For an early access to information on the product and technology development strategies for critically differentiating

as well as future-proofing the surgical stapling subsystem for your robotic assisted, soft tissue surgery system in

the current regulatory environment that is poised to evolve potentially in a drastic and precipitous manner, please

contact Endoscape Surgical.





SYNOPSIS




1. Legacy stapler instrument architecture and staple types (no offset staple legs, or bumps or steps on the cartridge

deck surface with an exception: Bumps on the deck surface of cartridge for the black staple type only may be allowed

provided that their uncontrolled interference with deformation of tissue during compression can be mitigated.)


- Historically tested and proven


- On solid scientific foundation in academic (although rudimentary) and real world (rich in clinical as well as adverse

events knowledge base) sense




2. (Differentiation) Incorporation of a Tissue Probe device for measuring a mechanical property of tissue in situ

(an FDA designated Breakthrough Device of Endoscape Surgical)


- Staple type selection based on a measured mechanical property of tissue, a key model parameter of the academic

foundation of the proposed stapling system


- Directly address the well known, highly visible problems, reported in the FDA MAUDE database, primarily caused by

over-/under-compression of tissue




3. (Differentiation and Future-proofing) New and significantly revised contents for 510(k) submission underpinned by

explicit and rigorous reference to the scientific foundation of the subject device and adherence to the scientific

methodology in research and development including, but not limited to, risk analysis, design and execution of

performances tests and algorithm for root cause analysis of and formulation of remedial solutions for adverse events




4. (Differentiation and Future-proofing) Expansion of staple type offering without significant increase in the profile

diameter of stapler instrument architecture to cover organ tissue with thickness beyond the capabilities of the legacy

staple types




5. (Future-proofing) Ready for seemless transition to the reinvented surgical stapling system following requisite real

world tests and debugging in the clinical hand-held applications







DESIGN PRINCIPLES OF STAPLING INSTRUMENTS (including ANCHOR STAPLE APPLIER for hysterectomy & hernia

repair) FOR ROBOTICS (and manual surgery)*




1. Design of stapling instrument, hand-held as well as robotic, needs to be varied appropriately in consideration of

the anatomical structure, mechanical characteristics and internal contents of target organ (or tissue part),

physiological and anatomical functions of target organ (or tissue part), accessibility of surgical site and intended

clinical performance of stapling operation.




2. Design of stapling instrument needs to be differentiated between robotic and hand-held applications in

consideration of differences in capabilities and limitations of instrument control subsystem of a robotic assisted

surgery system and manual instrument control skill of a surgeon operator to maximize likelihood of optimal clinical

performance of stapling operation.




3. Simple mapping or one-to-one replication of hand-held stapling instruments and conventional techniques used in

manual stapling operation onto a stapling subsystem, including instruments and operational control algorithm, of a

robotic assisted surgery system would result in loss of opportunity to distinctively improve and enhance the clinical

performance of surgical stapling in a way and to an extent only the digitally controlled surgical operation system can

provide.







TISSUE PROBE**, ***




1. A force sensor cartridge accessory configured for use mounted on the cartridge jaw of the stapling instrument of a

leading manufacturer of robotic assisted surgery system




2. A hand-held, manual and powered, tissue probe instrument adapted and optimized for use with the stapling

instrument of a leading manufacturer of robotic assisted surgery system




3. A staple type selection algorithm optimized for use with the stapling instrument of a leading manufacturer of

robotic assisted surgery system







STAPLER & ANCHOR STAPLE APPLIER for a leading manufacturers of robotic assisted surgery system




1. Method and devices for hernia repair surgery




2. Method and devices for hysterectomy




3. Method and devices for reconstruction of the pelvic anatomy