
KWO, KWQ
Device Description
The SEEplate Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The SEEplate Cervical Plate System is manufactured from wrought Ti-6Al-4V in accordance with ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7), anterior spine
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)
Testing performed indicates the subject device is substantially equivalent to predicate devices.
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.
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
§ 888.3060 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.
0
K082037
Page 1 of 2
Amedica SEEplate Cervical Plate System Special 510(k)
SEP & 6 2008
5. 510(k) Summary
| Contact: | Mr. Adam Herder
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | SEEplate Cervical Plate System |
| Manufacturer: | Amedica Corp.
615 Arapeen Drive, Suite 302
Salt Lake City, UT 84108 |
| Classification: | 21 CFR §888.3060, Spinal intervertebral body fixation
orthosis |
| Class: | II |
| Product Code: | KWO |
Indications For Use:
The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate 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 Description:
The SEEplate Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The SEEplate Cervical Plate System is manufactured from wrought Ti-6Al-4V in accordance with ISO 5832-3.
Predicate Device(s):
The SEEplate Cervical Plate System was shown to be substantially equivalent to the Amedica Valeo Cervical Plate System (K071990) and has the same indications for use, design, function, and materials used.
1
K082037
Page 2 of 2
Amedica SEEplate Cervical Plate System Special 510(k)
Performance Standards:
Testing performed indicates the subject device is substantially equivalent to predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
Amedica Corporation % Musculoskeletal Clinical Regulatory Advisers Mr. Adam Herder 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
K082037 Trade/Device Name: SEEplate Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 15, 2008 Received: September 16, 2008
Dear Mr. Herder:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 – Mr. Adam Herder
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark of Milker
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Amedica SEEplate Cervical Plate System Special 510(k)
4. Indications for Use
K082037 510(k) Number (if known): _
Device Name: SEEplate Cervical Plate System
The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate 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, pscudoarthrosis, 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.
Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation
Mark A. Millerson
Division Sign-Off) Division of General, Restorative, and Neurological De
510(k) Number K082037