Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide some of them.

for NSR;
-Digital Mammography [Note: an IDE is required when safety and effectiveness data are collected which will be submitted in support of a marketing application.]
-Electroencephalography (e.g., new recording and analysis methods, enhanced diagnostic capabilities)
-Externally Worn Monitors for Insulin Reactions
-Functional Electrical Neuromuscular Stimulators
-General Biliary Catheters General Urological Catheters (e.g., Foley and diagnostic catheters)
-Wound Dressings, excluding absorbable hemostatic devices and dressings (also excluding Interactive Wound and Burn Dressings)

SR
Orthopedics and Restorative:
-Bone Growth Stimulators
-Calcium Tri-Phosphate Hydroxyapatite
-Ceramics Collagen and Bone Morphogenic Protein Meniscus Replacements
-Implantable Prostheses (ligament, tendon, hip, knee, finger)
-Computer Guided Robotic Surgery

As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devices is looking at the classification which is defined by the FDA. If a device is labeled as NSR, it would most likely be a Class I medical device, due to its non-invasive nature. Whereas a SR device would be labeled to either a Class II or Class III medical device, which is more invasive and may act as an implant or be life sustaining.

Hi Neb2,

From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is used for normal IV infusion may be considered a non significant risk, while as an infusion pump used for epidural anesthesia is Considered a SR since it might cause significant risk.

Therefore, I usually look at the risk profile based on the intended use, use environment and user population.

- Fady Khalla

Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention, depending of the used of the device the risk could change. In addition to this, it got me thinking about combination of product. There are different type of combination product, Drug, biologic, and device. This product can be combine for example we could have Drug/Device, Biologic/device, Drug/biologic. Each could have different type of class depending on the risk of the combine product.

Hi All,

I would agree with the examples and the points given above. I believe that SR vs. NSR is really determined by a combination of the classification of the device and the application of the device. As was mentioned if a device is classified as a low class it may be a NSR. However if the device had an application that was more risky it may be then considered a SR.

However as was mentioned in the lecture, the sponsor makes the initial determination and then the decision is evaluated by the IRB, who makes the final decision.

-Andrew Nashed

There are major differences in a SR vs. NSR studies. A SR needs to submit an IDE and must follows all regulations associated with it in 21 CFR 812. They also need that IDE approved before they can proceed with the study. However, for a NSR, the IDE application does not need to be approved by the FDA. However, it needs to follow the abbreviated requirements in 21 CFR 812.

Few examples of SR devices that we commonly know of:

Epidural and Spinal Needles
Intravascular stents
Replacement Heart valves
Pacemaker
Breast Implants
Sutures
TENS device
Intrauterine Devices (IUDs)

The definition of A Significant Risk (SR),is a device presents a potential for serious risk of health, safety and welfare of a subject, and are intended to be used as an implant and; purported to support or sustain human life; and is used for substantial importance in diagnosing, curing, mitigating, or treating disease. Examples of SR devices include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.SR devices must meet all regulatory requirements in 21 CFR 812, including the requirement for approval by both IRB and the FDA before beginning the study. SR studies requires high intensity monitoring.
Non-significant risk (NSR) device studies do not pose a significant risk to patients. Non-significant risk should not be confused with “minimal risk”. Examples of NSR devices include most day-wear contact lenses and lens solutions, and tongue depressor.

The first medical product that comes to mind when I heard of significant risk is a pacemaker. It is an implant which contains an electrical circuit that sends electrical impulses to the heart. My father has a pacemaker and it has so many benefits, but it does propose a health risk. A pacemaker takes the role of the SA node within the electrical system of the heart. It is a class III medical device and can cause harm to a patient due to the fact that it is implanted. A non-significant risk medical product is a tongue depressor. Its not implantable, it doesn’t propose any serious health risk to the user. It doesn’t place the well-being of the user at risk. A tongue depressor is a class I medical device which doesn't create any electrical simulation directed toward the heart.

In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body would have significant risk as these sutures are used to sustain life. However, you can also have a suture that applied topically on smaller wounds and removed which would have non significant risk. Before a clinical trial is ran, companies already have some form of draft of a risk assessment done. Companies have a very clear idea whether a product has significant or non signficant risk prior to reaching clinical trial stages

Just to add to the conversation of determining Significant vs Non significant risk medical device studies, the FDA has a guidance document.
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf

The guidance document is intended to provide information and advice to sponsors, clinical investigators, and IRBs on how to determine the differences between significant risk and nonsignificant risk medical device studies. It supersedes the Significant Risk and Nonsignificant Risk Medical Device Studies(1998). This document was updated to include a list of examples of significant and nonsignificant risk devices, to clarify the IRB’s responsibilities when making the risk determination for investigational medical devices, and to make the guidance consistent with the Agency’s good guidance practices regulations (21 CFR 10.115).

The biggest determinants for the classification are one the basis for the risk determination. The second, the nature of the harm that may result from the use of the device, this is the biggest key in determining the class because its results are the real world. Lastly knowing if the subjects need to undergo an additional procedure as part of the investigational study, these are risk factors, because the increase in involvement and procedure can increase the overall risk as well.