Uscom Kft

During an inspection of your firm located in Boglarka Utca # 17, Street Budapest, Budapest, 1119 Hungary on January 27, 2025, through January 30, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following spirometers: SpiroThor (also marketed as mSpirometer or mSpiro), Spirosonic, SpiroSonic AIR, SpiroSonic FLO, and SpiroSonic SMART. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are 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.

Our inspection revealed that SpiroSonic AIR is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not for this device 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). This device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(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.

You currently have clearance, dated May 27, 2015, for a different spirometer device called SpiroThor (also marketed as mSpirometer or mSpiro), which was cleared under K150137 with the following indications for use: “SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians’ offices, industrial medical, and hospital settings.”

On April 6, 2022, your firm submitted a premarket notification submission (K220982) for SpiroSonic AIR and several other spirometer devices, with the following indications for use: “The SpiroSonic spirometers are a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. SpiroSonic AIR spirometer use Bluetooth and a phone app to display and transfer data that is intended for testing in physicians' offices, industrial medical, hospital and home settings.”

In the Table of Comparison and Differences in your premarket notification submission (K220982), your firm identified several differences between SpiroSonic AIR and SpiroThor. First, you stated that the flow tube for SpiroSonic AIR is intended for “multi-patient, multi-use,” whereas the flow tube for SpiroThor is for single patient use and is disposable (K150137). These changes can significantly affect the safety of the device by creating a risk of cross-contamination of the device and the possibility of patient infections. Second, you reported new and different technology used in SpiroSonic AIR devices, i.e., the use of Bluetooth and a phone app to display and transfer data, which is not used in SpiroThor (K150137). These changes can significantly impact the functionality, safety, and performance of the device. Third, you stated that SpiroSonic AIR is intended for use in patient environments including home settings whereas SpiroThor (K150137) is not intended for use in home settings. These changes can significantly affect the device’s risk profile by increasing the possibility of user error.

As a result, on August 16, 2022, FDA issued a Request for Additional Information Letter (AINN), explaining that FDA reviewed your K220982 submission for SpiroSonic AIR and several other spirometer devices, and determined that additional information was required. The AINN letter explained that your response was due within 180 days from the date of the request and that FDA would consider the submission withdrawn and delete it from FDA’s review system if a complete response was not received by that date. Your firm did not respond to that letter. Accordingly, on February 14, 2023, FDA sent you a Close-Out Letter, entitled “Deletion of Submission for Lack of Response to Additional Information Request.” The letter explained that FDA considered your K220982 submission to be withdrawn and that it had been deleted from FDA’s review system.

Currently, your firm’s SpiroSonic AIR device does not have 510(k) clearance. The design changes and the changes in the intended use of SpiroSonic AIR constitute a significant change or modification in design compared to SpiroThor that could significantly affect the safety or effectiveness of the device as well as a major modification in the intended use of the device. As FDA explained in its August 16, 2022 AINN letter to your firm, “You may not market this device until you have received a letter from FDA allowing you to do so. If you market the device without FDA clearance, you will be in violation of the Federal Food, Drug, and Cosmetic Act.”

For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)."FDA requests that your firm cease any activities that result in the misbranding or adulteration of your devices.

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 responses from Mr. Zoltan Zsoter, Chief Operating Officer Uscom Europe dated February 19, 2025, and March 31, 2025, 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 these responses 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 for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. In addition, design validation shall include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g).

Specifically, your firm failed to validate the current SpiroSonic Mobile Software V1.16 that is intended to be used with SpiroSonic AIR. There is no documented rationale for the decision.

We reviewed your firm's February 19, 2025 and March 31, 2025 responses and conclude that the adequacy cannot be determined at this time. Your firm developed a procedure to validate the software that is intended to be used with SpiroSonic AIR, however, that process is not yet complete. Your firm expects to complete this process by December 31, 2025.

2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Specifically, for the following CAPA records 1/2023, 2/2023, 2/2024 and 3/2025 for SpiroThor, your firm failed to adequately investigate the cause of nonconformities relating to product, processes, and the quality system, identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, and verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.

We reviewed your firm’s February 19, 2025 and March 31, 2025 responses and conclude that they are not adequate. In the February 19, 2025 response, your firm stated that a CAPA was initiated on January 30, 2025 to review and rewrite CAPAs for the past five years to put them in a new format. In your March 31, 2025 response, the status of the CAPA was not provided.

3. Failure to validate with a high degree of assurance a process where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).

Specifically, the cleaning and disinfection process for SpiroThor used during production of the device and documented in the device user manual to be performed before and after patient use has not been validated.

We reviewed your firm’s February 19, 2025 and March 31, 2025 responses and conclude that they are not adequate. On January 30, 2025, your firm initiated a CAPA to define testing tasks in order to validate disinfection based on the new procedure. Your firm however did not provide the new procedure which will be used to validate the cleaning and disinfection process for SpiroThor and stated that the validation for cleaning and disinfection of SpiroThor is expected to be completed by October 31, 2025. Additionally, your March 31, 2025 response did not provide the status of the CAPA.

4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR § 820.90(a).

Specifically, your firm does not identify, document, and evaluate nonconforming SpiroThor products. The nonconforming products are segregated and discarded without any further action and documentation. This is a repeat observation from the previous FDA inspection of your firm in 2017.

We reviewed your firm’s February 19, 2025 and March 31, 2025 responses and conclude that they are not adequate. Your firm’s procedure, entitled “Handling of Unsuitable Product, MDR ME-04, Rev. 01,” states that evaluation of non-conforming products must include the following steps: “identify, mark, separate and manage non-conforming products.” However, your firm is not following that procedure. On January 30, 2025, your firm initiated a CAPA to separate scrap and non-conforming products, maintain statistics on them, and investigate their potential impacts. However, your firm did not provide documentation on how you would separate scrap and non-conforming products. Additionally, your March 31, 2025, response did not provide the status of the CAPA.

5. Failure to adequately maintain complaint files, as required by 21 CFR 820.198(a), failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b), and failure to maintain in a separate portion of the complaint files any complaint that represents an event which must be reported to FDA under part 803, as required by 21 CFR 820.198(d).

Specifically, your firm’s complaint handling procedure does not adequately ensure that complaints about SpiroThor are evaluated to determine whether the complaint represents an event which is required to be reported to FDA. In addition, your firm’s complaint handling procedure does not adequately ensure that complaints are reviewed and evaluated to determine whether an investigation is necessary, and that the records of investigation include a determination of whether the device failed, whether the device was being used, the relationship of the device to the reported incident or event, the name of the device, the date the complaint was received, the device UDI or UPC, the name and address and phone number of the complainant, the dates and results of the investigation, any corrective action taken and the reply to the complainant. Your firm also failed to create a complaint record for 19 SpiroThor devices returned by the customer in USA due to missing parts, rattling and cracked housing which were required to be reported to FDA under part 803.

We reviewed your firm’s February 19, 2025 and March 31, 2025 responses and conclude that they are not adequate. Your firm had initiated a CAPA and identified the root cause of the issue to be due to “insufficiently defined and implemented complaint handling procedures. Contributing factors may include unclear procedural guidelines, inadequate training, or lack of oversight in the complaint management process.” The corrective action per this CAPA was to revise your firm’s Complaint Handling Procedure to include a requirement that complaints received by Uscom must be investigated and evaluated. Your firm has not provided the revised Complaint Handling Procedure with the changes to the FDA. In addition, your firm did not provide your evaluation of the complaints using the revised procedure.

6. Failure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a).

Specifically, your “Document and Track the Service Process Work Instruction” procedure does not ensure that service reports that represent an event which must be reported to FDA are automatically considered as a complaint and processed as a complaint. For example, three service reports, MNK00058/2023, MNK00050/2023, and MNK00053/2023 reviewed involving three SpiroThor devices received from a customer in USA were repaired by replacement of the flow tube of the devices and were not processed as complaints. The service reports lacked adequate documentation as to why the devices were returned and why the flow tube/sensor assemblies were replaced. The flow tube houses the sensors and is a critical component to the device functional performance. One service report, MNK00039/ 2023 involved five returned SpiroThor devices due to a disconnected battery and cracked housing from a USA customer, that was not processed and documented by your firm as a complaint.

Your firm’s February 19, 2025 and March 31, 2025 response to Observation 7 of the FDA 483 are not adequate. Your firm initiated a CAPA on January 30, 2025 to revise your servicing procedure. In addition, upon receipt of a returned device from a customer, the CAPA requires completion of your firm’s service worksheet and treatment of the returned device as a customer complaint. However, your March 31, 2025 response did not provide the status of the revised servicing procedure.

Your firm should take prompt action to address any violations identified in this letter. Failure to 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. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

In addition, we offer the following comments:

We are aware that your firm also manufactures SpiroSonic, SpiroSonic FLO, and SpiroSonic SMART. During the inspection, your firm told the FDA investigator that your firm has made a business decision not to distribute any of these devices in the United States (b)(4). We remind you that, should your firm decide to introduce these devices into the United States, you will be responsible for obtaining clearance or approval to market the devices in the United States and for ensuring that these devices comply with all applicable legal requirements.

Our records indicate that your firm has fulfilled annual registration and listing requirements for fiscal year 2025 for SpiroThor, also marketed as mSpirometer or mSpiro. However, your firm incorrectly listed SpiroSonic and SpiroSonic AIR under premarket submission number K150137. As discussed above, SpiroSonic and SpiroSonic AIR lack 510(k) clearance and they were not cleared under K150137. Please remove Spirosonic and SpiroSonic AIR from your listing. If you submit a 510(k) for the devices and obtain clearance to market the devices in the United States, you will need to create a new listing using the premarket submission number. Instructions explaining how to create a new listing can be found at: Create Listings for Medical Device Products.

The import record dated June 19, 2024, describes one of your products as “USCOM SPIROMETER FOR INVESTIGATIONAL USE ONLY” and lists it under premarket submission number K150137. However, you do not have an approved application for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). We remind you that device labeling must be truthful and not misleading.

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, including 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 action (which should address systemic problems) that 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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. 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 via email to CDRHWarningLetterResponses@fda.hhs.gov. Refer to CMS case #707338 when replying. If you have any questions about the contents of this letter, please contact Rachana Visaria, Ph.D. at Tel: 240-402-5628.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.