(45 days)
The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
This document is a 510(k) Premarket Notification from the FDA for the Biomet Microfixation RibFix Blu Thoracic Fixation System. It grants substantial equivalence to a previously cleared device. As such, it does not contain the detailed study information typically found when a novel device is being introduced and rigorous performance criteria need to be established and proven.
Here's why the requested information cannot be fully provided:
- No new acceptance criteria or study: The document explicitly states: "Non-clinical testing was not necessary for the determination of substantial equivalence." and "Clinical testing was not necessary for the determination of substantial equivalence." This means there were no new studies conducted to prove the current device meets acceptance criteria distinct from its predicate. The device is considered substantially equivalent because its indications, design, sterilization, and materials are identical to the predicate device (K152253).
- Focus on substantial equivalence: The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety or effectiveness.
Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not present in this 510(k) summary because no new performance studies were required for this specific filing.
However, based on the principle of substantial equivalence, we can infer the acceptance criteria and performance are identical to the predicate device (K152253). Since this document doesn't provide those details, I cannot create the table or answer the specific questions about the study design.
If this were a new device requiring performance demonstration, the information would typically include:
- A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative measures (e.g., tensile strength, fatigue life, bending stiffness, biocompatibility results) with their targets and the actual measured performance from testing.
- Sample size used for the test set and the data provenance: Details on how many devices were tested, if it was an in-vitro, ex-vivo, or in-vivo study, and where the data originated.
- Number of experts and qualifications: If human interpretation or evaluation was involved (e.g., in a clinical study or imaging study), details about the physicians or specialists involved in assessments.
- Adjudication method: How disagreements among experts were resolved.
- MRMC comparative effectiveness study: Not typically applicable for hardware like fixation systems, but if comparing diagnostic performance, this would quantify improvements with AI assistance.
- Standalone performance: The performance of the algorithm itself, without human input, if AI was involved.
- Type of ground truth used: What was considered the definitive truth (e.g., histopathology, surgical confirmation, long-term outcomes).
- Sample size for the training set: If machine learning was used, the size of the dataset used to train the algorithm.
- How the ground truth for the training set was established: How accurate labels were assigned to the training data.
In summary, the provided document indicates that the Biomet Microfixation RibFix Blu Thoracic Fixation System is substantially equivalent to a previously cleared device, and thus, no new non-clinical or clinical performance data were deemed necessary for this 510(k) submission.
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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 consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Biomet Microfixation Ms. Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K162974
Trade/Device Name: Biomet Microfixation Ribfix Blu Thoracic Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 24, 2016 Received: October 25, 2016
Dear Ms. 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
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the quality systems (OS) 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 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, Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System
Indications for Use: The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
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/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, sans-serif font. Below that, in a smaller font, is the word "MICROFIXATION". Underneath the words is a thin, horizontal line. Below the line are the words "One Surgeon. One Patient."
510(k) Summary
Prepared October 24, 2016
| 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 RibFix Blu Thoracic Fixation System
Common or Usual Name: Bone Plate and Bone Screw
Classification Name: Plate, Fixation, Bone and Screw, Fixation, Bone
| Device Classification: | ||||
|---|---|---|---|---|
| ProductCode | DeviceName | DeviceClassification | RegulationNumber | Regulation Description |
| HRS | Plate,Fixation,Bone | 2 | 888.3030 | Single/multiple componentmetallic bone fixation appliancesand accessories |
| HWC | Screw,Fixation,Bone | 2 | 888.3040 | Smooth or threaded metallic bonefixation fastener |
Indications for Use: The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
Contraindications: 1. Spanning a midline sternotomy; 2. Active infection; 3. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation: 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
Device Description: The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
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Predicate Devices:
K152253, Biomet Microfixation RibFix Blu Thoracic Fixation System
The similarities of the subject devices to the predicate devices are as follows:
- The indications for use and contraindications are identical to that of the predicate device.
- The design of the subject devices is equivalent to the predicate devices.
- o The sterilization method (steam sterilization) of the subject devices is identical to the predicate devices.
- The materials of the subject devices are identical to the predicate devices.
The changes proposed by this Special 510K are to update various sections of the Package Insert to provide additional information to users.
Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: The implants are provided non-sterile to be sterilized by the end user.
Substantial Equivalence: The proposed devices have indications for use as the predicate devices. The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates. It is concluded that the information included in this summary supports substantial equivalence.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.