(80 days)
Not Found
Not Found
No
The summary describes a bone screw, a mechanical device, and contains no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is described as bone screws intended for trauma and reconstruction, which are surgical interventions rather than therapeutic treatments aimed at curing or alleviating a disease or condition.
No
The device is described as "bone screws intended for craniofacial and mandibular trauma and reconstruction," which are therapeutic or reconstructive functions, not diagnostic.
No
The 510(k) summary describes "DRG MF Ti Alloy Bone screws," which are physical implants made of titanium alloy. This clearly indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "craniofacial and mandibular trauma and reconstruction." This describes a surgical or procedural use within the body, not a diagnostic test performed on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: While the description is "Not Found," the intended use strongly suggests a physical implant or surgical tool.
- Lack of IVD Indicators: There is no mention of analyzing samples, diagnostic testing, or any of the typical characteristics of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The DRG MF Ti Alloy Bone screws, as described, are used for structural support and repair within the body.
N/A
Intended Use / Indications for Use
The DRG MF 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
DRG MF Titanium (Ti) Alloy Bone Screws
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)
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
§ 872.4880 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines representing the branches of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Richard Deslauriers, M.D. President Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716
Re : K974817 DRG MF Titanium (Ti) Alloy Bone Screws Trade Name: 1.0mm, 1.2mm, 1.3mm, 1.5mm, 2.0mm, 2.0mm and 2.4mm II Requlatory Class: Product Code: DZL December 12, 1997 Dated: Received: December 23, 1997
Dear Dr. Deslauriers:
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 ... A ... .................................................................................................................... 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Dr. Deslauriers
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 one 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.fdp.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
Statement of indications for use:
510(k) Number (if Known): _ K 974817
Device Name: DRG MF Titanium (Ti) Alloy Bone Screws
Indications for use:
The DRG MF Ti Alloy Bone screws are intended for craniofacial and mandibular trauma and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON NOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use ~ (Per 21 CFR 801.109)
OR
Over-The-Counter Use