Implantable Pacemaker_NMPA Approval in November 2017
Product Name: Implantable Pacemaker
Category: Domestic Class III
Registration Pathway: Innovation
NMPA Approval Time: November 2017
Product Structure and Composition: The product consists of an implantable pulse generator and its accessories, including a torque wrench.
Scope of Application: The treatment of chronic arrhythmias.
Model/Specification: LD100DR, LD200D, LD300D, LD300SR, LD300S
Working Principle: The pacemaker detects the electrical activity of the patient's heart through electrodes on the implanted leads. Dual-chamber pacemakers sense through two electrode leads in the atrium and ventricle, while single-chamber pacemakers sense through an electrode in either the right ventricle or atrium. Based on programmable settings, the pacemaker delivers therapeutic pulses through these electrode leads.
Performance Research: Meets the requirements of GB16174.1-1996 and YY/T 0491-2004 standards. Product performance indicators include pacing pulse frequency, amplitude, pulse width, sensing sensitivity, upper tracking frequency, protection against environmental impacts, surface physical properties, protection against current-induced patient harm, protection against unintended actions, protection from damage caused by external defibrillators, protection against changes induced by high-power electric fields directly affecting the patient, protection against changes caused by mixed medical treatments, protection against non-ionizing electromagnetic radiation, and chemical properties.
Biocompatibility: As an implantable device in long-term contact with tissue, the applicant has conducted a biocompatibility evaluation according to the GB/T 16886 series standards.
Sterilization: The product is provided in a sterile state, using ethylene oxide sterilization.
Product Service/Shelf Life and Packaging: The product has a shelf life of 18 months. The applicant has provided a shelf life validation report, using accelerated and real-time aging tests to validate the product's shelf life and packaging integrity. Additionally, documentation verifying the product's service life under different working conditions has been submitted.
Animal Experiment: Referring to the "Technical Guidance for the Registration Review of Implantable Pacemakers," experiments were conducted using a canine model to measure pacing threshold, impedance, and PR wave amplitude, verifying the product's safety and effectiveness in the canine model.
Software Research: The product's software safety level is Class C, with a release version of 1.0.
Clinical Evaluation: A clinical evaluation was using a comparison approach with similar products. Three marketed products were used as predicates, and the justifications for the differences were submitted.