The NMPA granted innovation approvals to Intuitive Surgical’s bronchial navigation system and issued a review report.

These published review reports serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients’ specific products to gain more clarity and be more efficient in their submission and approval process. As NMPA standardizes and streamlines the review process for fast-track approval, big players in the space like Medtronic, J&J, Body Vision Medical, Veran Medical and Noah Medical can benefit from our expertise and experience.

Product overview

• Product structure and composition
• Intended Use

This product consists of four parts: navigation operation control system, positioning catheter, visualization probe and catheter guide.

The four parts are used together to generate lung three-dimensional reconstruction models and guide paths based on patient CT images, perform image display of the adult bronchial tree, and assist doctors in navigating and positioning within lung tissue.

The bronchoscope navigation optical fiber positioning catheter, controlled by a mechanical arm, is remotely guided to the target area of the bronchus to provide positioning information and to serve as an instrument channel for compatible tools such as the bronchoscope navigation visualization probe and biopsy needle.

The bronchoscope navigation visualization probe is used for observing imaging and providing illumination of the bronchus.

The bronchoscope navigation optical fiber positioning catheter guide is used to support the bronchoscope navigation optical fiber positioning catheter to prevent bending and deformation of the catheter axis.

• Model/Specification
• Working principle

Pre-clinical

• Product Performance Evaluation

Research and compilation of product performance research materials and technical requirements have been provided, which include specifications of system performance (range of motion, control accuracy, positioning accuracy, system functionality, software functionality, network security), positioning catheter performance (operational performance, mechanical performance, assembly performance, chemical performance), visualization probe performance (image quality, illumination performance, sealing performance, connectivity performance, chemical performance), catheter guide performance (operational performance, connection strength, chemical performance), as well as the determination basis for functional and safety indicators such as electrical safety and electromagnetic compatibility.

• Biocompatibility

The applicant evaluated the biocompatibility of the positioning catheter, visualization probe directly in contact with patients, and the catheter guide indirectly in contact with patients according to GB/T 16886.1-2011. The evaluated materials were in short-term contact with human mucosal tissue, and biological tests (cytotoxicity, intradermal reaction, sensitization) were conducted. Biological test reports issued by overseas testing institutions were submitted.

• Sterilization

The components such as the mechanical arm and control console only require cleaning and disinfection. The applicant has provided validation data for intermediate-level disinfection.

The positioning catheter and visualization probe are for reusable purposes, and users are responsible for cleaning and high-level disinfection, typically through chemical immersion. The applicant has submitted research data on cleaning effectiveness, disinfection efficacy, and compatibility, along with validation data for the waterproofing effect of the sealing cover used during the disinfection process.

The catheter guide is also reusable and undergoes cleaning and sterilization. The sterilization method involves high-temperature and high-pressure steam. The applicant has submitted research data on cleaning effectiveness, sterilization efficacy, and compatibility.

• Product Shelf Life and Packaging
• Software
• Active device safety
• Accuracy Study

The applicant has provided validation data on the fusion registration accuracy of the entire system based on live pig models. This validation was conducted by using virtual targets for positioning and marking, simulating actual clinical operations to verify the system. During this process, the animals were subjected to radiological examinations to confirm the absence of safety issues such as bleeding or injury. Data on manipulation accuracy has been provided, employing a third-party (NDI) infrared optical probe for observation. Testing based on optical fiber positioning accuracy showed results meeting clinical requirements.

Furthermore, validation data on planning accuracy has been provided. This involved comparing the system’s performance with that of mature and recognized software already on the market. The consistency between the two was deemed acceptable.

Clinical

The applicant conducted clinical evaluation with predicate comparison. It selected predicate device, Auris Health’s Monarch Platform, which is already on the China market. The applicant compares the declared product with the similar product in terms of basic principles, structural composition, and scope of application. There are differences in performance parameters and manufacturing materials. To address these differences, comprehensive tests were conducted to assess the system’s navigation, positioning, and control accuracy. These tests included bench tests, animal experiments, and cadaver experiments.

Bench tests involved precision testing based on human bronchial models, assessing puncture accuracy and surgical planning functionality. They verified the accuracy of planning software in reading, measuring, and displaying CT data. Registration function tests demonstrated the product’s ability to complete all registration steps, while navigation function tests validated software functionality, catheter accessibility, and positioning accuracy.

Animal experiments, conducted on live pigs, comprised four studies. The first aimed to validate safety and usability, simulating preoperative planning, registration, puncture biopsy operations, and emergency handling. The success rates for reaching various anatomical sites were assessed, with no serious bleeding incidents and a pneumothorax rate within acceptable limits.

The second study, also on healthy pig models, focused on validating puncture accuracy. Implants of tumor models (10-20mm diameter) in animal airways were used to verify puncture success rates, exceeding preset acceptance standards.

The third study, still on healthy pig models, aimed to validate accessibility and accuracy in marking nodules within airways. Successful marking of tumor models was achieved using benchmark markers.

The fourth study, again on healthy pig models, aimed to validate accessibility to nodules within airways and confirm product requirements. The successful removal of extraneous growths within airways was demonstrated.

Cadaver experiments aimed to validate navigation accuracy, puncture precision, and access to challenging anatomical sites. Multiple virtual lesions were implanted in cadavers’ lungs, and successful puncture rates exceeded expected standards.

Additionally, a clinical study conducted in Australia with 30 subjects aimed to support product usability. The study demonstrated 100% navigation success rates and 96.7% biopsy success rates, with no device-related adverse events.

In addition to these tests, the applicant provided post-approval clinical application data from overseas.

Please email us at info@ChinaMedDevice.com to see if NMPA released review reports for your device. We can translate for you with nominal fees.

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• Source: https://chinameddevice.com/navigational-bronchoscopy-system/