(326 days)
The TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones.
TriMed Radiocarpal Fusion plates are designed to provide total immobilization of the wrist during wrist arthrodesis and for fixation of fractures of other small bones. The TriMed Radiocarpal Fusion System comprises of bone plates and screws. All plates and screws are similar to predicate devices. TriMed Radiocarpal Fusion plates come in a variety of lengths, bend angles, and screw mating configurations. All plates are designed to accommodate locking and non-locking screws. TriMed cortical bone screws for the wrist fusion application are available in diameters of 2.7 mm and 3.2 mm. All screws come in a variety of lengths and plate locking conditions. The Radiocarpal Fusion plates and screws are made of either ASTM F138/139 implant grade stainless steel or ASTM F136 implant grade Titanium alloy.
This document describes the TriMed Radiocarpal Fusion System, a device for wrist arthrodesis and fixation of fractures of other small bones.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Verification of safety and functionality through theoretical calculations and mechanical tests (static bending loads). | Results demonstrate that the physical properties of the TriMed Radiocarpal Fusion Plating System are substantially equivalent to the predicated devices. |
| The new product does not change the intended use or scientific principles used for safe and effective implantation of the device compared to predicate devices. | The new product does not change the intended use or scientific principles used for safe and effective implantation of the device. |
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical data or patient cases. The evaluation appears to be based on theoretical calculations and mechanical testing.
- Data Provenance: The data provenance is not applicable as the evaluation primarily relies on theoretical calculations and mechanical tests rather than patient-specific data from a particular country or source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study relies on engineering principles (theoretical calculations and mechanical testing) rather than expert-established ground truth from clinical cases. There is no mention of experts being used in this capacity.
4. Adjudication method for the test set:
Not applicable. The evaluation involves mechanical testing and theoretical calculations, not clinical adjudication.
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 device is a medical implant (radiocarpal fusion system), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical implant, not an algorithm, so the concept of standalone algorithmic performance is irrelevant.
7. The type of ground truth used:
The "ground truth" for this device's evaluation is based on established engineering and biomechanical principles verified through theoretical calculations and mechanical tests. The acceptance criteria are met when these tests demonstrate substantial equivalence to predicate devices, indicating that the device performs safely and effectively as expected for its intended use.
8. The sample size for the training set:
Not applicable. This device's evaluation does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth to be established for it.
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TriMed.
AUG 1 9 2011
510(K) Summary of Safety and Effectiveness RADIOCARPAL FUSION SYSTEM
| Submitted By: | TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355(800) 633-7221 |
|---|---|
| Registration #: | 2031009 |
| Prepared By: | Doug Steinberger,QA/RA Manager |
| Proprietary Name: | Radiocarpal Fusion System |
| Classification: | Class II: Plate Fixation, BoneHRS - Section 888.3030 |
| Class II: Screw Fixation, BoneHRS - Section 888.3040 | |
| Predicate Devices: | K042355 - Synthes LCPWrist Fusion System |
| K011335 - Synthes One-ThirdTubular DCL Plate | |
| Indications for Use: | The TriMed Radiocarpal Fusion System plates and screws are intended forwrist arthrodesis and fixation of fractures of other small bones. |
| Device Description: | TriMed Radiocarpal Fusion plates are designed to provide totalimmobilization of the wrist during wrist arthrodesis and for fixation offractures of other small bones.The TriMed Radiocarpal Fusion System comprises of bone plates andscrews. All plates and screws are similar to predicate devices. TriMedRadiocarpal Fusion plates come in a variety of lengths, bend angles, andscrew mating configurations. All plates are designed to accommodatelocking and non-locking screws. |
| TriMed cortical bone screws for the wrist fusion application are available indiameters of 2.7 mm and 3.2 mm. All screws come in a variety of lengthsand plate locking conditions. The Radiocarpal Fusion plates and screws are |
ADVANCED FIXATION TECHNOLOGIES"
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102785
Image /page/1/Picture/1 description: The image shows the logo for TriMed. The logo consists of a stylized graphic to the left of the word "TriMed." The graphic is black and appears to be an abstract representation of three interconnected arches. The word "TriMed" is also in black, with a small trademark symbol to the right of the word. A horizontal line runs beneath the graphic and the word.
Preparation Date: July 26, 2011
made of either ASTM F138/139 implant grade stainless steel or ASTM F136 implant grade Titanium alloy.
Substantial Equivalence:
Theoretical calculations and mechanical tests in the form of static bending loads have been performed to verify the safety and functionality of the device. Results demonstrate that the physical properties of the TriMed Radiocarpal Fusion Plating System are substantially equivalent to the predicated devices. The new product does not change the intended use or scientific principles used for safe and effective implantation of the device
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ADVANCED FIXATION TECHNOLOGIES™
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TriMed Inc. % Mr. Doug Steinberger QA/RA Manager 28337 Maitland Lane Saugus. California 91350
AUG 1 9 2011
Re: K102785
Trade/Device Name: Radiocarpal Fusion Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 26, 2011 Received: July 27, 2011
Dear Mr. Steinberger:
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
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Page 2 - Mr. Doug Steinberger
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric Keith
forMark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
(in mm).
Device Name: Radiocarpal Fusion Plate System
Indications For Use:
The TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones
02785
x Prescription Use AND/OR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102785
1 Page 1 of
§ 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.