(30 days)
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.
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.
The provided document describes the EAGLE™ + Anterior Cervical Plate System, a medical device. It does not contain information about software or AI, and therefore, does not include acceptance criteria for algorithm performance, a study proving such criteria are met, or details related to AI/algorithm performance.
The document is a 510(k) summary for a spinal implant system. It discusses:
- Device Description: The EAGLE + Anterior Cervical Plate System consists of plates and screws manufactured from ASTM F-136 implant grade titanium alloy. It also includes Class 1 manual surgical instruments.
- Intended Use/Indications for Use: The system is for anterior cervical intervertebral body fixation for patients needing stability after anterior cervical fusion, for levels C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, re-operation for failed fusion, or instability following surgery for these indications.
- Predicate Device: The EAGLE™ Anterior Cervical Plate System (K040197).
- Performance Data: The document states "Performance data were submitted to characterize the EAGLE + Anterior Cervical Plate System," but it does not detail what that performance data is or what acceptance criteria were used or met. It's highly probable that this performance data would relate to mechanical testing (e.g., fatigue, static strength) suitable for a spinal implant, rather than diagnostic accuracy or algorithmic performance.
Therefore, for your specific questions regarding acceptance criteria for an algorithm/AI and related studies, the provided text does not offer any relevant information.
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K070994
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IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, 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 consistsof an assortment of plates and screws. | |
| The EAGLE + Anterior Cervical Plate System alsocontains Class 1 manual surgical instruments andcases that are considered exempt from premarketnotification. | ||
| INTENDED USE: | The indications for use for the modified devicesdescribed in this submission are the same as thosefor the previously cleared EAGLE Anterior CervicalPlate System (K040197). The indications are asfollows: | |
| The EAGLE + Anterior Cervical Plate System isintended for anterior cervical intervertebral bodyfixation. These systems are indicated for patients inwhich stability is desired following anterior cervicalfusion for the indications listed below. The intendedlevels for treatment range from C2 to T1. | ||
| Indications include symptomatic cervical spondylosis,trauma, fracture, post-traumatic kyphosis or lordosis,tumor, degenerative disc disease (defined asdiscogenic pain with degeneration of the disc |
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K070994
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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.
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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.
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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
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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
§ 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.