(61 days)
Not Found
No
The summary describes a mechanical screw system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The Intended Use / Indications for Use section states that the device is used for "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation," which are therapeutic applications.
No
The device is described as a system of screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, which implies a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states it consists of "multiple diameter headed and headless cannulated screws of various lengths and instruments," 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 describes the device as being used for surgical procedures on bones (bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation). This is a direct intervention on the body.
- Device Description: The device is described as screws and instruments for implanting them. These are physical implants and surgical tools.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The information provided consistently points to a surgical implant system, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.
Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device.
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 Performance Data Summary
- ASTM F-543
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the EPIC Extremity Cannulated Screw System are considered substantially equivalent to the Wright Compression Screw System & aap Cannulated Screw/Darco Headed Screws in material, construction, and performance characteristics.
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.
Wright Compression Screws (K082320), aap Cannulated Screw/Darco Headed Screws (K080101)
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 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, stacked on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Epic Extremity, LLC % Mr. Lee Strnad President Intrepid Orthopedics, LLC 3046 Brecksville Road, Suite 4 Richfield, Ohio 44286
Re: K153333
Trade/Device Name: Epic Extremity Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2015 Received: November 23, 2015
Dear Mr. Strnad:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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 yours,
Lori A. Wiggins -S
for
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Epic Extremity Cannulated Screw System
Indications for Use (Describe)
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.
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)
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 annonmal the and review the collection of information. Send comments regarding this burden estimate or any other spect 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."
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Image /page/3/Picture/0 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 swoosh shape with the word "EXTREMITY" written in smaller, white letters. The logo is simple and modern.
510(k) Summary
Submitter Information
| Applicant: | Epic Extremity, LLC
120 Marquerite Dr., Ste 301
Cranberry Twp., PA 16066 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lee A. Strnad
Management Representative
Intrepid Orthopedics
3046 Brecksville Rd, Ste 4
Richfield, OH 44286
(330) 659-0855 |
| Date Prepared: | November 10, 2015 |
| Name of Device: | Epic Extremity Cannulated Screw System |
| Common Name: | Bone Screws |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (per 21
CFR 888.3040) - Class II |
| Product Code/Panel: | HWC/Orthopedics/87 |
| Predicate Devices: | Wright Compression Screws (K082320)
aap Cannulated Screw/Darco Headed Screws (K080101) |
Intended Use:
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.
Screws are intended for single use only.
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Image /page/4/Picture/0 description: The image shows the logo for "EPIC EXTREMITY". The word "EPIC" is in large, bold, black letters. Underneath "EPIC" is a blue and gray swoosh design, and below that is the word "EXTREMITY" in smaller, white letters.
510(k) Summary
Device Description
The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.
Technological Characteristics
The EPIC Extremity Cannulated Screw System have the same intended use as the predicate devices. The EPIC Extremity Cannulated Screw System have similar indications for use as the predicate devices. The EPIC Extremity Cannulated Screw System are manufactured from the same materials as the predicate devices. EPIC Extremity Cannulated Screw System implants are manufactured from Ti-6AI-4V per ASTM F-136. The range of sizes of the EPIC Extremity Cannulated Screw System are similar to the predicate devices.
Non-Clinical Performance Data Summary
- ASTM F-543
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the EPIC Extremity Cannulated Screw System are considered substantially equivalent to the Wright Compression Screw System & aap Cannulated Screw/Darco Headed Screws in material, construction, and performance characteristics.