(140 days)
No
The device description and intended use clearly define a mechanical implant system for spinal fixation, with no mention of software, algorithms, or data processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a "supplemental fixation device" and "temporary fixation device until fusion is achieved" for spinal conditions, not as a device that provides therapeutic treatment itself. Its purpose is to stabilize the spine to facilitate natural healing processes like fusion.
No
The provided text explicitly states that the device is a "fixation device" and lists its intended use as "anteriorly placed supplemental fixation" and a "temporary fixation device until fusion is achieved," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the system consists of plates, screws, and surgical instruments, which are hardware components.
No, 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 provided text clearly describes a surgical implant (plates and screws) used for fixation of the lumbar spine. It is a physical device implanted into the body to provide structural support.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is purely mechanical and structural.
Therefore, based on the provided information, the AEGIS Anterior Lumbar Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.
The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The AEGIS Anterior Lumbar Plate System consists of an assortment of plates and screws.
The AEGIS Anterior Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior lumbar (L1 - S1)
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 were submitted to characterize the AEGIS Anterior Lumbar Plate System components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy AcroMed M-2 Anterior Plate System, K972718, Medtronic Sofamor Danek PYRAMID Anterior Plate Fixation System, K013665
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
§ 888.3060 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
AEGIS Anterior Lumbar Plate System
510(k) Summary IX.
? ੋਵਿੰਗ ਤੇ
SUBMITTER: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780
- CONTACT PERSON: Mary Gray Phone: (508) 828-3649 Fax: (508) 828-3797
- DATE PREPARED: January 12, 2006
- CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis 8888.3060
- AEGIS Anterior Lumbar Plate System PROPRIETARY NAME:
- DePuy AcroMed M-2 Anterior Plate System, K972718 PREDICATE DEVICES: Medtronic Sofamor Danek PYRAMID Anterior Plate Fixation System, K013665
- DEVICE DESCRIPTION: The AEGIS Anterior Lumbar Plate System consists of an assortment of plates and screws.
The AEGIS Anterior Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
- INTENDED USE: The indications for use for the devices described in this submission are as follows:
The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.
1
AEGIS Anterior Lumbar Plate System
The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium alloy. |
|---|---|
| ------------ | ------------------------------------------------------------ |
PERFORMANCE DATA:
Performance data were submitted to characterize the AEGIS Anterior Lumbar Plate System components.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a triple-line design, resembling a stylized human form, which is a common symbol associated with HHS.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
Ms. Mary Gray Senior Regulatory Affairs Associate Depuy Spine 325 Paramount Drive Raynham, MA 02767
Re: K052546
Trade Name: AEGIS Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: January 12, 2006 Received: January 13, 2006
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have letermined 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 accordailed with the provisions of the Pourmay, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general construction, 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 rryour do nec 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 I oter a 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 - Mr. Noah Bartsch
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
A 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
510(k) Number (if known): K052546
AEGIS Anterior Lumbar Plate System Device Name:
Indications For Use:
The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.
The device is intended as a temporary fixation device until fusion is achieved . The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (1.1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with dcgcneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEIEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K052546