Product Classification

• Device: surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
• Physical State: The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue
• Technical Method: The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound
• Target Area: Cardiac tissue.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: Cardiovascular
• Product Code: OCL
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• 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

Recognized Consensus Standard

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03
  Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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