(111 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a spinal implant for temporary stabilization during cervical spinal fusions, which is a structural device, not a therapeutic device designed to treat or cure a disease or condition through non-structural means.
No
This device is described as an anterior cervical plate system intended for fracture fixation and stabilization of the spine, not for diagnostic purposes. Its function is to provide physical support for fusions, not to diagnose medical conditions.
No
The device description explicitly states it consists of "a variety of bone plates and screws" and is made from "titanium alloy," indicating it is a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "interior 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) for structural support and stabilization.
- Device Description: The description details bone plates, screws, and associated instruments made from titanium alloy, designed to be implanted into the vertebral bodies. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize the spine.
N/A
Intended Use / Indications for Use
"Properly used, this system is interior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
"The PREMIER™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The PREMIER™ Anterior Cervical Plate System features a sliding washer that covers the heads of the bone screws to prevent screw back-out. The sliding washer is fixed into place with a set screw. The sliding washer and set screw come pre-assembled to the plate. Associated instruments are available to facilitate the implantation of the device.
The PREMIER™ Anterior Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136 or ISO 5832-3. This material is not compatible with other metal alloys. Do not use any of the PREMIER™ Anterior Cervical Plate System components with the components from any other system or manufacturer. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon/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)
Not Found
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.
Not Found
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
SEP 17 2002
0 21761 p%/
PREMIER™ Anterior Cervical Plate System 510(k) Summary Mav 2002
| I. | Company: | Medtronic 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 |
lll. Device Description:
The PREMIER™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The PREMIER™ Anterior Cervical Plate System features a sliding washer that covers the heads of the bone screws to prevent screw back-out. The sliding washer is fixed into place with a set screw. The sliding washer and set screw come pre-assembled to the plate. Associated instruments are available to facilitate the implantation of the device.
The PREMIER™ Anterior Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136 or ISO 5832-3. This material is not compatible with other metal alloys. Do not use any of the PREMIER™ Anterior Cervical Plate System components with the components from any other system or manufacturer. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
IV. Device Indications:
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
V. Substantial Equivalence:
The PREMIER™ Anterior Cervical Plate System was claimed to be substantially equivalent to itself.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with three lines representing its wings.
SEP 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K021761
Trade/Device Name: PREMIER™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 21, 2002 Received: August 23, 2002
Dear Dr. Treharne:
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.
2
Page 2 – Dr. Richard W. Treharne
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O Mark-N Melherson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): (0217 (e)
Device Name: PREMIER™ Anterior Cervical Plate System
Indications for Use:
Properly used, this system is interior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment 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 Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
Over-the-counter Use
Mark N. Millican
al. Restorative
510/k) Number