Gastroenterology, Urology

QSW · Endoscopic Traction Device

Gastroenterology, Urology · 21 CFR 876.4410 · Class 2

Overview

Identification

An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal. The ProdiGI system includes a Traction Wire (indicated for esophagus, stomach, and colon) and a Traction Magnet (indicated for stomach and colon) for use in adults during Endoscopic Submucosal Dissection (ESD) procedures.

Classification Rationale

Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.

Special Controls

In combination with the general controls of the FD&C Act, the endoscopic traction device is subject to the following special controls: - (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: - Perforation, bleeding, and mucosal injury; (i) - Ease of insertion and removal of the device; (ii) - Visualization during the procedure; and (iii) - Ease of procedure as reported by the intended user. (iv) - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: - Device deployment and detachment: (i) - Ability to retract tissue; (ii) - (iii) Tensile strength; - Potential for laceration caused by the device or procedure using the device; (iv) - Dimensional verification; and (v) - (vi) For devices that contain a magnet, magnet strength verification and safety assessment. - (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. - (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. - (5) The patient-contacting components of the device must be demonstrated to be biocompatible. - (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. - (7) Labeling must include: - The recommended training for safe use of the device; (i) - (ii) Anatomical locations and lesion sizes that have been demonstrated to be safe to use with the device: and - A shelf life. (iii)

Cleared Devices (2)

Top Applicants

• Micro-Tech (Nanjing) Co., Ltd. — 1 clearance
• Covidien, LLC — 1 clearance