1 2 3 Based on the contents detailed below, assess the substantial equivalence to a legally marketed predicate device. In that case, the standards, et

Transcription

1 Attachment 8 Application for Treatment Positive Airway Pressure Unit, etc. (1) Scope of application Continuous positive airway pressure units and Continuous-automated positive airway pressure units in Appendix 1-8 of the Ministerial notification No.112 shall be Continuous positive airway pressure units and Continuous-automated positive airway pressure units prescribed as No.785 and 789 in Appendix 1 regarding specially controlled medical devices, controlled medical devices, and general medical devices designated by the Minister of Health, Labour and Welfare (MHLW Ministerial Notification No.298 dated 2004) pursutant to the provision of Art.2, para.5 to 7 of "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics". A heated humidifiers or breathing systems as components may be included. However, this does not include the following equipment. 1 Equipment intended to be used as a life-support system 2 Equipment that include central apnea syndrome as a therapeutic target 3 Equipment intended for neonates 4 Equipment with disease diagnostic functions and display functions of new clinical indicators 5 6 Equipment with respiratory modes besides the ones defined in the following section (2) paragraph 3 item (a) Equipment controlled remotely or by devices used in combination. However, this excludes equipment with the following functions. Equipment in which the setting can be confirmed on a remote controller as well as on the screen or lamp of the actual equipment. Furthermore, the remote controller is a component with operational parameters that are within the scope of the actual equipment s operational parameters and is a component that is used by the patient. Equipment that has the function to adjust prescribed pressure under the supervision of healthcare professionals. However, adjustment of prescribed pressure must be limited to within the medical facility. (2) Primary endpoints to assess the substantial equivalence to a legally marketed predicate device and their criteria

2 1 2 3 Based on the contents detailed below, assess the substantial equivalence to a legally marketed predicate device. In that case, the standards, etc. applied to the legally marketed predicate device (refer to (3) List of applicable standards, etc. in order to conform with the essential principles) shall be used. Maximum airway pressure Assess maximum supply pressure expected of continuous positive airway pressure units, etc. (For example, refer to MAXIMUM LIMITED PRESSURE PROTECTION DEVICE noted in ISO :2015 Medical Electrical Equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment ). Airway pressure accuracy Assess accuracy of supply pressure expected of continuous positive airway pressure units, etc. (For example, refer to Stability of static AIRWAY PRESSURE ACCURACY (long-term accuracy) noted in ISO :2015 Medical Electrical Equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment ). Self-adjusting pressure function (a) Operating principle Assess that the operating principle and operational contents of respiratory modes expected of continuous positive airway pressure units, etc. are within the following range. CPAP Mode Respiratory mode that achieves positive airway pressure by continuously adding constant pressure set by the physician. Functions for forced ventilation or assisted ventilation and functions that intentionally add vibration waveforms to airway pressure are not included in this mode. Automated CPAP Mode CPAP mode that has functions to monitor conditions of airway pressure, and, when apnea, hypopnea, flow restrictions, and snoring are detected, automatically increases airway pressure within the range set by the physician, and decreases pressure before elevation when applicable conditions cease.

3 Comfort functions Function that reduces patient burden from when inhalation ends to when exhalation ends by temporarily decreasing the supplied pressure within the range set by the physician. Also includes a lamp function to sets a time-limit for achieving the pressure set by the physician. (b) Automated adjustment range for supplied pressure If there is an automated CPAP mode on the continuous positive airway pressure units, etc., assess the automated adjustment range for supplied pressure. (For example, 2.0 to 30.0 hpa). (c) Range of time setting for lamp function If there is a lamp function on the continuous positive airway pressure units, etc., assess the range of time setting for the lamp function. (For example, 0 to 45 minutes). 4 Shape and dimension for conical connector If there is a conical connector, assess the shape and accuracy of the conical connector. (For example, refer to BREATHING GAS PATHWAY connectors noted in ISO :2015 Medical Electrical Equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment ). 5 Performance for accessories (a) If the component includes a heating humidifier, assess the efficacy and safety of the heating humidifier. (For example, JIS T 7207:2005 Medical humidifiers General requirements for humidification systems ). (b) If the component includes a breathing circuit tube, assess the efficacy and safety of the breathing circuit tube. (For example, JIS T : 2005 Anesthetic and respiratory equipment Part 4: Breathing tubes for anesthetic devices and mechanical ventilators ). (3) List of applicable standards, etc. in order to conform with the essential principles In regards to conformity with certification standards, applicable standards, etc. to explain compliance with essential principles are as follows. Conformity with the requirements of the stanards, etc shall be demonstrated when demonstrating

4 compliance with essential principles. In addition, if conformity with these standards, etc. cannot be demonstrated, one can demonstrate compliance with essential principles with adequate justification for any deviation from the standards. 1 Standards to be used to assess the substantial equivalence ISO , Medical Electrical Equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment JIS T 7207, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems JIS T , Anesthetic and respiratory equipment Part 4: Breathing tubes for anesthetic devices and mechanical ventilators ISO 5367, Anaesthetic and respiratory equipment Breathing sets and 2 Other connectors JIS Q 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes JIS T 14971, Medical devices Application of risk management to medical devices ISO 14971, Medical devices Application of risk management to medical devices JIS T , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process JIS T , Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC , Medical electrical equipment Part 1: General requirements for basic safety and essential performance JIS T , Medical electrical equipment Part 1-2: General requirements for safety Electromagnetic compatibility Requirements and tests

5 IEC , Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests JIS T , Anesthetic and respiratory equipment Part 2-1: Anesthetic devices and mechanical ventilators Conical connectors Cone and socket ISO , Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets JIS T , Anesthetic and respiratory systems Part 2-2: Anesthetic devices and mechanical ventilators Conical connectors Screw-threaded weightbearing connectors ISO , Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO , Sleep apnoea breathing therapy Part 2: Masks and application accessories