(25 days)
No
The device description and intended use focus solely on mechanical fixation components (screws and plates) and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for use in the stabilization and fixation of fractures in the chest wall, promoting union, which directly contributes to restoring health and function.
No
The Biomet Microfixation Thoracic Fixation System is a fixation device used to stabilize and fix fractures in the chest wall, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is composed of metallic locking screws and bone plates, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The device is composed of "metallic locking screws that are utilized with previously cleared metallic locking bone plates." These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of biological samples.
Therefore, the Biomet Microfixation Thoracic Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet Microfixation 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
HWC
Device Description
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking screws that are utilized with previously cleared metallic locking bone plates. These devices provide rigid fixation of fractures and osteotomies of the chest wall and sternum. The locking screws are offered in two diameters, 2.4mm and 2.7mm. The 2.4mm diameter screws are offered with two tip designs, self-drilling and self-tapping, and range in lengths from 7mm to 16mm. The 2.7mm diameter screws are offered with a self-tapping tip design and range in lengths from 7mm to 16mm. The locking screws are manufactured from 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, sternum
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
Non-clinical testing was not necessary for the determination of substantial equivalence.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
Biomet Microfixation Ms. Lauren Jasper Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K151173
Trade/Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 30, 2015 Received: May 1, 2015
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 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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
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
K151173 510(k) Number (if known):
Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System
Indications for Use: The Biomet Microfixation 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/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, dark gray letters. Below that, the word "MICROFIXATION" is in smaller, lighter gray letters. Underneath the words is a thin, light green line, and below that are the words "One Surgeon. One Patient." in a light gray font.
510(k) Summary
Prepared April 30, 2015
| 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
Common or Usual Name: Bone Screw
Classification Name: Screw, Fixation, Bone
Device Classification:
| Product Code | Classification
Name | Device
Classification | Regulation
Number | Regulation Description |
|--------------|--------------------------|--------------------------|----------------------|-------------------------------------------------------|
| HWC | Screw,
Fixation, Bone | 2 | 888.3040 | Smooth or threaded metallic
bone fixation fastener |
Indications for Use: The Biomet Microfixation 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 screws that are utilized with previously cleared metallic locking bone plates. These devices provide rigid fixation of fractures and osteotomies of the chest wall and sternum. The locking screws are offered in two diameters, 2.4mm and 2.7mm. The 2.4mm diameter screws are offered with two tip designs, self-drilling and self-tapping, and range in lengths from 7mm to 16mm. The 2.7mm diameter screws are offered with a self-tapping tip design and range in lengths from 7mm to 16mm. The locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).
Predicate Devices:
K142823, Biomet Microfixation Thoracic Fixation System
4
The similarities of the new thoracic fixation device to the predicate device are as follows:
- o The indications for use are identical to that of the predicate device.
- o Both systems leverage rigid fixation technology through the use of locking plates and locking screws.
- Locking plates and screws are manufactured out of the same materials as the predicate devices. ●
- Locking screw self-drilling tip geometry is identical to predicate screw design. There are no ● changes to material, thread design, or manufacturing processes from the predicate devices.
- o There are no changes to sterilization methods; subject and predicate devices are sold non-sterile and are intended to be sterilized by the user prior to implantation.
The changes proposed by this new thoracic fixation device are as follows:
- The addition of a self-tapping screw in the 2.4mm diameter (the predicate device only features a ● self-drilling tip in the 2.4mm diameter). The predicate device utilizes a self-tapping screw design only in the 2.7mm diameter.
- The addition of the shorter 7mm length screw. Predicate device featured a shortest length of 8mm. As a result the IFU will be updated to reference this additional screw length.
- Screw lengths from 8mm to 16mm of both the self-drilling 2.4mm and self-tapping 2.7mm diameter are identical to predicate screws, except they have been given a new part number to coordinate with their system.
| Subject Device | Predicate Device | |
|---|---|---|
| Minimum Length | 7mm | 8mm |
| Maximum Length | 16mm | 20mm |
| Diameter | 2.4mm and 2.7mm | 2.4mm and 2.7mm |
| Tip Design | Primary (2.4mm): Self- | |
| Drilling and Self-Tapping | Primary (2.4mm): Self- | |
| Drilling | ||
| Emergency (2.7mm): Self- | ||
| Tapping | Emergency (2.7mm): Self- | |
| Tapping |
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-sterily 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.