Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
This guidance outlines the information required for 510(k) premarket notification submissions for hysteroscopes and gynecologic laparoscopes. It covers both rigid rod-lens, fiberoptic, and electronic video (CCD) devices, whether operative or diagnostic, rigid, flexible, or steerable, and 2-D or 3-D.
What You Need to Know? 👇
What are the key safety requirements for hysteroscopes and laparoscopes in 510(k) submissions?
The guidance requires thermal safety testing (maximum 41°C for patient-contacting parts, 50°C for distal tip), electrical safety compliance with IEC 601-2-18, and electromagnetic compatibility certification. Testing must demonstrate safe operation for at least two hours at maximum light intensity.
Which hysteroscopic and laparoscopic accessories are exempt from 510(k) requirements?
Basic accessories like forceps, scissors, clamps, retractors, and suction probes are exempt if they lack specialized delivery systems, adaptors, or portals for electrosurgical/laser sources. The exemption became effective February 16, 1996.
What biocompatibility testing is required for these endoscopic devices?
Hysteroscopes are classified as limited duration surface devices contacting mucosal membranes, while laparoscopes are external communicating devices contacting tissue/bone. Testing must follow ISO-10993 standards or demonstrate identical materials to legally marketed devices.
What sterilization validation requirements must be included in the 510(k) submission?
Submissions must provide detailed reprocessing instructions including cleaning, rinsing, leak testing, and sterilization parameters. At least one validated sterilization method must be specified with certification signed by a legally responsible individual.
What optical performance data is required for endoscope 510(k) submissions?
Required data includes focal length, field of view, direction of view, illumination fiber ratios, resolution testing using USAF bar patterns or MTF, and distortion characteristics. Video systems require pixel counts and CCD specifications.
What software documentation is needed for endoscopes with electronic components?
Documentation must include software development activities, quality assurance procedures, system requirements, verification/validation testing with pass/fail criteria, hazard analysis, and current version information with any remaining bugs listed.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including dimensions, materials, and components
- Conduct and document thermal safety testing
- Perform electrical safety testing if applicable
- Validate optical performance specifications
- Prepare detailed software documentation if applicable
- Validate sterilization and cleaning procedures
- Develop comprehensive labeling including all required warnings and instructions
- Obtain biocompatibility data or certification
- Create comparison documentation with predicate devices
- Ensure compliance with referenced standards (IEC, ISO)
Key Considerations
Non-clinical testing
- Thermal safety testing showing temperature vs time plots for key locations (max 41°C except tip at 50°C)
- Electrical safety testing for devices with electrosurgical compatibility
- Electromagnetic compatibility testing for electronic components
- Optical performance testing (resolution, distortion)
- Mechanical testing including effects of sterilization
Software
- Software development and QA procedures documentation
- System and software requirements
- Structure chart of functional units
- Verification and validation activities documentation
- Test results summary
- Current version number and remaining bugs list
Labelling
- Detailed indications for use
- Contraindications
- Warnings and precautions
- Instructions for use including cleaning/sterilization
- Compatible equipment identification
Biocompatibility
- Testing results for patient-contacting materials
- Or certification of identical materials used in legally marketed devices
Safety
- Thermal safety requirements
- Electrical safety requirements
- EMC requirements if applicable
Other considerations
- Device description including dimensions and materials
- Sterilization validation and reprocessing instructions
- Optical performance specifications
Relevant Guidances 🔗
- Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms 📂
- IEC 601-2-18: Particular requirements for the safety of endoscopic equipment
- IEC 601-1-2: EMC requirements for medical devices
- ISO 10993: Biological evaluation of medical devices
- CISPR 11: EMC emissions standard