Product Classification

• Device: low energy direct current thermal ablation system
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Ablation of soft tissue
• Physical State: it includes the LEDC generator, electrodes and accessories
• Technical Method: it applies a low energy direct current (LEDC) pulse or series of pulses between two electrodes to cause an ablation effect to occur
• Target Area: soft tissue including cardiac and smooth muscle
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: OAB
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4400
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc