WARNING LETTER
Trexo Robotics Holdings Inc.
MARCS-CMS 673150 —
February 07, 2024
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Manmeet Maggu
Trexo Robotics Holdings Inc.
6705 Millcreek Drive, Unit 3
Mississauga
ON
L5N 5M4
Canada
(b)(6)@trexorobotics.com
Issuing Office:
"OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality"
10903 New Hampshire Ave.
White Oak Building 66
Silver Spring
,
MD
20993
United States
WARNING LETTER CMS #673150
February 07, 2024
Dear Manmeet Maggu:
During an inspection of your firm located in Mississauga, Ontario, Canada on June 3 through June 5, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Trexo Home and Trexo Plus medical devices, hereafter referred to as the Trexo devices, and offers the product for sale in the United States. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Based on the evidence collected during the June 2023 inspection and other information, including statements on your firm’s website, www.trexorobotics.com, last reviewed on October 05, 2023, FDA has determined that the Trexo devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Trexo devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81.
You have listed the Trexo devices under classification regulation 21 CFR 890.1925. Devices classified under 21 CFR 890.1925, Isokinetic Testing and Evaluation System, are exempt from premarket notification unless they exceed the limitations of exemption at 21 CFR 890.9(a). Based on evidence collected during FDA’s inspection and a review of your firm’s website, FDA has determined that the Trexo devices are intended for uses that are different from those of legally marketed devices in the generic type of device under 21 CFR 890.1925, Isokinetic Testing and Evaluation System. Generic devices of this type are rehabilitative exercise devices intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints. However, your firm is marketing the Trexo devices for a different intended use; specifically, as a robotic powered gait training device to assist children with different levels of disability with ambulatory functions such as walking and standing. For example, statements made by your firm in labeling include the following:
• “Introducing Trexo Robotic legs to help children with mobility challenges get upright and walk independently.”
• “Depending on your child’s needs, you may adjust the amount of weight bearing, the gait pattern, speed of the device, and level of assist. The active assist feature may be used by children who have some ability to initiate steps or walk.”
Because the Trexo is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.1925, it exceeds the limitations described in 21 CFR 890.9(a) thus requires approval prior to marketing.
In addition, your device appears to operate using a different fundamental scientific technology than legally marketed devices in the generic type of device under 21 CFR 890.1925. For example, based on information in the product manual, the Trexo device use actuators such as a “powered hip joint” (part #1) and a “powered knee joint” (part #5) to generate forces or torques to the swing leg that assist human movement. In contrast, devices classified under 21 CFR 890.1925 are typically stationary machines that consist of a chair or a bench with a resistance mechanism that allows for controlled resistance for measuring muscular performance such as strength, power, and resistance. To the extent the Trexo devices operate using different fundamental scientific technology than legally marketed devices in the generic type of device under 890.1925, they also exceed the limitations of exemption from section 510(k) of the Act as described in 21 CFR 890.9(b).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Manmeet Maggu dated June 30, 2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example: Your firm’s procedures, QMS-S09-730-2, Design and Development Control, Rev 2 (Dated June 7, 2023) and QMS-S09-730-2, Design and Development Control, Rev 1 (Dated May 13, 2023), do not ensure that the design control process has been followed for the Trexo Home and Trexo Plus devices or that design validation was performed under defined operating conditions on the initial production units or the results from design validation were documented in the Device History File (DHF) of the devices.
We reviewed your firm’s response and concluded that it is not adequate.
Your firm indicated that CAR-39 is related to this observation. The proposed corrective actions include: 1) your firm will be continuing with design change activities according to QMS-SOP-730-1, Design and Development Control, and 2) QMS-PLN-003, Trexo Home/Plus Verification and Validation Plan, will be revised to implement design change activities with a proposed completion target date of November 30, 2023. The review of the cited procedure, QMS-SOP-730-1, Design and Development Control, does not address all of the requirements for 21 CFR 820.30. For example, this procedure does not clearly explain how your firm used change control during its design process or how approved design inputs are implemented as part of the change control process.
Additionally, the review of the QMS-PLN-003, Trexo Home/Plus Verification and Validation Plan, revealed that this procedure does not address all of the requirements for 21 CFR 820.30(g). For example, this procedure did not summarize how the clinical evaluations of the device ensure the device meets user needs and the intended uses, and this procedure did not clearly define how risk management issues were addressed throughout the design control process for these devices. In addition, it is unclear what design change activities are being conducted and how these design change activities will result in the revision of the QMS-PLN-003.
Your firm should provide evidence that the procedure has been updated to include all of the requirements of 21 CFR 820.30, and evidence of implementation of the validation activities that were conducted as part of the design control process for the Trexo devices.
2. Failure to adequately establish and maintain procedures where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example: The procedure, QMS-SOP-756-1, Process Validation, Rev 1.0 (dated June 6, 2023) does not ensure that a process that cannot be fully verified has been adequately validated. For example, the PCBA and motor tests for the Trexo Home and Trexo Plus have not been validated.
We reviewed your firm’s response and concluded that it is not adequate.
Your firm indicated that CAR-53 is related to this observation. The proposed corrective actions include: 1) drafting QMS-DOC-756.001, Required Process Validations, to list all of the processes that require validation and 2) to implement the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities that were specified in QMS-DOC-756.001. Your firm did not indicate if the procedure, QMS-SOP-756-1, Process Validation, would be updated to meet the requirements of 21 CFR 820.75(a). In addition, a copy of the QMS-DOC-756.001 document was not provided for review. Without this document, it is unknown what IQ, OQ and PQ activities are being performed on the Trexo devices. In addition, your firm did not specifically address the criteria that will be utilized in order to conduct the PCBA and motor validation tests
3. Failure to adequately establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).
For example: The procedure, QMS-S09-851-0, Corrective and Preventative Actions (CAPA), Rev. 2 (dated May 1, 2023; and the same procedure, Rev 1, dated April 14, 2023) does not ensure that all data sources are reviewed as possible CAPAs. For example, non-conformance reports (NCRs) are not included as a Quality Objective.
We reviewed your firm’s response and concluded that it is not adequate.
Your firm indicated that CAR-59 has been initiated in response to this observation. The proposed corrective actions are: 1) to update QMS-DOC-001, Quality Policy & Quality Objectives, to include measurable Key Performance Indicator (KPI) reporting metrics required for NCRs and CAPAs; 2) to revise CEMS-SOP-851-2, Corrective and Preventative Actions, to include all data sources. Your firm did not provide copies of the updated procedures, QMS-DOC-001, Quality Policy & Quality Objectives and QMS-S09-851-0, Corrective and Preventative Actions for review. Your firm’s response does not mention if the updated procedures will be utilized to conduct a retrospective review of past NCRs and CAPAs.
4. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: 1) All complaints are processed in a uniform and timely manner; 2) Oral complaints are documented upon receipt; and 3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a).
For example: The procedures, QMS-SOP-821-2, Feedback and Complaint Handling, Rev 2 (dated May 17, 2023 (and the previous version, Rev 1 dated April 21, 2023)) and QMS-WRK-821-1, Feedback and Complaint Work Instructions, Rev 1 (dated June 2, 2023) do not ensure that complaints received by your firm are adequately handled. Specifically:
A. Your procedures do not ensure that all complaints are handled as complaints instead of feedback. Each of the four feedback records should have been designated as complaints but were instead handled as feedback. Feedback records do not require evaluation for MDRs.
B. Your procedures do not ensure complaints that do not require investigations are documented. Five out of seven complaints reviewed did not require investigations due to the investigations being previously investigated. This information was not documented in the five complaints.
The adequacy of your firm’s response cannot be determined at this time.
Your firm indicated that CAR-46 is related to this observation. The proposed corrective actions are: 1) to retrain the Customer Service Engineer (CSE) on the Feedback and Complaint Handling procedure, QMS-SOP-821-2; 2) to review past tickets to ensure that the tickets were handled correctly as complaints, to evaluate these tickets for compliance with the MDR procedure, and to investigate these tickets (if required); 3) to update the Feedback and Complaint Report, QMS-FRM-821, to reference an ISSUE ID (ISSUE ID group the complaints based on the causes of the complaints); and 4) to update the Feedback and Complaint Work Instruction, QMS-WRK-821, to describe the process of grouping a new complaint to an existing ISSUE ID in order to determine if an investigation is necessary. Without all of the aforementioned supporting evidence, the evidence needed to evaluate the adequacy of this response is incomplete.
Our office requests that your firm, Trexo Robotics Holdings Inc., cease any activities that result in the misbranding or adulteration of the Trexo devices, such as the commercial distribution of the devices for the uses discussed above.
Your firm should take prompt action to address any violations identified in this letter. Failure to promptly adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS #673150 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Heather Dean, Ph.D., Assistant Director, Physical Medicine-Acute Injury Devices Team at (240) 402-9874.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Sincerely yours,
/S/
CAPT Nina Mezu-Nwaba, PharmD., MPH., MSc.
Deputy Director
OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
06/04/2024
Regulated Product(s)
Medical Devices