(72 days)
Not Found
No
The summary describes a physical implant (mesh system) for spinal surgery and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for use in the thoracolumbar spine to replace diseased vertebral bodies, achieve anterior decompression, and restore height, as well as for treating fractures. These uses are directly involved in the treatment of diseases and injuries, classifying it as a therapeutic device.
No
The Devex Mesh System is indicated for use in the thoracolumbar spine to replace/restore a vertebral body, treat fractures, and maintain biomechanical integrity. These are therapeutic and structural functions, not diagnostic ones.
No
The device description and intended use clearly describe a physical implant (mesh system) used in spinal surgery, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a "Devex Mesh System" used in the thoracolumbar spine to replace vertebral bodies, treat fractures, and restore spinal height. This is a surgical implant, not a diagnostic test performed on bodily fluids or tissues.
- Intended Use: The intended use clearly states the device is for surgical implantation in the spine for structural support and restoration. This is a therapeutic intervention, not a diagnostic process.
The information provided describes a medical device used for surgical treatment, not for diagnosing a condition using samples from the body.
N/A
Intended Use / Indications for Use
The Devex Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
Product codes
MQP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
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)
Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003043, K020522, K990148, K001340
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
VIII. 510(k) Summary
K023835
Page 1 of 1
| SUBMITTER: | DePuy AcroMed"), Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02767-0350 USA |
JAN 2 9 2003
CONTACT PERSON: Karen F. Jurczak
November 15, 2002 DATE PREPARED:
Devex Mesh™ System PROPRIETARY NAME:
CLASSIFICATION NAME: Implant, fixation device Spinal intervertebral body fixation orthosis device
PREDICATE DEVICE Surgical Titanium Mesh System (K003043, K020522) Stackable Cage System (K990148, K001340)
The Devex Mesh System is indicated for use in the INTENDED USE: thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Devex Miesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
MATERIALS:
Titanium alloy (Ti-6Al-4V)
PERFORMANCE DATA:
Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines suggesting movement or energy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2003
Mr. Frank Maas Director, Regulatory Affairs DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K023835
Trade/Device Name: Devex Mesh™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Device Regulatory Class: Class II Product Code: MQP Dated: January 8, 2003 Received: January 9, 2003
Dear Mr. Maas:
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. Iisting 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.
2
Page 2 - Mr. Frank Maas
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" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,
sincerely, yours,
Mark N Millman
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
3
III. Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Page 1 of 1
Devex Mesh™ System Device Name:
Indications For Use:
The Devex Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | OR Over-The-Counter Use: |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division
and
510(k) Number: K023835