Process to Rule out Level of Concern of Software Medical devices for 510(k) Submission
Software Level of Concern (LOC) relates to an estimate of the severity of injury that a device could permit or inflict, either directly or indirectly, on a patient or operator because of device failures, design flaws, or simply by employing the device for its intended use.
The software documentation recommended by FDA for Premarket submission, or 510(k) submission depends on the determination of the Level of Concern. The Level of Concern is one of the critical steps in the process of the 510(k) documentation for the applicant of software medical devices.
The level of concern is categorized into 3 types they are:
- Major LOC
- Moderate LOC
- Minor LOC
The software device is also considered the major level of concern if:
- The Software Device control a life-supporting or life-sustaining function.
- The Software Device controls the delivery of potentially harmful energy that could result in death or serious injuries, such as radiation treatment systems, defibrillators, and ablation generators.
- The Software Device controls the delivery of treatment or therapy such that an error or malfunction could result in death or serious injury.
- The Software Device provides diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death.
- The Software Device provides vital signs monitoring and alarms for potentially life-threatening situations in which medical intervention is necessary.
The Level of Concern depends on the influence of the operation of the software associated with device function and its effects on the patient or operator. The effect may be direct or indirect. The decision flow process of the Level of Concern for software devices is given in Fig.1. Thus, the decision flow process rules out the type of level of concern, helps in appropriate documentation of 510(k) submission and it is also a crucial part to include the conclusion of decisive point regarding the type of level of concern in the software section of 510(k) documentation.