(188 days)
No
The summary describes a passive bone fixation plate and does not mention any AI/ML components or functions.
No
Explanation: A therapeutic device is used to treat or manage a disease or condition. This device is a bone fixation implant used to fix fractures and fusions, which is a structural repair rather than a therapeutic treatment.
No
This device is a bone fixation plate used for treating fractures and fusions in the foot and ankle, not for diagnosing conditions.
No
The device is a physical implant (Titanium bone fixation device) and not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of bone fractures and fusions in the foot and ankle." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The device is described as a "Titanium bone fixation device intended to be permanently implanted." This further confirms its role as a surgical implant.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used for structural support within the body.
N/A
Intended Use / Indications for Use
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixation device intended to be permanently implanted. The implant is contoured with a tapered proximal end and contoured bend on the distal end. The implant has a 3-hole design and is 1.74 inches in length. The implant is single-use and may be available in sterile and non-sterile versions.
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
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)
Static and fatigue bending strength testing was conducted in accordance with ASTM F382-17 to demonstrate that the Arthrex Minimally Invasive Ankle Fusion Plate performed statistically equivalent to the predicate device cleared under K141735 Arthrex Ankle Fusion Plating System on August 15, 2014.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Minimally Invasive Ankle Fusion Plate utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex Minimally Invasive Ankle Fusion Plate meets pyrogen limit specifications.
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
October 16, 2019
Arthrex, Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190953
Trade/Device Name: Arthrex Minimally Invasive Ankle Fusion 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: April 5, 2019 Received: April 11, 2019
Dear Rebecca R. Homan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190953
Device Name
Arthrex Minimally Invasive Ankle Fusion Plate
Indications for Use (Describe)
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared | October 15, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Caroline Bloemker |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 71639 | |
| caroline.bloemker@arthrex.com | |
| Name of Device | Arthrex Minimally Invasive Ankle Fusion Plate |
| Common Name | Plate, Fixation, Bone |
| Product Code | HRS, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliance |
| and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K141735: Arthrex Ankle Fusion Plating System |
| K040907: Arthrex Small Fragment Plates and Screws (Reference) | |
| K150456: Arthrex Plates, Screws, and Staples (Reference) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Minimally Invasive Ankle Fusion Plate. | |
| Device Description | The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixation |
| device intended to be permanently implanted. The implant is contoured with a | |
| tapered proximal end and contoured bend on the distal end. The implant has a 3- | |
| hole design and is 1.74 inches in length. The implant is single-use and may be | |
| available in sterile and non-sterile versions. | |
| Indications for Use | The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for |
| fixation of bone fractures and fusions in the foot and ankle. The Arthrex | |
| Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile | |
| Screws. | |
| Performance Data | Static and fatigue bending strength testing was conducted in accordance with |
| ASTM F382-17 to demonstrate that the Arthrex Minimally Invasive Ankle Fusion | |
| Plate performed statistically equivalent to the predicate device cleared under | |
| K141735 Arthrex Ankle Fusion Plating System on August 15, 2014. |
MRI force, torque, and image artifact testing were conducted in accordance with
FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Minimally Invasive
Ankle Fusion Plate utilizing the Kinetic Chromogenic Method in accordance with
ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was
performed in compliance with US FDA good manufacturing practice (GMP)
regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates
that the Arthrex Minimally Invasive Ankle Fusion Plate meets pyrogen limit
specifications. |
| Conclusion | The Arthrex Minimally Invasive Ankle Fusion Plate is substantially equivalent to
the predicate device in which the basic design features and intended uses are the
same. Any differences between the proposed device and the predicate device
are considered minor and do not raise different questions of safety or
effectiveness. |
4
K190953
Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex Minimally Invasive Ankle Fusion Plate is substantially equivalent to the currently marketed predicate device.