(72 days)
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.
Yes
Explanation: The device is indicated for temporary stabilization of the cervical spine due to various conditions like degenerative disc disease, trauma, and tumor, which are medical conditions that require treatment. It helps in the development of solid spinal fusion, aiming to restore stability and function to the spine.
No.
Explanation: The device is a cervical plate system used for temporary stabilization of the spine during fusion, which is a treatment and not a diagnostic process.
No
The device description explicitly states that the system consists of bone plates, screws, and surgical instruments, all of which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The SC-AcuFix Thinline Anterior Cervical Plate System is a surgical implant used to stabilize the cervical spine within the body. It consists of plates, screws, and instruments used during surgery.
- Intended Use: The intended use is for the temporary stabilization of the cervical spine during fusion, addressing conditions like degenerative disc disease, trauma, tumors, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following 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), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
Product codes
KWQ
Device Description
The SC-AcuFix Thinline Anterior Cervical Plate System consists of various sizes of bone plates, screws and surgical instruments. The screws are used to secure the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. Plates and screws are manufactured from titanium alloy (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 (C2-C7)
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, was collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design changes met design requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 3 2002
K013979
page 1 of 1
SC-AcuFix Thinline Anterior Cervial Plate 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 | November 30, 2001 |
| CLASSIFICATION NAME | KWQ: Spinal Intervertebral Body Fixation Orthosis. Class II. |
| COMMON NAME | Spinal Fixation System |
| PROPRIETARY NAME | SC-AcuFix Thinline Anterior Cervical Plate System |
| PREDICATE DEVICE | SCI Anterior Cervical Plate System, later trademarked
SC-AcuFix (K990005). This is a design modification per
established design control procedures. |
DEVICE DESCRIPTION
The SC-AcuFix Thinline Anterior Cervical Plate System consists of various sizes of bone plates, screws and surgical instruments. The screws are used to secure the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. Plates and screws are manufactured from titanium alloy (ASTM F-136) and may be supplied sterile or non-sterile.
INDICATIONS
The SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following 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), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
MECHANICAL TEST DATA
Mechanical testing data, collected in accordance with ASTM 1717, was collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design changes met design requirements.
Spinal Concepts, Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2002
David M. Hooper, Ph.D. Manager, Clinical and Regulatory Affairs Spinal Concepts 12012 Technology Blvd., Suite 100 Austin, Texas 78727
K013979 Re:
Trade Name: SC-AcuFix Thinline Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 28, 2002 Received: January 29, 2002
Dear Dr. Hooper:
We have reviewed your Section 510(k) premarket 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) 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 - 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,
Miriam C. Provost
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
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Kdl3979
INIDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name:
Spinal Concepts, Inc. SC-AcuFix Thinline Anterior Cervical Plate System
Indications for Use:
The SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following 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), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter: (Optional Format 1-2-96)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K'013979