(180 days)
Not Found
No
The summary describes a mechanical bone staple and associated instruments, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
No
The device is a non-powered orthopedic staple used for bone fixation and reconstruction, which is not considered a therapeutic device in the context of actively treating or alleviating a disease or condition. Its function is mechanical support.
No
The device is described as an "EPIC Extremity Small Staple" intended for "fixation of bone fractures or bone reconstruction," which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of a "Small Staple" and "instruments to assist in implanting the device," 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 the device is for "fixation of bone fractures or bone reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description talks about an "implant" and "instruments to assist in implanting the device." This further reinforces its use in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:
-
Wedge osteotomy of the first phalanx (Akin osteotomy)
-
Treatment of hallux valgus in order to correct valgus or pronation of the first ray
-
Wind swept toes
The Small Staple is intended for single use only
Product codes
JDR
Device Description
The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (specifically mentioned: first phalanx, first ray)
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
Non-Clinical Performance Data Summary:
ASTM F-564-10 Static bend testing, fatigue bend testing, and pullout testing of the subject device performance was compared to predicate performance.
Clinical Performance Data Summary:
No clinical testing was required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Epic Extremely, LLC Randy Schlemmer Director Of New Product Development 120 Marguerite Drive, Suite 301 Cranberry Township, Pennsylvania 16066
Re: K163226
Trade/Device Name: EPIC Extremely Small Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: April 17, 2017 Received: April 20, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/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
2
Indications for Use
510(k) Number (if known) K163226
Device Name EPIC Extremity Small Staple
Indications for Use (Describe)
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:
-
Wedge osteotomy of the first phalanx (Akin osteotomy)
-
Treatment of hallux valgus in order to correct valgus or pronation of the first ray
-
Wind swept toes
The Small Staple 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/2 description: The image shows the word "EPIC" in large, bold, black letters. Below the word "EPIC" is the word "EXTREMITY" in a smaller font. There is a blue swoosh design that underlines the word "EXTREMITY".
510(k) Summary
Submitter Information
| Applicant: | EPIC Extremity, LLC
120 Marguerite Drive, Suite 301
Cranberry Twp., PA 16066 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Randy Schlemmer
EPIC Extremity, LLC
120 Marguerite Drive, Suite 301
Cranberry Twp., PA 16066
(574)248-0060 |
| Date Prepared: | November 16th, 2016 |
| Name of Device: | EPIC Extremity Small Staple |
| Common Name: | Staple, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances
and accessories (per 21 CFR 888.3030) - Class II |
| Product Code/Panel: | JDR/Orthopedics/87 |
| Predicate Devices: Primary - | Compression Staple and Simple
Staple (K043059)
Secondary - Sniper Staple System (K162354) |
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Image /page/4/Picture/2 description: The image shows the logo for Epic Extremity. The word "EPIC" is in large, bold, black letters. Below that, the word "EXTREMITY" is in smaller, white letters on a blue background.
510(k) Summary
Intended Use:
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction.
Examples Include:
*Wedge osteotomy of the first phalanx (Akin osteotomy)
*Treatment of hallux valgus in order to correct valgus or pronation of the first ray *Wind swept toes
The Small Staple is intended for single use only.
Device Description
The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.
Technological Characteristics
The EPIC Extremity Small Staple
- 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 is similar to the predicate device. ●
Non-Clinical Performance Data Summary
ASTM F-564-10 Static bend testing, fatigue bend testing, and pullout testing of the subject device performance was compared to predicate performance.
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 Small Staple is considered substantially equivalent to the Wright Medical Simple Staple in material, construction, and performance characteristics.