(90 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "anterior cervical plate system" intended for "anterior screw fixation to the cervical spine C2-C7" for various medical conditions like degenerative disc disease, trauma, and tumors. This description clearly indicates its use in treating and stabilizing a medical condition, which aligns with the definition of a therapeutic device.
No
The device is described as an Anterior Cervical Plate System for anterior screw fixation to the cervical spine, used to treat various conditions. It consists of plates and screws, which are implantable medical devices for structural support, not for diagnosing conditions.
No
The device description clearly states it consists of plates, screws, and set screws made of titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to fix the cervical spine. This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details plates and screws made of titanium alloy, designed to be attached to the vertebral body. This is consistent with a surgical implant, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fixation.
N/A
Intended Use / Indications for Use
The ASSURE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The ASSURE™ Anterior Cervical Plate System consists of plates used with either standard screws or rigid screws and set screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants are composed of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
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)
Static and dynamic mechanical testing, in accordance with ASTM F1717, was conducted.
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.
K926453, K030866, K971730, K031702
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
510(K) Summary III.
0407d/
page 1 of 2
SUBMITTED BY:
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker Prepared: March 18, 2004
DEVICE NAME:
ASSURE™ Anterior Cervical Plate System
CLASSIFICATION:
The device classification is Class II as per 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis. The product code is KWQ. The panel code is 87.
PREDICATE DEVICES:
Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971730, SE date November 3, 1997. Howmedica Osteonics (Stryker) Reflex: K031702, SE date August 8, 2003. The product code for these devices is KWQ.
DEVICE DESCRIPTION:
The ASSURE™ Anterior Cervical Plate System consists of plates used with either standard screws or rigid screws and set screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants are composed of titanium alloy.
INTENDED USE:
The ASSURE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
1
yoZal
510(k) Premarket Notification - ASSURE™System
PERFORMANCE DATA:
Static and dynamic mechanical testing, in accordance with ASTM F1717, was State and dynamic moonamed. As a basis for substantial equivalence.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The ASSURE™ Anterior Cervical Plate System implants are similar to the predicate Synthes CSLP (K926453, K030866), Depuy PEAK (K971730), Howmedica Osteonics (Stryker) Reflex (K031702), anterior cervical plate systems with respect to technical characteristics and performance.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures in profile, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Globus Medical Inc. . c/o Kelly J. Baker, Ph.D. 303 Schell Lanc Phoenixville, PA 19460
Re: K040721
Trade/Device Name: ASSURE™ 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: March 18, 2004 Received: March 19, 2004
Dear Dr. Baker:
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
3
Page 2 -- Kelly J. Baker, Ph.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 557 - 32 described in your Section 510(k)
This letter will allow you to begin marketing your device of your davice to a legal This letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The FDA iniding of substanted by July 2017 11:50
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
r the regulation and consisted on the collected on the regulation ontitled If you desire specific advice for your de not of the mote the regulation entitled. contact the Office of Complanes at (301) 27 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Division of Small " Misbranding by reference to premarket nouthead on the Act from the Division of Small other general information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frememain html Manufacturers, International and Consumer Passion. As a gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
R. Mark A. Millerson
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
510(k) Premarket Notification - ASSURE™System
| II. | Indications for Use Statement |
|---|---|
| ----- | ------------------------------- |
| 510(k) Number: | K040721 |
|---|---|
| Device Name: | ASSURE™ Anterior Cervical Plate System |
Indications:
The ASSURE™ Anterior Cervical Plate System is intended for anterior screw The ASSURL - Antenor Oct Noar Flato System Andications: degenerative likation to the cervical Spine SE Onlin of discogenic origin with degeneration of disc disease (as delined by nook pain of accographic studies), trauma the uise connimed by pations history ity (defined as kyphosis, lordosis, or (Including fractures), turnors, dolormity (dolined aspondylolisthesis, and spinal stenosis.
Prescription Use (Per 21 CFR §801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K04072