(21 days)
Not Found
Not Found
No
The summary describes a system of screws for surgical procedures and does not mention any AI or ML components or functionalities.
No.
Explanation: The device is an implant system (screws and plates) used for fixation in surgical procedures, not for treating a disease or condition in itself. It is a surgical tool/implant.
No
Explanation: The device description indicates that it is a system of screws intended for surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly mentions physical components like screws, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Synthes Low Profile Neuro System consists of screws intended for surgical implantation in the midface and craniofacial skeleton.
- Intended Use: The intended use is for surgical procedures related to trauma, reconstruction, and orthognathic surgery.
This device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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)
DZL
Device Description
Synthes Ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and Ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton; 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.
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
JUL മ 2003
3. 510(k) Summary:
| Submitter | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith
(610) 647-9700 |
| Name of the Device | Synthes Low Profile Neuro System - 3 mm Screws |
| Predicate Device | Synthes Low Profile Neuro System |
| Device Description | Synthes Ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and Ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. |
| Intended Use | 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. |
| Substantial Equivalency: | Documentation is provided which demonstrates that the Synthes Low Profile Neuro System - 3 mm Screw Is substantially equivalent* to other legally marketed Synthes devices.
- The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. |
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol representing the human form, depicted as three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K031807
Trade/Device Name: Low profile Neuro System - 3 mm Screws Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: June 10, 2003 Received: June 11, 2003
Dear Ms. Smith:
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. Smith
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 (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,
Süsen Ruinir
Susan Runner, DDS, MA Interim 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
Special 510(k) Line Extension
INTENDED USE STATEMENT
510(k) Number (if known):
Device Name:
Indications
Low Profile Neuro System -- 3 mm Screws
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)
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000
| Prescription Use | X | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Kein Muly fo MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031807 |
|---|---|
| ---------------- | --------- |
CONFIDENTIAL