(154 days)
The CONTOUR™ Curved Cutter Stapler and Reloads 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 document is a 510(k) summary for the CONTOUR™ Curved Cutter Stapler and Reloads. It does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices in the US. This pathway does not typically require detailed performance studies against specific acceptance criteria to be submitted as part of the 510(k) summary for review by the public. Instead, it relies on the device being similar enough to a previously cleared device.
Therefore, I cannot provide values for the following:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone performance study was done
- The type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Key takeaway from the document:
The CONTOUR™ Curved Cutter Stapler is deemed "substantially equivalent" to predicate devices K040038 (Curved Cutter Stapler) and K061156 (ENDOPATH® Linear Cutters and Staplers) based on:
- Identical technological characteristics to the K040038 Curved Cutter Stapler predicate device.
- Same intended use as the ENDOPATH® Linear Cutters and Staplers.
This implies that the performance of the CONTOUR™ device is considered comparable to these existing, legally marketed devices, rather than being demonstrated against novel acceptance criteria in this specific submission. Performance data, if generated, would typically be internal to the manufacturer and not explicitly stated in a 510(k) summary unless it's a novel device requiring such proof for substantial equivalence.
§ 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.