Regulatory Open Forum

That's a very interesting question, Aliva.  I hadn't thought of that situation and how it affects the application of design controls.

I would say yes, but you would need to back up to a broader view of what can be applied generally and what can't.  For example, with user requirements, each user may have their own specific requirements, but all users require it to be effective in alleviating their sleep apnea.  There are undoubtedly risks associated with use of the device that will apply to all users, as well.

I will have to ponder how/if this might affect V&V, but those are some quick thoughts late on a Friday afternoon.  I will be interested to see what insights others have to offer.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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Original Message:
Sent: 28-Apr-2017 15:33
From: Aliva Das
Subject: Sleep apnea device 510(k) and design requirements

Hello everyone,

Does anyone work with sleep apnea devices. This device is regulated by FDA ( product code: LRK) and requires a 510(k).

However, every sleep device is custom made to patient requirements. Does it still need to follow the design control requirements.

Any thoughts and feedback on this is appreciated.

Original Message------

That's a very interesting question, Aliva.  I hadn't thought of that situation and how it affects the application of design controls.

I would say yes, but you would need to back up to a broader view of what can be applied generally and what can't.  For example, with user requirements, each user may have their own specific requirements, but all users require it to be effective in alleviating their sleep apnea.  There are undoubtedly risks associated with use of the device that will apply to all users, as well.

I will have to ponder how/if this might affect V&V, but those are some quick thoughts late on a Friday afternoon.  I will be interested to see what insights others have to offer.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message------

Hello there,

Yes it still follows design controls. The design controls apply to how you arrived at the device you sell to the physician, and how it is customized should be within your general parameters of instructions for use. 

This is similar to dental devices which are "customized" for the patient by the dentist. Think of crowns that are created from a mold of your tooth. The base material of zirconia is subject to design controls and 510(k) but the crown is milled from a block of material using software in a lab or the dental office, to match the patient's mouth. 

Unless your apnea device is Class 1 and exempt from most of QSR, design controls apply.

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

(715) 307-1850

Original Message------

Hello there,

Yes it still follows design controls. The design controls apply to how you arrived at the device you sell to the physician, and how it is customized should be within your general parameters of instructions for use. 

This is similar to dental devices which are "customized" for the patient by the dentist. Think of crowns that are created from a mold of your tooth. The base material of zirconia is subject to design controls and 510(k) but the crown is milled from a block of material using software in a lab or the dental office, to match the patient's mouth. 

Unless your apnea device is Class 1 and exempt from most of QSR, design controls apply.

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

(715) 307-1850

This would be more of a customized device versus an actual custom device which is built differently for every patient.  Think "Invisalign" or something similar which is customized for each patient but the primary design intent and high level user needs do not change on a per patient basis.  Also I would assume there are parameters around what can be customized without affecting product performance.

You should conduct design validation against your primary user needs and then also verification against the shared design requirements.  You should also document what the the allowable modifications/customizations are and that they do not affect device performance.

------------------------------
Sandra Aprahamian RAC
Sr. Regulatory Scientific Advisor
Network Regulatory Partners
www.networkrp.com
------------------------------

Original Message:
Sent: 28-Apr-2017 15:33
From: Aliva Das
Subject: Sleep apnea device 510(k) and design requirements

Hello everyone,

Does anyone work with sleep apnea devices. This device is regulated by FDA ( product code: LRK) and requires a 510(k).

However, every sleep device is custom made to patient requirements. Does it still need to follow the design control requirements.

Any thoughts and feedback on this is appreciated.

Dear Aliva,

I am not a frequent contributor in this forum, but I started my medical device career in Sleep Disorder diagnosis and treatment, so your post caught my eye.  

Seems your question about if design controls are required has been thoroughly answered by others in the forum.  However, it sounds from your questions you have not yet submitted a 510K.  When you do your submission it should have a design window for your device.  This allows the reviewer to understand how each device may differ in size, shape, features, etc, and to ensure all possible configurations are safe and effective.  It also sets boundaries for the design engineers to ensure Safety and Effectiveness is not compromised.  If a case should come up that is outside the design window you have cleared in your 510K, you may need to consider a new submission, or if it is truly a unique case and there is not another device on the market that could adequately treat the case, you may consider submitting for a "custom device exemption" for that instance.

Hope this provides a little more information to help you.

Good Luck and Best Regards,

Paul

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Paul Boatner
Sr Regulatory Affairs Specialist
Zimmer Biomet CMF
Jacksonville, FL
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Original Message:
Sent: 29-Apr-2017 12:19
From: Sandra Aprahamian
Subject: Sleep apnea device 510(k) and design requirements

This would be more of a customized device versus an actual custom device which is built differently for every patient.  Think "Invisalign" or something similar which is customized for each patient but the primary design intent and high level user needs do not change on a per patient basis.  Also I would assume there are parameters around what can be customized without affecting product performance.

You should conduct design validation against your primary user needs and then also verification against the shared design requirements.  You should also document what the the allowable modifications/customizations are and that they do not affect device performance.

------------------------------
Sandra Aprahamian RAC
Sr. Regulatory Scientific Advisor
Network Regulatory Partners
www.networkrp.com
------------------------------

Original Message:
Sent: 28-Apr-2017 15:33
From: Aliva Das
Subject: Sleep apnea device 510(k) and design requirements

Hello everyone,

Does anyone work with sleep apnea devices. This device is regulated by FDA ( product code: LRK) and requires a 510(k).

However, every sleep device is custom made to patient requirements. Does it still need to follow the design control requirements.

Any thoughts and feedback on this is appreciated.