(491 days)
Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.
The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).
This document is a 510(k) Premarket Notification for a medical device called the "Truemed Hand, Foot and Ankle Plates System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
This document describes a medical device (plates and screws for bone fixation) and its equivalence to other similar devices based on engineering and mechanical testing, NOT an AI/ML powered device, therefore the request regarding acceptance criteria and study proving it meets acceptance criteria for an AI/ML device is not applicable.
However, I can extract the information provided about the device's testing and safety:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plates: | |
| Static bending yield strength | Proved to be as strong as predicate devices |
| Static torsional yield strength | Proved to be as strong as predicate devices |
| Screws: | |
| Torsional properties | Performed in accordance with ASTM F543 ANNEX: A1 |
| Insertion and Removal Torque | Performed in accordance with ASTM F543 ANNEX: A2 |
| Axial Pullout Strength | Performed in accordance with ASTM F543 ANNEX: A3 |
| Materials: | |
| Stainless Steel (ASTM 138-13a) | Meets specifications and chemical/physical characteristics for medical implants according to ISO 5832 |
| Titanium (ASTM F136-12a) | Meets specifications and chemical/physical characteristics for medical implants according to ISO 5832 |
| Biocompatibility | Biocompatibility risk assessment performed for all components |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size used for the mechanical and engineering tests, nor does it mention data provenance (country of origin, retrospective or prospective).
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 information is not applicable and not provided. The "ground truth" in this context is the performance relative to established material standards and predicate devices, assessed through engineering and mechanical testing, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. The "test set" here refers to physical components undergoing mechanical and engineering evaluation, not clinical data requiring 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
- This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by engineering analyses, mechanical testing against material standards (ASTM, ISO), and direct comparison to the physical and functional characteristics of legally marketed predicate devices.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- This information is not applicable. There is no "training set."
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July 9, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Truemed Group LLC Nina Galeana Rodriguez Coordinator 2002 Timberloch Place Suite 200 The Woodlands, Texas 77380
Re: K200575
Trade/Device Name: Truemed Hand, Foot and Ankle Plates 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, HWC Dated: June 4, 2021 Received: July 8, 2021
Dear Nina Rodriguez:
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 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
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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: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
| 510(k) Number (if known) | K200575 |
|---|---|
| Device Name | Truemed Hand Foot and Ankle Plates System |
| Indications for Use (Describe) | Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents. |
| 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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Image /page/3/Picture/1 description: The image contains the logo for TrueMed Group. The logo consists of a teal-colored abstract symbol on the left, resembling a stylized human figure within a circle. To the right of the symbol, the word "TRUEMED" is written in a bold, dark gray font, with "GROUP" in a smaller, teal font below it. A horizontal line extends from the word "GROUP" to the right.
Premarket Notification 510(k) Summary
| 1. Submitter's Name: | Truemed Group LLC |
|---|---|
| 2. Contact Person: | Nina V. Galeana2002 Timberloch Place Suite 200 The Woodlands, TX 77380Telephone: 832 442 2310 |
| 3. Date Prepared: | July 8th, 2021 |
| 4. Device Name: | Truemed Hand, Foot and Ankle Plates System |
| 5. Common Name: | plates and screws |
| 6. Classification Name: | Primary: Plate, Fixation, Bone and accessories per 21 CFR section 888.3030Secondary: Screw, Fixation, Bone and accessories per 21 CFR section 888.3040 |
| 7. Product Codes: | HRS, HWC |
| 8. Devices Classification: | Class II |
| 9. Regulation Numbers: | 21 CFR 888.3030/21 CFR 888.3040 |
| 10. Predicate Devices: | PRIMARY PREDICATEK150099 -Depuy Synthes Variable Angle Locking Hand System (1.3 Y 2.0 Mm Plates and Screws).SECONDARY PREDICATESK030310 -Synthes Stainless Steel Modular Hand System.K050110-Synthes (USA) LCP Modular Foot Plates.K100776-Synthes 2.4 Mm / 2.7 Mm Variable Angle (Va)- LCP Forefoot/Midfoot System.K071264-Synthes (USA) 2.4/2.7mm Locking Foot Module.K020401-Synthes Calcaneal Plate.K120854-Synthes Variable Angle LCP Ankle Trauma System.K143191-McGinley Innovations IntelliSense Drill. |
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K200575 Page 2 of 3
Image /page/4/Picture/1 description: The image contains the logo for TrueMed Group. The logo consists of a teal-colored abstract symbol on the left, resembling a stylized person within a circle. To the right of the symbol is the text "TRUEMED" in a bold, dark gray font, with "GROUP" underneath in a smaller, teal font. A horizontal line extends from the right side of the word "GROUP".
11. Device Description:
The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).
-
- Indications for Intended use for fixation of complex intra and extra- articular fractures use: and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non- unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.
- Truemed Hand, Foot and Ankle Plates System and predicate devices 13.Technological Arzzt Radius and Ulna System (K182650) are manufactured from the Comparison same metals (stainless steel 316LS and Ti 6AI-4V ELI). Both materials meet specifications and chemical and physical characteristics that are necessary for the development of medical implants according to ISO 5832 Implants for surgery metallic materials.
We performed engineering analyses comparing the static bending and 14.Test static torsional yield strengths of the locking plates to the predicate Performed: devices proving to be as strong as the predicate devices. Mechanical Testing was also performed on the screws in accordance to ASTM F543 ANNEX: A1, A2 and A3 (Torsional properties, Insertion and Removal Torque, Axial Pullout Strength).
Engineering Analysis was performed on the plates in comparison to the predicate device. We used sectional views to calculate the Area moment of inertia and distance from the neutral axis to the surface at the minimum cross section using SolidWorks.
According to the minimum yield stress for stainless steel (ASTM F138-13a) and Titanium alloy (ASTM F136-12a), subject device proves to be as functional as predicate device.
Biocompatibility risk assessment was also performed for all components included in the subject device.
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Image /page/5/Picture/1 description: The image contains the logo for TrueMed Group. On the left is a teal-colored abstract symbol that appears to be a person inside of a circle. To the right of the symbol is the text "TRUEMED" in a bold, dark gray font, with the word "GROUP" underneath in a teal font. A horizontal line extends from the right side of the word "GROUP".
- ASTM F 983-86 (Reapproved 2009) Standard Practice . Permanent Marking of Orthopedic Implant for Components
- ASTM F 543 13 Standard Specification and Test ● Methods for Metallic Medical Bone Screws
- ASTM F 382-99 Standard Specification and Test . Method for Metallic Bone Plates
15. Substantial Equivalence:
- The Truemed Hand, Foot and Ankle Plates System has an intended use, target population, materials, performance properties equal to those featured in the predicates K150099, K030310, K050110, K100776, K071264, K020401, K120854, K143191 and K182650. In consideration of the technological and morphological characteristics of the devices, K150099, K030310, K050110, K100776, K071264, K020401, K120854, K143191 and K182650, a review of the product features and design lead us to find substantial equivalence. Engineering analysis and mechanical testing performed on the plates and screws that make up the Truemed Hand, Foot and Ankle Plates System indicate that they are substantially equivalent to the predicate devices in performance and functionality.
CONCLUSION
Based on the testing and technological properties of the subject device as compared to the predicate device, we believe that no new questions of safety and effectiveness have been raised, and that the subject device is substantially equivalent to the predicate devices.
§ 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.