(22 days)
Not Found
No
The device description focuses on mechanical components (plates and screws) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
The device is used for stabilization and fixation of fractures of the anterior chest wall, including sternal fixation, and sternal reconstructive surgical procedures to promote fusion, which falls under the definition of a therapeutic device.
No
The device is a sternal closure system used for stabilization and fixation of fractures, not for diagnosing medical conditions.
No
The device description explicitly states it contains plates and screws made of titanium, which are physical 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 clearly states the device is for the "stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details plates and screws made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Biomet Microfixation Sternal Closure System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
Product codes
HRS
Device Description
The Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter screws with a minimum length of 8mm and a maximum length of 20mm. The tip of the 2.4mm screw is designed to be self-drilling so that a predrilled hole is not required. There are threaded features on both the plates and screws to allow for the screw to be locked into the plate when fully seated. The plates are manufactured from Commercially Pure Titanium (conforming to ASTM F67) and the screws are manufactured from Titanium Alloy (Ti-6Al-4V conforming to ASTM F136). The devices are sold non-sterile and intended to be sterilized by the user prior to implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior 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
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
§ 888.3030 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 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 an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2016
Biomet Microfixation Ms. Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K161896
Trade/Device Name: Biomet Microfixation Sternal Closure 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: July 6, 2016 Received: July 11, 2016
Dear Lauren 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 Parts 801); medical device reporting (reporting of medical devicerelated 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,
VincentJ. Devlin -S
- for 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): K161896
Device Name: Biomet Microfixation Sternal Closure System
Indications for Use: The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
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. Below that, the word "MICROFIXATION" is in smaller, lighter gray letters. Underneath that, there is a thin green line, and below that, the words "One Surgeon. One Patient." are in a smaller, lighter gray font.
510(k) Summary
Prepared July 6, 2016
| Submitter: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialist
lauren.jasper@zimmerbiomet.com
Telephone: (904) 741-9259
Fax: (904) 741-9425 |
Device Name: Biomet Microfixation Sternal Closure System
Common or Usual Name: Bone Plate
Classification Name: Plate. Fixation. Bone
Device Classification:
| Product Code | Classification
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 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
Contraindications: 1. Active infection. 2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
Device Description: The Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter screws with a minimum length of 8mm and a maximum length of 20mm. The tip of the 2.4mm screw is designed to be self-drilling so that a predrilled hole is not required. There are threaded features on both the plates and screws to allow for the screw to be locked into the plate when fully seated. The plates are manufactured from Commercially Pure Titanium (conforming to ASTM F67) and the screws are manufactured from Titanium Alloy (Ti-6Al-4V conforming to ASTM F136). The devices are sold non-sterile and intended to be sterilized by the user prior to implantation.
Predicate Devices:
K121302, Biomet Microfixation Sternal Closure System
4
The similarities of the subject devices to the predicate devices are as follows:
- o The indications for use and contraindications are identical to that of the predicate device.
- o The design of the subject devices is equivalent to the predicate devices.
- o The sterilization method (steam sterilization) of the subject devices is equivalent to the predicate devices.
- The materials of the subject devices are equivalent 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.