New FDA 510(k) Approvals for March 2008- Part 2-Endoscope Multi-instrument Accessory Channel
The FDA has published its 510(k) approval letters for March 2008. In terms of surgery, endoscopy, and imaging a few items caught my eye.
Part 1 looked at a new monitor.Â Here is a device from Ethicon that allows accessory instruments to be placed along with endoscopes- primarily for flexible scopes primarily used for the lung or GI tract.
These concepts of placing multiple instruments through new and unique entry devices is a huge area of research and development in surgery including Natural Orifice Surgery and SIngle Port Surgery.
First the announcement from FDA:
DEVICE: ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL – ETHICON ENDO-SURGERY, INC. 510(k) NO: K073484(TRADITIONAL)
ATTN: RENEE L ROWE PHONE NO : 513-337-8243 4545 CREEK RD. SE DECISION MADE: 10-MAR-08 CINCINNATI, OH 45242-2839
Text from Ethicon’s application on how it works.
The flexible Sheath is installed over the insertion tube of the endoscope. The Sheath
contains a track (C-Channel) along which the Articulating External Accessory Channel can
be can be introduced and removed without removing and re-introducing the endoscope,
allowing for multiple intubations and/or specimen retrieval independent of the endoscope.
The Articulating External Accessory Channel enables the use of two accessory devices
simultaneously – one in the Articulating External Accessory Channel and the other in the
endoscope working channel. The Articulating External Accessory Channel provides off
axis articulation to off the shelf accessory devices, thereby allowing the user to more
effectively direct devices to the targeted tissue.
The external accessory channel of the new device is not fixed to the scope and can be
introduced and removed without a need to remove or re-introduce the endoscope. The
LSI Solutions Endoscopic External Accessory Channel predicate device is fixed to the
endoscope and must be must be removed and re-introduced with the endoscope.
* The new device enables articulation of compatible commercially available endoscopic
accessory devices for improved ability to reach the target tissue.