(42 days)
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients. The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. Indications include the following: osteotomies and non-unions, fixation of fractures, normal bone density and osteopenic bone.
The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.
The provided text describes a 510(k) submission for a medical device called the "VariAx 2 One-Third Tubular Plating System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies.
Therefore, the requested information regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test and training sets, expert involvement, and adjudication methods is not applicable in this case.
Here's why and what information is available:
- Acceptance Criteria and Device Performance: Not applicable. For 510(k) submissions, the device's "performance" is assessed relative to predicate devices through non-clinical testing to demonstrate that it performs at least as safely and effectively. There are no pre-defined numerical performance metrics or acceptance criteria in the typical sense of a clinical study for a novel device.
- Study Proving Acceptance Criteria: Not applicable.
- Sample size for test set and data provenance: Not applicable. No clinical test set.
- Number of experts and qualifications: Not applicable. No ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. No training set as there is no AI algorithm.
- How the ground truth for the training set was established: Not applicable.
What was done (Non-Clinical Testing):
The submission states:
- Non-Clinical Testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence.
- Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.
- The following testing was performed:
- 4-Point Bending Out of Plane Testing
- 4-Point Bending Construct Out of Plane Testing
This non-clinical testing would have involved mechanical tests to compare the strength and performance of the new device to the predicate devices under simulated physiological conditions. The "acceptance criteria" here implicitly would be that the new device's performance in these mechanical tests is equivalent to or better than the predicate devices, thereby supporting the claim of substantial equivalence. However, specific numerical thresholds are not provided in this document.
Summary Table (with N/A where information is not applicable to a 510(k) for a physical device):
| Information Category | Details from K141204 |
|---|---|
| Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Implicitly, the device must perform as safely and effectively as the predicate devices in mechanical stress tests. Specific numerical criteria are not provided in this summary. Reported Device Performance: "Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing." The tests conducted were "4-Point Bending Out of Plane Testing" and "4-Point Bending Construct Out of Plane Testing." |
| Sample size (test set) & Data Provenance | Not applicable (no clinical test set). |
| Number & Qualifications of Experts (ground truth) | Not applicable (no ground truth established by experts for a clinical study). |
| Adjudication Method (test set) | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable (this is a physical medical device, not an AI/software device). |
| Standalone (algorithm only) performance study | Not applicable (this is a physical medical device, not an AI/software device). |
| Type of Ground Truth Used | Not applicable. The "ground truth" equivalent would be the established performance characteristics of the predicate devices. |
| Sample size (training set) | Not applicable (no training set). |
| How ground truth for training set was established | Not applicable. |
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K141204 Page 1 of 2
510(k) Summary
Proprietary Name:
VariAx 2 One-Third Tubular Plating System
Common Name:
Bone plates
Classification Name and Reference:
Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR $888.3030
Regulatory Class:
Class II
Product Codes:
Sponsor:
Contact Person:
Switzerland Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
87 HRS: Plate, Fixation, Bone
Stryker Trauma AG
Bohnackerweg 1 CH-2545 Selzach
Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com
Date Prepared:
May 7, 2014
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 One-Third Tubular Plating System. The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.
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Intended Use
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.
Indications
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.
Indications include the following:
- · osteotomies and non-unions
- · fixation of fractures
- · normal bone density and osteopenic bone
Summary of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices:
Non-Clinical Testing
Non-clinical laboratory testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.
The following testing was performed
- 4-Point Bending Out of Plane Testing .
- . 4-Point Bending Construct Out of Plane Testing
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices identified in this premarket notification.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
June 20, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Trauma AG Ms. Estela Celi Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K141204
Trade/Device Name: VariAx 2 One-Third Tubular Plating 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: May 7, 2014 Received: May 9, 2014
Dear Ms. Celi:
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 - Ms. Estela Celi
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -A
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141204
Device Name
VariAx 2 One-Third Tubular Plating System
Indications for Use (Describe)
The Stryker VariAx 2 One-Third Tubular Plating System is internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.
Indications include the following:
- · osteotomies, and non-unions
- · fixation of fractures
- · normal bone density and osteopenic bone
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabet同办公Frank -S
Division of Orthopedic Devices
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
§ 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.