Preamble

The purpose of this guideline is to guide the registration applicant to prepare and write the registration information of Nitric Oxide Therapeutic Apparatus (NOTRA), and also to provide reference for the technical review department to review the registration information.

This guideline is a general requirement for Nitric Oxide Therapeutic Apparatus, and the applicant should determine whether the content is applicable or not according to the specific characteristics of the product. If it is not applicable, it is necessary 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 data.

This guideline is for registration applicants and technical reviewers to use the guiding documents, but does not include the administrative matters involved in the review and approval, and not as a mandatory implementation of regulations, should be used under the premise of complying with the relevant laws and regulations of this guideline. If there are other methods that can meet the requirements of the relevant regulations, they can also be used, but need to provide detailed research information and validation information.

This guideline is formulated under the current regulations and standards and the current level of knowledge, with the continuous improvement of regulations and standards, as well as the continuous development of science and technology, the relevant content will be adjusted in due course.

 
Scope of application
Nitric oxide therapeutic instrument delivers nitric oxide gas with controllable concentration to the patient's respiratory tract, and at the same time monitors the concentration of nitric oxide, nitrogen dioxide, and oxygen, and provides the corresponding alarm function. Some products are equipped with gas generators for the production of nitric oxide. Nitric oxide therapeutic devices are generally used in conjunction with respiratory equipment or can be integrated into respiratory equipment to assist in the treatment of pulmonary hypertension.

This guideline applies to nitric oxide therapeutic devices, as well as respiratory devices with integrated nitric oxide therapy.

 
KeyPoints for Registration Review
Product name, it is recommended to use the common name: Nitric Oxide Therapeutic Apparatus.
Management category and classification code, the product is managed according to the third class of medical devices, the classification code is 08-03.
Registration unit division, different technical principles of the product is divided into different registration units.
Products with nitric oxide generators do not require external medical nitric oxide gas cylinders, and products without nitric oxide generators require external medical nitric oxide gas cylinders to provide treatment. The two aforementioned products are classified as different registration units.

Nitric oxide generators are available in a variety of technical principles. Nitric oxide gas can be produced by electrochemical reactions, by air pulse discharges or by other principles. Products that use different technical principles of generators are classified as different registration units.

For products with multiple models and specifications, the differences between the models and specifications are clarified in accordance with the requirements of the product description above. Comparison tables and pictures and charts with explanatory text are used to describe the structural composition (or configuration), functions, product features and operation modes, performance indexes, etc. of all models and specifications.

Performance research information

According to the scope of application and technical characteristics of the declared products, provide an overview of non-clinical studies, describing the studies carried out one by one, and summarizing the research methods and conclusions. According to the non-clinical research review, provide the corresponding research information, the research can be carried out through literature research, laboratory research, modeling studies, etc., generally should contain research programs, research reports. If modeling studies are used, product modeling study information should be provided.

Software research

The software of the product is a software component, used to control the operation of the product, including the control of parameters, monitoring and alarm, software security level is categorized as serious. Refer to the requirements of "Guidelines for Review of Medical Device Software Registration" (Revision 2022) and "Guidelines for Review of Medical Device Cybersecurity Registration" (Revision 2022) to provide research information.

Biological characterization study

The applicant shall state the parts of the product expected to contact with gas and submit the list of materials in contact with gas; state the basic information of the materials used, such as the composition of the materials, composition information, physical and chemical properties of the materials, etc., and shall ensure the safety of the materials used. It is recommended to refer to the YY/T 1778.1 series of standards and submit the product gas access biocompatibility study information.

Clinical evaluation information

Nitric oxide therapeutic instrument can generally take the path of comparison with the same species to carry out clinical evaluation. Compare with the output nitric oxide concentration and flow rate of products of the same species when used with respiratory equipment; for products with nitric oxide gas generator, compare the gas quality with medical nitric oxide gas or other approved products of the same species.

If there is a big difference between the output nitric oxide concentration and flow rate of the product and that of the product of the same species when used with respiratory equipment, or if the declared product has other special functions (e.g. physiological closed-loop control, etc.), consider submitting clinical trial data.