(151 days)
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are focused on mechanical properties and material science.
Yes
The device is used to treat fractures, osteotomies, and arthrodesis, which are medical conditions, making it a therapeutic device.
No
The device description indicates it is an implantable staple for fracture fixation, and the performance studies describe engineering tests (e.g., pull-out strength, bending, fatigue, corrosion), not diagnostic performance metrics.
No
The device description explicitly states it is a sterile, non-bioabsorbable, implantable device manufactured from medical grade Nitinol, which are physical hardware components. It also mentions re-usable instruments for implantation.
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, osteotomy, and arthrodesis in small bones of the hand and foot. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a sterile, non-bioabsorbable, implantable staple made of Nitinol. It is designed to be surgically inserted into bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the TriMed Nitinol Staple System does not involve any testing of biological samples.
Therefore, the TriMed Nitinol Staple System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.
Product codes
JDR
Device Description
The TriMed Staple is a sterile, non-bioabsorbable, implantable device designed to address common types of deformity corrections, fractures and osteotomies in extremities amenable to staple fixation, all depending on the size, shape, and location of the fractured bone and bone fracture fragments. TriMed Staples are manufactured from medical grade Nitinol. Two types of staple leg configuration are available; symmetrical and asymmetrical. The staple is implanted with a set of re-usable instruments designed for: preparation of the implant site and insertion of the implant into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
To demonstrate product performance, TriMed conducted the following tests and compared the results to the predicate device.
- Pull-Out Fixation Strength;
- Elastic Static Bending;
- Constant Amplitude Bending Fatigue;
- Corrosion Susceptibility Testing; and
- Quantification of the titanium oxide layer thickness
In addition, the transformation temperature (At) was quantified.
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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July 1, 2019
TriMed, Inc. % Jean Asquith Regulatory Affairs Consultant Jean Asquith 4221 Lost Oasis Hollow Austin, Texas 78739
Re: K190166
Trade/Device Name: TriMed Nitinol 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: May 24, 2019 Received: May 30, 2019
Dear Jean Asquith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190166
Device Name TriMed Nitinol Staple System
Indications for Use (Describe)
The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.
| 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
1. SUBMITTER INFORMATION
TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355
| Company Contact: | David Medoff
Tel: (661) 255-7406
Fax: (661) 254-8485 |
|----------------------------|------------------------------------------------------------|
| Email: | davidmedoff@trimedortho.com |
| 510(k) Consultant Contact: | Jean Asquith
Tel: (512) 680-5802 |
| Email: | jtasquith.ra@gmail.com |
| Date Prepared: | June 21, 2019 |
2. DEVICE IDENTIFICATION
| Device Trade Name: | TriMed Nitinol Staple |
|---|---|
| Device Common Name: | Staple, Fixation, Bone |
| Regulation Number: | 21 CFR 888.3030 |
| Regulation Description: | Single/multiple component metallic bone fixation appliance |
| and accessories | |
| Product Code: | JDR |
| Device Class: | Class II |
| Classification Panel: | Orthopedic |
3. DEVICE DESCRIPTION
The TriMed Staple is a sterile, non-bioabsorbable, implantable device designed to address common types of deformity corrections, fractures and osteotomies in extremities amenable to staple fixation, all depending on the size, shape, and location of the fractured bone and bone fracture fragments. TriMed Staples are manufactured from medical grade Nitinol. Two types of staple leg configuration are available; symmetrical and asymmetrical. The staple is implanted with a set of re-usable instruments designed for: preparation of the implant site and insertion of the implant into bone.
4. INDICATIONS FOR USE
The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.
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5. COMPARISON TO PREDICATE DEVICES
The TriMed Nitinol Staple System is substantially equivalent to the following device:
| 510(k) Number | Device | Applicant |
|---|---|---|
| K112794 | Eleos Staple (included as part of | |
| the TriMed EOS Small Bone | ||
| Fixation System) | TriMed |
The TriMed Nitinol Staple is substantially equivalent to the Eleos Staple when comparing the following characteristics:
- Intended Use ●
- Principles of Use
- Fundamental Technology
- Basic Design ●
- Materials Used ●
- Where used ●
- Sterilization Method o
6. TESTING AND PERFORMANCE DATA
To demonstrate product performance, TriMed conducted the following tests and compared the results to the predicate device.
- Pull-Out Fixation Strength; ●
- Elastic Static Bending;
- Constant Amplitude Bending Fatigue; ●
- Corrosion Susceptibility Testing; and ●
- Quantification of the titanium oxide layer thickness ●
In addition, the transformation temperature (At) was quantified.
7. CONCLUSIONS
The TriMed Nitinol Staple is substantially equivalent to the predicate device as the basic design features and intended uses are the same. Any differences between the subject and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed, Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device.