(87 days)
Not Found
No
The summary describes a mechanical fixation system made of titanium alloy and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a fixation system intended to re-attach a cranial bone flap, which is a structural or mechanical function, not a therapeutic one that treats or cures a disease.
No
The device is described as a system intended to re-attach a cranial bone flap, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a bone plate manufactured of titanium alloy, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "re-attach a cranial bone flap to the surrounding cranium after a craniotomy procedure." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone plate manufactured of 6Al 4V titanium alloy that utilizes a combination of fastening tabs and spring action to re-attach a cranial bone flap." This describes a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such testing.
The Bioplate® Bioclip® Craniotomy Fixation System is a surgical implant used for bone fixation.
N/A
Intended Use / Indications for Use
The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:
The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm
Product codes
JEY
Device Description
The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of 6Al 4V titanium alloy that utilizes a combination of fastening tabs and spring action to re-attach a cranial bone flap following a craniotomy procedure. Each device is provided non-sterile and must be sterilized prior to use. The device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone / cranium
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0/3055
Summary of Safety and Effectiveness
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: Carol E. Jones
Trade Name of Device
The Bioplate® Bioclip® Craniotomy Fixation System
Common name
Bone Plate
Classification name
Bone Plate
Device Classification
76 JEY (21CFR - 872.4760)
Predicate Devices
The Bioplate® Bioclip® Craniotomy Fixation System -(K001530) (K002879) (K011380)
Description of the device
The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of 6Al 4V titanium alloy that utilizes a combination of fastening tabs and spring action to re-attach a cranial bone flap following a craniotomy procedure. Each device is provided non-sterile and must be sterilized prior to use. The device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Intended used of the device
The Bioplate® Bioclip® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
1
The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:
The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm
Comparison of the devices' technological characteristics with those of predicate devices
The Bioplate® Bioclip® Craniotomy Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc. All of the technical characteristics of The Bioplate® Bioclip® Craniotomy Fixation System 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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Ms. Carol E. Jones Executive Vice President Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038
Re: K013055
Trade/Device Name: The Bioplate Bioclip Craniotomy Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plates and Bone Screws Regulatory Class: II Product Code: JEY Dated: September 11, 2001 Received: September 11, 2001
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.
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.
3
Page 2 - Ms. Jones
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 et rear of 7) equality 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 s 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
Enclosure
4
Page 1 of 1
Bioplate Inc. APPLICANT:
510(k) NUMBER: (if known):____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Bioplate® Bioclip® Craniotomy Fixation System
INDICATIONS FOR USE:
The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a The Bloplate® Blocilip® Craniotomy procedure. The clipplate is used to align and cranial bone nap following a craniconiy procuse. Each device is intended for single stablize bony tissue while normal healing occarer Lich world and the results and
The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:
The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801.109) Over-The-Counter-
(Optional Format 1-2-96)
Susan Pierce
(Division Sign-Off) Olvision of Dental, Infection Control, ematon of Deneral Hospital Devicess
బంగార General Hospital Devicess
No.Gli - Number 110();; Number _______________________________________________________________________________________________________________________________________________________________
OR