Grapefruit USA Inc (GPFT)

[goldcoastoh]

chevyman -- under the medical devices section...

NEW DEVICES THAT ARE COMBINATIONS OF OLD DEVICES

A new device is a so-called "combination" device when it claims to have the same intended uses as two or more different types of predicate devices. Normally, this is achieved by combining two or more predicate devices into a device that is sold as a unit, e.g., a urinary catheter may incorporate a temperature measuring device; or a cardiac monitor, electrocardiograph, and blood pressure computer that were sold separately prior to May 28, 1976, might be combined into one electronic monitoring device.

When a new device combines types of devices from different classes, questions have arisen about what classification the new device will have.

In its review of the 510(k), the Center will subject the combination device to the same sorts of questions and documentation requirements that are applied to a single device. When such a device is found to be SE, it combines devices from different classes and is classified in the highest of the predicate device classifications unless the combined devices are regulatable as separate articles, e.g., they are detachable. In that case, the separately regulatable articles will be regulated in separate classes.

1/ H.R. Rep. No. 94-853 pp. 36-37. The Amendments, as enacted, are comprised primarily of the bill H.R. 11124 as drafted by the Subcommittee on Health and the environment of the Committee on Interstate and Foreign Commerce and adopted by the House of Representatives. This report provides the only Congressional guidance on the criteria for substantial equivalence.

2/ This document does not provide guidance on what changes in marketed devices are significant enough to require the submission of a 510(k), but the Center plans to issue such guidance in the near future.

3/ Ordinarily, intended use is determined by reference to "labeling" or promotional claims; only in rare cases might it be necessary to infer intended use from other types of information.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081383.htm

*****

thus, as i've stated:

the fda wanted QA data = high/low contrast data for the cone beam CT specifically...

i took that to mean that the FDA was seriously considering the cone beam CT aspect of the DViS...

now = it sounds like the FDA has hammered out the comparable issue and got some objective data from those images which were sent in...please refer to number 3 above.

new device = dominion DViS:

a combination of

1.// fluoro
2.// cone beam CT.

a mobile combination of these two things...

new because it is the only device/mobile device to provide realtime 3D imaging.

*****

from my earlier post:

yes images were QA (quality assurance), and remember they were pertinent to the CT (i.e., cone beam CT) feature only...as we understood from previous...

in the world of CT, the QA aspect is what an operator would do for documenting the units are calibrated to standards for quality control.

however, annually or biannually a medical physicist ensures high/low contrast (among other batteries of tests, referred to as physics acceptance standards), and annually companies do PM, i.e., preventative maintenance.

i take the actual requested images (now old news, as they were submitted and now the FDA just wants to finalize labeling) this to mean that the FDA took the CT component seriously.

by the way, both acceptance testing and PMs are done in fluoro too. so the same concepts would apply to the fluoro features. QA as far as imagery isn't really necessary for daily/weekly performance in mobile fluoro...

the concepts of these tests are to provide objective data (both for the FDA and for the real world ultimately upon clearance), and is why patient or clinical images aren't necessary.


*****

in the prior cc's, he stated he "narrowed the use" or maybe more specifically limited the application by not applying for use in mammo or in weight bearing applications...in order not to muddle the waters...and that those two uses could be applied for after initial clearance.

i suspect two uses will the two uses will be:

1.// fluoroscopically-guided procedures/surgery -- i would think this would be all inclusive, and not state which types.
2.// cone-beam CT -- any part of the body or some part of the body, etc.

*****

i'll have to wait to listen again to the cc to pick up on the context of any mention of '...narrowed the use...', i had get out of the call early. i remember that that synopsis post posted by nihonto chicken state weight bearing so perhaps that was the context for the narrowed the use comment here again, or even as PET/CT hybrid use...but all these surely are plausible future indications.