(292 days)
Not Found
Not Found
No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a bone screw intended for mechanical fixation in trauma and reconstruction, which aids in healing but does not directly provide a therapeutic effect itself.
No
The device, SMF Ti Alloy Bone Screws, is intended for craniofacial and mandibular trauma and reconstruction, serving as an implant rather than a tool for diagnosis.
No
The device description clearly states the device is a physical bone screw made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states the device is "SMF Ti Alloy Bone Screws" intended for "craniofacial and mandibular trauma and reconstruction." These are physical implants used directly in the body during surgery.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
The device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SMF Ti Alloy Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The screws are available in 1.5 mm and 2.0 mm diameters, and feature self-drilling, selftapping tips and a square drive recess. The screws are available in 4 mm - 8 mm lengths in 1 mm increments and are manufactured from a titanium alloy.
The screws will be provided to the user non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial and mandibular
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)
It is our opinion that the SMF Ti Alloy Bone Screws are substantially equivalent to the predicate devices based on mechanical testing.
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
§ 872.4880 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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. The logo and the word are both in black, contrasting with the white background. There is a registered trademark symbol to the right of the word.
JUN 24 1997
Attachment I: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Angela Silvestri (610) 647-9700 June 1997
The SMF Ti Alloy Bone Screws are compared to Synthes 1.0 mm, 1.3 mm, 2.0 mm and 2.4 mm bone screws , and are intended for craniofacial and mandibular trauma and reconstruction.
The screws are available in 1.5 mm and 2.0 mm diameters, and feature self-drilling, selftapping tips and a square drive recess. The screws are available in 4 mm - 8 mm lengths in 1 mm increments and are manufactured from a titanium alloy.
The screws will be provided to the user non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
It is our opinion that the SMF Ti Alloy Bone Screws are substantially equivalent to the predicate devices based on mechanical testing.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Silvestri Manager, Requlatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
JUN 2 4 1997
Re: K963546 Trade Name: SMF Titanium (TI) Alloy Bone Screws Regulatory Class: II Product Code: DZL Dated: April 21, 1997 Received: April 21, 1997
Dear Ms. Silvestri:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Silvestri
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Alvitrust
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/10 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.
:
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
| Page 1 of 1 |
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K963546 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):
SMF Ti Alloy Bone Screws______________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
(
The SMF Ti Alloy Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Dental, Infection Control, | |||
| and General Hospital Devices | |||
| 510(k) Number | K963346 | ||
| Prescription Use | |||
| (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use ______ |