(293 days)
Not Found
Not Found
No
The summary describes a bone filler material and its physical properties and performance, with no mention of AI or ML technology.
Yes
The device is a bone filler indicated for the repair and augmentation of bone in the craniofacial skeleton, which directly treats or restores a bodily function.
No
The device is a bone filler used for repair and augmentation of the craniofacial skeleton, not for diagnosing conditions.
No
The device is a physical bone filler comprised of a powder and liquid, not a software application.
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 repair and augmentation of bony defects in the craniofacial skeleton. This is a direct application to the patient's body for structural support and restoration.
- Device Description: The description details a bone filler material that is mixed and applied to the defect site. This is a physical material used in a surgical context.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant/filler.
N/A
Intended Use / Indications for Use
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation and restoration of bony contour in the craniofacial skeleton.
Product codes
84GXP, 84JBA
Device Description
Craniofacial Calcium Phosphate Ceramic Bone Filler is comprised of a calcium phosphate powder and a liquid component. The two components are mixed to produce a homogenous paste, which can then be applied to burr holes, bone gaps, and other defect sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniofacial 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
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Summary of Performance Studies
Biocompatibility testing and animal studies demonstrate the safety of the material. The material is found to be non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic. Mechanical testing determined the material has adequate strength for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter: Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
Contact Person: Michelle L. McKinley
Product Code: 84GXP, 84JBA
Device Name: Craniofacial Calcium Phosphate Ceramic Bone Filler
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation and restoration of bony contour in the craniofacial skeleton.
Craniofacial Calcium Phosphate Ceramic Bone Filler is comprised of a calcium phosphate powder and a liquid component. The two components are mixed to produce a homogenous paste, which can then be applied to burr holes, bone gaps, and other defect sites.
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a biocompatible material, and is similar to the predicate device used in the same non-load bearing indications. Biocompatibility testing and animal studies demonstrate the safety of the material. The material is found to be non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic. Mechanical testing determined the material has adequate strength for the intended use.
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Image /page/1/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" around the perimeter. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards, often interpreted as representing human aspiration and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 8 1999
Ms. Michelle L. McKinley Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K990290 Re: Craniofacial Calcium Phosphate Ceramic Bone Filler Requlatory Class: II Product Code: GXP Dated: August 26, 1999 Received: August 27, 1999
Dear Ms. McKinley:
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 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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਦੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Michelle L. McKinley
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510 (k) NUMBER (IF KNOWN): K990690
DEVICE NAME: Craniofacial Calcium Phosphate Ceramic Bone Filler
INDICATIONS FOR USE:
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
(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) :
में
OR
Over-The-Counter-
(Optional Format 1-2-96)
Division Sign. Org.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990292
000003