(240 days)
Not Found
No
The device description focuses on the mechanical properties and material of the staple, and the performance studies are standard mechanical and biocompatibility tests. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is described as a "mechanical osteosynthesis device" used for "fixation of fractures and osteotomies" and "to encourage early bone healing," which directly indicates a therapeutic purpose.
No
Explanation: The device is a surgical staple used for fixation of fractures and osteotomies. Its purpose is to encourage bone healing, not to diagnose a condition.
No
The device description clearly states it is a mechanical osteosynthesis device fabricated from a nickel-titanium alloy (Nitinol) and describes physical dimensions and material properties, indicating it is a hardware device. The performance studies also focus on mechanical and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and osteotomies of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a mechanical osteosynthesis device (a staple) made of Nitinol. This is a physical implant used to stabilize bone.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The Trilliant Surgical Sniper Staple System is indicated for fixation of the hand, foot, and bones appropriate for the size of the device.
Product codes
JDR
Device Description
The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.
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
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.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
April 20, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Trilliant Surgical LTD % J.D. Webb Authorized Contact Person The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K162354 Trade/Device Name: Sniper Staple System 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: March 6, 2017 Received: March 8, 2017
Dear J.D. Webb:
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
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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
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Sniper Staple System
Indications for Use (Describe)
The Trilliant Surgical Sniper Staple System is indicated for fixation of the hand, foot, and bones appropriate for the size of the device.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: Sniper Staple System
| Date Prepared | April 7, 2017 |
|---|---|
| Submitted By | Trilliant Surgical, LTD |
| 6721 Portwest Dr. | |
| Suite 160 | |
| Houston, TX 77024 | |
| Tele: 713-388-6055 | |
| Contact: Jon Olson | |
| email: jolson@trilliantsurgical.com | |
| Regulatory | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Sniper Staple System |
| Common Name | bone staple |
| Classification Name | Staple, Fixation, Bone |
| Class | II |
| Product Code | JDR |
| CFR Section | 21 CFR section 888.3030 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | MemoFix Super Elastic Nitinol Staple System (Metasurg (Integra), K123926) |
| Secondary Predicate | |
| Devices | Super Staple Classic (Metric Medical Devices, K123363) |
| Smith and Nephew Richards Staple, (pre-amendment device) | |
| Device Description | The Sniper Staple is a mechanical osteosynthesis device allowing for fixation |
| and compression of the bone fragments in order to encourage early bone | |
| healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and | |
| possesses super-elastic properties at room temperature. The staple offering | |
| is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped | |
| wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm | |
| sizes. | |
| Materials | Nickel-titanium alloy (Nitinol) per ASTM F2063 |
| Summary of | |
| Technological | |
| Characteristics | The rationale for substantial equivalence is based on consideration of the |
| following characteristics: | |
| Intended Use: The subject device and the predicate devices are intended for | |
| bone fixation. | |
| Indications for Use: The subject device and the predicates have equivalent | |
| indications for use. | |
| Materials: The subject device and predicate devices are manufactured from | |
| Nitinol | |
| Design Features: The subject device has similar design features to that of the | |
| predicates. | |
| Dimensions: The dimensions of the subject device and the predicates are | |
| equivalent. | |
| Sterilization: The subject device and one of the predicate devices are | |
| provided sterile by gamma irradiation. | |
| Indications for Use | The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures |
| and osteotomies of the hand, foot, and bones appropriate for the size of the | |
| device. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Four-point Bending (ASTM F564) | |
| • Pull-out Testing (ASTM F564) | |
| • Bend and Free Recovery Testing per ASTM F2082 | |
| • Corrosion testing per ASTM F2129 | |
| • Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) | |
| assay. The testing demonstrated that the subject device meets the | |
| recommended maximum endotoxin level of 20 EU per device. | |
| The results of these evaluations indicate that the Sniper Staple is equivalent | |
| to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: | |
| Non-clinical and | |
| Clinical | Trilliant Surgical 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. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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