Classification of a disposable Screen Pointer for use by surgeons on monitors?

M

MIREGMGR

#1
We're being asked to make a disposable screen pointer, used by surgeons for touch screen monitor interface during invasive procedures to avoid contaminating their monitor screen.

This device has no patient contact. It's sold sterile, because of course the surgeon touches it.

It's not a pen. It has no marking capability. It's also not a surgical instrument per se.

It's presently for sale, made elsewhere. Apparently it's considered Class I...there doesn't appear to be a 510(k).

Anyone have any ideas as to Product Code? I think it's a medical device, but I'm a bit stumped as to how to classify it. I'm not eager to have to file for a new code if that can be avoided.
 
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G

gar4guv

#2
i could not find anything that specific. if i was in your situation, i would classify it as a surgical instrument for general use.

the section below does not have a stylus or pointer on the list, but the first sentence seems to be kind of a catch-all.

Sec. 878.4800 Manual surgical instrument for general use.

(a)Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
 
M

MIREGMGR

#3
Yeah, maybe KDC. I haven't come up with anything better.

I've been trying to stay away from surgical instrument classifications because there's a tendency to slip into application of patient-contact biocompatibility expectations. But, I don't see any better choices.
 
G

gar4guv

#4
oops, i forgot you asked about a product code.

after looking at the list, i think KDC would be the best choice. you could probably get away with MDM as well.

i can't think of any way to get around these two listings, especially if you plan to market it for use in an operating room.
 
W

Watchwait

#5
I'm assuming the screen pointer is NOT a laser pointer? If not, then I have a hard time convincing myself, based on the FDA definition of a medical device that this item IS a medical device. You might consider actually calling DSMA or to get a definitive answer submit a Form 513(g) Request for Classification. But I'd start with the free phone call to DSMA....sometimes they can be suprisingly helpful!
 
M

MIREGMGR

#6
No, it's not a laser pointer...it's used with a touch screen, so it has to make physical contact. It's basically a plastic stick with a scratch-protective foam cap on one end, sterilized, three to a pouch.

If the identified classification options were Class II, we might consider the 513(g) approach, perhaps beginning with an informal inquiry through DSMICA. I can create a sufficient rationale for KDC (Class I), though, and the 513(g) approach would have some response-uncertainty (i.e. they might go off the deep end and classify as II or III) and therefore cost-risk.

I like avoiding risks, so I think we'll just go with KDC.
 
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