REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C

• K Number: K071023
• Device Name: REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
• Manufacturer: REACH SURGICAL, INC
• Date Cleared: 2008-08-28 ( 505 days)
• Product Code: GDW , GAG
• Regulation Number: 878.4750
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K024275

Intended Use

The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

Device Description

The REACH™ RCS Circular Stapler is a single patient use device which places a double staggered row of titanium staples. During staple formation, the instrument knife blade resects the excess tissue, creating a circular anastomosis.

AI/ML Overview

This information is not available in the provided text. The document is a 510(k) summary for a medical device (REACH™ RCS Circular Stapler) and declares substantial equivalence to a predicate device (Auto Suture PREMIUM PLUS CEEA Disposable Stapler).

A 510(k) summary typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not usually include detailed acceptance criteria, performance studies with specific sample sizes, ground truth establishment, or multi-reader multi-case studies as these are often part of the original predicate device's clearance or pre-market approval, or may be conducted when significant new claims are made.

Based on the provided text, the relevant sections state:

• "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) K024275"
• "The REACH™ RCS Circular Stapler's technological and safety characteristics are identical to those described in 510(k) K024275"
• "The REACH™ RCS Circular Stapler's performances is identical to those described in 510(k) K024275"
• "The data submitted in this 510(K) Premarket Notification supports the finding that this product is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed predicate device."

Therefore, the document does not contain the specific information requested about acceptance criteria and the study proving the device meets those criteria, as it relies on the predicate device's established equivalence. To find such information, one would need to review the 510(k) submission for the predicate device (K024275).

Regulation Number and Section

§ 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.