(112 days)
TriMed Volar Plates and Radial Peg Plates
The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates:
- Fractures, non-unions or osteotomies of the distal radius.
TriMed Ulnar Peg Plates
Fractures, non-unions and osteotomies of the distal end of the ulna.
TriMed Pin Plates
The following fracture configurations may be applicable for treatment using the TriMed Pin Plates: - Fractures of the radial column of the wrist.
- Fractures of the dorsal ulnar cortex of the distal radius.
TriMed Wire Forms and Hook Plates
Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable corex of cortical bone.
TriMed Volar Plates consist of anatomically shaped plates used for fractures, non-unions or osteotomies of the distal radius. TriMed Bearing plates utilize distal bearings to allow peg angulation up to 30 degrees. Fixed Angle Volar Plates have pre-defined peg-hole trajectories. TriMed Fixed Angle and Bearing Plates are compatible with 2.4mm locking pegs and 2.4mm non-locking cortical bone screws distally and 3.2mm screws proximally.
TriMed Wrist Hook Plates are anatomically shaped plates used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wrist Hook Plates are compatible with 2.4mm screws and locking pegs.
TriMed Radial Peg Plates are anatomically shaped for the radial column used for fractures, nonunions or osteotomies of the distal radius. TriMed Radial Peg Plates are compatible with 2.4mm screws and locking pegs.
TriMed Ulnar Peg Plates are semi-tubular straight plates used for fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Ulnar Peg Plates are compatible with 2.4mm screws and locking pegs.
TriMed Pin Plates are anatomically shaped plates used for the treatment of fractures of the radial column of the wrist and fractures of the dorsal ulnar cortex of the distal radius. TriMed Pin Plates are compatible with 1.1mm k-wires and 2.4mm screws.
TriMed Buttress Pins are wire forms that are contoured to be used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed buttress pins are used with washers and 2.4mm threaded pegs and 2.4mm screws.
All TriMed Wrist Fixation System implants are made from 316L Stainless Steel per ASTM F138/139 and are supplied non-sterile.
The provided text describes a medical device submission (K222637) for the TriMed Wrist Fixation System 3, which is a metallic bone fixation appliance.
The information provided does not pertain to an AI/ML medical device, but rather to a traditional orthopedic implant. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical evidence (mechanical testing and engineering analyses) and states that clinical testing was not necessary.
Here's an analysis of the provided text with respect to the questions, noting the inapplicability to AI/ML:
1. A table of acceptance criteria and the reported device performance
The document describes several non-clinical tests performed on the TriMed Wrist Fixation System 3, comparing them to predicate devices or established standards. However, it does not present a table with explicit acceptance criteria and corresponding performance for each test in a clear, summarized format. It generally states that results were "compared to the acceptance criteria" or showed "substantial equivalence."
- Construct Cyclic endurance (Volar and Peg Plates): Compared to predicates.
- Construct Static load displacement (Volar and Peg Plates): Compared to predicates.
- 4-point bending (Longest Volar Plate): Conducted according to ASTM F382; results compared to acceptance criteria in FDA guidance document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway."
- Engineering analysis: To predicates (Hook Plates, Pin Plates and Buttress Pins).
- Cytotoxicity, Sensitization and Irritation testing: In accordance with ISO 10993-1:2018 (All implants).
- System screws testing (per ASTM F543-17):
- Torsional Strength
- Driving Torque
- Axial Pullout Strength Calculation
- Results compared to acceptance criteria in FDA guidance document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This question is not applicable as the submission is for a physical orthopedic implant, not an AI/ML diagnostic or prognostic device requiring a test set of data. The "tests" mentioned are mechanical and biocompatibility tests on the physical device components.
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)
This question is not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML performance evaluation based on human interpretation (e.g., image reading). For this device, "ground truth" (or accepted standards) is established by recognized engineering and biocompatibility standards (e.g., ASTM, ISO guidelines) and comparison to predicate devices, not by medical experts interpreting data for an algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert readers in AI/ML performance studies. This is not relevant for the mechanical and material testing described for the TriMed Wrist Fixation System 3.
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
This question is not applicable. An MRMC study assesses the impact of an AI tool on human performance. This submission is for an implant, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human input or review. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests mentioned would be the established acceptance criteria within the referenced ASTM and ISO standards, and the performance characteristics of the predicate devices. For example, for 4-point bending, the "ground truth" is passing the specified load and displacement requirements as per ASTM F382 and the FDA guidance document. For biocompatibility, it's meeting the criteria of ISO 10993-1:2018.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device.
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December 21, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
TriMed, Inc. % David Anderson Principal Consultant Tech2Med. LLC 6450 Old Darby TRL NE Ada, Michigan 49301
Re: K222637
Trade/Device Name: TriMed Wrist Fixation System 3 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, NDL, NDG Dated: November 22, 2022 Received: November 22, 2022
Dear David Anderson:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)
K222637
Device Name TriMed Wrist Fixation System 3
Indications for Use (Describe)
TriMed Volar Plates and Radial Peg Plates
The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates:
- Fractures, non-unions or osteotomies of the distal radius.
TriMed Ulnar Peg Plates
Fractures, non-unions and osteotomies of the distal end of the ulna.
TriMed Pin Plates
The following fracture configurations may be applicable for treatment using the TriMed Pin Plates:
-
- Fractures of the radial column of the wrist.
- Fractures of the dorsal ulnar cortex of the distal radius.
TriMed Wire Forms and Hook Plates
Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable corex of cortical bone.
| 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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K222637
Page 1 of 3
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510(K) SUMMARY
| Submitted By: | TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355United States of America |
|---|---|
| Contact Person: | David AndersonPrinciple Regulatory ConsultantOffice – (574) 377-0111Fax – (661) 254-8485 |
| Date: | December 21, 2021 |
| Proprietary Name: | TriMed Wrist Fixation System 3 |
| Common Name(s): | Plate, Fixation, BoneScrew, Fixation, BonePin, Fixation, smoothWasher, Bolt, Nut, Non-Spinal Metallic |
| Classification Name: | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories (Primary).21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Regulatory Class:Product Codes: | IIHRS, HWC, NDL, NDG |
| Predicate Device: | Primary PredicateK040112 - TriMed Bearing Plate / TriMed Volar Bearing Plate,TriMed, Inc. (USA) |
| Additional Predicate DevicesK951302 - Small Fragment Plates and Screws, MEDPAC.(USA)K951303 - Small Fragment Clamp and Buttress, MEDPAC,(USA)K010545 - Tension Band Wires, TriMed, (USA) |
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Image /page/4/Picture/1 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like a stylized letter "T" with curved arms, followed by the text "TriMed" in blue. A blue line is underneath the text.
Device Description
TriMed Volar Plates consist of anatomically shaped plates used for fractures, non-unions or osteotomies of the distal radius. TriMed Bearing plates utilize distal bearings to allow peg angulation up to 30 degrees. Fixed Angle Volar Plates have pre-defined peg-hole trajectories. TriMed Fixed Angle and Bearing Plates are compatible with 2.4mm locking pegs and 2.4mm non-locking cortical bone screws distally and 3.2mm screws proximally.
TriMed Wrist Hook Plates are anatomically shaped plates used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wrist Hook Plates are compatible with 2.4mm screws and locking pegs.
TriMed Radial Peg Plates are anatomically shaped for the radial column used for fractures, nonunions or osteotomies of the distal radius. TriMed Radial Peg Plates are compatible with 2.4mm screws and locking pegs.
TriMed Ulnar Peg Plates are semi-tubular straight plates used for fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Ulnar Peg Plates are compatible with 2.4mm screws and locking pegs.
TriMed Pin Plates are anatomically shaped plates used for the treatment of fractures of the radial column of the wrist and fractures of the dorsal ulnar cortex of the distal radius. TriMed Pin Plates are compatible with 1.1mm k-wires and 2.4mm screws.
TriMed Buttress Pins are wire forms that are contoured to be used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed buttress pins are used with washers and 2.4mm threaded pegs and 2.4mm screws.
All TriMed Wrist Fixation System implants are made from 316L Stainless Steel per ASTM F138/139 and are supplied non-sterile.
Indications for Use
TriMed Volar Plates and Radial Peg Plates
The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates:
- Fractures, non-unions or osteotomies of the distal radius.
TriMed Ulnar Peg Plates
Fractures, non-unions and osteotomies of the distal end of the ulna.
TriMed Pin Plates
The following fracture configurations may be applicable for treatment using the TriMed Pin Plates:
-
- Fractures of the radial column of the wrist.
-
- Fractures of the dorsal ulnar cortex of the distal radius
TriMed Wire Forms and Hook Plates
Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
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Image /page/5/Picture/1 description: The image shows the TriMed logo. The logo consists of a blue symbol on the left and the word "TriMed" in blue on the right. There is a blue line underneath the word "TriMed". The symbol on the left appears to be three overlapping arches.
Technological Characteristics
The subject TriMed Wrist Fixation System Devices are similar to the predicate devices in material, size, packaging, sterility, and has similar indications for use.
Substantial Equivalence: - Non-Clinical Evidence Performance Data
TriMed Wrist Fixation System 3 Implants were evaluated for following:
- Construct Cyclic endurance (Volar and Peg Plates) to predicates .
- Construct Static load displacement (Volar and Peg Plates) to predicates .
- . 4-point bending (Longest Volar Plate) were conducted according to ASTM F382, and results were compared to the acceptance criteria listed in FDA guidance document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway"
- Engineering analysis to predicates (Hook Plates, Pin Plates and Buttress Pins) ●
- Cytotoxicity, Sensitization and Irritation testing in accordance with ISO 10993-1:2018 (All ● implants)
- All system screws were tested per ASTM F543-17 for: ●
- Torsional Strength O
- O Driving Torque
- Axial Pullout Strength Calculation o
- Results were compared to the acceptance criteria listed in FDA guidance document O "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway "
Substantial Equivalence: - Clinical Evidence
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence - Conclusions
TriMed Wrist Fixation System 3 devices are substantially equivalent to the predicate devices in which basic design features, intended uses, indications for use, manufacturing, packaging, and labeling are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.
The submitted mechanical testing data and engineering analyses show the subject devices are substantially equivalent to that of the predicate devices for the desired indications.
Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. has determined that the proposed devices are substantially equivalent to the currently marketed predicate device.
§ 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.