(28 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fixation, with no mention of AI/ML or related concepts like image processing, data analysis, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for conditions such as degenerative disc disease, trauma, tumor, and spinal stenosis, which are medical conditions that it aims to treat or manage.
No
The device description clearly states it is a "plate system" and "consists of bone plates, screws, and instrumentation intended for anterior fixation to the cervical spine." Its stated use is for the development of solid spinal fusion, indicating it is an implanted medical device for treatment, not diagnosis. The "Intended Use / Indications for Use" section lists conditions that lead to instability requiring such fixation, but the device itself does not diagnose these conditions.
No
The device description explicitly states it consists of "bone plates, screws, and instrumentation," which are physical hardware components, not software.
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 surgical implant for stabilizing the cervical spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details bone plates, screws, and instrumentation for surgical fixation. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to provide structural support and facilitate fusion.
N/A
Intended Use / Indications for Use
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
-
- Degenerative disc disease (DDD) 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 (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The SC-Acul IX The Cor Dynamed for anterior fixation to the cervical spine. The plate system serews, and motioninentign that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.
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)
PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL): Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this device.
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
AUG 2 9 2005
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|---|---|
| ESTABLISHMENT REGISTRATION NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch |
| Specialist, Regulatory Affairs | |
| Telephone: 512.533.1840 | |
| Fax: 512.918.2784 | |
| DATE: | July 29, 2005 |
| TRADE NAME: | SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System |
| COMMON NAME: | Spinal Fixation System |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation Orthosis |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050 |
| PREDICATE DEVICE: | Spinal Concepts, Inc. (now Abbott Spine, Inc.) Ant-Cer Dynamic Anterior Cervical Plate System, K024326, cleared January 23, 2003. |
DEVICE DESCRIPTION:
Divice Discurix Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, The SC-Acul IX The Cor Dynamed for anterior fixation to the cervical spine. The plate system serews, and motioninentign that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.
INDICATIONS:
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acul ix All Cor Dyname Panepine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with ﻨﺴﺒ degeneration of the disc confirmed by patient history and radiographic studies;
- Trauma (including fractures); 2.
- Tumor; 3.
- Spondylolisthesis; 4.
- Spinal stenosis; న్.
1
K os 5 207 a
p 2 of 2
- Deformity (i.e., scoliosis, kyphosis, lordosis); 6.
- Pseudarthrosis; and 7.
- Failed previous fusions. 8.
The subject device is the result of design COMPARISON TO PREDICATE DEVICE: I he subject to the predicate device, has the same intended use, and is substantially equivalent to the predicate device. NON-CLINICAL PERFORMANCE AND CONCLUSIONS: PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL): Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS:
Clinical data and conclusions were not needed for this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and two wavy lines below, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
AUG 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K052072
K032072
Trade Name: SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: July 29, 2005 Received: August 1, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally mancties provice Americal Device American son to commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval approval application (PMA). and Costnetic Act (Act) that do not require approvince approvisions of the Act. The Act. The You may, merciole, market the actives, bases of the more of registration, listing of
general controls provisions of the Act include requirements for annual registereding and general controls provisions of the rist 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 If your device is classified (sec above) into exist on a considerating your device can
may be subject to such additional controls. Existing major regal consected and them ED may be subject to such additional controls. Existing may of to 898. In addition, FDA may be found in the Code of Feach 1988.
publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Noah Bartsch
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a delerinmation that your as roo be roo be recension would be in or any Federal statules and regulations deminds. but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not areastice asset comply with an the Act s requirements, more 801); good manufacturing practice requirements as setting as set CFR Part 807), labeling (21 CFRT art 807), good and if applicable, the electronic forth in the quality systems (QD) regaliation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Declons of 1 evice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your d I his letter will anow you to oegin maneting your antial equivalence of your deventity ware development premarket notification. THC PDA miding of baction 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), please If you desire specific advice for your ac-1.0. Also, please note the regulation entitled, and colliact the Office of Comphalled at (210) = 15 = 18 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 " Misbranding by relefence to premanter noalities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K052072 510(k) Number (if known):
Device Name:
The SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System
Indications for Use:
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acult ix Allt Oct Dyname i alspine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
-
- Degenerative disc disease (DDD) as defined by neck pain of discogenic origin with Degenerative disc discusse (DDD) - ) - (DD) - ) - ) - ( - ) - ) - ( - ) - ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
-
- Trauma (including fractures);
-
- Tumor;
-
- Spondylolisthesis;
- Spinal stenosis; 5.
-
- Deformity (i.e., scoliosis, kyphosis, lordosis);
-
- Pseudarthrosis; and
-
- Failed previous fusions.
Prescription Use X (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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOS 2072 * (k) Number
Page 1 of 1