(107 days)
The EPIC Extremity Fusion Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.
The EPIC Extremity Fusion Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.5mm/5.5mm locking and non-locking screws that mate into the plates, 5.5mm fully and partial threaded cancellous, 5.5mm cannulated partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fusion Plate System is also designed to be used with various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
The provided document is a 510(k) premarket notification for the EPIC Extremity Fusion Plate System. This document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and performance characteristics, primarily through non-clinical testing and cross-sectional analysis.
It explicitly states:
- "No clinical testing was required." This means a clinical study, as typically described by the detailed questions you've asked regarding clinical acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, was not performed or required for this device's clearance.
- The entire document describes a medical device (bone fixation plates/screws), not an AI/ML-driven diagnostic or assistive software device that would typically involve a test set, ground truth experts, and MRMC studies.
Therefore, I cannot provide answers to the majority of your questions (1-9) because they pertain to a type of device and study not relevant or described in the provided text. The device in question is a physical implant, not a software algorithm requiring clinical performance evaluation against human readers or expert-established ground truth from medical images.
Summary of relevant information from the document (limited to what is present):
- Type of Device: Bone fixation plates and screws (physical implant).
- Study Type: Non-clinical performance data (cross-sectional analysis, bending strength testing in comparison to predicates).
- Ground Truth: Not applicable in the context of clinical expert review; mechanical properties were compared to predicate devices.
- Acceptance Criteria & Performance: The document states "Cross-sectional analysis demonstrated substantial equivalence." and "the addition of the EPIC Extremity Fusion Plates are substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system." This is the "acceptance" in a regulatory sense for this type of device. Specific quantitative criteria and detailed performance metrics are not given in this summary document, beyond the qualitative statement of substantial equivalence to predicates in bending strength.
Table of Acceptance Criteria and Reported Device Performance (based on the provided text's focus on substantial equivalence via non-clinical data):
| Acceptance Criteria Category (Implied by FDA 510(k) pathway) | Reported Device Performance (from text) |
|---|---|
| Material Equivalence | Manufactured from the same materials as the predicate devices. |
| Design/Construction Equivalence | Comparable in construction and anatomic location to predicate devices; identified differences (larger screw diameters, cannulated screws, anatomic specific plate families) are considered minor and do not raise new safety/effectiveness questions. |
| Performance (Bending Strength) | Substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system. |
| Indications for Use Equivalence | Identical indications for use as the predicate devices. |
| Intended Use Equivalence | Same intended use as the predicate devices. |
Regarding your specific questions (1-9):
- A table of acceptance criteria and the reported device performance: See table above, derived from the regulatory focus on substantial equivalence for this physical device. No clinical performance criteria are present.
- Sample sizes used for the test set and the data provenance: Not applicable. This was non-clinical testing comparing to predicate devices, not a clinical trial with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was based on engineering analysis and comparison to predicate device specifications/performance, not expert medical opinion on images.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, explicitly states "No clinical testing was required."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used: For this device, the "ground truth" (or basis for comparison) was the established performance and characteristics of the predicate devices in non-clinical testing.
- The sample size for the training set: Not applicable, as there is no machine learning component described.
- How the ground truth for the training set was established: Not applicable.
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EPIC Extremity, LLC Randy Schlemmer Director of Product Development 120 Marguerite Drive. Suite 301 Cranberry Twp, Pennsylvania 16066
February 13, 2019
Re: K182991
Trade/Device Name: EPIC Extremity Fusion Plate 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: January 7, 2019 Received: January 9, 2019
Dear Randy Schlemmer:
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/cdrl/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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/11 description: The image shows a digital signature. The signature is for Jesse Muir -S. The date of the signature is 2019.02.13 and the time is 10:16:53-05'00'.
For
10:16:53 -05'00' 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) K182991
Device Name
EPIC Extremity Fusion Plate System
Indications for Use (Describe)
The EPIC Extremity Fusion Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.
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)
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Image /page/3/Picture/1 description: The image shows the word "EPIC" in large, bold, black letters. Below the word "EPIC" is the word "EXTREMITY" in smaller, white letters against a blue and gray gradient background. The word "EPIC" is the main focus of the image, and the word "EXTREMITY" appears to be a secondary element.
EPIC Extremity Fusion Plate System
Submitter Information
| Applicant: | EPIC Extremity, LLC120 Marguerite Dr., Ste 301Cranberry Twp., PA 16066 |
|---|---|
| Contact Person: | Randy SchlemmerEPIC Extremity, LLC120 Marguerite Dr., Ste 301Cranberry Twp., PA 16066(574)248-0060 |
| Date Prepared: | October 15th, 2018 |
| Name of Device: | EPIC Extremity Fusion Plate System |
| Common Name: | Bone Fixation Plate |
| Classification Name | Single/Multiple component metallic bone fixation appliances andaccessories (per 21 CFR 888.3030) - Class II |
| Product Code/Panel: | HRS/Orthopedics |
| Predicate Devices: | EPIC Extremity Fracture Plate System (K172441)EPIC Extremity Cannulated Screw System (K153333)Ortholoc 3DI Ankle Fusion Plating System (K121425) ReferenceOrtholoc 3DI Ankle Fusion Plating SystemLine Extension (K163650) Reference |
Indications for Use:
The EPIC Extremity Fusion Plate System is indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.
Device Description
The EPIC Extremity Fusion Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.5mm/5.5mm locking and non-locking screws that mate into the plates, 5.5mm fully and partial threaded cancellous, 5.5mm cannulated partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fusion Plate System is also designed to be used with various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
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Image /page/4/Picture/1 description: The image shows the logo for EPIC Extremity. The word "EPIC" is written in large, bold, black letters. Below the word "EPIC" is a blue and gray graphic with the word "EXTREMITY" written in smaller, white letters. The logo is simple and modern.
EPIC Extremity Fusion Plate System
Technological Characteristics
The EPIC Extremity Fusion Plate System has the same intended use as the predicate devices. The EPIC Extremity Fusion Plate System has identical indications for use as the predicate devices. The EPIC Extremity Fusion Plate System is manufactured from the same materials as the predicate devices. The EPIC Extremity Fusion Plate System has the following differences from the predicate device:
- a. Introduction larger 4.5mm & 5.5mm screw diameters
- b. Introduction of cannulated 5.5mm screw diameter
- c. Introduction of anatomic specific plate families
Any differences between the EPIC Extremity Fusion Plate System and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
Non-Clinical Performance Data Summary
Cross-sectional analysis demonstrated substantial equivalence. Through this analysis it was determined that the addition of the EPIC Extremity Fusion Plates are substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system.
Based on the analysis results and the comparisons provided, the EPIC Extremity Fusion Plate System is considered substantially equivalent to the EPIC Extremity Fracture Plate System (K172441), Ortholoc 3DI Ankle Fusion Plating System (K121425), Ortholoc 3DI Ankle Fusion Plating System Line Extension (K163650) and EPIC Extremity Cannulated Screw System (K153333) in material, construction, size, anatomic location and performance characteristics.
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on the analysis results and the comparisons provided, the EPIC Extremity Fusion Plate System is considered substantially equivalent to the EPIC Extremity Fracture Plate System (K172441), Ortholoc 3DI Ankle Fusion Plating System (K121425), Ortholoc 3DI Ankle Fusion Plating System Line Extension (K163650) and EPIC Extremity Cannulated Screw System (K153333) in material, construction, size, anatomic location and performance characteristics.
§ 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.