(84 days)
Not Found
No
The summary describes a bone plating system, which is a mechanical device, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for "treatment of fractures and reconstructive procedures" of a specific anatomical site, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate it is an implantable device (plates and screws) for treating fractures and performing reconstructive procedures, not for diagnosing conditions.
No
The device description explicitly states "plate and screw designs," which are physical hardware components used in surgical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation". This describes a surgical implant used directly on the patient's body.
- Device Description: The description refers to "plate and screw designs" which are physical implants.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to fix bones within the body.
N/A
Intended Use / Indications for Use
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Product codes
JEY
Device Description
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton
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.
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/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
JUN - 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol E. Jones · Biomedics, Incorporated 536 Rimpau Boulevard Los Angels, California 90020
Re : K980983 The Bioplate Rigid fixation Bone Plating Trade Name: System for Craniomaxillofacial Surgery Requlatory Class: II Product Code: JEY Dated: March 17, 1998 Received: March 17, 1998
Dear Ms. Jones:
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 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). 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 aqainst 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. And more substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 - Ms. Jones
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) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Page 1 of 1
510(k) Number (if known): K980593
Device Name: The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.
Indications for Use:
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device 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)
Susan Kuppe
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K980982
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)