(201 days)
The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The Medicon Stern-a-Fix Stermal Closure System consists of titanium plates and 2.4 mm locking and standard bone screws, as well as 2.7 mm emergency screws. All 2.4 mm screws are self- drilling, i.e., a predrilled hole is not required, but may be used if desired. Screws are provided in lengths from 7-15 mm.
The plates are affixed to the sternum using the screws. They include thinner horizontal sections to facilitate quick re-entry.
The provided text describes a medical device, the Medicon Stern-a-Fix Sternal Closure System, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any AI/software performance.
Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. The "study" mentioned is a comparative fixation strength study against cerclage wire.
Here's an analysis based on the information provided, explicitly stating where information is missing for your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fixation Strength: | "Significantly greater stability was recorded for the Medicon Stern-a-Fix sternal closure system in all regions of the sternum, particularly at the xyphoid" compared to cerclage wire. |
| (Specific quantitative thresholds for "significantly greater stability" are NOT provided.) | (No specific numerical performance metrics are provided for the Stern-a-Fix system itself beyond the comparative statement.) |
| Biocompatibility: | (Not explicitly mentioned, but implied by material (titanium) and regulatory class. Detailed acceptance criteria and performance data are not in this summary.) |
| Mechanical Properties (e.g., fatigue, tensile strength of components): | (Not explicitly mentioned. These would typically be part of a comprehensive device submission but are not detailed in this summary.) |
| Clinical Outcomes (e.g., reoperation rate, infection rate): | (Not mentioned. The study referenced is a biomechanical comparison, not a clinical outcomes study.) |
| Intended Use Equivalence: | "The Medicon Stern-a-Fix Sternal Closure System is the same as the predicate devices in indicated use, method of rigid bone fixation, operating principle and materials." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document references a study by "Dasika et al" titled "Lower Sternal Reinforcement Improves the Stability of Sternal Closure." However, the sample size for this study is not provided in the given text.
- Data Provenance: Not specified. It's unclear if the study was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" here relates to biomechanical fixation strength, not diagnostic interpretations from experts. The study likely involved physical testing or simulations, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. This refers to expert consensus in diagnostic studies, which is not what was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document does not describe a MRMC study or any study where human readers' performance with/without AI assistance was evaluated. The device is a surgical implant, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. The device is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the comparison was biomechanical fixation strength (stability) in a model of a sternum, rather than expert consensus, pathology, or outcomes data. This would typically involve objective measurements from mechanical testing.
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The term "training set" is generally used in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI algorithm or training set for this physical device.
Summary of Device and Evidence:
The Medicon Stern-a-Fix Sternal Closure System is a physical metallic bone fixation appliance. Its regulatory clearance is based on substantial equivalence to existing predicate devices for its intended use (stabilization and fixation of anterior chest wall fractures). The primary "proof" cited in this 510(k) summary regarding performance is a biomechanical comparison study ("Dasika et al") which found that the Stern-a-Fix system provided "significantly greater stability" than cerclage wire for sternal closure. This study is primarily focused on the physical performance (fixation strength) of the device, and not on diagnostic accuracy, AI performance, or clinical outcomes as might be seen for software or diagnostic devices.
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510(K) SUMMARY
Submitter:
Contact Person:
Date Prepared:
Trade Name:
Common Name:
Classification Name and
Number:
Regulatory Class:
Predicate Devices:
Description:
Intended Use:
Substantial Equivalence:
Medicon. E.G.
Gaensaecker 15
Tuttlingen, D-78532
Germany
Phone: 011-49-7462-20090
Fax: 011-49-7462-2009-9956
Andreas Burger
December 20, 2005
Stern-a-Fix Sternal Closure System
Plate, Fixation, Bone
Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 880.3030, Product Code HRS)
Class II
•KLS-Martin Sternal Plating System, K032413
• Lorenz Sternal Closure System with Modular Screw, K011076
•Lorenz Sternal Closure System, K033740
The Medicon Stern-a-Fix Stermal Closure System consists of
titanium plates and 2.4 mm locking and standard bone screws, as
well as 2.7 mm emergency screws. All 2.4 mm screws are self-
drilling, i.e., a predrilled hole is not required, but may be used if
desired. Screws are provided in lengths from 7-15 mm.
The plates are affixed to the sternum using the screws. They
include thinner horizontal sections to facilitate quick re-entry.
The Medicon Stern-a-Fix Sternal Closure System is intended for
use in stabilization and fixation of anterior chest wall fractures
including sternal fixation subsequent to sternotomy and sternal
reconstructive procedures.
The Medicon Stern-a-Fix Sternal Closure System is the same as
the predicate devices in indicated use, method of rigid bone
fixation, operating principle and materials.
Fixation strength of the Medicon Stern-a-Fix bone plate for stemal
closure was compared to cerclage wire on the basis of the study
"Lower Sternal Reinforcement Improves the Stability of Sternal
Closure", by Dasika et al. Significantly greater stability was
recorded for the Medicon Stern-a-Fix sternal closure system in all
regions of the stemum, particularly at the xyphoid.
JUL 17 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2006
Medicon, E.G. % Business Support International Ms. Angelika Scherp Regulatory Consultant AMSTEL 320-I Amsterdam Netherlands 1017AP
Re: K053624
Trade/Device Name: Medicon Stern-a-Fix Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 6, 2006 Received: June 14, 2006
Dear Ms. Scherp:
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 such 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 complics 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); good manufacturing practice requirements as set
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Page 2 - Ms. Angelika Scherp
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbara Buerm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KO5 3629
Device Name: Medicon Stern-a-Fix Sternal Closure System
Indications for Use:
The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
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(Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number_2053024
§ 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.