(68 days)
Not Found
No
The document describes a mechanical implant system and surgical instruments, with no mention of AI or ML technology.
Yes
The device is intended for "anterior cervical intervertebral body fixation" to provide "stability...following anterior cervical fusion," which are therapeutic actions. It treats multiple medical conditions such as "symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease...spinal stenosis, re-operation for failed fusion, or instability."
No
The device is described as an anterior cervical plate system used for stabilization following fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of plates, screws, and manual 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 devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The EAGLE Plus Micro Anterior Cervical Plate System is a surgical implant (plates and screws) used for fixation in the spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is for anterior cervical intervertebral body fixation following surgery, not for analyzing biological samples.
The information provided clearly describes a surgical implant and associated instruments, which falls under the category of medical devices used in vivo (within the body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The EAGLE Plus Micro 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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Product codes
KWQ
Device Description
The EAGLE Plus Micro Anterior Cervical Plate System consists of a variety of plates and screws designed for use alone or adjacent to a previously implanted anterior cervical plate.
The EAGLE Plus Micro 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, levels 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 Plus Micro 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
X. 510(k) Summary
·
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank S. Jurczak |
| DATE PREPARED: | January 24, 2008 |
| CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis | |
| PROPRIETARY NAME: | EAGLE Plus Micro Anterior Cervical Plate System |
| PREDICATE DEVICES: | K070994 Eagle Plus Anterior Cervical Plate System |
| | K914362 Acroplate Anterior Cervical Plate System
(cleared as the Top Cervical Spine Stabilization
System) |
| DEVICE DESCRIPTION: | The EAGLE Plus Micro Anterior Cervical Plate
System consists of a variety of plates and screws
designed for use alone or adjacent to a previously
implanted anterior cervical plate.
The EAGLE Plus Micro Anterior Cervical Plate
System also contains Class 1 manual surgical
instruments and cases that are considered exempt
from premarket notification. |
| INTENDED USE: | The EAGLE Plus Micro 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, post-traumatic kyphosis or lordosis,
tumor, degenerative disc disease (defined as
discogenic pain with degeneration of the disc
confirmed by history and radiographic studies), spinal
stenosis, re-operation for failed fusion, or instability
following surgery for the above indications. |
.
DePuy Spine, Inc.
510(k)
APR - 2 2008
:
12080191
Page 1 of 2
Page 18
1
K080191
Page 2 of 2
MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System.
DePuy Spine, Inc. 510(k)
Page 19
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine, Incorporated c/o Mr. Frank Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767
APR - 2 2008
Re: K080191 Trade/Device Name: Eagle Plus Micro 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: February 29, 2008 Received: March 3, 2008
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.
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.
3
Page 2 - Mr. Frank Jurczak
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K080191
page 1 of 1
IV. Indications for Use
K080191 510(k) Number (if known):
EAGLE Plus Micro Anterior Cervical Plate System Device Name:
Indications For Use:
The EAGLE Plus Micro 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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Prescription Use: OR Over-The-Counter 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)
Nulh Rl. Gyd fr MXM
on of General. Restorative. d Neurological Devic
umber K080/91