(124 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested. It's important to note that this document describes a medical device (bone staple), not an AI/algorithm-based device. Therefore, many of the requested fields pertinent to AI (like human reader improvement with AI assistance, training set details, or ground truth for AI) will not be applicable.
1. A table of acceptance criteria and the reported device performance
For a medical device like the Sniper Staple System, acceptance criteria are typically demonstrated through performance testing against established consensus standards.
| Acceptance Criteria (Measured against ASTM Standards) | Reported Device Performance (as stated in the summary) |
|---|---|
| Elastic Static Bending Strength: Meets ASTM F564-10 (2015), Annex IV - Test Method for Elastic Static Bending of Metallic Bone Staples. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate) |
| Pull-Out Fixation Strength: Meets ASTM F564-10 (2015), Annex II - Test Method for Pull-Out Fixation Strength of Metallic Bone Staples. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate) |
| Transformation Temperature: Meets ASTM F2082 (2016), Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate, ensuring the Nitinol material behaves as expected for its intended function, specifically its superelastic/shape memory properties relevant to bone fixation) |
| Corrosion Resistance: Meets 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." (Implies compliance with the standard such that it is equivalent to the predicate, ensuring the material is suitable for long-term implantation without detrimental corrosion) |
| Biocompatibility: Demonstrated acceptable biocompatibility (referenced against other Trilliant Surgical K-numbers). | Demonstrated through cross-reference to prior 510(k) submissions for similar devices and materials (Nitinol) from Trilliant Surgical (K081510, K121452, K153338, and K123926 for Metasurg Nitinol Staple by Metasurg, indicating proven material safety in vivo). This indicates that the materials used in the Sniper Staple System are widely accepted as biocompatible for medical implant use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of staples or test specimens used for each non-clinical test (elastic static bending, pull-out, transformation temperature, corrosion resistance). It only states that "The following tests were performed."
- Data Provenance: Not applicable as these are non-clinical (laboratory/bench) tests on manufactured device samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For non-clinical performance testing of a physical medical device, "ground truth" is established by adherence to recognized engineering and material science standards (ASTM in this case), and the results are quantified through laboratory measurements. Expert opinions in the context of clinical interpretation are not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies or image interpretation tasks where there's variability in human assessment. These are objective engineering tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical bone staple device, not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical bone staple device, not an algorithm. The "standalone" performance here refers to the device's material and mechanical properties as tested against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is defined by the objective pass/fail criteria and quantitative measurements specified within the referenced ASTM (American Society for Testing and Materials) standards. These standards prescribe specific methodologies, acceptable ranges, and performance benchmarks for metallic bone staples and Nitinol materials.
8. The sample size for the training set
Not applicable. This refers to a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This refers to a physical medical device, not a machine learning model.
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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 LTD6721 Portwest Dr.Suite 160Houston, TX 77024Telephone: 713-388-6055Contact: Jon OlsonEmail: 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 andaccessories. |
| 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 |
§ 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.