(35 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, rivets) and their physical properties and configurations. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies section also indicates no non-clinical testing was performed, which would typically be required for AI/ML-based devices.
Yes
The device is intended for anterior fixation to the cervical spine to treat various spinal conditions like degenerative disc disease, trauma, and deformities, which implies a therapeutic purpose.
No
The device is described as an anterior cervical plate system intended for surgical fixation to the cervical spine, meaning it is an implantable medical device used for treatment, not diagnosis. The "Indications for Use" section lists conditions that would be treated by the device, not conditions it would diagnose.
No
The device description clearly outlines physical components like plates, screws, sub-plates, rivets, and associated instruments, indicating it is a hardware-based medical device.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The description clearly states that the Degas Anterior Cervical Plate System is a system of plates, screws, and associated instruments intended for anterior fixation to the cervical spine. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for surgical procedures to stabilize the cervical spine for various conditions. This is a therapeutic and structural function, not a diagnostic one.
The information provided describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Degas Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates. screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.
The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.
The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.
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)
Non-clinical testing was not performed as part of this submission.
The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling.
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.
Dio Medical Rex Anterior Cervical Plate System (K121862)
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
K132366 ::: page 1 of 2
| SUBMITTED BY | Accel Spine
14901 Quorum Dr. Ste. 125
Dallas, TX 75254 | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 3009051471 | |
| OWNER/OPERATOR
NUMBER | 10035914 | SEP 0 3 2013 |
| CONTACT PERSON | Aekta Patel
General Counsel
Accel Spine
Phone: 214-545-5833
Fax: 888-831-4892 | |
| SUBMISSION PREPARED BY | Lisa Peterson
Kaedon Consulting, LLC
Email: Ipeterson@kaedonconsulting.com
Phone: 512-507-0746 | |
| DATE PREPARED | July 24, 2013 | |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation Orthosis | |
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 888.3060 (Product Code KWQ) | |
| COMMON NAME | Anterior Cervical Plate System | |
| PROPRIETARY NAME | Degas Anterior Cervical Plate System | |
| IDENTIFICATION OF PREDICATE
DEVICE(S) | Dio Medical Rex Anterior Cervical Plate System (K121862) | |
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K132366 ::: page 2 of 2
DEVICE DESCRIPTION
The Degas Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates. screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.
The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.
The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.
INDICATIONS
The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this Special 510(k) is to obtain clearance to market the subject device as the Degas Anterior Cervical Plate System. The subject device was previously cleared as the Dio Medical Rex Anterior Cervical Plate System (K121862). Documentation the legal right to distribute the Degas Anterior Cervical Plate System is maintained at Accel Spine.
The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. The System implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
DISCUSSION OF NON-CLINICAL TESTING
Non-clinical testing was not performed as part of this submission.
CONCLUSIONS
The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. Documentation was provided as part of this Special 510(k) to demonstrate that the Degas Anterior Cervical Plate System is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The HHS logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
September 3, 2013
Accel Spine % Ms. Lisa Peterson Kacdon Consulting, LLC 14001 Hunters Pass Austin, Texas 78734
Re: K132366
Trade/Device Name: Degas Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 1, 2013 Received: August 7, 2013
Dear Ms. Peterson:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Lisa Peterson
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K132366
Device Name: Degas Anterior Cervical Plate System
Indications for Use:
The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices