(201 days)
Not Found
No
The description focuses on the mechanical components and materials of a sternal closure system, with no mention of AI or ML capabilities.
No.
The device is described as a sternal closure system for stabilization and fixation of sternal fractures, aiming to promote fusion, which is a structural and mechanical function rather than a therapeutic one (i.e., treating or curing a disease).
No
The device is described as a "Sternal Closure System" intended for "stabilization and fixation of fractures of the sternum." This indicates it is a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly details multiple hardware components made of metallic materials (titanium, stainless steel) and a polymer coating, which are surgically implanted. This is not a software-only device.
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 sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion." This describes a surgical implant used to physically support and stabilize bone, not a test performed on biological samples to diagnose a condition or provide information about a patient's health status.
- Device Description: The description details a system of metallic plates, bands, and screws designed for surgical implantation. This aligns with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the SternaLock® 360 Sternal Closure System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The SternaLock® 360 Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium: the band is manufactured from Commercially Pure Titanium and coated with Parvlene-C: the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and the needle (not implantable) is manufactured from Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: A single SternaLock® 360 banded-box plate was compared to a single SternaLock® Blu box-shape plate in both static and fatigue testing. A recommended configuration for SternaLock® 360 (banded-box, banded-box) was compared to a recommended configuration for SternaLock® Blu (L-shape, X-shape, X-shape) in both static and fatigue testing. All non-clinical performance testing passed according to the acceptance criteria and the proposed device was found to be statistically equivalent or stronger in all testing than the predicate device. Testing was conducted as follows:
- Single Implant Static Testing .
- Single Implant Fatigue Testing
- 3-Implant Construct Static Testing ●
- 3-Implant Construct Fatigue Testing ●
- MR Compatibility Testing ●
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2015
Biomet Microfixation Ms. Lauren Jasper Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K151019 Trade/Device Name: Sternalock® 360 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: September 17, 2015 Received: September 18, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Lauren Jasper
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 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: K151019
Device Name: SternaLock® 360 Sternal Closure System
Indications for Use: The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or 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, gray letters. Below that, the word "MICROFIXATION" is in smaller, gray letters. Underneath the words is a thin, green line, and below that is the phrase "One Surgeon. One Patient."
510(k) Summary
Prepared October 29, 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: SternaLock® 360 Sternal Closure System
Common or Usual Name: Bone Plate
Classification Name: Plate, Fixation, Bone
Device Classification:
| Product Code | Classification Device | Regulation | Regulation Description | |
|---|---|---|---|---|
| Name | Classification | Number | ||
| HRS | Plate, Fixation | 888.3030 | Single/multiple component | |
| Bone | metallic bone fixation | |||
| appliances and accessories |
Indications for Use: The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or 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 SternaLock® 360 Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from
4
Commercially Pure Titanium: the band is manufactured from Commercially Pure Titanium and coated with Parvlene-C: the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and the needle (not implantable) is manufactured from Stainless Steel.
Predicate Devices:
K121302, Biomet Microfixation Sternal Closure System
Similarities to Predicate Devices:
The similarities of the new sternal closure device to the predicate device are as follows:
- The indications for use are similar to that of the predicate device.
- . 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 plate geometry is similar to the plates previously cleared in the predicate system. Both systems offer a box and X-shape design.
- Locking screw geometry is identical to predicate screw design. There are no changes to . material, design, or manufacturing processes from the predicate device. There are no additional lengths of screws offered outside the lengths previously cleared in the predicate system.
Differences to Predicate Devices:
The changes proposed by this new sternal closure device are as follows:
- . The proposed device is designed to approximate, compress, and fixate sternal bone after a sternotomy or through reconstruction.
- . The polymer coating used in the cerclage band design is an additional material, compared to the predicate device.
- . The addition of a needle attached to the end of the band to allow the device to be wrapped around or through the sternal bone. The needle is manufactured from stainless steel and is intended to be cut off after use and prior to tensioning the device.
- . Device-specific tensioning instrumentation to be offered single-use pre-assembled to the implants to aid in implantation of the device.
- Device sterilization: proposed device is offered sterile via exposure to Ethylene Oxide . gas. The predicate device is offered non-sterile and intended to be sterilized by the user prior to implantation.
Non-Clinical Performance Data: A single SternaLock® 360 banded-box plate was compared to a single SternaLock® Blu box-shape plate in both static and fatigue testing. A recommended configuration for SternaLock® 360 (banded-box, banded-box) was compared to a recommended configuration for SternaLock® Blu (L-shape, X-shape, X-shape) in both static and fatigue testing. All non-clinical performance testing passed according to the acceptance criteria
5
and the proposed device was found to be statistically equivalent or stronger in all testing than the predicate device. Testing was conducted as follows:
- Single Implant Static Testing .
- Single Implant Fatigue Testing
- 3-Implant Construct Static Testing ●
- 3-Implant Construct Fatigue Testing ●
- MR Compatibility Testing ●
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: The implants are provided sterile by the manufacturer; sterilization method is exposure to Ethylene Oxide gas. Implants are single use and cannot be re-sterilized by the user.
Substantial Equivalence: The SternaLock® 360 Sternal Closure System utilizes similar locking plate and locking screw technology as the predicate device. Testing identified in this summary has passed all acceptance criteria and the proposed devices are equivalent or better than predicate devices, where applicable. Indications for use of the predicate and proposed devices are similar. It is therefore concluded that the proposed device is considered substantially equivalent to the predicate device.