(114 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Biomet Microfixation OmniMax MMF System. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, with the key difference being the addition of MR Conditional labeling for the subject device. The study described focuses on establishing the device's safety within an MRI environment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (MRI Safety) | Reported Device Performance |
|---|---|
| Static Magnetic Field Exposure | Safe for 1.5T and 3.0T MR systems. |
| Maximum Spatial Gradient Field | Safe for a maximum spatial gradient field of 3,000 gauss/cm (30 T/m). |
| Maximum MR System Reported, Whole Body Averaged Specific Absorption Rate (SAR) | Safe for a maximum MR system reported, whole body averaged SAR of 2.0 W/kg (Normal Operating Mode). |
| Maximum Temperature Rise (after 15 minutes of continuous scanning) | Expected to produce a maximum temperature rise of less than 6°C. |
| Image Artifact | Image artifact extends approximately 1.4cm from the device when imaged with a gradient echo pulse sequence and a 3.0T MRI System. |
Study Details:
The study was a non-clinical performance study focusing on MRI safety.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "implant models" were used for modeling and simulation, and "actual heating was measured" using the worst-case heating locations. It doesn't specify a numerical sample size for individual devices tested beyond "worst-case locations."
- Data Provenance: The data is from non-clinical testing (modeling and simulation, and physical implant testing), not human or patient data. Therefore, concepts like country of origin or retrospective/prospective are not applicable in the human data sense. It is laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of study does not involve human experts establishing ground truth in the traditional sense of clinical diagnosis. The "ground truth" for MRI compatibility is established by adherence to recognized ASTM standards for MRI safety testing (ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182) and the scientific principles behind MRI physics and heat transfer.
- The "experts" would be the personnel conducting and interpreting the engineering and physics tests, who would have qualifications in fields like biomedical engineering, materials science, and MRI physics. Their number and specific qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
- Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human expert review of imaging. This is not applicable here as the test set involves physical and simulated tests, not human assessments against a ground truth developed by multiple experts. The results are based on objective physical measurements and simulation outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This study is focused on the intrinsic MR safety properties of the device itself ("standalone" performance in an MRI environment), not on how human readers' performance improves with or without the device. The "effect size" of human readers with/without AI assistance is not relevant to this type of device safety testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study (in terms of device performance in an MRI environment) was conducted. The testing evaluated the device's behavior (heating, artifact, displacement) directly when exposed to MRI conditions, without human intervention in the device's function or the MRI assessment process. The "algorithm" here refers to the physical interactions of the device with the MRI field.
7. The Type of Ground Truth Used
- The ground truth is derived from established scientific principles, engineering models, and validated physical measurement techniques as defined by the referenced ASTM standards. It's an objective measurement of physical phenomena (temperature rise, artifact size, displacement) under controlled MRI conditions. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This concept is not applicable. This is not an AI/machine learning study that requires a training set. The "modeling and simulation testing" refers to engineering simulations, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- This is not applicable, as there is no training set in the context of this device safety evaluation.
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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.
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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
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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)
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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 Microfixation1520 Tradeport DriveJacksonville, FL 32218 |
|---|---|
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialistlauren.jasper@zimmerbiomet.comTelephone: (904) 741-9259Fax: (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
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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 MicrofixationOmniMax MMF System | Primary Predicate:Biomet Microfixation OmniMax MMF System(K143336) | |
|---|---|---|
| Principle ofOperation | No change from predicatedevice | Metallic implants for the temporary stabilization ofmandibular and maxillary bone during fracturehealing and/or temporarily maintain a stableocclusion during surgeryMandibular and Maxillary Fixation (MMF) isachieved through application of fixation plates andlocking screws to bone; wire or elastics are thensecured around hooks |
| Indications forUse | No change from predicatedevice | The Biomet Microfixation OmniMax MMF Systemis indicated for temporary stabilization ofmandibular and maxillary fractures to maintainproper occlusion during surgery and for post-operative fracture healing in adults and adolescents(age 12 and older) in whom permanent teeth haveerupted. |
| Components | No change from predicatedevice | Fixation Plate (Arch Bar), Locking Screws |
| PlateGeometry | No change from predicatedevice | Design: Plate with an in-plane bend and 12 slots toaccept screws and 12 hooks |
| ScrewGeometry | No change from predicatedevice | Design: Self-drilling screwsDiameter: 2.0mmLength: minimum 7mm, maximum 11mm |
| Material | No change from predicatedevice | Plates: Commercially Pure TitaniumScrews: Titanium Alloy, Ti-6Al-4VWires: Stainless Steel |
| Sterility | No change from predicatedevice | 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.
§ 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.