(227 days)
No
The device description and intended use focus on mechanical fixation using plates and screws. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies described are related to physical and MRI safety testing, not algorithmic performance.
No
The device is a system of plates and screws used for the stabilization and fixation of fractures in the chest wall, which is a structural repair rather than a therapeutic treatment in the sense of addressing a disease or condition itself.
No
Explanation: The device description and intended use focus on the stabilization and fixation of fractures, which are treatment-oriented functions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description explicitly states it is composed of metallic locking bone plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "stabilization and fixation of fractures in the chest wall". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "metallic locking bone plates and locking screws". These are physical implants used to fix bones.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The provided information does not mention any such use or components.
Therefore, the Biomet Microfixation RibFix Blu Thoracic Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HRS, HWC
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 and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall, sternal
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)
MRI simulation and physical testing were performed to support the MR Safety Information in the labeling. 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
§ 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.
0
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Biomet Microfixation Ms. Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K152253
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: February 23, 2016 Received: February 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K152253
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)
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, dark gray letters on the top line. Below that, in smaller, lighter gray letters, is the word "MICROFIXATION". A thin green line is below the word "MICROFIXATION", and below that is the phrase "One Surgeon. One Patient" in gray letters.
510(k) Summary
Prepared March 22, 2016
| Submitter: | Biomet Microfixation |
|---|---|
| 1520 Tradeport Drive | |
| Jacksonville, FL 32218 | |
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialist |
| lauren.jasper@biomet.com | |
| Telephone: (904) 741-9259 | |
| Fax: (904) 741-9425 |
Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System
Device Classification:
| Product
Code | Device
Name | Device
Classification | Regulation
Number | Regulation Description |
|-----------------|-----------------------------|--------------------------|----------------------|-----------------------------------------------------------------------------------|
| HRS | Plate,
Fixation,
Bone | 2 | 888.3030 | Single/multiple component
metallic bone fixation appliances
and accessories |
| HWC | Screw,
Fixation,
Bone | 2 | 888.3040 | Smooth or threaded metallic
bone fixation 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.
The Biomet Microfixation RibFix Blu Thoracic Fixation System is Device Description: composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
Predicate Devices:
K142823, Biomet Microfixation Thoracic Fixation System
4
K151173. Biomet Microfixation RibFix Blu Thoracic Fixation System
Similarities to Predicate Devices: The predicate and subject devices are metallic implants intended to be used for the fixation of bone in the thoracic anatomy. The indications for use are identical for the predicate and subject devices. All implant systems consist of locking plates and locking screws to achieve rigid fixation of bone. The predicate and subject devices are manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
Non-Clinical Performance Data: MRI simulation and physical testing were performed to support the MR Safety Information in the labeling.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: The implants are provided non-sterilized by the end user.
Substantial Equivalence: The Biomet Microfixation RibFix Blu Thoracic Fixation System has the same indications for use as the predicate devices and utilizes similar design features and rigid fixation technology. The labeling has been updated to include MR Safety Information. It is therefore concluded that the subject devices are considered substantially equivalent to the predicate devices.