Product Classification

• Device: impedance measuring device utilizing oscillation techniques
• Regulation Description: Diagnostic spirometer.
• Definition: This device measures respiratory impedance.
• Physical State: Device could include a loudspeaker or other means to generate pressure oscillatory signals. The system could also include a bias flow.
• Technical Method: Device applies pressure oscillatory signals at the patient’s mouth during spontaneous breathing and measures the response of the respiratory system in terms of impedance, which is the complex ratio between the recorded mouth pressure and the airflow. The frequency of the test signal varies. The device is not intended to be used as a standalone diagnostic device.
• Target Area: Lung and airways.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: PNV
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.1840
• 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 Standards

• 1-173 ISO 18562-1 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-174 ISO 18562-2 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-175 ISO 18562-3 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-176 ISO 18562-4 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-178 ISO 23747 Second edition 2015-08
  Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
• 1-179 ISO 26782 First edition 2009-07
  Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]

Third Party Review

Not Third Party Eligible