(114 days)
Not Found
No
The device description and performance studies focus on mechanical properties and MRI compatibility, with no mention of AI or ML.
Yes
The device is indicated for "temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing," which directly addresses a physical condition (fractures) and promotes healing, indicating a therapeutic purpose.
No.
The device is intended for temporary stabilization of fractures and maintaining occlusion, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of metallic plates and locking screws, which are hardware components. The performance studies also focus on the physical properties and behavior of these metallic components in an MRI environment.
Based on the provided information, the Biomet Microfixation OmniMax MMF System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary stabilization of mandibular and maxillary fractures" and "maintain proper occlusion during surgery and for post-operative fracture healing." This describes a surgical implant used directly on the patient's body for structural support and healing.
- Device Description: The description details metallic plates, screws, and wires used for "temporary stabilization of mandibular and maxillary bone." This further confirms its function as a physical implant.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. This is the core definition of an IVD.
- Performance Studies: The performance studies focus on the device's physical properties, MRI compatibility, and mechanical performance, not on its ability to analyze biological samples.
Therefore, the Biomet Microfixation OmniMax MMF System is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Product codes
JEY, DZL
Device Description
The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The arch bar plate is manufactured from Commercially Pure Titanium; the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and wires (if used) are manufactured from Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary bone
Indicated Patient Age Range
adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
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 Performance Data: MRI simulation and physical testing were performed according to standards ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182 to support the MR Conditional labeling.
Modeling and Simulation Testing: This test was conducted to determine the worst-case locations for heating on the implant models at two different resonance frequencies. The results of this testing indicated that the worst-case locations were the ends of the bars and the tips of the screws.
Physical Implant Testing: Using the worst-case heating locations determined during modeling and simulation testing (described above), actual heating was measured in the 1.5T and 3.0T environments; additionally, observed artifact and displacement were also measured in the 1.5T and 3.0T environments.
The completion of testing described above resulted in MR Conditional labeling and demonstrated that a patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5T and 3.0T
- Maximum spatial gradient field of 3,000 gauss/cm (30 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg (Normal Operating Mode)
Under these scan conditions, the OmniMax MMF System is expected to product a maximum temperature rise of less than 6°C after 15 minutes of continuous scanning. Further, the image artifact caused by the device extends approximately 1.4cm from the device when imaged with a gradient echo pulse sequence and a 3.0T MRI System.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and uses a single color, which appears to be black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10,2015
Biomet Microfixation Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K152326
Trade/Device Name: Biomet Microfixation Omnimax Mmf System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 13, 2015 Received: November 16, 2015
Dear Lauren Jasper:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K152326 510(k) Number (if known):
Device Name: Biomet Microfixation OmniMax MMF System
Indications for Use: The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Prescription Use xx_______________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, gray letters on the top line. The word "MICROFIXATION" is in smaller, gray letters on the second line. A thin, green line is below the word "MICROFIXATION", and the phrase "One Surgeon. One Patient." is in gray letters below the green line.
510(k) Summary - K152326
Prepared December 10, 2015
| Submitter: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialist
lauren.jasper@zimmerbiomet.com
Telephone: (904) 741-9259
Fax: (904) 741-9425 |
Device Name: Biomet Microfixation OmniMax MMF System
Device Classification:
Primary Regulation:
| Product Code | Device Name | Device Classification | Regulation Number | Regulation Description |
|---|---|---|---|---|
| JEY | Plate, Bone | 2 | 872.4760 | Bone Plate |
Secondary Product Code:
| Product Code | Device Name | Device Classification |
|---|---|---|
| DZL | Screw, Fixation, Intraosseous | 2 |
Indications for Use: The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Contraindications: 1. Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions; 2. Patients with limited blood supply, insufficient quantity or quality of bone; 3. Foreign body sensitivity; where material sensitivity is suspected, testing is to be completed prior to implantation; 4. Severely comminuted fractures or unstable fractures; 5. Active or latent infection; 6. Patients in whom damage to un-erupted permanent teeth is anticipated.
The Biomet Microfixation OmniMax MMF System is composed of Device Description: metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The arch bar
4
plate is manufactured from Commercially Pure Titanium; the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and wires (if used) are manufactured from Stainless Steel.
Predicate Devices:
K143336, Biomet Microfixation OmniMax MMF System
Similarities to Predicate Devices: The predicate and subject devices are metallic implants intended to be used for the stabilization of mandibular and maxillary fractures. The indications for use are identical for the predicate and subject devices. All implant systems consist of plates and locking screws to achieve a stable occlusion during fracture healing or surgery. The predicate and subject devices are manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V). There are no changes to the stainless steel wires that may be used to achieve the MMF closure.
Differences to Predicate Devices: The subject devices are considered MR Conditional per the compatibility restrictions found in the devices' instructions for use.
Non-Clinical Performance Data: MRI simulation and physical testing were performed according to standards ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182 to support the MR Conditional labeling.
Modeling and Simulation Testing: This test was conducted to determine the worst-case locations for heating on the implant models at two different resonance frequencies. The results of this testing indicated that the worst-case locations were the ends of the bars and the tips of the screws.
Physical Implant Testing: Using the worst-case heating locations determined during modeling and simulation testing (described above), actual heating was measured in the 1.5T and 3.0T environments; additionally, observed artifact and displacement were also measured in the 1.5T and 3.0T environments.
The completion of testing described above resulted in MR Conditional labeling and demonstrated that a patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5T and 3.0T ●
- Maximum spatial gradient field of 3,000 gauss/cm (30 T/m)
- . Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg (Normal Operating Mode)
Under these scan conditions, the OmniMax MMF System is expected to product a maximum temperature rise of less than 6°C after 15 minutes of continuous scanning. Further, the image artifact caused by the device extends approximately 1.4cm from the device when imaged with a gradient echo pulse sequence and a 3.0T MRI System.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
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Sterilization Information: The implants are provided non-sterily to be sterilized by the end user.
Substantial Equivalence: The Biomet Microfixation OmniMax MMF System has the same indications for use as the predicate devices and both systems feature the same part numbers with the same designs and materials. Testing identified in this summary has determined these devices can be safely used in the MRI environment and may be labeled as MR Conditional. It is concluded that the information included in this summary supports substantial equivalence.
| | Subject Device:
Biomet Microfixation
OmniMax MMF System | Primary Predicate:
Biomet Microfixation OmniMax MMF System
(K143336) |
|---------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | No change from predicate
device | Metallic implants for the temporary stabilization of
mandibular and maxillary bone during fracture
healing and/or temporarily maintain a stable
occlusion during surgery
Mandibular and Maxillary Fixation (MMF) is
achieved through application of fixation plates and
locking screws to bone; wire or elastics are then
secured around hooks |
| Indications for
Use | No change from predicate
device | The Biomet Microfixation OmniMax MMF System
is indicated for temporary stabilization of
mandibular and maxillary fractures to maintain
proper occlusion during surgery and for post-
operative fracture healing in adults and adolescents
(age 12 and older) in whom permanent teeth have
erupted. |
| Components | No change from predicate
device | Fixation Plate (Arch Bar), Locking Screws |
| Plate
Geometry | No change from predicate
device | Design: Plate with an in-plane bend and 12 slots to
accept screws and 12 hooks |
| Screw
Geometry | No change from predicate
device | Design: Self-drilling screws
Diameter: 2.0mm
Length: minimum 7mm, maximum 11mm |
| Material | No change from predicate
device | Plates: Commercially Pure Titanium
Screws: Titanium Alloy, Ti-6Al-4V
Wires: Stainless Steel |
| Sterility | No change from predicate
device | Non-sterile to be sterilized by the end user |
| MRI Safety | MR Conditional | Not evaluated |
Conclusion: There are no changes from the predicate device regarding the principles of operation, indications for use, components, plate geometry, screw geometry, material, and sterility. The completion of the non-clinical testing described above resulted in MR Conditional labeling and demonstrated that a patient with this device can be safely scanned in an MR system meeting the conditions described in the Instructions for Use included in the package of the device. Upon consideration of this information, it is determined that the subject device is substantially equivalent to the declared predicate device.