(148 days)
Not Found
No
The device description and intended use describe a mechanical fixation system using plates and screws, with no mention of AI or ML capabilities.
Yes
The device is used for the "stabilization and fixation of fractures" to "promote union", which are therapeutic actions.
No
Explanation: The device is described as a system for stabilizing and fixing fractures in the chest wall, acting as an implant. It is not used to identify, detect, or monitor a medical condition.
No
The device description explicitly states it is composed of metallic locking bone plates and screws, 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. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is composed of metallic plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on these in vitro tests.
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 (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Biomet Microfixation 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 including sternal; anterior chest wall and sternum; ribs, sternum, and chest wall
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2015
Biomet Microfixation Ms. Lauren Jasper Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K142823
Trade/Device Name: Biomet Microfixation 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 Dated: January 16, 2015 Received: January 20, 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
1
Page 2 - Ms. Lauren Jasper
(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 forth in 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/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 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
K142823 Pg.1/1
Indications for Use
510(k) Number: K142823
Device Name: Biomet Microfixation 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/0 description: The image is a logo for Biomet Microfixation. The word "BIOMET" is in large, bold, sans-serif font, and the word "MICROFIXATION" is in a smaller, sans-serif font below it. A thin green line is below the word "MICROFIXATION", and the phrase "One Surgeon. One Patient." is in a smaller, sans-serif font below the line.
510(k) Summary
Prepared February 23, 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 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 |
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 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).
Predicate Devices:
K121302, Biomet Microfixation Sternal Closure System K133616, Synthes MatrixRIB Plating System
4
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. All implant systems consist of locking plates and locking screws to achieve rigid fixation of bone.
The subject device is indicated for use in the chest wall and sternum. The Biomet Microfixation Sternal Closure System is indicated for use in the anterior chest wall and sternum; the Synthes MatrixRIB Plating System is indicated for use in the ribs, sternum, and chest wall.
The subject device is manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V); the same materials as the Biomet Microfixation Sternal Closure System.
Differences to Predicate Devices: The subject devices consist of locking plates and locking screws. The Synthes MatrixRIB Plating System consists of locking plates, locking screws, and additionally, intramedullary splints.
The subject device is manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V). The Synthes MatrixRIB Plating System is manufactured from Titanium Alloy; however, the composition of this alloy is Ti-6Al-7Nb.
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-sterilized by the end user.
Substantial Equivalence: The proposed devices have intended 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 (2) the proposed devices are at least as safe and effective as the predicates. It is concluded that the information included in this submission supports substantial equivalence.