(27 days)
The CONTOUR™ Curved Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
The CONTOUR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature which prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded five times, for a maximum of six firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.
This 510(k) summary (K091322) is for the CONTOUR™ Curved Cutter Stapler and Reloads and does not contain information typically found in a study or a rigorous test report to establish acceptance criteria for device performance. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a performance study report for a novel device.
Therefore, the provided document does not contain the information requested in points 1-9 to describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states:
"The CONTOUR™ Curved Cutter Stapler is identical to the Curved Cutter Stapler marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (package insert) that has been revised to add contraindications, as well as other clarifications to ensure safer, more effective use of the device."
This explicitly indicates that the device has not undergone new performance testing for substantial equivalence, but rather relies on the equivalency to a previously cleared device (K062869) and only has labeling changes.
To answer your request, if this were a typical device submission that included performance data, the information would be found in sections detailing:
- Performance Data: Often presented as a separate section within the 510(k) or in referenced reports.
- Bench Testing: Details on mechanical tests, and their acceptance criteria.
- Animal Studies (if applicable): Information on study design, endpoints, and results.
- Clinical Studies (if applicable): Often not required for 510(k) submissions, but if present, would contain details about participant numbers, methods, results, and statistical analyses.
Since the provided text does not offer this information, I cannot complete the table or answer the specific questions below.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.