(124 days)
No
The 510(k) summary describes a mechanical staple system made of Nitinol and tested using standard mechanical and material property tests. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies.
Yes
The device is indicated for fixation of fractures and osteotomies, which are therapeutic interventions.
No
Explanation: The device is described as a "Staple System" intended for "fixation of fractures and osteotomies." This indicates its purpose is treatment or surgical intervention, not diagnosis.
No
The device description explicitly states the system consists of physical staples made of Nitinol, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Trilliant Sniper Staple System is described as a system of staples made of Nitinol intended for the fixation of fractures and osteotomies of bones. This is a surgical implant used directly on the body, not for testing samples taken from the body.
The information provided clearly indicates this is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The Trilliant Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
Product codes
JDR
Device Description
The Sniper Staple System consists of different-sized staples composed of Nitinol (Nickel-Titanium alloy) intended for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device. The system will be offered non-sterile in a tray for sterilization at the user's facility prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, and 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
No clinical studies were performed.
Non-Clinical Test Summary:
- Elastic Static Bending Strength per ASTM F564-10 (2015), Standard o Specification and Test Methods for Metallic Bone Staples, specifically Annex IV - Test Method for Elastic Static Bending of Metallic Bone Staples.
- . Pull-Out Fixation Strength per ASTM F564-10 (2015), Standard Specification and Test Methods for Metallic Bone Staples, specifically Annex II - Test Method for Pull-Out Fixation Strength of Metallic Bone Staples.
- . Transformation temperature testing per ASTM F2082 (2016), Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
- o Corrosion resistance testing per ASTM F2129 (2017), Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K081510, K121452, K153338, K123926
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2017
Trilliant Surgical Jon Olson President, CEO 6721 Portwest Drive. Suite 160 Houston, Texas 77024
Re: K172405
Trade/Device Name: Sniper Staple System. Non-sterile 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: November 8, 2017 Received: November 8, 2017
Dear Jon Olson:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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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.
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/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,
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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Trilliant Sniper Staple System
Indications for Use (Describe)
The Trilliant Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
| 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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510(k) Summary Sniper Staple System
In accordance with 21 CFR 807.92(c) of the Federal Code of Regulations, the following 510(k) summary is submitted for the Sniper Staple System.
| I. GENERAL INFORMATION | |
|---|---|
| Date Prepared | December 11, 2017 |
| Submitted By | Trilliant Surgical LTD |
| 6721 Portwest Dr. | |
| Suite 160 | |
| Houston, TX 77024 | |
| Telephone: 713-388-6055 | |
| Contact: Jon Olson | |
| Email: jolson@trilliantsurgical.com | |
| Trade Name | Sniper Staple System |
| Common Name | Bone staple |
| Device | Staple, Fixation, Bone |
| Regulatory Description | Single/multiple component metallic bone fixation appliances and |
| accessories. | |
| Class | II |
| Product Code | JDR |
| CFR Section | 21 CFR Section 888.3030 |
| Device Panel | Orthopedic |
| Predicate Device | Sniper Staple System, Sterile (Trilliant Surgical LTD, K162354) |
-GENERAL INFORMATION
II. DEVICE DESCRIPTION
The Sniper Staple System consists of different-sized staples composed of Nitinol (Nickel-Titanium alloy) intended for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device. The system will be offered non-sterile in a tray for sterilization at the user's facility prior to use.
Materials
Nitinol per ASTM F2063
Substantial Equivalence Claimed to Predicate Devices
The Sniper Staple System is substantially equivalent to the primary predicate device in terms of intended use, design, materials used, mechanical safety and performance. The Sniper Staple System is sterilized to the same sterility assurance level as the predicate device. The technological characteristics of the proposed device and the predicate are identical: both are U-shaped metallic fixation devices made from Nitinol that use two legs and a single bridge to fixate bone segments.
lll. Indications for Use
The Trilliant Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
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IV. Non-Clinical Test Summary
The following tests were performed:
- Elastic Static Bending Strength per ASTM F564-10 (2015), Standard o Specification and Test Methods for Metallic Bone Staples, specifically Annex IV - Test Method for Elastic Static Bending of Metallic Bone Staples.
- . Pull-Out Fixation Strength per ASTM F564-10 (2015), Standard Specification and Test Methods for Metallic Bone Staples, specifically Annex II - Test Method for Pull-Out Fixation Strength of Metallic Bone Staples.
- . Transformation temperature testing per ASTM F2082 (2016), Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
- o Corrosion resistance testing per ASTM F2129 (2017), Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device.
V. Clinical Test Summary
No clinical studies were performed.
VI. Conclusions: Non-Clinical and Clinical
Trilliant Surgical LTD considers the Sniper Staple System to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.
VII. Other device submission references
Multiple device submissions from Trilliant Surgical were used to demonstrate acceptable biocompatibility of the subject device. The reference submissions are as follows:
| 510(K) Number | Device Name | Decision Date | Manufacturer |
|---|---|---|---|
| K081510 | Tiger Cannulated Screw System | 08/04/2008 | Trilliant |
| K121452 | Gridlock Plating System | 08/20/2012 | Trilliant |
| K153338 | Tiger Cannulated Screw System | 01/14/2016 | Trilliant |
| K123926 | Metasurg Nitinol Staple | 05/03/2013 | Metasurg |