(29 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a self-setting calcium phosphate cement indicated for repairing bony defects in the craniofacial skeleton, which is a therapeutic intervention.
No
The device is described as a bone void filler used for repair and augmentation of bony contours, rather than for diagnosing conditions.
No
The device description clearly states it is a bone void filler packaged as separate powder and liquid components that are mixed to form a paste. This describes 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 "self-setting calcium phosphate cement indicated for the following craniofacial procedures." These procedures involve direct application to bone defects within the body.
- Device Description: The description details a material that is mixed and applied intraoperatively to bone gaps or defects.
- Lack of In Vitro Testing: The description of performance studies mentions non-clinical testing demonstrating equivalence to a predicate device, but there is no mention of testing biological samples outside of the body, which is the hallmark of an IVD.
- No Mention of Analyzing Samples: The device's function is to fill bone voids, not to analyze biological samples like blood, urine, or tissue for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant/material used to repair bone defects in vivo.
N/A
Intended Use / Indications for Use
The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
-
- Repair of neurosurgical burr holes
-
- Craniotomy cuts and other cranial defects
-
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm²
Product codes (comma separated list FDA assigned to the subject device)
84GXP
Device Description
The QuickSet Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are designed to be mixed intraoperatively to produce a homogenous paste, which can then be applied to bone gaps or defects. Because of its apatitic nature, the material is highly biocompatible.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3GHzO7+2H2O). The liquid component is a solution comprised of anhydrous citric acid (CGHsO7) and distilled water (H3O).
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate device.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
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.
Mimix™ Bone Void Filler (K990290)
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
§ 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
10237/8
DEC 04 2002
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, FL 32229-8009
Establishment Registration Number: 1032347 |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | QuickSet Mimix™ Bone Void Filler |
| Common or Usual Name: | Calcium Phosphate Cement |
| Device Classification: | Implant, endosseous for bone filling and/or
reconstruction (872.3640) |
| Device Product Code: | 84GXP |
| Legally Marketed Devices
To Which Substantial
Equivalence Is Claimed: | Mimix™ Bone Void Filler (K990290) |
Indicated Use:
The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
-
- Repair of neurosurgical burr holes
-
- Craniotomy cuts and other cranial defects
-
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm²
Device Description: The QuickSet Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are designed to be mixed intraoperatively to produce a homogenous paste, which can then be applied to bone gaps or defects. Because of its apatitic nature, the material is highly biocompatible.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3GHzO7+2H2O). The liquid component is a solution comprised of anhydrous citric acid (CGHsO7) and distilled water (H3O).
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate device.
| Clinical Testing: Clinical testing was not used to establish substantial equivalence. | |||
|---|---|---|---|
| MAILING ADDRESS | SHIPPING ADDRESS | ||
| P.O. Box 587 | 56 E. Bell Drive | ||
| Warsaw, IN 46581-0587 | Warsaw, IN 46582 | ||
| OFFICE | |||
| Mimix is a trademark of Biomet, Inc | FAX | ||
| 574.267.8137 | |||
| biomet@biomet.com |
50
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 features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kacv Arnold, RN, MBA Regulator Affairs Specialist Biomet Manufacturing, Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Re: K023718
Trade Name: QuickSet Mimix™ Bone Void Filler Regulation Number: 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: October 31, 2002 Received: November 5, 2002
Dear Ms. Arnold:
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 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). 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 111 (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
2
Page 2 - Ms. Kacy Arnold
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 legallypredicate 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) 594-4659. 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 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,
sincerely yours,
U Mark N. Melberras
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
510 (k) Number (if known) : K023718
Device Name: QuickSet Mimix™ Bone Void Filler
Indications for Use:
The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
-
- Repair of neurosurgical burr holes
- Craniotomy cuts and other cranial defects 2.
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger 3. that 25 cm²
Márk N. Millenson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0237
(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)