(64 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 fixation following anterior cervical fusion to address various conditions like spondylosis, trauma, and degenerative disc disease, which are therapeutic interventions.
No
The device is described as a system for intervertebral body fixation following anterior cervical fusion, indicating it is an implant for treatment rather than a diagnostic tool.
No
The device description explicitly states that the system consists of plates, screws, and surgical instruments, which are physical 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" and lists various spinal conditions. This describes a surgical implant used in vivo (within the body) to provide structural support and stability.
- Device Description: The description details plates, screws, and surgical instruments made from titanium alloy. These are all components of a surgical implant system, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used to treat a condition directly within the body.
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 (comma separated list FDA assigned to the subject device)
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 spine, ranging from 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): 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.
Peak Polyaxial Anterior Cervical Plate System (K971730)
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
| IX. 510(k) Summary | APR - 2 2004 |
|---|---|
| SUBMITTER: | DePuy Spine, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02780 | |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | January 22, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Eagle Anterior Cervical Plate System |
| PREDICATE DEVICES: | Peak Polyaxial Anterior Cervical Plate System |
| (K971730) | |
| 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 Peak Polyaxial Anterior | |
| Cervical Plate System (K971730). 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
2 af 2
Eagle Anterior Cervical Plate System
confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
- Manufactured from ASTM F-136 implant grade MATERIALS: 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
Ms. Lisa Gilman Regulatory Affairs Associate Depuy Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K040197
Trade Name: Eagle Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Namc: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 10, 2004 Received: March 12, 2004
Dear Ms. Gilman:
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 - Ms. Lisa Gilman
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 (301) 594-4659. 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/dsma/dsmamain.html.
Sincerely yours.
Mark N Milbersen
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
4
Indications for Use III.
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 The Eagle Antonor ocernoal + late systems are indicated for patients in which Intervertebrar body incuses 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 traumatic kyphoolo of leraosteration of the disc confirmed by history and discogents "pair" with" dogemendation for failed fusion, or instability following surgery for the above indications.
Mark N. Millkeusen
Division of General, Restorative, and Neurological Devices
510(k) Number K010197
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× ____________________________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use: __ Prescription Use: __ (Per 21 CFR 801.109)