Product Classification

• Device: magnetically maneuvered capsule endoscopy system
• Regulation Description: Magnetically maneuvered capsule endoscopy system.
• Definition: A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
• Physical State: The device consists of an ingestible capsule that contains a magnet, a data recorder, a portable magnetic scanner, and a magnetic controller.
• Technical Method: The magnetic controller is used for direct the location and view of the camera contained with an ingested capsule. The camera captures images of the gastrointestinal mucosa and transmits the images to a data recorder.
• Target Area: Stomach and duodenum
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: QKZ
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.1310
• 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 Standards

• 9-146 ISO 8600-4 Third Edition 2023-01
  Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
• 9-147 CIE ISO 11664-2 First edition 2022-08
  Colorimetry - Part 2: CIE standard illuminants
• 9-148 CIE ISO 11664-6 Second edition 2022-08
  Colorimetry - Part 6: CIEDE2000 colour-difference formula

Third Party Review

Not Third Party Eligible