Search Results

Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.

The provided document is a 510(k) Pre-market Notification for a medical device: "Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document explicitly states:

• "Substantial Equivalence: PANACRYL sutures have been cleared by FDA - K964345; ETHIBOND sutures have been approved by FDA - NDA 17-804 & 17-809; ORTHOCORD sutures have been cleared by FDA- K040004"
• "Safety: These sutures have been cleared through K964345 (PANACRYL), NDA 17-804 & 17-809 (ETHIBOND) and K040004 (ORTHOCORD). Safety data may be referenced in these documents."

This indicates that the current submission relies on the safety and effectiveness data of the predicate sutures themselves, and not a new study on the "Passing Needle" device that would establish new performance criteria. The "Passing Needle" likely refers to the delivery mechanism for these pre-existing sutures.

Ask a specific question about this device