Accessory to a medical device?

  • 4 September 2022
  • 2 replies

Two-part question:

1) We have an FDA-cleared neonatal phototherapy device (Class II, 510(k) in 2019). We are in the process of launching a line of swaddling garments (not medical devices on their own) that can be used to comfort neonates in the NICU and/or in other areas of the hospital. As long as we are clearly not marketing the two together and the garment is not intended to be used with our phototherapy device, the two products can co-exist, correct?

2) In the future we wish to explicitly market the two products together. We will have evidence to support claims that the garment supports and augments the performance of the phototherapy device, we will have established a DHF and other design control measures for the garment, and we would update our IFU for the phototherapy device. We are lead down the path of a new 510(k) due to changes in contraindications (source: FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device). Does the fact that we will have previously established the swaddling garment on the market negatively impact this 510(k) in any way?

2 replies

Userlevel 2

@Etienne Know of anyone who could help Matt with this question? Thanks!

Userlevel 5

Hey @mcorbo - thank you for your patience, and thank you @Niki for putting this back on my radar!

I made the not-so-great decision to attend back-to-back conferences in Phoenix and San Francisco, so I’m excited to fly home tomorrow and remember how things are supposed to go.

To answer your questions… 

  1. You are correct - the swaddling garment is not a medical device, and as long as you don’t make any marketing claims indicating otherwise, then you should be good. It’s ok for a company that sells medical devices to also sell products that are not medical devices.
  1. There are a few assumptions I’d like to unpack. It sounds like you are pretty confident that the swaddling garment actually does impact the way the medical deice works. Is this because the use of ANY swaddling garment improves the effect of the device, or is it because your specific swaddling garment has a unique aspect that improves the effect of the device?
    If there is something unique about the interaction of YOUR swaddling garment and the device, then that may change the conversation slightly depending on what the interaction is… but either way, it doesn’t sound like it should have any negative impact on future 510(k)’s (sounds like it would be a Special 510(k))

Lastly, I appreciate your work! Pediatric devices don’t seem to get enough attention, and I’m always especially appreciative for MedTech professionals who are focusing on them.

All the best,
Etienne Nichols