(19 days)
Not Found
No
The summary describes a system of bone plates and screws for surgical fixation, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as a system of plates and screws for fixation in craniomaxillofacial surgery, which aids in structural support and healing but does not directly deliver a therapeutic agent or energy.
No
The device is a Bioplate Rigid Fixation Bone Plating System intended for treatment of fractures and reconstructive procedures, not for diagnosis.
No
The device description explicitly states it includes physical components like titanium plates and screws, which are hardware.
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-weight bearing fixation. This is a surgical implant used directly on the patient's body.
- Device Description: The description details bone plates and screws made of titanium, designed for physical fixation of bone tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium allov implants.
The modified plates designs for use 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-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 plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue
The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton, craniomaxilloffacial bony tissue, craniofacial, maxillofacial, cranial bone, orbital, brow
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.
K021684, K980983, K972463, K953273, 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
K0238/0
Summary of Safety and Effectiveness DEC 0 4 2002
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 (323) 549-9500 (323) 935-0110 (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. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K021684
- (2) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K980983
- (3) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463
1
- Bioplate. Inc. (4) Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K953273
- (5) Bioplate. Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071
Description of the device
The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue
The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards
Intended used of the device
The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium allov implants.
Comparison of the devices' technological characteristics with those of predicate devices
The modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery has the same indications for use as the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery (K021684, K980983, K972463, K953273, and K943071) 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "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 wing-like extensions, suggesting movement or flight.
Public Health Service
ood and Drug Administration 00 Corporate Boulevard Rockville MD 20850
DEC 04 2002
Ms. Judy Sokua Regulatory Affairs Associate Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038-3305
Re: K023810
Trade/Device Name: Modified Plate designed for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 14, 2002 Received: November 15, 2002
Dear Ms. Sokua:
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. Sokua
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. 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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known):
Device Name: Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Indications for Use:
The modified plates designs for use 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-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 | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use (Optional Format 1-2-96)
Suxin Rair
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KCd 3810 510(k) Number _