Name: Brain Navi Navigation System for Brain Surgery
Brand: Brain Navi Biotechnology Co., Ltd.

Product Description

Design & Tech Principles

NaoTrac emphasizes minimal invasion and automation. By eliminating invasive headframes, this frameless, contactless navigation system reduces surgical cognitive loads and shortens anesthesia time. The system fuses pre-op CT/MRI scans into a 3D model. In the OR, a 3D camera captures facial features, using AI for rapid, non-invasive registration. A real-time detector tracks micro-movements for dynamic compensation, guiding the 6-axis robotic arm to the target path with absolute accuracy.

Features & Applications

Manufactured under ISO 13485 and QMS standards, NaoTrac holds TFDA, US FDA, and CE marks across 7 regions. It achieves automated patient registration within 120 seconds, delivering sub-2mm clinical precision (test results at 0.22-0.37mm) via an open platform compatible with major imaging brands.

Clinical

Optimized for neurosurgery, NaoTrac focuses on SEEG lead placement and DBS targeting. Partnering with Erasmus M.C. and Taipei Veterans General Hospital, the system utilizes clinical cases to refine its algorithms. It also excels in brain biopsy, ventriculostomy, and neuroendoscopy, uniquely supporting the prone position.

Approvals

United States : 510k no. K242575, Stereotaxic Guiding Surgical Device, NaoTrac S
EU : CE704048, Stereotaxic Guiding Surgical Device, NaoTrac S
TFDA : Certifica No.:007512, “Brain Navi Biotechnology” Stereotaxic Guiding Surgical Devices
Boliva : Certifica No.:3570/2024, NAOTRAC S
Turkey : Firma no.：2667269100883, Stereotaksik Yönlendirme Cerrahi Cihazlar
Indonesia : PB-UMKU: 812011100129300020021, BRAIN NAVI BIOTECHNOLOGY Stereotaxic Guiding Surgical Devices
India : Import License No. IMP/MD/2026/000025, Stereotaxic Guiding Surgical Devices, NaoTrac
Spain : Nº Comunicación：PS/2025/03559, Software para procedimientos estereotáxicos

Manufacturer

Brain Navi Biotechnology Co., Ltd.

Product Verification

Sterilization Validation Report
Transportation Validation Report / Shipping Validation Report
Electrical Safety Standards: IEC 60601 Series
Electromagnetic Compatibility (EMC): IEC 60601-1-2 Series
Product Accuracy Verification / Product Precision Validation
Usability Assessment Report IEC 62366
Clinical Trials / Clinical Studies

QC Implementation

【Quality Control Points & Quantitative Metrics】

Operating under ISO 13485 and QMS standards, we enforce strict QC checkpoints and data-driven KPIs across NaoTrac's production lifecycle to ensure maximum safety and stability:

Incoming Quality Control (IQC)

Focus : Verifying critical dimensions, electrical safety, and COA for robotic arms, optical cameras, and PCBA to intercept defects.
Metrics : Incoming Acceptance Rate 98.5%; Supplier Defect Rate (DPPM) < 1,000.

In-Process Quality Control (IPQC)

Focus : Setting up mandatory self-inspections and QA patrols at sub-assembly stations (robotic integration, wiring, software installation). Ensuring strict ESD monitoring.
Metrics : First Article Inspection (FAI) Pass Rate at 100%; First Pass Yield (FPY) 95% across all stations; CAPA closure rate at 100%.

Final & Outgoing Quality Control (FQC/OQC)

Focus : 100% full inspection on finished robots. This includes electrical safety testing (IEC 60601-1), software verification (IEC 62304), environmental aging, and system accuracy calibration.
Metrics : Final Inspection Pass Rate at 100%; Clinical Positioning Accuracy 1.5mm verified per ASTM F2554 (internal repeatability 0.5mm); shipping label accuracy at 100%.

Post-Market Stability Monitoring (PMS)

Metrics : System Uptime at clinical sites 99%; annual customer quality satisfaction score > 90/100.

Risk Management System

We establish a lifecycle risk management mechanism encompassing incoming, in-process, finished product, and post-market stages for NaoTrac, fully complying with ISO 13485 and QMS standards.

Incoming Quality Control (IQC):
We enforce strict supplier evaluation. All critical components (e.g., robotic arms, vision sensors) undergo rigorous self-inspection upon arrival, verifying Certificates of Analysis (COA) and dimensional tolerances to prevent defective materials from entering production.
In-Process Quality Control (IPQC):
Standard inspection checkpoints are set across key assembly stations. A dual-track system combining quality assurance (QA) patrols and operator self-checks is implemented. Real-time testing for electrical safety and assembly ensures immediate CAPA activation upon variance.
Final Quality Control (FQC/OQC):
Prior to release, an independent QA team conducts comprehensive testing, including product accuracy verification (ASTM F2554), software validation (IEC 62304), and safety checks to guarantee 100% regulatory compliance.
Post-Market Surveillance (PMS):
A cross-functional Risk Management Task Force (comprising R&D, QA, and clinical specialists) is established. We actively monitor clinical feedback from sites, managing a robust complaint and adverse event reporting system to ensure patient safety.

Post-Market Surveillance

Post-Market Surveillance (PMS)
Pursuant to ISO 13485 and QMS standards, we establish a robust Post-Market Surveillance system for NaoTrac to ensure its long-term safety and performance in clinical environments.

Safety Monitoring & Clinical Feedback:
We implement both proactive and reactive monitoring. Proactively, our clinical specialists regularly collect performance data from sites. Reactively, a centralized complaint system tracks field issues to maintain safety metrics.
Software Maintenance & Updates:
In compliance with IEC 62304, standard protocols govern NaoTrac's AI algorithms and vision software updates. Based on clinical feedback, we release periodic optimizations and cybersecurity patches, deployed securely via certified engineers.
Crisis Management & Adverse Event Reporting:
A cross-functional Medical Device Safety Committee is formed with strict crisis handling workflows. Upon receiving a critical alert, the committee initiates a root-cause investigation within 24 hours, handling regulatory reporting (TFDA/FDA) and field safety corrective actions if required.
Corrective and Preventive Actions (CAPA):
Any quality deviation or clinical anomaly triggers the CAPA process. The QA team conducts root-cause analysis to execute necessary design or manufacturing modifications. All CAPA records are reviewed regularly to ensure permanent hazard mitigation.