(78 days)
Biomet Microfixation SternaLock Blu 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
Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.
The provided text describes a 510(k) premarket notification for the Biomet Microfixation Sternal Closure System. The acceptance criteria and the study proving it meets these criteria are outlined in the "Substantial Equivalence" section of the document.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Requirement) | Reported Device Performance |
|---|---|
| Meet or exceed parameters of predicates for Torsional insertion and fracture test. | Exceeded Requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "mechanical testing" and "the devices" which implies a sample of devices were tested, but the specific number is not provided.
- Data Provenance: Not explicitly stated. However, given that it's mechanical testing of a medical device, it would be considered prospective testing performed in a controlled laboratory setting. The origin isn't specified beyond being conducted by Biomet Microfixation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for this type of mechanical testing is based on established engineering parameters and predicate device performance, not expert human interpretation.
- Qualifications of Experts: N/A
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The tests are objective mechanical measurements, not subjective evaluations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is a medical device (sternal closure system) involving physical implantation and mechanical performance, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- The ground truth for the mechanical testing (Torsional insertion and fracture test) was based on: Established engineering parameters and the performance characteristics of predicate devices. The new device was required to "Meet or exceed parameters of predicates."
8. The sample size for the training set:
- Sample Size: Not applicable. This document describes mechanical testing for a physical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device submission.
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K 11 05 74 (1/2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the others. Below the word "BIOMET" is the word "MICROFIXATION" in a smaller, sans-serif font.
MAY 1 8 2011
510(k) Summary
Biomet Microfixation Contact: 1520 Tradeport Drive Jacksonville, FL 32218-2480
Sheryl Malmberg, Global RA Specialist 904-741-9465 fax 904-741-9425
Device Name: SternaLock Blu Biomet Microfixation Sternal Closure System
Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Device. Product Code: 87HRS (21 CFR 888.3030) Device Classification: Class II
Intended Use: SternaLock Blu 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.
Description: Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.
Material: Titanium
Sterility Information: The SternaLock Blu Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.
Possible risks:
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- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
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- Nonunion or delayed union, which may lead to breakage of the implant.
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- Migration, bending, fracture or loosening of the implant.
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- Metal sensitivity, or allergic reaction to a foreign body.
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- Decrease in bone density due to stress shielding.
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- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
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- Increased fibrous tissue response around the fracture site and/or the implant,
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- Necrosis of bone.
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- Inadequate healing.
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- Selection of screws which are longer than the depth of the sternum may cause possible impingement on structures internal to the chest wall including vessels, pleura and other structures.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.
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K//0574(2/2)
제
Substantial Equivalence
. . ..
| Characteristic | New Device | Predicate | |
|---|---|---|---|
| Design | The SternaLock Blu ClosureSystem includes screws withlonger lengths that lock intosystem plates to stabilize andfixate fractures of the anteriorchest wall. | K011076K033740K063506 | |
| Material | Plates: TI Grade IVScrews: TI-6AL-4V | K011076K033740K063506 | |
| Size Range | Plates: various configurationsScrews: 8mm to 20mm length | K011076K033740K063506 | |
| Test | Requirement | New Device | Predicate Device |
| Torsional insertion andfracture test | Meet or exceed parameters ofpredicates. | ExceededRequirements | K011076K033740K063506 |
| Conclusion: No clinical testing was necessary for a determination of substantial equivalence. The results ofmechanical testing indicated the devices performed within the intended use,did not raise any new safety and efficacy issues and were found to be substantially equivalentto the predicate device |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Microfixation % Ms. Sheryl Malmberg Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonsville, Florida 32218
MAY 1 8 2011
Re: K110574
Trade/Device Name: Biomet Microfixation Sternal Closure Systemal 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: April 20, 2011 Received: April 21, 2011
Dear Ms. Malmberg:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Sheryl Malmberg
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Aly B. Rte
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K110574
Device Name: Biomet Microfixation SternaLock Blu Sternal Closure System
Indications for Use:
Biomet Microfixation SternaLock Blu 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
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) for M.Melkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110574 Page 1 of 1
§ 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.