(84 days)
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.
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.
The provided text is a 510(k) premarket notification letter from the FDA to Biomedics, Incorporated, regarding their "Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This document does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device does not need to submit clinical trial data to demonstrate safety and effectiveness for this review pathway. Instead, substantial equivalence relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but no new questions of safety and effectiveness and is as safe and effective as the predicate device.
Therefore, I cannot provide the requested information based on the given text.
To be clear:
- Acceptance criteria and reported device performance: Not present.
- Sample size and data provenance for test set: Not applicable, as no study results are provided.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone algorithm performance: Not applicable (this is a medical device, not an algorithm).
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
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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
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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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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)
§ 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.