(134 days)
Not Found
Not Found
No
The summary describes a system of physical implants (plates, meshes, screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as consisting of titanium plates, meshes, and screws used for surgical reconstruction and repair of the craniofacial skeleton, which are structural components rather than devices that directly treat a disease or condition through non-invasive means or by delivering therapy.
No
Explanation: The device description states it consists of titanium plates, meshes, and screws used for reconstructive and surgical procedures, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of titanium plates, meshes, and screws, which are hardware components.
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: The Synthes Low Profile Neuro System consists of titanium plates, meshes, and screws. These are implants used within the body during surgical procedures.
- Intended Use: The intended use describes surgical procedures on the midface and craniofacial skeleton. This involves direct surgical intervention, not testing of samples.
Therefore, the device is a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes Low Profile Neuro System is 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 System consists of titanium plates, meshes, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton; craniofacial surgery; maxilla and 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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the handwritten text "KOa 2012". The letters and numbers are written in black ink on a white background. The handwriting is somewhat stylized, with the "a" looking like an alpha symbol and the "2" having a curved shape.
3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes Low Profile Neuro System |
| Device Classification(s) | Class II, §872.4760 -- Plate, Fixation, Bone
Class II, §882.5250 - Burr Hole Cover
Class II, §872.4880 - Screw, Fixation, Intraosseous |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Low
Profile Neuro System to be substantially equivalent to other legally
marketed devices. |
| Device Description | The Synthes Low Profile Neuro System consists of titanium plates,
meshes, and screws in a variety of shapes and sizes designed for
various cranio-facial procedures. |
| Indications | The Synthes Low Profile Neuro System is 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 | Plates & Meshes - Titanium
Screws - Titanium Alloy |
CONFIDENTIAL
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 NOV
Mr. Matthew Hull Regulatory Affairs SYNTHES (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-1222
Re: K022012
Trade/Device Name: Synthes Low Profile Neuro System Regulation Number: 872.4760, 872.4880 and 882.5250 Regulation Name: Bone Plate, Rotary Scaler and Burr Hole Cover Regulatory Class: II Product Code: JEY Dated: October 7, 2002 Received: October 15, 2002
Dear Mr. Hull:
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 vour 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.
2
Page 2 – Mr. Hull
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
ia
Synthes Low Profile Neuro System
The Synthes Low Profile Neuro System is 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
Susan Kunz
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number:
umber: k02012
CONFIDENTIAL Synthes(USA) Synthes Low Profile Neuro System 510(k)
1004