Product Classification

• Device: mobile / tablet software application to control settings of surgical and endoscopic camera
• Regulation Description: Endoscope and accessories.
• Definition: Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
• Physical State: Software only device without any physical part
• Technical Method: A software device that runs on a mobile or tablet device and wirelessly connects with compatible surgical or endoscopic camera control unit and patient information system.
• Target Area: Surgical sites within articular cavities, body cavities, hollow organs, canals and the thoracic cavity to obtain pictures or videos of these areas.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• Product Code: QGY
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 13-143 AAMI TIR45:2023
  Guidance on the use of AGILE practices in the development of medical device software

Third Party Review

Not Third Party Eligible