(25 days)
Not Found
No
The device description and intended use focus on the material properties and application of a bone void filler, with no mention of AI or ML technology.
Yes
The device is a self-setting calcium phosphate cement indicated for repairing cranial defects and augmenting bony contour in the craniofacial skeleton, which are therapeutic procedures.
No
The device description indicates Mimix™ MP Bone Void Filler is a material used for repairing bone voids and defects, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly states it is a bone void filler packaged as separate powder and liquid components intended to be mixed and set into a hard material. This is a physical material, not software.
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 bone void filler for craniofacial procedures. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a material that is mixed and sets into a hard substance for filling bone voids. This is consistent with a medical device used for surgical repair, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Mimix™ MP Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
- Repair of neurosurgical burr holes 1.
- Craniotomy cuts and other cranial defects 2.
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger than 3. 25cm².
Product codes
GXP
Device Description
The Mimix™ MP Bone Void Filler is packaged as separate, pre-measured powder and liquid components, to be mixed intraoperatively to produce a homogenous paste. Because of its apatitic nature, the material is highly biocompatible.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium phosphate. The liquid component is a dilute aqueous solution comprised of anhydrous citric acid (C6H8O7) and water (H2O).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniofacial skeleton area
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 substantial equivalence between this device and the predicate device.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Mimix™ Bone Void Filler K990290
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 21 2004
Image /page/0/Figure/2 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. The letters are bold and blocky, with a thick outline around each letter. The "INC" is smaller and stacked vertically on the right side of the logo.
510(k) Summary
Walter Lorenz Surgical, Inc. Applicant/Sponsor: (A wholly owned subsidiary of Biomet, Inc.) 1520 Tradeport Drive P.O. Box 18009 Jacksonville, FL 32229-8009 Establishment Registration Number: 1032347
- Kacy Arnold, RN, MBA Contact Person: Biomet Regulatory Specialist Telephone: 574-267-6639 Fax: 574-372-1683
Mimix™ MP Bone Void Filler Proprietary Name:
bone void filler Common Name:
Classification Name: Methyl Methacrylate for Cranioplasty (882.5300)
Legally Marketed Devices To Which Substantial
Equivalence Is Claimed: Mimix™ Bone Void Filler K990290
Device Description: The Mimix™ MP Bone Void Filler is packaged as separate, pre-measured powder and liquid Device Desemptions The Films - Internatively to be nixed intracperatively to produce a homogenous paste, evinponents - The are contracts. Ber ause of its apatitic nature, the material is highly biocompatible.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium (it at to be in The powaci component is a mixtare of a colution comprised of anhydrous citric acid (C,H,O,) and water (H,O).
Indications for Use:
Mimix™ MP Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures
- Repair of neurosurgical burr holes 1.
-
- Craniotomy cuts and other cranial defects
- Augmentation or restoration of bony contour in the craniofacial skeleton area no ကဲ larger than 25cm².
Summary of Technologies: Mimix™ MP is substantially equivalent in materials and processing to the predicate device.
Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate device.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Ms. Kacy Arnold, RN, MBA Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46582
Re: K043280
Trade/Device Name: Mimix™ MP Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: November 24, 2004 Received: November 26, 2004
Dear Ms. Arnold:
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. 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.
2
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 (240) 276-0120. 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 yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 10(k) Number (if known): _____________________________________________________________________________________________________________________________________________________ | |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
Mimix™ MP Bone Void Filler Device Name:
Indications For Use:
Mimix™ MP Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
- Repair of neurosurgical burr holes 1.
- Craniotomy cuts and other cranial defects 2.
- Craniotomy cuts and other cranial delects
Augmentation or restoration of bony contour in the craniofacial skeleton area no larger than 3. 25cm².
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use __XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, O fice of Device Evaluation (ODE)