Preamble

The purpose of this guideline is to guide the registration applicant to prepare and write the registration declaration of positive pressure ventilation therapy machine, and also to provide reference for the technical review department to review the registration declaration.

This guideline is a general requirement for positive pressure ventilation therapy machine, the applicant should determine whether the content is applicable according to the specific characteristics of the product. If not applicable, need to specify the reasons and the corresponding scientific basis, and based on the specific characteristics of the product to enrich and refine the content of the registration information.

Scope of application

This guideline applies to sleep apnea treatment devices that are used in homes and hospitals to alleviate symptoms of sleep apnea such as obstructive apnea and snoring during sleep by applying a single level of continuous positive pressure or two levels of alternating positive pressure to the upper airway of the patient by using non-invasive methods such as wearing a breathing mask to the patient, so as to achieve the therapeutic purpose. This guideline does not apply to therapeutic ventilators (life-supporting), emergency and transport ventilators, high-frequency ventilators, home ventilators (life-supporting), and home respiratory support devices (non-life-supporting).

Registration Review Keypoints

Regulatory Information
The applicant for registration (hereinafter referred to as the applicant) needs to describe the basis for determining the name of the product, regulatory categories, classification codes, specifications, product composition and other information.

Product name

The name of the product should be a common name and conform to the ‘Naming Rules for Common Names of Medical Devices’, ‘Classification Catalogue of Medical Devices’, with reference to the ‘Guiding Principles for the Naming of Common Names of Medical Devices’, standards, and other relevant regulations and normative documents.

The product name is recommended to be named with physical attributes, such as positive pressure ventilation therapy machine, and related to the working mode that the product has. If the product only has a single level of pressure output mode of operation, or on the basis of a single level with automatic pressure regulation, the product should be named single level positive pressure ventilation therapy machine or automatic adjustment of positive pressure ventilation therapy machine; if the product only has a double level of pressure output mode, or on the basis of a double level with automatic adjustment of pressure, the product can be named double level positive pressure ventilation therapy machine or double level automatic adjustment of Positive pressure ventilation therapy machine.

Management categories and classification codes

This guideline applies to devices intended to be used for the treatment of patients with obstructive sleep apnoea and snoring, which are regulated as Class II medical devices and should be classified as 08-01-06.

In the early years from the product classification, positive pressure ventilation therapy machine and non-invasive ventilator overlapped in their intended use. From the perspective of regulatory classification, clinical application and specialised standards, products intended for use in patients with pulmonary insufficiency or patients requiring respiratory support such as COPD, and products intended for use in central sleep apnoea should be classified as home use respiratory support equipment (non-life support), and such equipment should be classified as 08-01-05, which is outside the scope of this guideline.

 Scope of application and contraindications

Positive pressure ventilation therapy machines are intended for use in professional healthcare facilities and/or home care settings, usually under the control of healthcare professionals or non-healthcare professionals (inexperienced operators) with varying degrees of training, and are indicated for the treatment of patients with obstructive sleep apnoea, snoring. None of these devices should be used for life support. It is recommended that such devices be operated and used under the guidance of a practitioner's prescribing advice. Information on the target patient population (e.g., adult, child, infant, or neonate) and physiological parameters (e.g., weight) should also be specified. This guideline does not consider the requirements related to neonates.

The place of use should be specified, e.g., a specialised healthcare facility or a home care setting. See YY 9706.111 standard for details.

Contraindications:

Pneumothorax, mediastinal emphysema; cerebrospinal fluid leakage, craniocerebral trauma or intracranial trauma or intracranial pneumoperitoneum; shock due to various different causes and when it is not corrected; active stage of rhinorrhoea; upper gastrointestinal bleeding that is not effectively controlled; coma or with impaired consciousness unable to cooperate with or accept the treatment of the facemask; huge vocal polyps, etc.

Relative contraindications: severe coronary heart disease combined with left heart failure; otitis media in the acute period; respiratory secretions and cough weakness; weak spontaneous respiration (except T-mode); tracheal intubation (through the nose or mouth) and tracheotomy; severe nasal congestion caused by various reasons; pulmonary alveolus; respiratory mask allergy.

Product technical requirements should include the main performance indicators
Prepare the product technical requirements in accordance with the Guidelines for the Preparation of Technical Requirements for Medical Device Products.

The working conditions of the product may not be included in the performance indicators, such as test conditions, specified in the test method.

This part gives at least need to consider the main technical indicators and parameters of the product requirements, Schedule 1 of some of the performance indicators of the device gives a clear quantitative requirements, other performance indicators due to the consideration of the differences in different enterprise products, no limit value, enterprises need to quantify the characteristics of their own products combined with their own. Where the ‘recommended’ provisions are non-mandatory requirements, but it is recommended that enterprises take into account.

1. Technical parameter requirements

In addition to the working modes listed in Schedule 1, if the enterprise claims that the product also has other working modes, it should also consider the formulation of the corresponding performance and functional quantitative requirements. In addition, such as remote control and adjustment of equipment through software, should also consider the development of related requirements, and should also meet the requirements of Schedule 1.

2. Requirements related to product accessories:

2.1 Mask should be developed with reference to the standard YY/T 0671 (if applicable).

2.2 The pipeline shall be formulated with reference to the standard YY/T 0461 (if applicable).

If applicable to children, and shall take into account different tube sizes and differences between those used for adults and children, etc.

2.3 Warming humidifier should be developed with reference to YY 9706.274 (if applicable).

3.3 Relevant standard requirements

Depending on the intended use of the product, it should meet the requirements of GB 9706.1 and YY 9706.270 standards. Products with integrated heated humidifier should also meet the requirements of YY 9706.274 standard

Because the equipment is expected to be used in home care environment or other non-professional medical environment, it should also meet the requirements of YY 9706.111 standard.

The electromagnetic compatibility performance of the product shall comply with the requirements of YY 9706.102 standard.

Inspection report

The product for inspection should be able to represent the safety and effectiveness of the product applied for registration. Priority shall be given to the model with the most complex structure, the most complete functions, the highest risk and the most complete technical specifications. In the same registered unit, if the configuration is different, the function and performance are different, and the main technical indicators are not representative, the product for inspection can be more than one model. The same product should be tested separately under different power conditions to ensure that the product meets the requirements under different power conditions.

Clinical evaluation requirements

The product does not belong to the products listed in the ‘Catalogue of Medical Devices Exempted from Clinical Evaluation’, the applicant should be in accordance with the ‘Notice on the Release of Recommended Paths for Clinical Evaluation of Medical Devices Classification Catalogue’ Subcategories 01, 04, 07, 08, 09, 10, 19, 21 related products,’ Annex 5, “Medical Devices Classification Catalogue” Subcategory 08, “Respiratory, Anaesthesia and First Aid Devices”. Recommended path for clinical evaluation of products related to ‘Respiratory, anaesthesia and first aid devices’ and related clinical evaluation guidelines for clinical evaluation.

When analysing and evaluating the data obtained from clinical trials or clinical use of medical devices of the same species, positive-pressure ventilation therapy machine products with the same working mode are selected for comparison with the same species, and their safety and effectiveness can be proved to have no significant difference through sufficient non-clinical tests such as performance tests and algorithmic comparisons.

Translated with DeepL.com (free version)