(84 days)
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Not Found
No
The summary describes a physical bone plate and does not mention any software, algorithms, or AI/ML terms.
No
The device is used for trauma and reconstruction, which is a structural or mechanical purpose, not therapeutic.
No
The device, DRG Titanium Bone Plate, is described as being "intended for craniofacial and mandibular trauma and reconstruction," which implies it is a therapeutic or reconstructive device, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly states "DRG Titanium Bone Plate," indicating a physical hardware component.
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 implant used directly on the patient's body.
- Device Description: The device is a "DRG Titanium Bone Plate." This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to diagnose, monitor, or screen for diseases or conditions.
IVDs are devices used in vitro (in glass, or outside the body) to examine specimens from the human body. This device is clearly intended for in vivo (in the body) use.
N/A
Intended Use / Indications for Use
DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.
Product codes
JEY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
craniofacial and mandibular
Indicated Patient Age Range
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1999
Richard J. Deslauriers, M.D. President Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716
Re : K990920 DRG Titanium Bone Plate Trade Name: Regulatory Class: II Product Code: JEY Dated: March 15, 1999 March 18, 1999 Received:
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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Deslauriers
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regaracion chereica, "hibbidians" by Birastoo eneral 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,
Timothy A. Ulatowski
Director
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):
Device Name: DRG Titanium Bone Plate
Indications for use:
DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
| Susan Runne | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | IC990920 |