Anonymous writes:
Hi All,
Happy 2023!
I am preparing a submission and need some help in choosing a predicate. The submission device includes HW and 2 software (software 1 and 2). Here is the chronology of previous clearances of this device:
K1-Launch version included clearance for the whole System that includes HW and both software1 and 2
K2- Subsequent clearance focus was Software 1 and 2
K3- the third clearance was for change in Software 1
I am preparing for the 4th clearance that includes changes related to both SW1 and SW 2. Since SW 2 was not part of K3 (clearance focused on SW 1 only), should I use K2 as (clearance for SW 1 and 2) as a predicate?
Hi there,
Although each clearance after K1 focuses on the changes to the device, the result is a clearance of the device after the changes have been made, so K2 = K1 + K2 changes, K3 = K1 + K2 changes + K3 changes, and then K4 will desire clearance of the K3 device with K4 changes. K3 should be your predicate, since it is for the cleared device whose changes you wish to focus on in K4. I'm assuming any changes in functionality, indications, intended use etc. were improving/adding each time, so K1 feature set <= K2 feature set <= K3 feature set <= K4 feature set.
You can certainly reference your previous submissions since they may contain more relevant details for a SW 2 comparison. You would just need to make the connection in the submission that you are referencing K2 with respect to SW 2 content because no changes (or no substantial changes driving a 510(k)) have been made to the device since K2, and these new changes are driving K4.
I hope that's helpful.
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Kathleen Crowder
Sr. Mgr., Regulatory Affairs
Lake Zurich IL
United States
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Original Message:
Sent: 06-Jan-2023 19:49
From: Anonymous Member
Subject: Predicate device
This message was posted by a user wishing to remain anonymous
Hi All,
Happy 2023!
I am preparing a submission and need some help in choosing a predicate. The submission device includes HW and 2 software (software 1 and 2). Here is the chronology of previous clearances of this device:
- K1-Launch version included clearance for the whole System that includes HW and both software1 and 2
- K2- Subsequent clearance focus was Software 1 and 2
- K3- the third clearance was for change in Software 1
I am preparing for the 4th clearance that includes changes related to both SW1 and SW 2. Since SW 2 was not part of K3 (clearance focused on SW 1 only), should I use K2 as (clearance for SW 1 and 2) as a predicate?
Thanks,