(82 days)
Not Found
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a fixation system for treating fractures and reconstruction of the facial skeleton and mandible. While it aids in the healing process, it does not directly administer a therapeutic agent or perform a therapeutic action itself; it provides structural support.
No
The device description states it is a "Fixation System" intended for the "treatment" of fractures and reconstruction. This indicates a therapeutic or interventional purpose, not a diagnostic one.
No
The device description explicitly states "Modified Plate and Screw designs," which are hardware components. The intended use also describes a "Fixation System" used in the treatment of the facial skeleton and mandible, implying physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of the facial skeleton and mandible, including fractures and reconstruction." This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The description mentions "Modified Plate and Screw designs." These are physical implants.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Bioplate Mandible Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bioplate Mandible Fixation System is intended for use in the treatment of the facial skeleton and mandible, including fractures. The Bioplate Mandible Fixation System is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Product codes
JEY
Device Description
Modified Plate and Screw designs for use in conjunction with The Bioplate Mandible Fixation System.
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
facial skeleton and mandible
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.)
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Bioplate, Incorporate C/O Dr. Bruce F. Mackler Heller, Ehrman, White and Mcauliffe 1666 K Street NW, Suite 200 Washington, D.C. 20006-4004
Re: K012910
Trade/Device Name: The Bioplate Mandible Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plates and Bone Screws Regulatory Class: II Product Code: JEY Dated: August 30, 2001 Received: August 30, 2001
Dear Dr. Mackler:
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.
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.
1
Page 2 - Dr. Mackler
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 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 Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 2 0 2001
Page 1 of 1
Bioplate Inc. APPLICANT:
510(k) NUMBER: (if known): K012910
DEVICE NAME: Modified Plate and Screw designs for use in conjunction with The Bioplate Mandible Fixation System.
INDICATIONS FOR USE:
The Bioplate Mandible Fixation System is intended for use in the treatment of The Diopiate Manufic I ixation System of the facial skeleton and mandible, including iractares and 1000nbille is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
(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)
Over-The-Counter-Use OR (Optional Format 1-2-96)
Susan Rump
(Division Sign-Off) Consion of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________