(30 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and manual surgical instruments, with no mention of software, algorithms, or any terms related to AI/ML.
Yes.
The device is intended for anterior cervical intervertebral body fixation for various conditions like symptomatic cervical spondylosis, trauma, fracture, tumor, and degenerative disc disease, which are therapeutic indications.
No
This device is a surgical plate system used for spinal fixation (anterior cervical intervertebral body fixation), not for diagnosing conditions. Its purpose is to provide stability after fusion procedures for various cervical spine issues.
No
The device description explicitly states that the system consists of plates, screws, and manual surgical instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "anterior cervical intervertebral body fixation." This describes a surgical implant used to stabilize the spine.
- Device Description: The device is described as a system of plates and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The EAGLE™ + Anterior Cervical Plate System is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
The EAGLE™ + Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
Product codes
KWQ
Device Description
The EAGLE + Anterior Cervical Plate System consists of an assortment of plates and screws. The EAGLE + Anterior Cervical 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
cervical intervertebral body, C2 to T1
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 EAGLE + Anterior Cervical Plate System.
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
K070994
Page 1 of 2
IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 | MAY - 9 2007 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Frank S. Jurczak | |
| DATE PREPARED: | April 6, 2007 | |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis | |
| PROPRIETARY NAME: | EAGLE™ + Anterior Cervical Plate System | |
| PREDICATE DEVICES: | EAGLE™ Anterior Cervical Plate System
(K040197) | |
| DEVICE DESCRIPTION: | The EAGLE + Anterior Cervical Plate System consists
of an assortment of plates and screws. | |
| | The EAGLE + Anterior Cervical 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 modified devices
described in this submission are the same as those
for the previously cleared EAGLE Anterior Cervical
Plate System (K040197). The indications are as
follows: | |
| | The EAGLE + Anterior Cervical Plate System is
intended for anterior cervical intervertebral body
fixation. These systems are indicated for patients in
which stability is desired following anterior cervical
fusion for the indications listed below. The intended
levels for treatment range from C2 to T1. | |
| | Indications include symptomatic cervical spondylosis,
trauma, fracture, post-traumatic kyphosis or lordosis,
tumor, degenerative disc disease (defined as
discogenic pain with degeneration of the disc | |
1
K070994
Page 2 of 2
confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
- MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the EAGLE + Anterior Cervical Plate System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in a simple, black line drawing, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine, Incorporated c/o Mr. Frank Jurczak Regulatory Affairs Associate II 325 Paramount Drive Raynham, MA 02767
MAY - 9 2007
Re: K070994
Trade/Device Name: EAGLE + 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: April 06, 2007 Received: April 09, 2007
Dear Mr. Jurczak:
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.
3
Page 2 - Mr. Frank Jurczak
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbine Buent
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
EAGLE™ + Anterior Cervical Plate System Device Name:
Indications For Use:
The EAGLE™ + Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
X Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare bucm
(Division Sign-Off) Division of General. Restorative, and Neurological Devices
510(k) Number K070994