Once a new medical device is in the market through a 510(k) clearance, it’s critical to continue monitoring changes to that device throughout its lifecycle and evaluating if any of these changes trigger a new 510(k) for the medical device.
Various kinds of changes may be required to the device and often the inspiration may come from customer feedback, a complaint, a field trend, or simply to catch up with the updated technology. One common kind of change is the change in technology of the medical device.
Technological changes can range from minor engineering tweaks, like adjustments to a circuit board layout, to more significant modifications, such as switching from electromechanical to microprocessor control. Several types of technological changes can call for a new 510(k) submission.
Some technological changes to a medical device that likely trigger a new 510(k)
1. Control Mechanism Change
The process by which the actions of a medical device are directed is termed as a control mechanism. Usually and mostly all the control mechanism changes significantly impact the device’s safety and effectiveness hence, calling for a new 510(k) submission.
For example, let’s consider switching from analog to digital control in a medical device. While digital control can significantly enhance performance and effectiveness, integrating it into an analog system is complex and usually part of a major redesign. This type of change impacts the safety as well as effectiveness of the device, which in turn calls for a new 510(k) submission.
2. Changes in the Operating Principles of a Medical Device
Any change being introduced in the operating principles of medical devices can have a direct impact on the effectiveness and efficiency of a medical device, which would require a new 510(k) submission.
For example, let’s consider that the image reconstruction algorithm used in a computed tomography X-ray device was changed due to a change in the device’s operating principle. If these changes are made to any medical device, it should undergo a proper testing process at all levels of production and in the clinic. This testing helps determine the new device’s substantial equivalence. This is where you will need a new 510(k) submission, so the FDA can review the data and ensure that the device’s safety and efficacy remains intact.
3. Changes in Energy Type
If there are any changes introduced in either the output or input energy type, a new 510(k) submission is required.
Let’s consider an example of this change that calls for a new 510(k) submission. Let’s consider that the manufacturer decides to change the battery-powered operation of an infusion pump to AC power. This change affects the way energy is supplied to the device and can introduce new risks, such as electrical hazards or changes in performance during power fluctuations. The shift in energy source requires a reevaluation of the device’s safety and effectiveness, necessitating a new 510(k) submission.
NOTE: The above-mentioned three changes, control mechanism change, change in the operating system, and energy type, are usually considered under one umbrella by the FDA, and likely need a new 510(k) submission.
4. Changes in the Sterilization Method
If the sterilization method is changed in a medical device, as per the FDA a new 510(k) submission is necessary as the effectiveness and safety of the medical device will be impacted significantly, given the role sterilization plays in the safety of the device. It is essential to understand that the new sterilization method has no impact on the material or performance characteristics of the device.
An example of a change in the Sterility Assurance Level (SAL) that would require a new 510(k) submission is switching from an ethylene oxide (EtO) sterilization method to a gamma radiation method for a surgical implant. This change affects the sterility process, and the new method may alter the device’s material properties or biocompatibility. Since different sterilization techniques can impact the effectiveness of sterilization and the device’s overall safety, a new 510(k) submission would be required to ensure compliance with regulatory standards.
Note: Cleaning, sterilization, or disinfection changes might impact the device’s biocompatibility. Therefore, it is essential for manufacturers to test the product with changes to determine if the device’s risk profile changes. If it does, a new 510(k) submission must be processed.
5. Packaging or Expiration Date Changes
In most cases, changes to device packaging or the expiration date don’t require submitting a new 510(k) to the FDA. Instead, the FDA relies on the Quality System (QS) regulations (21 CFR Part 820 or compliance to ISO13485) to ensure the continued safety and effectiveness of devices with these modifications. This applies whether the expiration date is based on packaging integrity, such as sterility, or the device’s finite shelf life.
If a manufacturer introduces new methods or protocols not covered in a previously cleared 510(k) to support packaging integrity or shelf-life claims, a new 510(k) submission is likely required. However, if the updates involve newly recognized consensus standards, a new 510(k) is generally not necessary.
6. Design changes in the Device
6.1 Dimension Changes
Another technological change that might call for a new 510(k) is dimensional changes. To determine if any dimensional changes made to the device require a new 510(k) submission, a manufacturer needs to consider several factors, including the magnitude of the change, the criticality of the modified dimension and its impact on the safety.
The more critical the change in dimension is, the more likely it will impact the effectiveness and safety of the device; hence, a new 510(k) submission is needed.
For example, let’s consider a situation where the diameter of a catheter is increased. Even a slight change in the catheter’s size can affect its performance, such as how it navigates through blood vessels, its compatibility with other medical devices, or the risk of tissue damage during use. Since these changes can significantly impact the device’s safety and effectiveness, a new 510(k) submission would be necessary to evaluate the potential risks and ensure continued compliance.
6.2 Performance Changes
Any change that impacts the performance of the device is categorized as a performance change. These types of changes are usually made to improve the performance and effectiveness of the device and, therefore, need a new 510(k) submission.
6.3 Wireless Communication Changes
Any change made in the communication method between different components of the device, for example, if the device earlier was using a wired communication method and later the manufacturer switched it to wireless communication, it is considered to be a major change that may change the risk profile of the device with respect to data transmission and cybersecurity.
Let’s consider a situation where a manufacturer decides to update a patient monitoring system to transmit data wirelessly instead of through physical cables. This change introduces new risks, such as potential data transmission errors, interference, or security vulnerabilities, which could affect the device’s performance and reliability. Since the shift from wired to wireless communication impacts the system’s safety, effectiveness, and functionality, a new 510(k) submission would be necessary to ensure the device continues to meet regulatory requirements.
6.4. Changes in components or accessories
There is a possibility that the change in components or accessories may cause a significant impact on a medical device’s performance and safety. To determine if this is the case, a manufacturer must consider whether changes to the device’s accessories or components can impact compatibility between the device and component or can change its risk profile.
Let’s try understanding it with an example where the manufacturer has decided to replace the tubing material in a dialysis machine. If the original tubing is swapped with a different material, it could impact the device’s biocompatibility, durability, or performance, such as fluid flow rates or interaction with the dialysis solution. Since this change could affect the safety and effectiveness of the machine, a new 510(k) submission would be required to assess the impact of the new component and ensure it meets regulatory standards.
6.5. Change in Patient-User Interface
A medical device usually includes a user interface that helps in interactions between the product and the user. Usually, these interactions are done using elements like display, controls, and packaging.
Any changes to the patient-user interface could affect the user workflow and the device’s effectiveness, potentially requiring a new 510(k) submission.
Let’s understand it through a simple example: Suppose a manufacturer decided to redesign the display screen on an insulin pump from a simple text-based interface to a touchscreen with graphical controls. This modification alters how patients interact with the device, potentially affecting ease of use, accessibility, and the risk of user errors. Since such changes in the interface can impact the device’s safety and effectiveness, a new 510(k) submission would be necessary to evaluate the impact of the updated interface and ensure compliance with regulatory standards.
When design or technology changes are made, a medical device manufacturer must assess how these changes affect the device’s risk profile and performance. Depending on the impact, the manufacturer can determine if a new 510(k) submission is necessary.
When determining if a design change that enables the device to be used in a new environment could impact its safety or effectiveness, manufacturers should evaluate variations in environmental specifications, such as:
- Temperature and humidity levels that could influence device performance
- Noise levels that may interfere with auditory alarms
- Exposure to water, dirt, or light that might impact device functionality
- Proximity to other devices or equipment that could cause electromagnetic interference
- Potential use in Magnetic Resonance Imaging (MRI) environments
A Few Questions manufacturers must ask themselves when making any technological changes to the medical device -
✓ Does the risk-based assessment of the modified device identify any new or significantly changed risks?
✓ Is clinical data required to assess safety or effectiveness for design validation?
✓ Do design verification and/or validation activities reveal any unforeseen safety or effectiveness issues.
Now that we have reviewed the different types of technological changes that need a new 510(k), we recommend you check out this infographic on the process you need to follow if any of these technological changes happen in your device – Technology, Engineering & Performance Changes that Require New 510(k) Submission.
Conclusion
Technological changes in medical devices, whether they involve switching from analog to digital controls, altering operating principles, changing energy types, modifying sterilization methods, adjusting dimensions, or updating components, can significantly impact device safety and performance and must be evaluated for a new 510(k) requirement. Manufacturers must evaluate the implications of technological changes carefully, considering factors like new risks, the need for clinical data, and any unforeseen issues revealed during design verification and validation.
By thoroughly assessing these aspects, manufacturers can maintain device safety, effectiveness, and regulatory adherence in the face of evolving technology.
