(120 days)
Not Found
No
The 510(k) summary describes a mechanical screw and associated instruments for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical properties.
No
The device is described as a screw for fixation of bone fractures or bone reconstruction, which is a structural or mechanical function, not a therapeutic one that treats or cures a disease or condition.
Can you please provide the full document text? I cannot answer your question without it.
No
The device description explicitly states it consists of "headed snap off screws of various lengths and instruments to assist in implanting the devices," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of bone fractures or bone reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "headed snap off screw" and instruments for implantation. These are physical implants and tools used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
The information provided describes a surgical implant and associated instruments, which fall under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.
Examples include:
*Fixation of small bone fragments
*Weil osteotomy
*Mono-cortical fixation
*Osteotomies and fracture fixation in the foot and hand
The Snap-Off Screw is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
bone fractures or bone reconstruction (specifically foot and hand)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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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 (Snap-Off Screw)
- a. Annex A1-Torsional Properties
- b. Annex A2-Driving Torque Parameters
- c. Annex A3-Axial PullOut
- d. Annex A4-Self Tapping Performance
-
- Torque to Fail: Snap-Off Feature
Clinical Performance Data Summary
No clinical testing was required.
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.
Charlotte Snap-Off Screw (K043583), Charlotte Snap-Off Screw (K133713), EPIC Extremity Cannulated Screw (K15333)
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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Epic Extremity, LLC Randy Schlemmer Director Of New Product Development 1000 Hampton Center, Suite A Morgantown, West Virginia 26505
Re: K163038
Trade/Device Name: EPIC Extremity Snap-off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 12, 2017 Received: January 17, 2017
Dear Mr. 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. 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 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.
1
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K163038
Device Name EPIC Extremity Snap-Off Screw
Indications for Use (Describe)
The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.
Examples include:
*Fixation of small bone fragments
- Weil osteotomy
*Mono-cortical fixation
*Osteotomies and fracture fixation in the foot and hand
The Snap-Off Screw is 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 a blue and gray swoosh design. Underneath the swoosh is the word "EXTREMITY" in smaller, black letters. The overall design appears to be a logo.
510(k) Summary
Submitter Information
| Applicant: | EPIC Extremity, LLC
120 Marguerite Drive, Suite 301
Cranberry Twp., PA 16066 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Randy Schlemmer
EPIC Extremity
1000 Hampton Center, Suite A
Morgantown, WV 26505
(724)779-4747 |
| Date Prepared: | February 27, 2017 |
| Name of Device: | EPIC Extremity Snap-Off Screw |
| Common Name: | Snap-Off Screw |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (per 21
CFR 888.3040) - Class II |
| Product Code/Panel: | HWC/Orthopedics/87 |
| Predicate Devices: | Charlotte Snap-Off Screw (K043583)
Charlotte Snap-Off Screw (K133713)
EPIC Extremity Cannulated Screw (K15333) |
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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 swoosh and the word "EXTREMITY" is written in smaller, black letters to the right of the swoosh. The logo is simple and modern.
510(k) Summary
Intended Use:
The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.
Examples include:
- Fixation of small bone fragments
- Weil Osteotomy ●
- Mono-cortical fixation ●
- Osteotomies and fracture fixation in the foot and hand ●
The Snap-Off Screw is intended for single use only.
Device Description
The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.
Technological Characteristics
The EPIC Extremity Snap-Off Screw
- has the same intended use as the predicate device.
- has similar indications for use as the predicate device. ●
- is manufactured from the same materials as the predicate device. ●
- range of sizes of the Snap-Off Screw is similar to the predicate device. ●
Non-Clinical Performance Data Summary
-
- ASTM F-543 (Snap-Off Screw)
- a. Annex A1-Torsional Properties
- b. Annex A2-Driving Torque Parameters
- c. Annex A3-Axial PullOut
- d. Annex A4-Self Tapping Performance
-
- Torque to Fail: Snap-Off Feature
Clinical Performance Data Summary
No clinical testing was required.
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Image /page/5/Picture/1 description: The image shows the logo for "EPIC EXTREMITY". The word "EPIC" is written in large, bold, black letters. Below "EPIC" is the word "EXTREMITY" in a smaller font. There is a blue and gray swoosh design that underlines both words.
510(k) Summary
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the EPIC Extremity Snap-Off Screw is considered substantially equivalent to the Wright Medical Charlotte Snap-Off Screw in material, construction, and performance characteristics.