(57 days)
Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a line extension to the VariAx Clavicle System, which was previously cleared in VariAx Clavicle System (K113760 & K130116). The VariAx Clavicle System consists of anatomically contoured. Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The subject plates are fixed to the clavicle using 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056 and K132502. This 510(k) submission is intended to introduce Hook Plates to the currently marketed VariAx Clavicle System. The plates are manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes).
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate devices (VariAx Clavicle System, AAP AcroPlate, Synthes (USA) Clavicle Hook Plates) in terms of fatigue properties. | Testing demonstrated that the VariAx Clavicle Plate System is substantially equivalent to the predicate devices. Fatigue testing specifically confirmed substantial equivalence between the subject VariAx Clavicle Hook plate and the predicate AAP AcroPlate. |
| Biocompatibility | Materials consistent with established standards for medical implants (Titanium Alloy per ASTM F136, Commercially Pure Titanium per ASTM F67). | Plates manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes). This implicitly suggests compliance with biocompatibility standards for these materials. |
| Design | Substantial equivalence to predicate devices in design. | Design is stated to be substantially equivalent to predicate devices. |
| Intended Use | Alignment with intended use of predicate devices for fixation of specific clavicle conditions. | Intended use matches predicate devices: fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Non-clinical laboratory testing" and "fatigue testing" which would involve a certain number of test samples (e.g., plates) but the exact quantity is not specified.
- Data Provenance: The testing was "Non-clinical laboratory testing" conducted by the sponsor (Stryker Trauma AG). This indicates it was likely conducted in a controlled lab environment. No information on country of origin of data beyond the sponsor's location (Mahwah, NJ) is provided. It is considered prospective in the sense that the tests were designed and executed to evaluate this specific device prior to its marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This was a non-clinical, mechanical and material testing study, not a clinical study requiring expert assessment of patient data.
4. Adjudication Method for the Test Set
Not applicable, as it was a non-clinical, mechanical and material testing study. The "adjudication" was based on comparing the mechanical performance data (e.g., fatigue curves, stress analysis from FEA) of the subject device against the established performance of the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This document explicitly states: "Clinical testing was not required for this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This is a medical device (bone fixation plate), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established performance characteristics (e.g., fatigue limits, material properties, structural integrity) of the predicate devices. The subject device's performance was compared against these established standards as determined through engineering and material science testing (e.g., fatigue testing, Finite Element Analysis).
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the traditional sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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510(k) Summary
Proprietary Name:
Common Name:
Classification Name and Reference:
VariAx Clavicle Hook Plate
Plate, Fixation, Bone
Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030
Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040
Device Class:
Product Code(s):
Sponsor:
For Information Contact:
Class II
HRS & HWC
Stryker Trauma AG
Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: 201-831-5691 Fax: 201-831-4691
Date Prepared:
January 31, 2014
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a line extension to the VariAx Clavicle System, which was previously cleared in VariAx Clavicle System (K113760 & K130116). The VariAx Clavicle System consists of anatomically contoured. Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The subject plates are fixed to the clavicle using 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056 and K132502. This 510(k) submission is intended to introduce Hook Plates to the currently marketed VariAx Clavicle System. The plates are manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes).
APR 0 1 2014
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Intended Use
Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.
Indications for Use
Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.
Substantial Equivalence
The subject VariAx Clavicle Hook Plate is substantially equivalent to the VariAx Clavicle System (K113760 & K130116), AAP AcroPlate (K030909) and Synthes (USA) Clavicle Hook Plates (K061753) in regards to intended use, design, materials, and operational principles for use for use in internal fixation in the clavicle.
Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx Clavicle Hook Plate components to determine substantial equivalent. Testing demonstrated that the VariAx Clavicle Plate System is substantially equivalent to the predicate devices. A Finite Element Analysis (FEA) was conducted on the subject VariAx Clavicle Hook Plate in order to assess the worst case plate for performance verification testing. In addition to this, fatigue testing was also conducted to compare the fatigue properties of the subject plates to the predicate AAP AcroPlate. The aim of the testing was to demonstrate substantial equivalence between the subject VariAx Clavicle Hook plate and the predicate AAP AcroPlate.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject components of the VariAx Clavicle Hook Plate are substantially equivalent to the predicate devices identified throughout this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2014
Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K140259
Trade/Device Name: VariAx Clavicle Hook Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 12, 2014 Received: February 14, 2014
Dear Mr. Wreh:
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 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 - Mr. Elijah N. Wreh
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 vours.
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K140259 510(k) Number (if Known):
Device Name: VariAx Clavicle Hook Plate
Indicated for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
. Over-The-Counter Use
(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 43 of 265
§ 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.