(88 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and materials of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "temporarily stabilizing the cervical spine during the development of solid spinal fusion" for various medical conditions, including degenerative disease, trauma, and tumors, which are therapeutic interventions.
No
The device is an implantable plating system designed for stabilizing the cervical spine, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes physical components (plates and screws) made of titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for temporarily stabilizing the cervical spine during the development of solid spinal fusion. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details plates and screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's spine.
N/A
Intended Use / Indications for Use
The Cervive Anterior Cervical Plating System is indicated for use in temporarily stabilizing the cervical spine during the development of solid spinal fusion in patients with degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), primary and metastatic malignant tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, and/or spinal cord stenosis.
Product codes (comma separated list FDA assigned to the subject device)
87KWQ
Device Description
The Cervive Anterior Cervical Plating System includes plates and expanding screws, both of which are manufactured from titanium alloy (TiAl6V4) that conforms to BS 7252 Part 3 (ISO 5832-3) Metallic Materials for Surgical Implants - specifications for wrought TiAl6V4.
The plates range in length and number of holes for screw placement (see heading "Devices to be cleared in this submission" for a complete range of sizes/hole options). The expanding screws are offered in 13, 15 and 16mm lengths. Each screw provides monocortical fixation and consists of two components: the expanding screw and the conus (inner screw).
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
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)
Mechanical testing has been carried out in accordance with ASTM 1717-96. Protocols and reports from this testing are provided in Section 9.
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
510(k) SUMMARY
NOV 1 9 2002
Device: Cervive Anterior Cervical Plating System
Date: 08/22/02
Corin USA Applicant's name: 10500 University Center Drive, Suite 190 Tampa, FL 33612
Phone: (813) 977-4469 (813) 979-0042 Fax:
Joel Batts, Regulatory Affairs Manager Contact person:
Classification name: Appliance, fixation, spinal intervertebral body
Product codes: 87KWQ
C.F.R. section: 21.888.3060
Device class: II
Classification panel: Orthopedic
Indications for use
The Cervive Anterior Cervical Plating System is indicated for use in temporarily stabilizing the cervical spine during the development of solid spinal fusion in patients with degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), primary and metastatic malignant tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, and/or spinal cord stenosis.
Section 2 Page 1 of 2
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KO22798 Page 2/2
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Device description
The Cervive Anterior Cervical Plating System includes plates and expanding screws, both of which are manufactured from titanium alloy (TiAl6V4) that conforms to BS 7252 Part 3 (ISO 5832-3) Metallic Materials for Surgical Implants - specifications for wrought TiAl6V4.
The plates range in length and number of holes for screw placement (see heading "Devices to be cleared in this submission" for a complete range of sizes/hole options). The expanding screws are offered in 13, 15 and 16mm lengths. Each screw provides monocortical fixation and consists of two components: the expanding screw and the conus (inner screw).
Substantial equivalence basis
The sponsor claims substantial equivalence (SE) of the Cervive Anterior Cervical Plating System to the previously approved Synthes Cervical Spine Locking Plate (K945700) and Blackstone Anterior Cervical Plate (K974885).
Mechanical testing has been carried out in accordance with ASTM 1717-96. Protocols and reports from this testing are provided in Section 9.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be the primary content of the image. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel Batts Regulatory Affairs Manager Corin USA 10500 University Center Drive, Suite 190 Tampa, Florida 33612
Re: K022798 Trade Name: Cervive Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 22, 2002 Received: August 23, 2002
Dear Mr. Batts:
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.
Image /page/2/Picture/9 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 abstract symbol that resembles three curved lines or strokes, possibly representing human figures or abstract shapes.
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Page 2 - Mr. Joel Batts
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/dsmamain.html.
Sincerely yours,
for Mark A. Mullan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K022798
Device Name: Cervive Anterior Cervical Plating Syste
Indications for Use:
The Cervive Anterior Cervical Plating System is indicated for use in temporarily stabilizing the cervical spine during the development of solid spinal fusion in patients with degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), primary and metastatic malignant tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, and/or spinal cord stenosis.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millan
Division Sign-Off
Division of Comed. Restorative and Neurological Devices Optional Format 3-10-98) (Posted July 1, 1998)(k) Number -