"Guidelines for Intravascular Guide Wire Registration Review"

In order to further strengthen the management of intravascular guidewires, the Center for Device Review of the State Food and Drug Administration has organized and formulated the "Guidelines for the Registration and Review of Intravascular Guidewires", which are hereby issued.
Announce.

Attachment: Guidelines for Registration and Review of Intravascular Guide Wires Guidelines for Registration and Review (Download)

State Drug Administration

Medical Device Technology Review Center

March 15, 2022

Guidelines for Review of Intravascular Guide Wire Registration

The purpose of this guideline is to help and guide registration applicants to prepare the application materials for intravascular guidewire registration, so as to meet the basic requirements of technical review, and at the same time help reviewers to make a systematic review of product safety and efficacy.

These guidelines are general requirements for the registration application materials of intravascular guidewires. The registration applicant can enrich and refine the content of the registration application materials according to the characteristics of specific products. The applicant can also determine whether the specific content is applicable based on the characteristics of the specific product. If not, the reason and corresponding scientific basis shall be explained in detail.

This guideline is a guidance document for registration applicants and technical reviewers, but does not include administrative matters involved in registration approval, nor is it enforced as a regulation. If there are other scientific and reasonable alternative methods, they can also be used, but Detailed research and validation data are required. This guideline should be used in compliance with relevant regulations.

This guiding principle is formulated under the current system of regulations and standards and the current level of cognition. With the continuous improvement of regulations and standards, as well as the continuous development of science and technology, the relevant content of this guiding principle will also be adjusted in a timely manner.

1. Scope of application

This guideline applies to intravascular guidewires. For specially designed intravascular guide wires (such as pressure guide wires, etc.) and non-intravascular guide wires (such as natural lumen guide wires, non-natural lumen guide wires, etc.), you can refer to the applicable parts of this guideline.

2. Key points of registration review

The registration application materials should meet the requirements of the registration application materials in the State Drug Administration's "Announcement on the Announcement of the Announcement of the Format of Medical Device Registration Application Materials and Approval Documents", and should also meet the following requirements:

(1) Regulatory information

1. Management categories

This kind of product is classified and coded as 03-13-16 in the "Medical Device Classification Catalog". The management category of the product is Class III.

2. Registration unit division

The division of application product registration units shall be based on the requirements of the "Administrative Measures for Medical Device Registration and Filing" and "Guidelines for the Division of Medical Device Registration Units". Focusing on factors such as the technical principle, structural composition, performance index and scope of application of the product, it is recommended:

(1) Guide wires for auxiliary puncture and auxiliary positioning need to be divided into different registration units;

(2) If the same product can be applied to different anatomical positions of blood vessels at the same time, it can be divided into the same registration unit;

(3) Products with the same scope of application and differences in main structure and composition, but the difference does not have a substantial impact on safety and effectiveness, can be divided into the same registration unit;

(4) For the guide wire products in the instrument package, the registration unit can be divided according to the division principle of the registration unit of the instrument package.

(2) Summary data

1. It is necessary to describe the working principle of the product, the mechanism of action, the function of each component in the product, the connection method of each component (applicable to multi-component connected products), and the characteristics that distinguish it from other similar products.

2. Structural composition

Identify the core wire, winding wire (if any), safety wire (if any), sheath (if any) and other components (including accessories) of the product, and provide the overall axial cross-sectional structure diagram and the head end structure diagram. For tip shaping guide wires, the shape and size of tip shaping should be specified. Identify each component's name, applicable dimensional information, and measurement location in the illustration. If the same component is divided into different segments, the length of each segment shall be indicated. For guide wires with a coating on the surface, it is necessary to clarify the name, composition, coating range of the coating and describe the coating method.

3. Constituent materials

Identify the common name/chemical name, trade name/brand (if any), CAS number (if applicable), and material standards (if applicable) of all components of the product (including coatings, colorants, etc.) and accessories. information and identify the fluxes, adhesives, dyes/pigments, lubricants, etc. used in the manufacture of the product. It is recommended that the constituent materials of the product be provided in the form of a list and correspond one-to-one with the components identified in the product structure diagram. If the composition of the product is a mixture, specify the components and their proportions. If the component structure is designed with a layered/segmented structure, it needs to be described layer-by-layer/segment-by-segment.

For new materials that are applied to medical devices for the first time, relevant research data on the material's suitability for the intended use, site of use and safety of the material should be provided.

4. Model Specifications

Clarify the expression and division basis of product models/specifications, as well as the similarities and differences between models/specifications. Pictures and diagrams can be used to describe the structural composition and product characteristics of products of different models/specifications.

5. Packing Instructions

Describe the product's sterile barrier system information (including: information on other packaging in direct contact with the product) that is compatible with the sterilization method. It is recommended to provide a schematic diagram of the structure, materials, dimensions, etc., and to clarify the packaging of accessories sold with the product.

6. Scope of application and contraindications

Clarify the scope of product application and contraindications (if any). The scope of application can be further clarified based on the description in the "Catalogue of Medical Devices Exempted from Clinical Evaluation" and combined with the characteristics of product design.

Clarify the expected use environment and applicable population information. Indicate the diseases, parts, populations, etc. (if any) for which the product is contraindicated.

7. The situation of the referenced similar products or previous generation products

It is recommended that the information be provided in the form of a comparative illustration. Items recommended for comparison include but are not limited to product structure diagrams, scope of application, working principle, mode of action, structural composition, raw materials, sterilization methods, performance indicators, validity period, packaging, etc., such as similar products with reference or previous generation products If there is a difference, it is necessary to analyze whether the difference requires additional special safety and effectiveness evaluation based on the difference and the requirements of the safety and effectiveness list.

(3) Non-clinical data

1. Product technical requirements

It needs to comply with relevant standards such as YY0450.1 "Disposable Sterile Intravascular Catheter Accessories Part 1 Guiding Devices", and is formulated in combination with product design features and clinical applications, and also needs to comply with the "Guidelines for Compilation of Technical Requirements for Medical Device Products" " requirements.

1.1 Product model/specification and its division description

Clarify the product model/specification, clarify the difference and division between each model/specification, and the description of the model/specification must be consistent in all registration application materials.

1.2 Performance indicators

Product performance indicators can be formulated with reference to Table 1. If there are inapplicable clauses, the applicant shall explain the reasons in the application materials. If the product has a specific design, the applicant also needs to set the corresponding performance index according to the product design characteristics, and include it in the product technical requirements. If there are accessories declared together with the intravascular guide wire, no matter whether the accessories have obtained the medical device registration certificate or not, the performance indicators of the accessories must be formulated in the product technical requirements. For the qualitative or quantitative functional and safety indicators of finished products that can be objectively judged, they need to be included in the product technical requirements.

1.3 Inspection method

The inspection method of the product shall be set according to the technical performance index, and the inspection method shall be given priority to the method in the national standard/industry standard. For the inapplicable clauses in the relevant national standards/industry standards, the reasons for inapplicability shall be explained. All cited standards are indicated by their number, year or edition number. The self-built inspection method needs to provide the corresponding methodological basis and theoretical basis, and at the same time ensure the operability and reproducibility of the inspection method. If necessary, it can be described in the form of an appendix with corresponding diagrams. If the text is larger, it can be provided in the form of an appendix.

1.4 Appendix

It is recommended that the applicant provide the structural diagram of the product and the information on the manufacturing materials that directly and indirectly contact the human body in the form of an informative appendix.

2. Product inspection report

Provide the basis for the selection of the model/specification of the inspection sample. The tested models/specifications must be typical products that can represent other models/specifications in this registration unit. When the declared product includes multiple models and specifications, factors such as the raw material, structural composition, packaging method, sterilization method, production process and intended use of the intravascular guide wire shall be comprehensively considered. When one model cannot be completely covered, other models should be selected for supplementary testing of related performance. Note that the typical model/size is not necessarily the one commonly used in clinical practice.

3. Product performance research

3.1 Explain the basis for determining the performance indicators and inspection methods in the product technical requirements, and provide the reasons and theoretical basis for the adoption. According to the research results of product performance, the acceptance criteria for performance indicators are formulated in combination with clinical needs. For the self-built method, the corresponding basis and methodological verification data should be provided.

3.2 Provide performance research data. Performance studies need to use the final product and select a typical model/specification. If you need to use alternative samples, please provide reasonable reasons and basis (such as the use of uncoated samples for chemical property testing, etc.). The number of samples used in research projects shall be determined based on statistical considerations and product risks for applicable projects, and statistical analysis shall be carried out on the verification results of the projects used.

For intravascular guidewires, performance study items include but are not limited to those listed in Table 1. The applicant needs to consider the performance research items to be added according to the specific product characteristics. For the items listed in Table 1, if there are inapplicable items, the specific reasons should also be explained. For the puncture guide wire, please refer to the applicable items. For the qualitative or quantitative functional and safety indicators of finished products that can be objectively judged, they need to be included in the product technical requirements.

3.2.1 The performance research materials shall at least include the following:

(1) The research project and its acceptance criteria (if any).

(2) The specific research methods of each research project.

(3) Selection basis of typical models/specifications.

(4) The batch number of the product, the number of samples used in each research project and the basis for its determination.

(5) Deviation analysis (if any).

(6) Research results and analysis, research conclusions.

3.2.2 Model recommendations for simulating vascular anatomy:

The model that simulates the vascular anatomy should be able to reflect the most challenging vascular anatomy in the scope of application of the product. When designing the vascular anatomy model, the lumen diameter, bending radius, bending shape, bending number, blood vessel length, and inner surface of the blood vessel should be considered. Friction coefficient, model material, etc.

The application materials need to describe the model that simulates the anatomical structure of blood vessels. It is recommended to specify the materials, pictures, and schematic diagrams with key dimensions (such as length, lumen diameter, bending radius, etc.) of the model. At the same time, it is recommended to clarify the supporting data of the model selection of the vascular anatomy, including image information and relevant literature on the anatomical data of the applicable population. For guidewires suitable for neurovascular, it is recommended that a complete model to simulate the vascular anatomy should start from the proximal puncture and intervention site (such as radial artery, femoral artery), at least include the internal carotid artery siphon segment, two 180-degree bends, Two 360 degree bends. An alternative model that simulates neurovascular anatomy is available that can reflect and provide the basis for challenging vascular tortuosity based on the intended use location of the device and/or applicable to specific product performance research tests.

4. Research on biological characteristics

The parts of the final product that are expected to come into direct or indirect contact with the human body need to be evaluated for biocompatibility.

The intravascular guide wire in this guideline belongs to the external access device that is in short-term contact with circulating blood. Currently, according to the GB/T 16886 "Biological Evaluation of Medical Devices" series of standards, the considered biocompatibility evaluation endpoints need to include: pyrogen , cytotoxicity, sensitization, intradermal reaction, acute systemic toxicity, blood compatibility, etc. For new materials that need to be used in medical devices for the first time, it is also necessary to provide relevant research data on the safety of the materials for human use.

Factors that may affect the risk of biocompatibility (including but not limited to chemical composition of materials, proportion of constituent materials, physical structure of products, surface characteristics, production processes, sterilization methods, raw material suppliers, etc.) and technical specifications, inner packaging materials and other applicable items), the submitted reference product biological test report can be used to replace the biological test report of the declared product; if the declared product and the reference product are inconsistent with the above listed biological risk factors If the applicant still applies for the biological test report to replace the declared product, sufficient reasons and evidence should be provided, and the corresponding biological evaluation data should be supplemented if necessary, such as leachables analysis and toxicological risk assessment data, Supplementary tests for related biological test items, etc.

5. Other information

The applicant shall prove the safety and effectiveness of the product in terms of basic principles, structural composition, performance, safety, and scope of application in accordance with the "Technical Guiding Principles for the Comparison and Description of Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation". It is advisable to carry out a comparison and verification study of simulated use with similar products on the market to prove their equivalence. In addition to the simulated use, if there is a difference between the declared product and the comparison product, the analysis and research data on the impact of the difference on the safety and effectiveness should also be submitted.

(4) Clinical evaluation data

Guidewires that meet the classification code 03-13-16 under the "Catalogue of Medical Devices Exempted from Clinical Evaluation" (hereinafter referred to as the "Catalogue") are exempt from clinical evaluation, and therefore generally do not involve clinical evaluation data. For guide wires other than the "Catalogue", the corresponding clinical evaluation materials should be submitted.

(5) Product specification and label sample

In addition to the requirements of the "Medical Device Instructions and Labeling Management Regulations", the content of product instructions and label samples must also comply with the relevant regulations in YY 0450.1 "Disposable Sterile Intravascular Catheter Accessories Part 1 Guiding Devices". The description of product performance characteristics in the manual should not exceed the research data and product technical requirements, and should not contain unverified and exaggerated descriptions. The scope of application of the product in the instruction manual should be consistent with the application materials such as research materials. The expression of model/specification shall be consistent with the technical requirements of the product. Storage and shipping conditions should not exceed the shelf life verification of the product. Coating-related risk warnings must be included.

3. References

[1] "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739 of the State Council of the People's Republic of China) [Z].

[2] "Administrative Measures for Registration and Filing of Medical Devices" (Order No. 47 of the State Administration for Market Regulation) [Z].

[3] "Administrative Regulations on Instructions and Labels of Medical Devices" (Order No. 6 of the former State Food and Drug Administration) [Z].

[4] "Regulations on Naming Common Names of Medical Devices" (Order No. 19 of the former State Food and Drug Administration) [Z].

[5] "Medical Device Registration Application Materials Requirements and Instructions" (Announcement No. 121 of the State Drug Administration in 2021, Annex 5) [Z].

[6] "Medical Device Classification Catalog" (former State Food and Drug Administration Announcement No. 104 in 2017) [Z].

[7] "Guidelines for the Division of Medical Device Registration Units" (former State Food and Drug Administration Announcement No. 187 [2017]) [Z].

[8] "Guidelines for naming common names of medical devices" (State Drug Administration Circular No. 99 [2019]) [Z].

[9] "Notice on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation" (Notice of the State Food and Drug Administration [2021] No. 71) [Z].

[10] "Technical Guiding Principles for Comparative Description of Products Included in the Catalogue of Medical Devices Exempted from Clinical Evaluation" (Annex 5 of the State Food and Drug Administration Announcement No. 73 [2021]) [Z].

[11] "Guidelines for Compilation of Product Technical Requirements" (former State Food and Drug Administration Announcement No. 9 [2014]) [Z].

[12] YY0450.1 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Instruments" [S].

[13] GB/T 16886 "Biological Evaluation of Medical Devices" series of standards [S].

[14] "Pharmacopoeia of the People's Republic of China" 2020 Edition [S].Guidance for Industry and Food and Drug Administration Staff. Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recommended Labeling, FDA CDRH, October,2019[Z].2019