(82 days)
No
The device description and intended use clearly describe a mechanical plating system for spinal stabilization. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
This device is a plating system providing stabilization to promote fusion of the cervical spine, which directly treats conditions like degenerative disc disease and fractures.
No
This device is described as an implantable plating system used for stabilization to promote fusion of the cervical spine, not for diagnosing conditions.
No
The device description clearly states it is a physical plating system made of titanium alloy, including plates, screws, hooks, and cables, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the OctaFix Occipital Cervical Plating System is a physical implant designed to provide stabilization and promote fusion of the spine. It is a surgical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the OctaFix Occipital Cervical Plating System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The UBP II Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the OctaFix Occipital Cervical Plating System to allow for occipital fixation. These UBP II Bone Screws are limited to occipital fixation only.
The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.
The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
Product codes
KWP, KWQ
Device Description
The Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System consists of a single horse shoe shaped piece of alloyed titanium, resembling two rods that run axially along the cervical and upper thoracic spine and are joined by a flatter, plate-like section, that is intended for fixation to the occiput. Hooks, screws, and C-Fix™ cables are intended for fixation of the OctaFix Plate. UPB II Screws are intended for fixation to the occiput and Cannulated Side Loading Closed Screws are intended for fixation to the upper thoracic spine. The rods are to be fixed to the cervical spine through either cables or laminar hooks. Components of the OctaFix Occipital Cervical Plating System are manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136 and may be supplied sterile or non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipito-cervico-thoracic junction (occiput-T3), upper thoracic spine (T1-T3)
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 data, collected in accordance with ASTM 1717, were collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design met all functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes CerviFix System (K011969)
Reference Device(s)
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
JUN 1 8 2002
12021009
OctaFix Occipital Cervical Plating System 510(k) Summary
| SUBMITTED BY | Spinal Concepts, Inc.
12012 Technology Blvd., Suite 100
Austin, TX 78727 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | David M. Hooper, Ph.D.
Manager, Regulatory and Clinical Affairs |
| DATE PREPARED | June 4, 2002 |
| CLASSIFICATION NAME | Spinal Interlaminal Fracture Orthosis (888.3050/KWP)
Spinal Intervertebral Body Fixation Orthosis (888.3060/KWQ) |
| COMMON NAME | Spinal Fixation System |
| PROPRIETARY NAME | OctaFix Occiptal Cervical Plating System |
| PREDICATE DEVICE | Synthes CerviFix System (K011969) |
DEVICE DESCRIPTION
The Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System consists of a single horse shoe shaped piece of alloyed titanium, resembling two rods that run axially along the cervical and upper thoracic spine and are joined by a flatter, plate-like section, that is intended for fixation to the occiput. Hooks, screws, and C-Fix™ cables are intended for fixation of the OctaFix Plate. UPB II Screws are intended for fixation to the occiput and Cannulated Side Loading Closed Screws are intended for fixation to the upper thoracic spine. The rods are to be fixed to the cervical spine through either cables or laminar hooks. Components of the OctaFix Occipital Cervical Plating System are manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136 and may be supplied sterile or non-sterile.
INDICATIONS
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The UBP II Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the OctaFix Occipital Cervical Plating System to allow for occipital fixation. These UBP II Bone Screws are limited to occipital fixation only.
The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.
The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
1
MECHANICAL TEST DATA
Mechanical testing data, collected in accordance with ASTM 1717, were collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design met all functional requirements.
BASIS OF SUBSTANTIAL EQUIVALENCE
The OctaFix Occipital Cervical Plating System and the CerviFix are substantially equivalent in terms of fit, form and function. Both are made from titanium alloy, and include bone screws of occipital fixation, hooks and cables for cervical fixation and screws for thoracic fixation. Both systems are based upon a rod-plate component.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JUN 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
David M. Hooper, Ph.D. Manager, Clinical and Regulatory Affairs Spinal Concepts, Inc. 12012 Technology Blvd., Suite 100 Austin, Texas 78727
Re: K021009
Trade/Device Name: OctaFix Occipital Cervical Plating System Regulation Number: 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 26, 2002 Received: March 28, 2002
Dear Dr. Hooper:
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 - David M. Hooper, Ph.D.
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.
Sincerely yours,
Mark N Milkersen
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
INIDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): K021009
Device Name: Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System
Indications for Use:
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The UBP II Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the OctaFix Occipital Cervical Plating System to allow for occipital fixation. These UBP II Bone Screws are limited to occipital fixation only.
The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.
The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spir the indications specified above. - - -
Mark n Milkeren
(Division Sign-Off)
Division of General, Festorative and Neurological Devices
510(k) Number K021009
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR
Over-The-Counter: (Optional Format 1-2-96)