Product Classification

• Device: system, ablation, ultrasound and accessories
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NTB
• Premarket Review: General Surgery Devices (DHT4A); 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

Recognized Consensus Standard

• 12-281 IEC 60601-2-62 Edition 1.0 2013-07
  Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

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