(43 days)
These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed
The Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for Facial reconstruction procedures. The plates include variations of straight, angle, curved, L-shape, Tshape, double T-shape, Z-shape, Y-shape, double Y-shape, H-shape, triangle, square, rectangle, matrix, orbital floor, LeFort, and chin options with various lengths and thickness. Plates are offered flat or pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K121589 (cleared 9/21/12). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K121589.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material: Identical to predicate device. | "The subject Facial PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design." |
| Design: Identical to predicate device with an optional pre-bending process using VSP System. | "The subject Facial PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design. The only difference...is that the subject device, is not only shaped based on an anatomical specific model, but also the provided patient specific guides and instruments of the VSP System...where the predicate pre-bent plates are shaped based on an anatomical specific model only." |
| Indications for Use: Same as predicate device. | "When compared to the predicate devices...substantial equivalence is based on the same indications for use..." (Also explicitly listed: Fractures, Osteotomies, Reconstructive procedures, Revision procedures). |
| Manufacturing Process & Verification: Bending process conducted at Biomet Microfixation based on process specification and inspection criteria. Plates are verified to match the anatomical model. | "Biomet Microfixation has a process specification for bending plates and an inspection criteria to verify the plate matches the anatomical model. Because the plates are verified to a patient specific model they are 100% verified to the Medical Modeling output, anatomical model, for every case." |
| Safety & Effectiveness: No new issues; performs as well as predicate device. | "Based on the determination that no clinical or non-clinical testing was deemed necessary, it can be concluded that the subject devices...do not raise any new issues of safety and effectiveness and perform as well as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical or non-clinical testing was performed as the device was deemed substantially equivalent based on its identical characteristics to a previously cleared predicate device, with an additional pre-bending service.
- Data Provenance: Not applicable. No test set data was generated for this submission. The rationale for substantial equivalence relied on the predicate device's existing clearance and the verification process for the pre-bending.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No test set was used, and therefore no ground truth was established by experts for a test set. The pre-bent plate's congruence to the anatomical model is verified through an internal inspection process by Biomet Microfixation, which aligns with their process specification and inspection criteria.
4. Adjudication Method for the Test Set
- Not applicable. No test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical bone plate and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- For the verification of the pre-bent plates, the "ground truth" is the patient-specific anatomical model created by Medical Modeling from CT scans. The plates are 100% verified against this model. This is essentially a form of design verification/conformance to a patient-specific digital template/model.
- For the overall device clearance, the ground truth is implicitly tied to the established safety and effectiveness of the predicate device (K121589).
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device (bone plates) submission, not an AI algorithm that requires a training set. The "VSP System" mentioned generates patient-specific anatomical models and guides, but the submission does not detail its development as an AI system requiring a 'training set'.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an algorithm is described.
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510(k) Summary
| Date Prepared:Revised: | August 19, 2013September 30, 2013 | |
|---|---|---|
| Manufacturer: | Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218-2480 | OCT 0 2 2013 |
| Contact: | Elizabeth WheelerRegulatory Affairs Specialist904-741-4400 x 9558 | |
| Proprietary Name: | Biomet Microfixation Facial PreBent Plates with Virtual SurgicalPlanning | |
| Common or Usual Name: | Bone Plate | |
| Device Classification: | Class II | |
| Device Product Code: | 76 JEY (21 CFR 872.4760) | |
| Secondary DeviceProduct Code(s): | 76 DZJ90 LLZ | |
| Predicate Device: | K121589- Biomet Microfixation Facial Plating System |
Device Description:
The Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for Facial reconstruction procedures. The plates include variations of straight, angle, curved, L-shape, Tshape, double T-shape, Z-shape, Y-shape, double Y-shape, H-shape, triangle, square, rectangle, matrix, orbital floor, LeFort, and chin options with various lengths and thickness. Plates are offered flat or pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K121589 (cleared 9/21/12). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K121589.
K120956- VSP System (Medical Modeling)
Confidential
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Indications for Use:
These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures
-
- Osteotomies
-
- Reconstructive procedures
-
- Revision procedures where other treatments or devices have failed
Possible Risks:
-
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, cracking or fracture of the device.
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- Nonunion or delayed union, which may lead to breakage of the implant.
-
- Migration, bending, fracture or loosening of the implant.
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- Metal sensitivity or allergic reaction to a foreign body.
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- Decrease in bone density due to stress shielding.
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- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
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- Increased fibrous tissue response around the fracture site and/or the implant.
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- Necrosis of bone.
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- Inadequate healing.
Technological Characteristics:
The subject Facial PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design. The only difference between the subject device and the predicate device is that the subject device, is not only shaped based on an anatomical specific model, but also the provided patient specific guides and instruments of the VSP System (K120956, cleared December 12, 2012), where the predicate pre-bent plates are shaped based on an anatomical specific model only. Biomet Microfixation has a process specification for bending plates and an inspection criteria to verify the plate matches the anatomical model. Because the plates are verified to a patient specific model they are 100% verified to the Medical Modeling output, anatomical model, for every case. Therefore, no additional testing was conducted on the subject plates.
Sterility Information:
The plates will be marketed as non-sterile, single-use devices.
Clinical Testing:
Clinical testing was not performed to support this submission.
Non-Clinical Testing:
Non-clinical testing was not performed, as the predicate plates have been previously cleared and the subject devices are identical. We have provided the process specification for bending the plates and inspection criteria for inspecting the output to ensure the proper alignment to the anatomical model.
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Substantial Equivalence Conclusion:
When compared to the predicate devices, Biomet Microfixation Facial Plating System (K121589, cleared 09/21/12), substantial equivalence is based on the same indications for use and technological characteristics. The subject devices are identical to the predicate devices, but an update to the labeling will be made to give the option of the prebent plates with Medical Modeling VSP System to include patient specific guides, instruments and anatomical model.
Based on the determination that no clinical or non-clinical testing was deemed necessary, it can be concluded that the subject devices, Facial PreBent Plates with Virtual Surgical Planning, do not raise any new issues of safety and effectiveness and perform as well as the predicate devices. Therefore, we conclude that the subject devices are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of snakes.
Public Health Service
October 2, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Microfixation Ms. Elizabeth Wheeler Regulatory Affairs Specialist 1520 Tradeport Drive JACKSONVILLE FL 32218-2480
Re: K132600
Trade/Device Name: Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZJ, LLZ Dated: August 30, 2013 Received: September 3, 2013
Dear Ms. Wheeler:
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.
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Page 2 - Ms. Wheeler
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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/delault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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
510(k) Number (if known): K132600
Device Name: Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning
Indications For Use:
These devices are implantable bone plates and bone screws for facial procedures including: I . Fractures
-
- Osteotomies
-
- Reconstructive procedures
-
- Revision procedures where other treatments or devices have failed
AND/OR Prescription Use ж (Part 21 CFR 801 Subpart D)
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)
Michael E. Adjodha -S 2013.10.02 13:18:43 -04'00' for AIS
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Confidential
August 19, 2013
§ 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.