(105 days)
No
The 510(k) summary describes a mechanical internal fixation system (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical and material properties.
No.
The device is an internal fixation system used to stabilize fractures, which is a structural support function, not a therapeutic treatment.
No
The device is an internal fixation system used for treating fractures, not for diagnosing medical conditions.
No
The device description clearly states it is an "internal fixation device that consists of various plates used with compatible screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal fixation of fractures" in specific bones. This is a surgical procedure performed within the body to stabilize broken bones.
- Device Description: The description details plates and screws used for internal fixation. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status, disease, or condition. The performance studies focus on mechanical properties and safety within the body (like MR compatibility).
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to treat a physical injury.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:
· osteotomies, mal-unions, and non-unions
· single, segmental, and comminuted fractures
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-271mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula
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 laboratory testing was performed for the VariAx 2 Compression Plating System. The following tests were performed:
- . LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit
- . MR Compatibility:
- Magnetically Induced Displacement Force per ASTM F2052
- Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F2119 o
An engineering rationale has been provided to demonstrate equivalence of the subject device to the predicate with respect to static and dynamic bending strength.
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.
Stryker GmbH VariAx2 Compression Plating System, K140565
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.
Synthes Small Fragment DCL System, K000684
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/2 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 image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2017
Stryker GmbH Ms. Tina Mornak Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K170727
Trade/Device Name: VariAx 2 Compression 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: June 14, 2017 Received: June 15, 2017
Dear Ms. Mornak:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.
Mark N. Melkerson -S
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
510(k) Number (if known)
K170727
Device Name VariAx 2 Compression Plating System
Indications for Use (Describe)
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:
· osteotomies, mal-unions, and non-unions
· single, segmental, and comminuted fractures
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)
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| Proprietary Name: | VariAx 2 Compression Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Regulation Description: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg l | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Tina Mornak |
| Senior Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| tina.mornak@stryker.com | |
| Phone: 201-831-6365 | |
| Fax: 201-831-6500 | |
| Date Prepared: | March 6, 2017 |
| Primary Predicate: | Stryker GmbH VariAx2 Compression Plating System, K140565 |
| Reference Devices: | Synthes Small Fragment DCL System, K000684 |
510(k) Summary
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components and expand the indications for use to the VariAx 2 Compression Plating System, previously cleared in K130009 and K140565. The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-271mm in length.
Indications for Use
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:
4
- osteotomies, mal-unions, and non-unions
- · single, segmental, and comminuted fractures
Summary of Technologies
A comparison of the systems demonstrated that the subject VariAx 2 Compression Plating System is substantially equivalent to the Stryker GmbH VariAx2 Compression Plating System, K140565 and Synthes Small Fragment DCL System, K000684 in regards to intended use, material, design, and operational principles.
Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx 2 Compression Plating System. The following tests were performed:
- . LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit
- . MR Compatibility:
- Magnetically Induced Displacement Force per ASTM F2052 O
- Magnetically Induced Torque per ASTM F2213 O
- o Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F2119 o
An engineering rationale has been provided to demonstrate equivalence of the subject device to the predicate with respect to static and dynamic bending strength.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject VariAx 2 Compression Plating System is substantially equivalent to the Stryker GmbH VariAx2 Compression Plating System, K140565 and Synthes Small Fragment DCL System, K000684.