(84 days)
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No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an implant system used for temporary stabilization during spinal fusions, which is a structural support rather than a active therapeutic treatment.
No
Explanation: The device is a surgical implant (anterior cervical plate system) used for spinal stabilization and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of bone plates, screws, and associated instruments made from titanium alloy, which are physical hardware components.
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 screw fixation of the cervical spine" 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 description details bone plates, screws, and instruments made from titanium alloy. These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and analytical procedures performed in vitro (outside the body).
Therefore, the PREMIER™ Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PREMIER™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The PREMIER™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (slide washers and set screws are preassembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test data were provided in support of this notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
K'y92110
SEP 1 4 1991
PREMIER™ Anterior Cervical Plate System 510(k) Summary June 21, 1999
| I. | Company: | Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
|-----|----------------------|-----------------------------------------------------------------------------------|
| II. | Product Name: | PREMIERTM Anterior Cervical Plate System |
| | Classification Name: | Spinal intervertebral body fixation orthosis |
- The PREMIER™ Anterior Cervical Plate System consists of a variety of III. shapes and sizes of bone plates (slide washers and set screws are preassembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
- The PREMIER™ Anterior Cervical Plate System is intended for anterior IV. interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
- The PREMIER™ Anterior Cervical Plate System was claimed to be V. substantially equivalent to commercially available cervical plating systems. Literature concerning these devices was supplied in support of establishing equivalence.
Mechanical test data were provided in support of this notification.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall appearance is simple and straightforward, focusing on conveying the name of the organization.
ن تي تي
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
SEP 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K992110
Trade Name: Premier™ Anterior Cervical Plate and Screw System Regulatory Class: II Product Code: KWQ Dated: June 21, 1999 Received: June 22, 1999
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System , Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Dr. Richard W. Treharne Page 2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _ 1 of _ 1 June 21, 1999
510(k) Number (if known): K 992 // 0
Device Name:
Indications for Use:
The PREMIER™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or_failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992110 |
| Prescription Use
(Per 21 CFR 801.109)
| 2-96) | X |
|---|---|
| --------------------------------------------------- | --- |
OR
| Over-The-Counter Use
| (Optional Format 1-) | |
|---|---|
| ---------------------------------------------- | -- |