(16 days)
No
The document describes a mechanical internal fixation system and its components, with no mention of AI or ML capabilities.
Yes
The device is used for internal fixation, reconstruction, and treatment of fractures, which are therapeutic interventions.
No
This device is an internal fixation device used for surgical reconstruction and treatment, not for diagnosing conditions.
No
The device description explicitly states it is an internal fixation device consisting of plates and screws, which are 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 "internal fixation, reconstruction and treatment of fractures in the foot and ankle". This describes a surgical implant used within the body to stabilize bones.
- Device Description: The description details plates and screws used for internal fixation. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stryker VariAx 2 System is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:
- . Replantation
- Joint fusions
- Corrective osteotomies
- Osteopenic bone
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 O2.4mm, T10/T8 O2.7mm, and T10 O3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
Indicated Patient Age Range
adult and adolescent (12-21 years) patients
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 Testing: A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices -Application of risk management of medical devices." Records of the risk analysis process are retained in the design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject components in comparison to the previously cleared predicate device (K140376). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate device.
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.
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.
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/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Stryker Trauma AG Ms. Estela Celi Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K141992 Trade/Device Name: VariAx 2 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, HWC Dated: July 21, 2014 Received: July 22, 2014
Dear Ms. Estela 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
1
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/Resourcesfor You/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/ResourcesforYou/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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141992
Device Name VariAx 2 System
Indications for Use (Describe)
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:
· Replantation
- · Joint fusions
- · Corrective osteotomies
- · Osteopenic bone
Type of Use (Select one or both, as applicable)
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)
Elizabeth L. Frank -S
リ
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(k) Summary
| Proprietary Name: | VariAx 2 System |
|---|---|
| Common Name: | Bone plates and Screws |
| Classification Name and Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories 21 CFR §888.3030 | |
| Smooth or threaded metallic bone fixation fastener | |
| 21 CFR §888.3040 | |
| Regulatory Class: | Class II |
| Product Codes: | 87 HRS: Plate, Fixation, Bone |
| 87 HWC: Screw, Fixation, Bone | |
| Sponsor: | Stryker Trauma AG |
| Bohnackerweg 1 | |
| CH-2545 Selzach | |
| Switzerland | |
| Contact Person: | Estela Celi |
| Senior Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6461 Fax: (201) 831-3461 | |
| estela.celi@stryker.com | |
| Date Prepared: | July 21, 2014 |
Device Description
This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 Ø2.4mm, T10/T8 Ø2.7mm, and T10 Ø3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.
4
Intended Use
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients.
Indications
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:
- . Replantation
- Joint fusions
- Corrective osteotomies
- Osteopenic bone 0
Substantial Equivalence
The subject device components are substantially equivalent to the previously cleared VariAx 2 System (K140376) in regards to intended use, materials, and operational principles and similar with regard to design for use for internal bone fixation in adult patients.
Non-Clinical Testing
A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices -Application of risk management of medical devices." Records of the risk analysis process are retained in the design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject components in comparison to the previously cleared predicate device (K140376). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate device.
Conclusion
The VariAx 2 System is substantially equivalent to the predicate device identified in this premarket notification.