(27 days)
Not Found
No
The summary describes a mechanical bone plating system and screws, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is a bone plating system intended for the treatment of fractures and reconstructive procedures, which are corrective or supportive rather than directly therapeutic in the sense of treating a disease or condition actively.
No
The device is described as a "Bone Plating System" and "modified screw designs" intended for "treatment of fractures and reconstructive procedures" and "fixation," which are therapeutic and reconstructive actions, not diagnostic.
No
The device description explicitly states it includes "titanium alloy screws of varying diameters and lengths" and is part of a "Bone Plating System," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a system of plates and screws used for the surgical fixation of bones in the craniomaxillofacial region. This is a surgical implant used within the body (in vivo) to treat fractures and perform reconstructive procedures.
The device's function is mechanical support and fixation of bone, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
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-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton, cranial bone, brow, orbital
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.
K022890, K021684, K972463, K943071
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
Summary of Safety and Effectiveness
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA 90016 (310) 815-2100 (310) 815-2126 (fax)
Contact Person: Judy Sokua
Trade Name of Device
Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Common name
Bone Plates
Classification name
Bone Plate (21 CFR 872.4760)
Predicate Devices
- (1) Bioplate, Inc. Modified Screw Design for use with Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K022890
- (2) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K021684
- (3) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463
1
- (4) Bioplate. Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071
Description of the device
The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.
Intended used of the device
The modified 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 craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation, orbital fixation and brow fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Comparison of the devices' technological characteristics with those of predicate devices
The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surqery have the same indications for use as the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K943071 - K972463 - K021684 -K022890) predicate devices. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2003
Ms. Carol E. Jones Chief Operating Officer BioPlate, Incorporated 3643 Lenawee Avenue Los Angeles, California 90016
Re: K031028
Trade/Device Name: Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 31, 2003 Received: April 9, 2003
Dear Ms. Jones:
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.
3
Page 2 - Ms. Jones
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. 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.
Susan Renner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
The Bioplate® Rigid Fixation Bone Plating System for Device Name: Craniomaxillofacial Surgery.
Indications for Use:
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-weight bearing fixation. including cranial bone fixation, brow fixation and orbital 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)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use (Optional Format 1-2-96)
Kei Ruby for Msk
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
OR
510(k) Number: K 031028