(134 days)
Not Found
No
The summary describes a calcium phosphate bone cement and does not mention any AI or ML components or functionalities.
Yes
The device is a bone filler intended for the repair and augmentation of bone defects, which is a therapeutic function.
No
The device is described as a bone filler intended for repair and augmentation of bony contours, rather than for diagnosing any condition.
No
The device description clearly outlines physical components (powder and liquid) that are mixed and applied, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "self-setting calcium phosphate cement intended for 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." This describes a device used in vivo (within the body) for structural repair and augmentation.
- Device Description: The description details the components (powder and liquid) that are mixed and applied to bone gaps or defects. This is consistent with a surgical implant or bone filler, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed to diagnose, monitor, or screen for medical conditions by analyzing biological samples.
Therefore, the Injectable Mimix™ is a medical device used for surgical repair and augmentation of bone, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Injectable Mimix™ is a self-setting calcium phosphate cement intended for 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.
The bone filler is not intended for percutaneous injection use.
Product codes
84GXP, 84JBA
Device Description
The Injectable Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively and then inserted into a syringe style pipet that will be used to apply the filler to bone gaps or defects. The bone filler is indicated for the augmentation or restoration of bony contour in the craniofacial skeleton. The bone filler is not intended for percutaneous injection use.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3CgH3O7 2H2O). The liquid component is a solution comprised of anhydrous citric acid (CoHsO7) and distilled water (H2O).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniofacial skeleton, neurosurgical burr holes, craniotomy cuts, cranial defects
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
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
DEC 2 1 2001
Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. above the words "Corporate Headquarter". The logo is in black and white and features a stylized "BIOMET" with the "INC" stacked vertically to the right of the "T". The text is in a serif font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant or Sponsor: Walter Lorenz Surgical, Inc. (A wholly owned subsidiary of Biomet, Inc.) 1520 Tradeport Drive P.O. Box 18009 Jacksonville, Fla 32229-8009 Establishment Registration Number: 1032347 Contact Person: Sara B. Shultz Biomet Manufacturing, Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46582 Phone: (219) 267-6639 FAX: (219) 372-1683 Proprietary Name: Injectable Mimix™M Common Name: Calcium Phosphate Cement Classification Name: Methyl Metacrylate for Cranioplasty (882.5300) Prosthesis, Craniofacial (882.5330) Device Product Code: 84GXP. 84JBA
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Craniofacial Calcium Phosphate Ceramic Bone Filler, K990290
Intended Use: The Injectable Mimix™ is a self-setting calcium phosphate cement intended for 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. The bone filler is not intended for percutaneous injection use.
Device Description: The Injectable Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively and then inserted into a syringe style pipet that will be used to apply the filler to bone gaps or defects. The bone filler is indicated for the augmentation or restoration of bony contour in the craniofacial skeleton. The bone filler is not intended for percutaneous injection use.
MAILING ADDRESS SHIPPING ADDRESS Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587 Warsaw, IN 46580 OFFICE FAX E-MAIL 0 219.267.6639 219.267.8137 biomet@biomet.com
1
Image /page/1/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3CgH3O7 2H2O). The liquid component is a solution comprised of anhydrous citric acid (CoHsO7) and distilled water (H2O).
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
■
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
●
I·AX
219.267.8137
OFFICE 219.267.6639
E-MAII. biomet@hiomet.com
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three parallel lines that curve and flow, creating a sense of movement and dynamism.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2001
Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P.O Box 587 Warsaw, Indiana 46581-0587
Re: K012569
Trade Name: Injectable Mimix™ Regulation Number: 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: November 27, 2001 Received: November 30, 2001
Dear Ms. Shultz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your betermined 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 mendments, 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 the Federal I vou, Drag, and Coou may, therefore, market the device, subject to the general approvin upprovisions of the Act. The general controls provisions of the Act include controls provisions or 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 (1 mr ), in its) ob of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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. or most 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 and instille (2)
3
Page 2 -- Ms. Sara B. Shultz
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 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" (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,
Barbara Herrmanor for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Page_1_of_1
K012569 510 (k) Number (if known) :
Device Name: Injectable Mimix™M
Indications For Use:
The Injectable Mimix™ is a self-setting calcium phosphate cement intended for 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.
The bone filler is not intended for percutaneous injection use.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ OR Over-The Counter-Use
(Per 21 CFR 801.109) (Optional Division Sign-Off)
Division of General, Restorative
and Neurological Devices
00008 510(k) Number K012569