(9 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (mesh plates) made of titanium for surgical procedures. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
No
The device is a metallic mesh used for structural support in craniofacial and midface reconstruction, which is a surgical tool rather than a device intended to treat or cure a disease or condition.
No
The document describes a surgical implant (low profile neuro contourable mesh plates) used in reconstructive procedures and trauma repair. It is not a device intended to diagnose a condition.
No
The device description explicitly states the device is manufactured from Titanium and consists of physical plates, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Synthes Low Profile Neuro Contourable Mesh Plates clearly indicate they are surgical implants used for structural support and reconstruction in the craniofacial skeleton. They are physically implanted in the body and do not perform tests on biological samples.
Therefore, this device falls under the category of a surgical implant or medical device used for structural support, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes Low Profile Neuro Contourable Mesh Plates are manufactured from Titanium and consists of a variety of shapes and sizes designed for various cranio-facial procedures. These plates are now available to the user sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midface, craniofacial skeleton, maxilla, chin
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)
Not Found
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.
Synthes Low Profile Neuro System
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
OCT - 9 2003
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Low Profile Neuro Contourable Mesh Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes Low Profile Neuro System |
| DEVICE DESCRIPTION: | The Synthes Low Profile Neuro Contourable Mesh Plates are manufactured
from Titanium and consists of a variety of shapes and sizes designed for
various cranio-facial procedures. These plates are now available to the user
sterile. |
| INTENDED USE: | The Synthes Low Profile Neuro Contourable Mesh Plates are intended for
use in selective trauma of the midface and craniofacial skeleton;
craniofacial surgery; reconstructive procedures; and selective orthognathic
surgery of the maxilla and chin. |
| MATERIAL: | Titanium |
| SUBSTANTIAL
EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes Low
Profile Neuro Contourable Mesh Plates are substantially equivalent to other
legally marketed Synthes devices. |
:
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing right, composed of three thick, curved lines. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 9 - 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes, (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K033160
Trade/Device Name: Synthes (USA) Low Profile Neuro Contourable Mesh Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 26, 2003 Received: September 30, 2003
Dear Ms. Boyle:
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.
2
Page 2 - Ms. Boyle
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 (OS) 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) 594-4613. 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K033160 |
|---|---|
| Device Name: | Synthes (USA) Low Profile Neuro Contourable Mesh Plates |
| Indications: |
The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the
midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective
orthognathic surgery of the maxilla and chin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
Nor (Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital, Division of Ancolnectors, Infection Control.
Surfer
510(k) Number._
Special 510(k): Confidential Synthes (USA) Low Profile Neuro Contourable Mesh Plates